U.S. patent application number 11/080947 was filed with the patent office on 2007-01-11 for nutritionally fortified liquid composition with added value delivery systems/elements/additives.
Invention is credited to Suzanne Jaffe Stillman.
Application Number | 20070009576 11/080947 |
Document ID | / |
Family ID | 22923780 |
Filed Date | 2007-01-11 |
United States Patent
Application |
20070009576 |
Kind Code |
A1 |
Stillman; Suzanne Jaffe |
January 11, 2007 |
Nutritionally fortified liquid composition with added value
delivery systems/elements/additives
Abstract
A shelf-stable, ready to use, water-like composition for
humans/animals; as an adjunct to fiber-water, and/or safe drinking
water, consumed directly, tube feedings, or in the
preparation/reconstitution of food(s)/beverage(s). Fortified
Fiber-Water is fiber-water, with added delivery systems:
Encapsulations/particles, of different size(s), shape(s),
material(s), colors, non-visible, serving one or more functions:
improved taste, odor-masking; controlled release applications;
bio-availability of actives, avoid hygroscopicity; minimized
interactions, improved thermal, oxidative, and shelf-life;
decorative. Viscosity changing elements, (with one or more
viscosity changing additives, with or without encapsulations,
particles) to enhance delivery of active medicants/ingredients of
categories: pharmaceuticals, nutraceuticals, dietary supplements,
therapeutics, diagnostics, etc. Composition ensures hydration,
simultaneously providing soluble fiber (fiber-water), with
additives contained within the delivery systems, having the ability
to target specific health goals/needs: weight loss, diabetes,
cholesterol/heart, gastrointestinal tract disorders/improvement,
osteoporosis, cancer, pain, stress, relaxant, stimulant etc.
Inventors: |
Stillman; Suzanne Jaffe;
(Los Angeles, CA) |
Correspondence
Address: |
PATTON BOGGS LLP;ATTORNEYS AT LAW
2550 M Street, NW
Washington
DC
20037-1350
US
|
Family ID: |
22923780 |
Appl. No.: |
11/080947 |
Filed: |
March 16, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10244699 |
Sep 16, 2002 |
7115297 |
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11080947 |
Mar 16, 2005 |
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10204572 |
Apr 2, 2003 |
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10244699 |
Sep 16, 2002 |
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PCT/US01/05630 |
Feb 22, 2001 |
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10204572 |
Apr 2, 2003 |
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Current U.S.
Class: |
424/439 |
Current CPC
Class: |
A23K 50/48 20160501;
A23V 2002/00 20130101; A61K 31/715 20130101; A61K 2300/00 20130101;
A23V 2200/224 20130101; A23V 2002/00 20130101; A23L 33/10 20160801;
A61K 33/00 20130101; A23K 20/10 20160501; A23L 2/395 20130101; A23L
33/21 20160801; A61K 45/06 20130101; A61K 41/0004 20130101; A23L
2/52 20130101; A23K 50/42 20160501; A23P 10/30 20160801; A61K
31/715 20130101; A23L 33/30 20160801; A23K 20/163 20160501; A23L
2/38 20130101 |
Class at
Publication: |
424/439 |
International
Class: |
A61K 47/00 20060101
A61K047/00 |
Claims
1. A method comprising: providing a nutritionally fortified liquid
composition; and preventing (i) a disease and/or (ii) a progression
of the disease in at least one of a human and an animal by using
the composition, wherein the composition includes (i) safe water
and (ii) an encapsulated product containing a plurality of
different health enhancing ingredients and preserving the
biological activity of the plurality of different health enhancing
ingredients.
2. A method comprising: providing a nutritionally fortified liquid
composition; and curing a disease in at least one of a human and an
animal by using the composition, wherein the composition includes
(i) safe water and (ii) an encapsulated product containing a
plurality of different health enhancing ingredients and preserving
the biological activity of the plurality of different health
enhancing ingredients.
3. A method comprising: providing a nutritionally fortified liquid
composition; and diagnosing a medical condition in at least one of
a human and an animal by using the composition, wherein the
composition includes (i) safe water and (ii) an encapsulated
product containing a plurality of different health enhancing
ingredients and preserving the biological activity of the plurality
of different health enhancing ingredients.
4. A method comprising: providing a nutritionally fortified liquid
composition; and addressing one or more specific diagnosed medical
conditions of at least one of a human and an animal by using the
composition, wherein the composition includes (i) safe water and
(ii) an encapsulated product containing a plurality of different
health enhancing ingredients and preserving the biological activity
of the plurality of different health enhancing ingredients.
5. A method comprising: providing a nutritionally fortified liquid
composition; and addressing heart health of at least one of a human
and an animal by using the composition, wherein the composition
includes (i) safe water and (ii) an encapsulated product containing
a plurality of different health enhancing ingredients and
preserving the biological activity of the plurality of different
health enhancing ingredients.
6. A method comprising: providing a nutritionally fortified liquid
composition; and lowering serum cholesterol of at least one of a
human and an animal by using the composition, wherein the
composition includes (i) safe water and (ii) an encapsulated
product containing a plurality of different health enhancing
ingredients and preserving the biological activity of the plurality
of different health enhancing ingredients.
7. A method comprising: providing a nutritionally fortified liquid
composition; and removing a toxin from a body of at least one of a
human and an animal by using the composition, wherein the
composition includes (i) safe water and (ii) an encapsulated
product containing a plurality of different health enhancing
ingredients and preserving the biological activity of the plurality
of different health enhancing ingredients.
8. A method comprising: providing a nutritionally fortified liquid
composition; and lowering the risk of cancer of a human by using
the composition, wherein the composition includes (i) safe water
and (ii) an encapsulated product containing a plurality of
different health enhancing ingredients and preserving the
biological activity of the plurality of different health enhancing
ingredients.
9. A method comprising: providing a nutritionally fortified liquid
composition; and addressing a cancer of a human by using the
composition, wherein the composition includes (i) safe water and
(ii) an encapsulated product containing a plurality of different
health enhancing ingredients and preserving the biological activity
of the plurality of different health enhancing ingredients.
10. A method comprising: providing a nutritionally fortified liquid
composition; and addressing a carbohydrate metabolic disorder of a
human by using the composition, wherein the composition includes
(i) safe water and (ii) an encapsulated product containing a
plurality of different health enhancing ingredients and preserving
the biological activity of the plurality of different health
enhancing ingredients.
11. A method comprising: providing a nutritionally fortified liquid
composition; and moderating the absorption of a carbohydrate by at
least one of a human and an animal by using the composition,
wherein the composition includes (i) safe water and (ii) an
encapsulated product containing a plurality of different health
enhancing ingredients and preserving the biological activity of the
plurality of different health enhancing ingredients.
12. A method comprising: providing a nutritionally fortified liquid
composition; and addressing diabetes of at least one of a human and
an animal by using the composition, wherein the composition
includes (i) safe water and (ii) an encapsulated product containing
a plurality of different health enhancing ingredients and
preserving the biological activity of the plurality of different
health enhancing ingredients.
13. A method comprising: providing a nutritionally fortified liquid
composition; and managing weight of at least one of a human and an
animal by using the composition, wherein the composition includes
(i) safe water and (ii) an encapsulated product containing a
plurality of different health enhancing ingredients and preserving
the biological activity of the plurality of different health
enhancing ingredients.
14. A method comprising: providing a nutritionally fortified liquid
composition; and suppressing appetite of at least one of a human
and an animal by using the composition, wherein the composition
includes (i) safe water and (ii) an encapsulated product containing
a plurality of different health enhancing ingredients and
preserving the biological activity of the plurality of different
health enhancing ingredients.
15. A method comprising: providing a nutritionally fortified liquid
composition; and addressing a bone and/or joint disorder of at
least one of a human and an animal by using the composition,
wherein the composition includes (i) safe water and (ii) an
encapsulated product containing a plurality of different health
enhancing ingredients and preserving the biological activity of the
plurality of different health enhancing ingredients.
16. A method comprising: providing a nutritionally fortified liquid
composition; and disclosing plaque deposits on teeth of at least
one of a human and an animal by using the composition, wherein the
composition includes (i) safe water and (ii) an encapsulated
product containing a plurality of different health enhancing
ingredients and preserving the biological activity of the plurality
of different health enhancing ingredients.
17. A method comprising: providing a nutritionally fortified liquid
composition; and addressing inflammation of at least one of a human
and an animal by using the composition, wherein the composition
includes (i) safe water and (ii) an encapsulated product containing
a plurality of different health enhancing ingredients and
preserving the biological activity of the plurality of different
health enhancing ingredients.
18. A method comprising: providing a nutritionally fortified liquid
composition; and addressing pain of at least one of a human and an
animal by using the composition, wherein the composition includes
(i) safe water and (ii) an encapsulated product containing a
plurality of different health enhancing ingredients and preserving
the biological activity of the plurality of different health
enhancing ingredients.
19. A method comprising: providing a nutritionally fortified liquid
composition; and promoting relaxation of at least one of a human
and an animal by using the composition, wherein the composition
includes (i) safe water and (ii) an encapsulated product containing
a plurality of different health enhancing ingredients and
preserving the biological activity of the plurality of different
health enhancing ingredients.
20. A method comprising: providing a nutritionally fortified liquid
composition; and addressing free radicals of at least one of a
human and an animal by using the composition, wherein the
composition includes (i) safe water and (ii) an encapsulated
product containing a plurality of different health enhancing
ingredients and preserving the biological activity of the plurality
of different health enhancing ingredients.
21. A method comprising: providing a nutritionally fortified liquid
composition; and bolstering the immunity of at least one of a human
and an animal by using the composition, wherein the composition
includes (i) safe water and (ii) an encapsulated product containing
a plurality of different health enhancing ingredients and
preserving the biological activity of the plurality of different
health enhancing ingredients.
22. A method comprising: providing a nutritionally fortified liquid
composition; and addressing a viral infection of at least one of a
human and an animal by using the composition, wherein the
composition includes (i) safe water and (ii) an encapsulated
product containing a plurality of different health enhancing
ingredients and preserving the biological activity of the plurality
of different health enhancing ingredients.
23. A method comprising: providing a nutritionally fortified liquid
composition; and addressing a bacterial infection of a human by
using the composition, wherein the composition includes (i) safe
water and (ii) an encapsulated product containing a plurality of
different health enhancing ingredients and preserving the
biological activity of the plurality of different health enhancing
ingredients.
24. A method comprising: providing a nutritionally fortified liquid
composition; and addressing a parasite and/or yeast infection of at
least one of a human and an animal by using the composition,
wherein the composition includes (i) safe water and (ii) an
encapsulated product containing a plurality of different health
enhancing ingredients and preserving the biological activity of the
plurality of different health enhancing ingredients.
25. A method comprising: providing a nutritionally fortified liquid
composition; and addressing an auto-immune disease of at least one
of a human and an animal by using the composition, wherein the
composition includes (i) safe water and (ii) an encapsulated
product containing a plurality of different health enhancing
ingredients and preserving the biological activity of the plurality
of different health enhancing ingredients.
26. A method comprising: providing a nutritionally fortified liquid
composition; and addressing gastrointestinal tract function of at
least one of a human and an animal by using the composition,
wherein the composition includes (i) safe water and (ii) an
encapsulated product containing a plurality of different health
enhancing ingredients and preserving the biological activity of the
plurality of different health enhancing ingredients.
27. A method comprising: providing a nutritionally fortified liquid
composition; and addressing colon motility and bowel regularity of
at least one of a human and an animal by using the composition,
wherein the composition includes (i) safe water and (ii) an
encapsulated product containing a plurality of different health
enhancing ingredients and preserving the biological activity of the
plurality of different health enhancing ingredients.
28. A method comprising: providing a nutritionally fortified liquid
composition; and addressing a mood disorder of at least one of a
human and an animal by using the composition, wherein the
composition includes (i) safe water and (ii) an encapsulated
product containing a plurality of different health enhancing
ingredients and preserving the biological activity of the plurality
of different health enhancing ingredients.
29. A method comprising: providing a nutritionally fortified liquid
composition including (i) safe water and (ii) an encapsulated
product containing a plurality of different health enhancing
ingredients; and controlling the release of one or more of the
different health enhancing ingredients in a digestive system of at
least one of a human and an animal by delivering the composition
into the at least one of the human and the animal.
30. A method comprising: providing a nutritionally fortified liquid
composition; and addressing the aging of at least one of a human
and an animal by using the composition, wherein the composition
includes (i) safe water and (ii) an encapsulated product containing
a plurality of different health enhancing ingredients and
preserving the biological activity of the plurality of different
health enhancing ingredients.
31. A method comprising: providing a nutritionally fortified liquid
composition; and reducing breath and/or body odors of at least one
of a human and an animal by using the composition, wherein the
composition includes (i) safe water and (ii) an encapsulated
product containing a plurality of different health enhancing
ingredients and preserving the biological activity of the plurality
of different health enhancing ingredients.
32. A method comprising: providing a nutritionally fortified liquid
composition; and delivering nicotine and/or caffeine to at least
one of a human and an animal, while reducing the harmful effects of
the nicotine and/or the caffeine to the at least one of the human
and the animal, by using the composition, wherein the composition
includes (i) safe water and (ii) an encapsulated product containing
a plurality of different health enhancing ingredients and
preserving the biological activity of the plurality of different
health enhancing ingredients.
33. A method comprising: providing a nutritionally fortified liquid
composition; and addressing fatigue and/or lack of mental alertness
of at least one of a human and an animal by using the composition,
wherein the composition includes (i) safe water and (ii) an
encapsulated product containing a plurality of different health
enhancing ingredients and preserving the biological activity of the
plurality of different health enhancing ingredients.
34. A method comprising: providing a nutritionally fortified liquid
composition; and addressing arthritis of at least one of a human
and an animal by using the composition, wherein the composition
includes (i) safe water and (ii) an encapsulated product containing
a plurality of different health enhancing ingredients and
preserving the biological activity of the plurality of different
health enhancing ingredients.
35. A method comprising: providing a nutritionally fortified liquid
composition; and boosting the energy of at least one of a human and
an animal by using the composition, wherein the composition
includes (i) safe water and (ii) an encapsulated product containing
a plurality of different health enhancing ingredients and
preserving the biological activity of the plurality of different
health enhancing ingredients.
36. A method comprising: providing a nutritionally fortified liquid
composition; and treating premenopausal, menopausal and/or
postmenopausal woman by using the composition, wherein the
composition includes (i) safe water and (ii) an encapsulated
product containing a plurality of different health enhancing
ingredients and preserving the biological activity of the plurality
of different health enhancing ingredients.
37. A method comprising: providing a controlled release isotonic
sports drink; and maintaining a blood glucose level for a sustained
period of time of at least one of a human and an animal by using
the sports drink, wherein the sports drink includes (i) safe water
and (ii) one or more encapsulated products containing a plurality
of different health enhancing ingredients.
38. A method comprising: providing a nutritionally fortified liquid
composition; and reducing an intake of sweeteners and/or chemical
additives by at least one of a human and an animal by using the
composition, wherein the composition includes (i) safe water and
(ii) one or more encapsulated products containing a plurality of
different health enhancing ingredients.
39. A method comprising: providing a nutritionally fortified liquid
composition; and reducing an intake of sweeteners and/or chemical
additives by at least one of a human and an animal by using the
composition, wherein the composition includes (i) safe water and
(ii) an encapsulated product containing a plurality of different
health enhancing ingredients and preserving the biological activity
of the plurality of different health enhancing ingredients.
Description
[0001] The present application is a continuation-in-part
application of, and claims priority from, U.S. Ser. No. 10/204,572,
filed 21 Aug. 2002 which was a continuation of, and claims priority
from, PCT/US01/05630 filed 22 Feb. 2001, which in turn claims
priority from U.S. Ser. No. 09/510,400, filed 22 Feb. 2000 and
issued 19 Jun. 2001 as U.S. Pat. No. 6,248,390.
[0002] In modern society, regardless of age, people are obliged to
live with a multiplicity of various injurious, and stressful,
conditions that affect the body. Moreover, as we extend "life span"
there is a remarkable, and rapid, increase in the population of the
elderly (seniors) living under these circumstances, and further
there exists a high incidence of acute, and/or chronic, diseases
therefore providing an increasing need for addressing health
desires and challenges, ameliorating and/or preventing disease,
and/or maintaining and promoting health, and establishing well
being and wellness.
[0003] Upon being diagnosed with any life-threatening disease, a
prescribed method of treatment is the first step on the road to
recovery. Optimistically, new health trends show American patients
are becoming more interested in non-traditional treatments.
Additionally, populations are becoming more preventative, health
orientated, educated, and increasingly directed towards improving
their quality of life as well as longevity. Also, and fast
forwarding, seeking more and more "the means" by which they can
insure longer lasting good health for themselves and their
families. Animals too!
[0004] It is therefore the goal of the inventor, with all the
aforesaid in mind, taken to heart, and being a focus, while
noticing with keen observance, that there must be new delivery
systems by which to deliver active ingredients that is acceptable,
desirable, and foremost ethical for which to deliver target
specific, and target general, substances that will offer the
greatest return on investment . . . an investment in health.
[0005] Problematic today is the inconsistency of the consumer to
adhere to a routine, except perhaps, when it comes to
pharmaceuticals, which are basically for pain relief and address
illness, be it healing from an infection and/or disease. Succinctly
put, commercially available vitamin and mineral supplements are
convenient and useful in many circumstances where improved nutrient
uptake is desirable. However, adhering to a daily routine of
nutritional supplementation has had limited success. For example,
daily supplementation requires a change in normal habits and
practices of the user.
[0006] Further, some individuals find that supplements provide no
immediate physiological signal to help them perceive a benefit, or
to establish a consistent routine of use. A number of other
pharmacological agents taken for health are typically associated
with a, or more than one, noticeable bodily or physiological
response(s). We have, unfortunately, become far too much of a
society whereby you have to "feel it to believe it." It is believed
that the lack of a physiological signal from the vast majority of
nutritional supplements is responsible for limiting the overall
acceptability of them, which is unfortunate since there is a need
for supplementation to augment the daily intake of vitamins and
minerals found in foods.
[0007] At least the inventor found no resistance in getting a
consumer to have at least one bottle of water a day, sometimes
more. (Maybe not all drunk at once, but at least a bottle a day).
The water with fiber enrichment, invention Fiber-water (U.S. Pat.
No. 6,248,390 to the same inventor), elicited the same response as
plain water as it taste just like water.
[0008] Building on that, therefore it is the intention of the
inventor to present new and novel additions to the invention
Fiber-water by taking it to the next level, so as to address all
the aforesaid through safe, pure, fresh fiber enriched water while
maintaining basically the taste of water.
[0009] While the term "Functional Foods" has become more
commonplace, for many a better definition is necessary ergo the
term "Functional Foods", meaning foods containing functional
ingredients with documented beneficial health effects, consumed as
part of the daily diet.
[0010] Additionally of noteworthiness is an American study on
consumer behavior confirming that there has been a change in how
customers relate to health and well-being. Previously good health
meant, "taking the bad out," for example by reducing the salt or
fat content in food. Today we are seeing a shift in the word
"health" in connection with food, meaning, "putting the good in".
That was the goal of Fiber-water and now extending the novelty of
that invention by adding one or more additional benefits in one or
more categories of supplementation including but not limited to,
pharmaceuticals, nutraceuticals, dietary supplements, etc. It is
even more critical as noted by the inventor if we take a careful
and critical look at the quality of food produced today, (from
soils depleted in nutrients), protracted storage time in
warehouses, and extended shelf life in the consumer
marketplace.
[0011] Happy to report that surveys are showing that a large, and
continuously increasing, number of consumers are now taking more
responsibility for their own health. The inventor predicts, and
shall participate in, what she envisions is the future scenario . .
. consumers who will focus on "nutrition management" involving
personally formulated diets, with the results that the boundaries
between medicine and nutrition will become blurred. In order to
accomplish the aforesaid new technologies and methodologies will
have to be employed. These include but are not limited to the
delivery of ingredients, the manufacturing technologies, but the
methods by which business is conducted so that companies,
regardless of their size, will produce "quality" while operating
profitably. Business models, methods and opportunities are fully
covered in the inventor's CIP of PCT/US01/09171 titled: Method of
Hydration; infusion Packet System(s), Support Member(s) Delivery
System(s), and Method(s); with Business Model(s) and Method(s).
[0012] At the time of this writing the inventor is noticing an
ever-growing trend amongst adults who are becoming more aware and
specifically desirous of using beverages (nutritional drinking) to
help maintain their health. Further, parents and caregivers are
becoming increasingly aware (and with awareness comes
responsibility) of what they are giving to the younger generation.
Not only are they providing products "in the now" but also
hopefully teaching these impressionable minds how to make sound
healthy choices as they mature. This inventor takes great pains,
and is dedicated to providing to the beverage companies first, the
systems by which to deliver, and additionally suggestions and
formulations of what to deliver. Further the inventor is a major
supporter of those who wish to improve their health, those with
healthier goals, those with health challenges, be they infants,
children, teenagers, the aging population (seniors), regardless,
and even their pets.
[0013] There is one universal solvent, the one element that
everyone needs everyday to live, and that is water. Water provides
hydration, for without water one cannot live. So water, to this
inventor, in the simplistic of terms, becomes the essential
delivery system. Fiber is necessary to live healthier and now on to
the additional new and novel.
[0014] Building on this the invention Fiber-Water (to this
inventor, Stillman, U.S. Pat. No. 6,248,390 and now adding
additional systems into the Fiber-Water (or even into plain pure
water) which delivers fiber within one or more of the new and novel
delivery systems, not just the formulations, by which to deliver
the aforesaid. It is not far different than looking at society's
advancement in communication technologies such the inventions of
the telephone, (now wireless cell phones), walkie-talkies, fax
machines, internet, etc. New pathways of delivery in beverage
delivery must advance if we are to deliver the myriad of new
discoveries in substances that will not just address life span but
health span as well.
FIELD OF THE INVENTION
[0015] One of the main goals, call it the beauty if you will, of
Fiber-Water . . . water containing soluble fiber (U.S. Pat. No.
6,248,390) is the fact that it "taste just like water" yet delivers
a significant amount of soluble fiber, while simultaneously
providing pure fresh necessary water to live (hydration) for humans
and/or animals.
[0016] The next generation of fiber-waters is new and novel due to
the fact that, while the fiber in water composition still presents
a significant amount of soluble fiber, ergo contributing
significantly to daily hydration needs (pure fresh water, still or
sparkling), it further incorporates one or more systems designed to
deliver one or more additional health promoting/addressing
ingredients/components, while ensuring their stability, their
bio-availability, controlling their release (if deemed desirable
and/or appropriate), including but not limited to the groups
titled: pharmaceuticals, nutraceuticals, dietary supplements,
enzymes, amino-acids, diagnostics, pre-biotics, pro-biotics,
anti-inflamatories, anti-bacterials, herbal extracts, aroma(s),
flavor, color, etc.
[0017] By this new invention it is the goal of the inventor to
still present a product, following all the guidelines of
fiber-water as its basis, but to continue beyond fiber-water with
the aforesaid being innovational, while keeping the general taste
of water and/or a water composition that tastes just like, and/or
near to water.
[0018] It is to be noticed here, described in detail later, that
waters have different tastes due to their Total Dissolved Solids
and/or Total Dissolved Salts. Additionally some mineral waters are,
by nature, naturally sparkling. It is here conceived that they be
without gas, with natural gas, or the addition to gas in total or
in part. (Further if minerals (organic and/or inorganic) are added
then the TDS (total dissolved solids and/or salts may vary with the
varying viscosities as we shall discover later.
BACKGROUND OF THE INVENTION
[0019] In keeping current with modern trends, consumer's
preferences, and/or the like the inventor has noticed all the
flavored waters, enriched waters, and the like. It is irrelevant as
to the inventor's personal feeling on the value to the consumer of
these new products, but is focused on inventing beyond fiber-water,
ethically and scientifically sound product(s), and these may be
referred to by some as line extension of fiber-water: Fiber-Water
with the added value delivery systems/elements/additives addressing
specific, and/or special dietary use(s), and/or medical use(s) for
humans and animals.
[0020] The inventor calls first attention to the fact that while
many still enjoy the refreshing taste of pure spring and/or
purified water, others are desirous of water with a dash of flavor.
Still others wish that they had further supplementation/nutrition,
beyond water, but are desirous of having the "taste just like
water" taste. At most, lightly flavored water, even colored, yet
can remain transparent/clear (except if designed to be colorful and
cloudy for effect), following the guidelines set forth by the FDA
of the United States and the equivalent jurisdiction in other
countries.
[0021] Certainly companies have added excitement to the water
category by adding ingredients such as flavors, sweeteners, etc. As
an example of flavored waters Hydrator.TM., a new line of lightly
flavored still waters from Aqua Vie Beverage Corp., Ketchum, Id.,
includes varieties such as Avalanche (pear, guava and other
flavors), Bamboo (Japanese cherry), Harvest (French strawberry),
McIntosh (McIntosh apple), Paradise (orange, peach), Java (kona
coffee), Sun Tea (tea, lemon and other flavors).
[0022] Past just the flavors, new water-like beverages are rapidly
appearing in the marketplace. After years of research, limited
before filing for Fiberwater, and post issuance of U.S. Pat. No.
6,248,390 to the inventor, Stillman here, and World Intellectual
Property Organization (PCT WO 01/62108 A1), the inventor has come
to realize that there's a growing segment of enriched/enhanced
water-like drinks. The functional beverage trends are spilling over
into the water subcategory.
[0023] In Japan they are called "Near Water", as meaning close to
water. As an example, Nice One drink from Asahi contains vitamins
B.sub.1 and C, reishi, seaweed extract and chamomile as just an
example. Although the trend started in Japan, it is apparent that
these beverages are becoming more popular in the United States,
Europe and beyond.
[0024] Now many are beginning to believe that we can get Americans
to drink more water by making available these more mainstream
enhanced waters, offering healthy additives such as vitamins,
minerals, herbs and/or the like. However this inventor feels, that
as with anything else, responsibility must be taken by the
producing companies and the consumers as well.
[0025] The inventor calls attention to the following news release:
[0026] Jul. 1, 2002 American Institute for Cancer Research, Healthy
Drinks by Karen Collins, M.S., R.D., C.D.N.American Institute for
Cancer Research
[0027] Choosing a drink has never been so complicated. "New age"
waters, teas and juices--with added vitamins, herbs, or other
"healthy" ingredients--are now a billion-dollar business. Although
some of these new beverages may be simply a flavorful way to
increase consumption of liquids, others may not be appropriate for
everyone. Some added ingredients might cause health problems, while
others are in amounts so small they may have a negligible
effect.
[0028] Many of these new beverages are simply water or tea with
added flavorings like fruit essence, lemongrass, or ginger. They
are promoted on the premise that most Americans don't drink enough
water, and that people will drink more of flavored drinks than
plain water. Studies suggest that this may often be true. If a
flavored water or tea helps you drink more, it could be a great
choice.
[0029] Before selecting any of these drinks, consider whether you
want them to add or limit your calorie intake. If you're trying to
control your weight, an extra 250 to 375 calories may be
counter-productive. On the other hand, people who don't need to
lose weight might benefit from extra calories shortly before,
during, or after high-energy exercise.
[0030] Some drinks are fortified with vitamins or minerals. For
example, juices with added calcium may help people who don't or
can't consume dairy products and would benefit from this
fortification. On the other hand, B vitamins don't need to be added
to a drink since most of us consume adequate amounts. Added
vitamins or minerals can help make up for what is lacking in some
people's diets, but for those who meet recommended amounts through
diet or supplements, significant additions to drinks may be useless
or even harmful.
[0031] Many drinks contain herbals--like echinacea, guarana, ginkgo
biloba, or kava--that supposedly help energize, calm, or promote
well-being in other ways. But the effectiveness of many of these
herbs is either questionable or still under study. For example,
echinacea is currently thought to help the immune system fight some
illnesses in the short term, but continued long-term use is
believed to actually depress the immune system.
[0032] In some cases, herbal ingredients that seem likely to have
possible health benefits are added in amounts too small to have any
real effect. Drinks containing St. John's Wort usually provide 250
milligrams (mg) per 20-ounce bottle, but studies show that 900 to
1,500 mg a day are needed to create mood-enhancing effects. The low
levels found in most drinks might reduce the chance of consuming
too much of this herb, but it also means consumers are paying extra
for something they aren't getting in any significant amount.
[0033] People assume that any new drink on the market must be safe.
But some added ingredients, if present in significant amounts,
might pose health dangers for certain people. Warnings have
recently been issued about kava as a possible cause of liver
damage. Kava should be avoided by anyone who drinks alcohol daily
or takes medicines that could affect the liver. St. John's Wort and
ginkgo biloba can interact with medications. Guarana and some kinds
of ginseng can raise blood pressure.
[0034] Don't be misled by new marketing ploys. Before buying a
pricey "health" beverage, check what and how much added ingredients
it contains, and how it relates to your needs.
[0035] AICR is the only major cancer charity focusing exclusively
on the link between diet, nutrition and cancer. The Institute
provides education programs that help millions of Americans learn
to make changes for lower cancer risk.
[0036] PepsiCo launched a purified water called Aquafina, and will
break soon with a line of fruit-flavored, vitamin-mineral enhanced
waters called Aquafina Essentials. Coca-Cola, Atlanta, decided to
produce a bottled water with added minerals, Dasani, and now they
too will be launching Desani Nutri-waters adding additional
nutritive value to their existing mineral fortified water.
[0037] Aquafina rang up $214 million in sales last year, while
Dasani brought in $168 million, according to Information Resources,
while sales of carbonated beverages, such as soda, have dropped
about 4 percent in the last five years, sales of bottled water have
more than tripled, as people have become more health conscious and,
simultaneously, leery of the quality of tap water.
[0038] With soda sales slipping, and energy drinks losing their
buzz among consumers, beverage companies are hoping these enhanced
waters can build on the success of bottled water, providing
consumers something new that will have an effect on their body,
and/or won't make them feel guilty.
[0039] The first such products out on supermarket shelves in the
last years were Energy Brand's VitaminWater, Veryline's Fruit20,
and Propel.TM. by Quaker Oats, now a part of PepsiCo's Gatorade
brand that is a so-called a "fitness water", with vitamins B and C
in flavors such as black cherry and/orange.
[0040] In coming months, in addition to PepsiCo Inc., Coca Cola Inc
much of the rest of the beverage industry will be jumping in
including Snapple Beverage Group Inc. with its Elements
fruit-flavored waters, and health products maker Baxter
International Inc. with Pulse, a fruity water supplement designed
to ward off prostate trouble in men and ease menopause in
women.
[0041] Other companies will roll out a barrage of lightly sweetened
"waters" laced with fruit flavors, vitamins, herbs and even
ingredients used to treat specific medical conditions. In coming
months, more and more products are coming to market with all sorts
of twists, ergo it is firmly apparent that the nation's largest
beverage makers are about to launch an all-out campaign to change
the definition of water. With bottled water a $6 billion a year
business it is possible that this so-called potential sub-category
can be extremely profitable.
[0042] The belief is that this so called sub-category is blossoming
quickly and will be booming by year 2003 forward. If the sales of
the Japanese Near Waters are an indication then this is correct. In
fact some editorials claim that the distribution between natural
spring waters and the flavored/functional variety are approaching a
split down the middle potential.
[0043] The inventor has noticed that there are other enriched
waters on the market that containing recognizable ingredients such
as caffeine, nicotine, oxygen, and/or the like. They sell not
necessarily based on hydration, even though that might be a part of
it, but on the "effect" that the additional ingredient is supposed
to illicit for the user.
[0044] The inventor has also noticed that noticed that most
enhanced waters, with 10 to 40 calories per 8-ounce serving, are
still lower in calories than juice or soda, but some have as many
as 80 calories per serving, bringing the total calorie count to 160
for the average 16-ounce container. By contrast, non-diet colas
have about 215 calories per 16-ounce servings and/orange juice has
about 225 calories.
[0045] It also seems to the inventor that the higher-calorie waters
are "starting to be more like a juice drink" at best, and at worst
just flavored sugar water for which the inventor is opposed.
[0046] When you start adding one or more additional ingredients,
especially needed to mask undesirable taste, the inventor has many
mixed feelings. Amongst the major concerns, the just said may
greatly increase the caloric count and/or, just as negative, use
chemicals, must be taken into consideration while additionally
noting that the efficacy equation most likely gets muddled. While
there are benefits to offering healthy additives, caution, and
certainly responsibility, should be taken by both the companies and
the consumers.
[0047] The inventor feels that flavored water, because it is a
clear product just like water, is more closely linked to water's
heritage. Flavored waters are just a way to add variety and keep
people from getting bored with plain water. Then to you can color
water and governed by association have no flavor in the water at
all but the color fools the perception.
[0048] As more people live lives on the go, we are seeing a
tremendous increase in sales of bottled water due to the fact that
users are deciding to carry bottles with them. (Bottled water
sales, U.S. only, are about $6 billion annually) Other packaging is
becoming more and more noteworthy.
[0049] Beyond the just flavored waters are the enriched waters and
with the enriched waters it is the inventor's concern relative to
such additional additives. While the general idea is to have
another alternative that consumers still see as healthy (Propel is
focused on fitness-conscious customers, while Snapple appears to be
targeting its Elements at the energy drink set with vibrant colors
and exotic ingredients such as ginseng, guarana, bee pollen and
gingko biloba, as well as more traditional health enhancers like
beta carotene), the inventor, by this invention, wants to use
innovative methodologies/technologies, into water, to assure her
position.
SUMMARY OF THE INVENTION
[0050] There is an old expression that says, "You can't have your
cake and eat it too" . . .
[0051] In the aforementioned fiber-water patent, issued (U.S. Pat.
No. 6,248,390) and pending international (PCT WO 01/62108 A1), the
inventor presented the antithesis of that expression: an invention
composed specifically of water and soluble fiber (that's simple
enough) that is tasteless, odorless and colorless, much like water
itself.
[0052] Into the invention called fiber-water, the inventor has
added one, or more than one, additional elements, be they
complimentary, aesthetic, and/or desired, and/or functional when it
comes to ingredients in a healthy palatable form and, that will not
only contribute to hydration requirements, fulfill a portion of
ones daily need of fiber, but do so, with practically the same
caloric intake and/or an additional minimal caloric intake as a
glass of the invention, fiber-water, with the addition of
encapsulations (a carrier for additives) and/or viscosity changes,
(a carrier for additives) and/or by unique technologies whereby the
water is changed/processed in such a way as to enhance its ability
to be taken up by the cells of the body of humans (and/or animals),
prevent the growth of organisms, promote health, and/or medical
benefits and/or the like by the priority techniques of processing
the water solely and/or along with the delivery system(s) used.
[0053] As an example, [0054] a. Penta.TM. water (San Diego Calif.)
claims to be able to micro-cluster water so as to be taken up more
rapidly by the cells. [0055] b. U.S. Pat. No. 5,824,353 to Tsunoda
et al. (Taisho Pharmaceutical Co., Ltd. Tokyo JP), issued Oct. 20,
1998, titled Mineral water abstracts; [0056] i. The present
invention relates to small-cluster water whose cluster (water
molecule groups or hydrates) is small on the average and is
retained as it is stably for a very long period of time. Water
usually forms clusters (groups of molecules) consisting of a large
number of molecules by hydrogen bonds, and the clusters always vary
in size, depending on various conditions of a place where the water
is present. [0057] ii. Water whose cluster is small on the average
is known to be very useful physiologically and medically as
follows: it tastes good because it completely gets into the taste
buds (taste cells) of tongue owing to vigorous molecular motion; it
gets into cells easily to activate them; it accelerates the
absorption of a drug or food and drink because of its rapid
absorption through a digestive tract; and it has cancer-preventive
effect because it reduces the production of mutagens from the
contents of intestines by controlling or activating enteric
microorganisms and digestive tract tissue cells. [0058] c. U.S.
Pat. No. 5,904,851 to Taylor et al. (Life international Products
Inc. Naples Fla.), issued May 18, 1999, titled: Oxygenating
apparatus, method for oxygenating liquid therewith, and
applications thereof teaches that suitable therapeutic processes in
which liquids made in accordance with the present invention can be
advantageously employed to include, for example, increasing the
oxygen content of blood and tissues.
[0059] The main 3 systems that will be used include encapsulations,
viscosity changes, and/or what the inventor commonly refers to as
the "lava lamp" type containments using water and oil principles
relating technologies (emulsions, suspensions, and/or solutions,
etc.)
[0060] It is also noted, and fully respected, are the guidelines
set forth by the (American) Food and Drug Association (FDA) and the
equivalents in other countries as related to production of
drinkable products safely and in accordance, with or without the
need for refrigeration.
[0061] During the research and development of fiber-water for
commercialization many procedural options were tried and/or
considered. In fact at the time of this writing the formal/final
production methodology has not been solidified. The inventor here
makes full disclosure that while the goal is to produce product at
a neutral Ph, production technologies are not fully developed to be
able to do so under existing governmental regulations.
[0062] To that end not just the use of thermal processing
technologies may be needed to be employed, but the use of organic
and/or inorganic acidulates and/or the like maybe needed to prevent
organism contamination and growth as well. Further ingredients, and
maybe even those considered as part of the sweetener family may be
needed to counteract the taste of acid necessary to reduce
potential contamination. If a sweetener is used in the production
of fiber-water it is solely used for the ability to counteract the
acid so as to present a product that tastes like water and not
"acid water". The same holds true for this invention.
[0063] It is also noted that with the additions, encapsulation(s)
and/or changing viscosities, in total and/or in part it might be
desirous, and/or necessary to add one, or a combination of
minerals, (organic and/or inorganic) to be used for specific
reasons and/or conditions, which may or may not bring the TDS above
500. Note: With a product that has more than one viscosity change,
which may stay in suspension or move around (like the "lava lamp"
conceptualization) there may be assigned to each viscosity change a
different TDS.
[0064] Much of the innovativeness of this invention is primarily
based on the first system, encapsulations; regardless of size,
structure, compositions, content(s), and/or the like to bring forth
all the valuable components that come with the use of the
aforesaid. (The varying viscosity mediums may or may not include
encapsulations) It is further with the understanding that flavoring
can be added, along with aroma, and colorants.
[0065] To understand the market positioning of this sort of
product, with its many variations, the inventor calls forth the
need to understand governmental regulations:
Definitions of Regulations as Set Forth by our Government:
[0066] The term "Dietary Supplement" which is described in the
Dietary Supplement Health and Education Act of 1994 (DSHEA) [0067]
In 1994 Congress passed legislation known as the Dietary Supplement
Health and Education Act (DSHEA). The law restricted the Food and
Drug Administration (FDA) in the regulations it could enforce
limiting label claims on dietary supplements. Specifically, DSHEA
allows dietary supplement labels to carry statements dealing with
structure/function claims such as "supports the immune system."
Section 6 of DSHEA states that structure/function statements are
"statements of nutritional support . . . that describe the role of
a nutrient or dietary ingredient intended to affect the structure
or function in humans." [0068] The intent of DSHEA was to provide
consumers access to more health-related information about dietary
supplements. However, sifting through the complicated language
contained in the legislation is a formidable task. The fine line in
semantics with respect to a supplement "supporting" a normal body
function as opposed to "treating a disease" remains as
controversial an area as the current debate over how the FDA
actually defines "diseases."
[0069] Incorporated herein is the entire DSHEA for ease of
reference and for the ability to logically look at the reference
while reviewing the filing. [0070] `Dietary Supplement Health and
Education Act of 1994'. [0071] An Act [0072] To amend the Federal
Food, Drug, and Cosmetic Act to establish standards with respect to
dietary supplements, and for other purposes. [0073] Be it enacted
by the Senate and House of Representatives of the United States of
America in Congress assembled, [0074] SECTION 1. SHORT TITLE;
REFERENCE; TABLE OF CONTENTS. [0075] (a) SHORT TITLE--This Act may
be cited as the `Dietary Supplement Health and Education Act of
1994`. [0076] (b) REFERENCE--Whenever in this Act an amendment or
repeal is expressed in terms of an amendment to, or repeal of, a
section or other provision, the reference shall be considered to be
made to a section or other provision of the Federal Food, Drug, and
Cosmetic Act. [0077] (c) TABLE OF CONTENTS--The table of contents
of this Act is as follows: [0078] Sec. 1. Short title; reference;
table of contents. [0079] Sec. 2. Findings. [0080] Sec. 3.
Definitions. [0081] Sec. 4. Safety of dietary supplements and
burden of proof on FDA. [0082] Sec. 5. Dietary supplement claims.
[0083] Sec. 6. Statements of nutritional support. [0084] Sec. 7.
Dietary supplement ingredient labeling and nutrition information
labeling. [0085] Sec. 8. New dietary ingredients. [0086] Sec. 9.
Good manufacturing practices. [0087] Sec. 10. Conforming
amendments. [0088] Sec. 11. Withdrawal of the regulations and
notice. [0089] Sec. 12. Commission on dietary supplement labels.
[0090] Sec. 13. Office of dietary supplements. [0091] SEC. 2.
FINDINGS. [0092] Congress finds that-- [0093] (1) improving the
health status of United States citizens ranks at the top of the
national priorities of the Federal Government; [0094] (2) the
importance of nutrition and the benefits of dietary supplements to
health promotion and disease prevention have been documented
increasingly in scientific studies; [0095] (3) (A) there is a link
between the ingestion of certain nutrients or dietary supplements
and the prevention of chronic diseases such as cancer, heart
disease, and osteoporosis; and [0096] (B) clinical research has
shown that several chronic diseases can be prevented simply with a
healthful diet, such as a diet that is low in fat, saturated fat,
cholesterol and sodium, with a high proportion of plant-based
foods; [0097] (4) healthful diets may mitigate the need for
expensive medical procedures, such as coronary bypass surgery or
angioplasty; [0098] (5) preventive health measures, including
education, good nutrition, and appropriate use of safe nutritional
supplements will limit the incidence of chronic diseases, and
reduce long-term health care expenditures; [0099] (6) (A) promotion
of good health and healthy lifestyles improves and extends lives
while reducing health care expenditures; and [0100] (B) reduction
in health care expenditures is of paramount importance to the
future of the country and the economic well-being of the country;
[0101] (7) there is a growing need for emphasis on the
dissemination of information lining nutrition and long-term good
health; [0102] (8) consumers should be empowered to make choices
about preventive health care programs based on data from scientific
studies of health benefits related to particular dietary
supplements; [0103] (9) national surveys have revealed that almost
50 percent of the 260,000,000 Americans regularly consume dietary
supplements of vitamins, minerals, or herbs as a means of improving
their nutrition; [0104] (10) studies indicate that consumers are
placing increased reliance on the use of nontraditional health care
providers to avoid the excessive costs of traditional medical
services and to obtain more holistic consideration of their needs;
[0105] (11) the United States will spend over $1,000,000,000,000 on
health care in 1994, which is about 12 percent of the Gross
National Product of the United States, and this amount and
percentage will continue to increase unless significant efforts are
undertaken to reverse the increase; [0106] (12) (A) the nutritional
supplement industry is an integral part of the economy of the
United States; [0107] (B) the industry consistently projects a
positive trade balance; and [0108] (C) the estimated 600 dietary
supplement manufacturers in the United States produce approximately
4,000 products, with total annual sales of such products alone
reaching at least $4,000,000,000; [0109] (13) although the Federal
Government should take swift action against products that are
unsafe or adulterated, the Federal Government should not take any
actions to impose unreasonable regulatory barriers limiting or
slowing the flow of safe products and accurate information to
consumers; [0110] (14) dietary supplements are safe within a broad
range of intake, and safety problems with the supplements are
relatively rare; and [0111] (15) (A) legislative action that
protects the right of access of consumers to safe dietary
supplements is necessary in order to promote wellness; and [0112]
(B) a rational Federal framework must be established to supersede
the current ad hoc, patchwork regulatory policy on dietary
supplements. [0113] SEC. 3. DEFINITIONS. [0114] (a) DEFINITION OF
CERTAIN FOODS AS DIETARY SUPPLEMENTS--Section 201 (21 U.S.C. 321)
is amended by adding at the end the following: [0115] (ff) The term
dietary supplement`-- [0116] (1) means a product (other than
tobacco) intended to supplement the diet that bears or contains one
or more of the following dietary ingredients: [0117] (A) a vitamin;
[0118] (B) a mineral; [0119] (C) an herb or other botanical; [0120]
(D) an amino acid; [0121] (E) a dietary substance for use by man to
supplement the diet by increasing the total dietary intake; or
[0122] (F) a concentrate, metabolite, constituent, extract, or
combination of any ingredient described in clause (A), (B), (C),
(D), or (E); [0123] (2) means a product that-- [0124] (A) (i) is
intended for ingestion in a form described in section 411
(c)(1)(B)(i); or [0125] (ii) complies with section
411(c)(1)(B)(ii); [0126] (B) is not represented for use as a
conventional food or as a sole item of a meal or the diet; and
[0127] (C) is labeled as a dietary supplement; and [0128] (3)
does-- [0129] (A) include an article that is approved as a new drug
under section 505, certified as an antibiotic under section 507, or
licensed as a biologic under section 351 of the Public Health
Service Act (42 U.S.C. 262) and was, prior to such approval,
certification, or license, marketed as a dietary supplement or as a
food unless the Secretary has issued a regulation, after notice and
comment, finding that the article, when used as or in a dietary
supplement under the conditions of use and dosages set forth in the
labeling for such dietary supplement, is unlawful under section
402(f); and [0130] (B) not include-- [0131] (i) an article that is
approved as a new drug under section 505, certified as an
antibiotic under section 507, or licensed as a biologic under
section 351 of the Public Health Service Act (42 U.S.C. 262), or
[0132] (ii) an article authorized for investigation as a new drug,
antibiotic, or biological for which substantial clinical
investigations have been instituted and for which the existence of
such investigations has been made public, which was not before such
approval, certification, licensing, or authorization marketed as a
dietary supplement or as a food unless the Secretary, in the
Secretary's discretion, has issued a regulation, after notice and
comment, finding that the article would be lawful under this Act.
[0133] Except for purposes of section 201(g), a dietary supplement
shall be deemed to be a food within the meaning of this Act` [0134]
(b) EXCLUSION FROM DEFINITION OF FOOD ADDITIVE--Section 201 (s)
[0135] (21 U.S.C. 321(s)) is amended-- [0136] (1) by striking `or`
at the end of subparagraph (4); [0137] (2) by striking the period
at the end of subparagraph (5) and inserting `; or`; and [0138] (3)
by adding at the end the following new subparagraph: [0139] (6) an
ingredient described in paragraph (ff) in, or intended for use in,
a dietary supplement.`. [0140] (c) FORM OF INGESTION--Section
411(c)(1)(B) (21 U.S.C. 350(c)(1)(B)) is amended-- [0141] (1) in
clause (1), by inserting `powder, softgel, gelcap,` after
`capsule,`; and [0142] (2) in clause (ii), by striking `does not
simulate and`. [0143] SEC. 4. SAFETY OF DIETARY SUPPLEMENTS AND
BURDEN OF PROOF ON FDA. [0144] Section 402 (21 U.S.C. 342) is
amended by adding at the end the following [0145] (f) (1) If it is
a dietary supplement or contains a dietary ingredient that-- [0146]
(A) presents a significant or unreasonable risk of illness or
injury under-- [0147] (i) conditions of use recommended or
suggested in labeling, or [0148] (ii) if no conditions of use are
suggested or recommended in the labeling, under ordinary conditions
of use; [0149] (B) is a new dietary ingredient for which there is
inadequate information to provide reasonable assurance that such
ingredient does not present a significant or unreasonable risk of
illness or injury; [0150] (C) the Secretary declares to pose an
imminent hazard to public health or safety, except that the
authority to make such declaration shall not be delegated and the
Secretary shall promptly after such a declaration initiate a
proceeding in accordance with sections 554 and 556 of title 5,
United States Code, to affirm or withdraw the declaration; or
[0151] (D) is or contains a dietary ingredient that renders it
adulterated under paragraph (a)(1) under the conditions of use
recommended or suggested in the labeling of such dietary
supplement. [0152] In any proceeding under this subparagraph, the
United States shall beat the burden of proof on each element to
show that a dietary supplement is adulterated. The court shall
decide any issue under this paragraph on a de novo basis. [0153]
(2) Before the Secretary may report to a United States attorney a
violation of paragraph (1)(A) for a civil proceeding, the person
against whom such proceeding would be initiated shall be given
appropriate notice and the opportunity to present views, orally and
in writing, at least 10 days before such notice, with regard to
such proceeding.`. [0154] SEC. 5. DIETARY SUPPLEMENT CLAIMS. [0155]
Chapter IV (21 U.S.C. 341 et seq.) is amended by inserting after
section 403A the following new section: [0156] DIETARY SUPPLEMENT
LABELING EXEMPTIONS [0157] SEC. 403B. (a) IN GENERAL A publication,
including an article, a chapter in a book, or an official abstract
of a peer-reviewed scientific publication that appears in an
article and was prepared by the author or the editors of the
publication, which is reprinted in its entirety, shall not be
defined as labeling when used in connection with the sale of a
dietary supplement to consumers when it-- [0158] (1) is not false
or misleading; [0159] (2) does not promote a particular
manufacturer or brand of a dietary supplement; [0160] (3) is
displayed or presented, or is displayed or presented with other
such items on the same subject matter, so as to present a balanced
view of the available scientific information on a dietary
supplement; [0161] (4) if displayed in an establishment, is
physically separate from the dietary supplements; and [0162] (5)
does not have appended to it any information by sticker or any
other method. [0163] (b) APPLICATION--Subsection (a) shall not
apply to or restrict a retailer or wholesaler of dietary
supplements in any way whatsoever in the sale of books or other
publications as a part of the business of such retailer or
wholesaler. [0164] (c) BURDEN OF PROOF--In any proceeding brought
under subsection (a), the burden of proof shall be on the United
States to establish that an article or other such matter is false
or misleading.`. [0165] SEC. 6. STATEMENTS OF NUTRITIONAL SUPPORT.
[0166] Section 403(r) (21 U.S.C. 343(r)) is amended by adding at
the end the following: [0167] (6) For purposes of paragraph
(r)(1)(B), a statement for a dietary supplement may be made if--
[0168] (A) the statement claims a benefit related to a classical
nutrient deficiency disease and discloses the prevalence of such
disease in the United States, describes the role of a nutrient or
dietary ingredient intended to affect the structure or function in
humans, characterizes the documented mechanism by which a nutrient
or dietary ingredient acts to maintain such structure or function,
or describes general well-being from consumption of a nutrient or
dietary ingredient, [0169] (B) the manufacturer of the dietary
supplement has substantiation that such statement is truthful and
not misleading, and [0170] (C) the statement contains, prominently
displayed and in boldface type, the following. `This statement has
not been evaluated by the Food and Drug Administration. This
product is not intended to diagnose, treat, cure, or prevent any
disease.`. [0171] A statement under this subparagraph may not claim
to diagnose, mitigate, treat, cure, or prevent a specific disease
or class of diseases. If the manufacturer of a dietary supplement
proposes to make a statement described in the first sentence of
this subparagraph in the labeling of the dietary supplement, the
manufacturer shall notify the Secretary no later than 30 days after
the first marketing of the dietary supplement with such statement
that such a statement is being made.`. [0172] SEC. 7. DIETARY
SUPPLEMENT INGREDIENT LABELING AND NUTRITION [0173] INFORMATION
LABELING. [0174] (a) MISBRANDED SUPPLEMENTS--Section 403 (21 U.S.C.
343) is amended by adding at the end the following. [0175] (s) If--
[0176] (1) it is a dietary supplement; and [0177] (2) (A) the label
or labeling of the supplement fails to list-- [0178] (i) the name
of each ingredient of the supplement that is described in section
201(ff); and [0179] (ii) (I) the quantity of each such ingredient;
or [0180] (II) with respect to a proprietary blend of such
ingredients, the total quantity of all ingredients in the blend;
[0181] (B) the label or labeling of the dietary supplement fails to
identify the product by using the term `dietary supplement`, which
term may be modified with the name of such an ingredient; [0182]
(C) the supplement contains an ingredient described in section
201(ff)(1)(C), and the label or labeling of the supplement fails to
identify any part of the plant from which the ingredient is
derived; [0183] (D) the supplement-- [0184] (i) is covered by the
specifications of an official compendium; [0185] (ii) is
represented as conforming to the specifications of an official
compendium; and
[0186] (iii) fails to so conform; or [0187] (E) the supplement--
[0188] (i) is not covered by the specifications of an official
compendium; and [0189] (ii) (I) fails to have the identity and
strength that the supplement is represented to have; or [0190] (II)
fails to meet the quality (including tablet or capsule
disintegration), purity, or compositional specifications, based on
validated assay or other appropriate methods, that the supplement
is represented to meet`. [0191] (b) SUPPLEMENT LISTING ON NUTRITION
LABELING--Section 403(q)(5)(F) (21 U.S.C. 343(q)(5)(F)) is amended
to read as follows: [0192] (F) A dietary supplement product
(including a food to which section 411 applies) shall comply with
the requirements of subparagraphs (1) and (2) in a manner which is
appropriate for the product and which is specified in regulations
of the Secretary which shall provide that-- [0193] (i) nutrition
information shall first list those dietary ingredients that are
present in the product in a significant amount and for which a
recommendation for daily consumption has been established by the
Secretary, except that a dietary ingredient shall not be required
to be listed if it is not present in a significant amount, and
shall list any other dietary ingredient present and identified as
having no such recommendation; [0194] (ii) the listing of dietary
ingredients shall include the quantity of each such ingredient (or
of a proprietary blend of such ingredients) per serving; [0195]
(iii) the listing of dietary ingredients may include the source of
a dietary ingredient; and [0196] (iv) the nutrition information
shall immediately precede the ingredient information required under
subclause (i), except that no ingredient identified pursuant to
subclause (i) shall be required to be identified a second time.`.
[0197] (c) PERCENTAGE LEVEL CLAIMS--Section 403(r)(2) (21 U.S.C.
343(r)(2)) is amended by adding after clause (E) the following:
[0198] (F) Sub-clause (i) clause (A) does not apply to a statement
in the labeling of a dietary supplement that characterizes the
percentage level of a dietary ingredient for which the Secretary
has not established a reference daily intake, daily recommended
value, or other recommendation for daily consumption.`. [0199] (d)
VITAMINS AND MINERALS--Section 411(b)(2) (21 U.S.C. 350(b)(2)) is
amended-- [0200] (1) by striking `vitamins or minerals` and
inserting `dietary supplement ingredients described in section
201(ff)`; [0201] (2) by striking `(2) (A)` and inserting `(2)`; and
[0202] (3) by striking subparagraph (B). [0203] (e) EFFECTIVE
DATE--Dietary supplements-- [0204] (1) may be labeled after the
date of the enactment of this Act in accordance with the amendments
made by this section, and [0205] (2) shall be labeled after Dec.
31, 1996, in accordance with such amendments [0206] SEC. 8. NEW
DIETARY INGREDIENTS. [0207] Chapter IV of the Federal Food, Drug,
and Cosmetic Act is amended by adding at the end the following.
[0208] `NEW DIETARY INGREDIENTS [0209] SEC. 413. (a) IN GENERAL--A
dietary supplement which contains a new dietary ingredient shall be
deemed adulterated under section 402(f) unless it meets one of the
following requirements: [0210] (1) The dietary supplement contains
only dietary ingredients which have been present in the food supply
as an article used for food in a form in which the food has not
been chemically altered. [0211] (2) There is a history of use or
other evidence of safety establishing that the dietary ingredient
when used under the conditions recommended or suggested in the
labeling of the dietary supplement will reasonably be expected to
be safe and, at least 75 days before being introduced or delivered
for introduction into interstate commerce, the manufacturer or
distributor of the dietary ingredient or dietary supplement
provides the Secretary with information, including any citation to
published articles, which is the basis on which the manufacturer or
distributor has concluded that a dietary supplement containing such
dietary ingredient will reasonably be expected to be safe. [0212]
The Secretary shall keep confidential any information provided
under paragraph (2) for 90 days following its receipt. After the
expiration of such 90 days, the Secretary shall place such
information on public display, except matters in the information
which are trade secrets or otherwise confidential, commercial
information. [0213] (b) PETITION--Any person may file with the
Secretary a petition proposing the issuance of an order prescribing
the conditions under which a new dietary ingredient under its
intended conditions of use will reasonably be expected to be safe.
The Secretary shall make a decision on such petition within 180
days of the date the petition is filed with the Secretary. For
purposes of chapter 7 of title 5, United States Code, the decision
of the Secretary shall be considered final agency action. [0214]
(c) DEFINITION--For purposes of this section, the term `new dietary
ingredient` means a dietary ingredient that was not marketed in the
United States before Oct. 15, 1994 and does not include any dietary
ingredient which was marketed in the United States before Oct. 15,
1994.`. [0215] SEC. 9. GOOD MANUFACTURING PRACTICES. [0216] Section
402 (21 U.S.C. 342), as amended by section 4, is amended by adding
at the end the following: [0217] (g) (1) If it is a dietary
supplement and it has been prepared, packed, or held under
conditions that do not meet current good manufacturing practice
regulations, including regulations requiring, when necessary,
expiration date labeling, issued by the Secretary under
subparagraph (2). [0218] (2) The Secretary may by regulation
prescribe good manufacturing practices for dietary supplements.
Such regulations shall be modeled after current good manufacturing
practice regulations for food and may not impose standards for
which there is no current and generally available analytical
methodology. No standard of current good manufacturing practice may
be imposed unless such standard is included in a regulation
promulgated after notice and opportunity for comment in accordance
with chapter 5 of title 5, United States Code.`. [0219] SEC. 10.
CONFORMING AMENDMENTS. [0220] (a) SECTION 201--The last sentence of
section 201 ( )(1) (21 U.S.C. 321 (g)(1)) is amended to read as
follows: `A food or dietary supplement for which a claim, subject
to sections 403(r)(1)(3) and 403(r)(3) or sections 403(r)(1)(B) and
403(r)(5)( ), is made in accordance with the requirements of
section 403(r) is not a drug solely because the label or the
labeling contains such a claim. A food, dietary ingredient, or
dietary supplement for which a truthful and not misleading
statement is made in accordance with section 403(r)(6) is not a
drug under clause (c) solely because the label or the labeling
contains such a statement.`. [0221] (b) SECTION 301--Section 301
(21 U.S.C. 331) is amended by adding at the end the following:
[0222] (u) The introduction or delivery for introduction into
interstate commerce of a dietary supplement that is unsafe under
section 413.`. [0223] (c) SECTION 403--Section 403 (21 U.S.C. 343),
as amended by section 7, is amended by adding after paragraph (s)
the following: [0224] `A dietary supplement shall not be deemed
misbranded solely because its label or labeling contains directions
or conditions of use or warnings.`. [0225] SEC. 11. WITHDRAWAL OF
THE REGULATIONS AND NOTICE. [0226] The advance notice of proposed
rulemaking concerning dietary supplements published in the Federal
Register of Jun. 18, 1993 (58 FR 33690-33700) is null and void and
of no force or effect insofar as it applies to dietary supplements.
The Secretary of Health and Human Services shall publish a notice
in the Federal Register to revoke the item declared to be null and
void and of no force or effect under subsection (a). [0227] SEC.
12. COMMISSION ON DIETARY SUPPLEMENT LABELS. [0228] (a)
ESTABLISHMENT--There shall be established as an independent agency
within the executive branch a commission to be known as the
Commission on Dietary Supplement Labels (hereafter in this section
referred to as the `Commission`). [0229] (b) MEMBERSHIP-- [0230]
(1) COMPOSITION--The Commission shall be composed of 7 members who
shall be appointed by the President. [0231] (2) EXPERTISE
REQUIREMENT--The members of the Commission shall consist of
individuals with expertise and experience in dietary supplements
and in the manufacture, regulation, distribution, and use of such
supplements. At least three of the members of the Commission shall
be qualified by scientific training and experience to evaluate the
benefits to health of the use of dietary supplements and one of
such three members shall have experience in pharmacognosy, medical
botany, traditional herbal medicine, or other related sciences.
Members and staff of the Commission shall be without bias on the
issue of dietary supplements. [0232] (c) FUNCTIONS OF THE
COMMISSION--The Commission shall conduct a study on, and provide
recommendations for, the regulation of label claims and statements
for dietary supplements, including the use of literature in
connection with the sale of dietary supplements and procedures for
the evaluation of such claims. In making such recommendations, the
Commission shall evaluate how best to provide truthful,
scientifically valid, and not misleading information to consumers
so that such consumers may make informed and appropriate health
care choices for themselves and their families. [0233] (d)
ADMINISTRATIVE POWERS OF THE COMMISSION-- [0234] (1) HEARINGS--The
Commission may hold hearings, sit and act at such times and places,
take such testimony, and receive such evidence as the Commission
considers advisable to carry out the purposes of this section.
[0235] (2) INFORMATION FROM FEDERAL AGENCIES--The Commission may
secure directly from any Federal department or agency such
information as the Commission considers necessary to carry out the
provisions of this section. [0236] (3) AUTHORIZATION OF
APPROPRIATIONS--There are authorized to be appropriated such sums
as may be necessary to carry out this section. [0237] (e) REPORTS
AND RECOMMENDATIONS-- [0238] (1) FINAL REPORT REQUIRED--Not later
than 24 months after the date of enactment of this Act, the
Commission shall prepare and submit to the President and to the
Congress a final report on the study required by this section.
[0239] (2) RECOMMENDATIONS--The report described in paragraph (1)
shall contain such recommendations, including recommendations for
legislation, as the Commission deems appropriate. [0240] (3) ACTION
ON RECOMMENDATIONS--Within 90 days of the issuance of the report
under paragraph (1), the Secretary of Health and Human Services
shall publish in the Federal Register a notice of any
recommendation of Commission for changes in regulations of the
Secretary for the regulation of dietary supplements and shall
include in such notice a notice of proposed rulemaking on such
changes together with an opportunity to present views on such
changes. Such rulemaking shall be completed not later than 2 years
after the date of the issuance of such report. If such rulemaking
is not completed on or before the expiration of such 2 years,
regulations of the Secretary published in 59 FR 395-426 on Jan. 4,
1994, shall not be in effect. [0241] SEC. 13. OFFICE OF DIETARY
SUPPLEMENTS. [0242] (a) IN GENERAL--Title IV of the Public Health
Service Act is amended by inserting after section 485B (42 U.S.C.
287c-3) the following: [0243] `SUBPART 4--OFFICE OF DIETARY
SUPPLEMENTS [0244] SEC. 485C. DIETARY SUPPLEMENTS. [0245] (a)
ESTABLISHMENT--The Secretary shall establish an Office of Dietary
Supplements within the National Institutes of Health. [0246] (b)
PURPOSE--The purposes of the Office are-- [0247] (1) to explore
more fully the potential role of dietary supplements as a
significant part of the efforts of the United States to improve
health care; and [0248] (2) to promote scientific study of the
benefits of dietary supplements in maintaining health and
preventing chronic disease and other health-related conditions.
[0249] (c) DUTIES--The Director of the Office of Dietary
Supplements shall-- [0250] (1) conduct and coordinate scientific
research within the National Institutes of Health relating to
dietary supplements and the extent to which the use of dietary
supplements can limit or reduce the risk of diseases such as heart
disease, cancer, birth defects, osteoporosis, cataracts, or
prostatism; [0251] (2) collect and compile the results of
scientific research relating to dietary supplements, including
scientific data from foreign sources or the Office of Alternative
Medicine; [0252] (3) serve as the principal advisor to the
Secretary and to the Assistant Secretary for Health and provide
advice to the Director of the National Institutes of Health, the
Director of the Centers for Disease Control and Prevention, and the
Commissioner of Food and Drugs on issues relating to dietary
supplements including-- [0253] (A) dietary intake regulations;
[0254] (B) the safety of dietary supplements; [0255] (C) claims
characterizing the relationship between-- [0256] (i) dietary
supplements; and [0257] (ii) (I) prevention of disease or other
health-related conditions; and [0258] (II) maintenance of health;
and [0259] (D) scientific issues arising in connection with the
labeling and composition of dietary supplements; [0260] (4) compile
a database of scientific research on dietary supplements and
individual nutrients; and [0261] (5) coordinate funding relating to
dietary supplements for the National Institutes of Health. [0262]
(d) DEFINITION--As used in this section, the term `dietary
supplement` has the meaning given the term in section 201(ff) of
the Federal Food, Drug, and Cosmetic Act. [0263] (e) AUTHORIZATION
OF APPROPRIATIONS--There are authorized to be appropriated to carry
out this section $5,000,000 for fiscal year 1994 and such sums as
may be necessary for each subsequent fiscal year.`. [0264] (b)
CONFORMING AMENDMENT--Section 401 (b)(2) of the Public Health
Service Act (42 U.S.C. 281(b)(2)) is amended by adding at the end
the following: [0265] (E) The Office of Dietary Supplements.`.
[0266] Speaker of the House of Representatives. [0267] Vice
President of the United States and [0268] President of the
Senate.
[0269] However, while the invention may include dietary
supplements, thus falling under DSHEA, a great portion of the
invention may be considered to fall under the government
regulations for Foods For Special Dietary Use, as described
below.
Foods for Special Dietary Uses (FSDU)
[0270] Unlike Nutritional Supplements, there is a regulatory
definition for the term "Foods for Special Dietary Uses" defined in
the code of federal regulations (21CFR 105.3, 1996) as the
following, which shall be adopted in the present invention: [0271]
1. The term "Special Dietary Uses" as applied to food for man,
means particular (as distinguished from general) uses of food, as
follows: [0272] a. Uses for supplying particular dietary needs
which exist by reason of a physical, psychological, pathological or
other condition, including but not limited to the conditions of
disease, convalescence, pregnancy, lactation, allergic
hypersensitivity to food, underweight, and overweight; [0273] b.
Uses for supplying particular dietary needs, which exist by reason
of age, including but not limited to, the ages of infancy and
childhood; [0274] c. Uses for supplementing or fortifying the
ordinary or usual diet with any vitamin, mineral, or other dietary
property. Any such particular use of a food is a special dietary
use, regardless of whether such food also purports to be, or is
represented for general use. [0275] 2. The use of an artificial
sweetener in a food, except when specifically and solely used for
achieving a physical characteristic in the food which cannot be
achieved with sugar or other nutritive sweetener, shall be
considered a use for regulation of the intake of calories and
available carbohydrate, or for use in the diets of diabetics and
therefore a special dietary use.
[0276] Examples of the Foods for Special Dietary Use, (FSDU) are
hypoallergenic foods, infant foods, foods for reducing and
maintaining body weight, foods for the use in the diets of
diabetics, and foods to regulate sodium intake and the like. It is
certainly conceived that to have a specific and effective
functional fiber-water product, it may be necessary to be
classified as a Medical Food. The guidelines for this category
described below will be respected as such:
Medical foods (MF)
[0277] There is also a regulatory definition for the term Medical
Food, defined in the Orphan Drug Act Amendments of 1988 [21 USC
360ee (b)(3)]. This definition was incorporated by reference into
the Nutritional Labeling and Education Act (P.L. 101-535) in
January 1990. It is incorporated into the FDA's final rule on
Mandatory Nutritional Labeling, January 1993.
[0278] For the purpose of this invention, the term "Medical Food"
shall mean a food which is formulated to be consumed or
administered by mouth, (tube feeding), any way internally,
enterally, under the supervision of a physician, and/or qualified
health administrator, and which is intended for the specific
dietary management of a disease or condition for which distinctive
nutritional requirements based on recognized scientific principles
are established by medical evaluation.
[0279] To be considered a Medical Food, a product must, at minimum
meet the following criteria: [0280] 1. The product is for tube
feeding; [0281] 2. The product is labeled for the dietary
management of a medical disorder, disease, or condition; and [0282]
3. The product is labeled, "to be used under medical supervision",
and is primarily obtained through hospitals, clinics, and other
medical and long-term care facilities. Medical Foods are
distinguished form the broader category of Foods for Special
Dietary Use and from foods that make health claims, but the
requirement that medical foods be used under medical
supervision.
[0283] The term "Medical Food" does not pertain to all foods fed to
sick patients. Medical Foods are foods that are specially
formulated and processed (as opposed to a naturally occurring foods
used in their natural state) for the patient who is seriously ill
or who requires the product as a major treatment modality. Typical
medical foods are enteral nutrition products, i.e., products
provided through gastrointestinal tract, taken by mouth, or
provided through a tube or a catheter that delivers nutrients
beyond the oral cavity or directly to the stomach.
[0284] Medical foods can be classified into the following four
groups: [0285] 1. Nutritionally complete formulas. [0286] 2.
Nutritionally incomplete formulas, including individual "modular"
type products that may be mixed with other products before use
(e.g., protein, carbohydrate, or fat modular). [0287] 3. Formulas
for metabolic (genetic) disorders in patients over 12 months of
age. [0288] 4. Oral re-hydration products.
[0289] In some Foods for Special Dietary Use (FDSU) and in some
Medical Foods (MF), the need for some nutritionally essential
mactonutrient and micronutrients may decrease. However, scientific
literature does not indicate any chronic condition that the need
for, and essential macronutrient or micronutrient is totally
eliminated. Consequently, (similar to Nutritional Supplements (NS)
Foods for Special Dietary Use (FDSU) and Medical Foods (MF) must
minimally contain and declare on their package (e.g., under % Daily
Value in the Nutritional Facts table), the concentration of all
nutritionally essential macronutrients and micronutrients (13
vitamins and 14 minerals), as indicated in the Code of Federal
Regulations 21 CFR 101.9 1996 (table 1). In Foods for Special
Dietary Use (FDSU) and Medical Foods (MF), no essential nutrient is
disregarded or is given the concentration of zero (except, for a
limited time, for fat in fat-free products, and fiber in
residue-free products).
[0290] To better understand this invention it is important to have
a uniform and comprehensive understanding of the following with
some examples presented here with, or later in a natural flow:
Understanding:
[0291] 1. Solution: The process by which a gas, liquid, or solid is
dispersed homogeneously (composed of all parts of the same kind) in
a liquid without chemical change. [0292] 2. Suspension: The state
in which the particles of a substance are mixed with a liquid but
remain undissolved. [0293] 3. Emulsion: A combination of two
liquids that do not ordinarily mix, such as oil and water, in which
tiny drops of one liquid are evenly distributed in the other.
Understanding Encapsulations: An Overview
[0294] Encapsulation, and/or micro-encapsulation: is the process of
enveloping certain ingredients regardless of classification in
polymetric matrices designed to be used in controlled release which
may or may not include delayed release applications.
[0295] Coatings and encapsulations: A coating may be defined as a
layer that covers a surface. Coatings have existed since the ninth
century with the introduction of silver and gold coatings of pills
in medicine. A fine powdered talcum, called pearl coating was
popular at one time. Gelatin was introduced in 1838, sugar in
France in 1842 and twelve years later in the US. And about 1890
enteric-coated pills were introduced. This invention covers any
and/or all enrobements, which provide a function even if that
function is only decorative. Encapsulation technologies, including
but not limited to liposomes, may better serve this invention but
coated, enteric coated, encapsulated, and/or any enrobing
technology may be used simultaneously, and/or individually, by
design and/or intent. Encapsulations are important not only for
protecting sensitive ingredients, but also for masking certain
aromas and negative tasting agents.
[0296] Further, the inventor believes that employing any or all the
above can reduce the high sugar content of so many of the drinks in
existence today most primarily due to the need to mask and/or
change/over-ride undesirable tastes.
Sources, Understandings, Referenced Patents
[0297] The inventor is familiar with organizations and large
companies that are devoted to nothing but encapsulation
technologies. At this writing the inventor will call attention to a
few, as well as referencing prior art in the form of noteworthy
patents.
[0298] The International Micro-encapsulation Society, founded in
1995, Glasgow, is dedicated to foster and promote communication and
collaboration between amongst science professionals. They define
micro-encapsulations as a process that allows liquid or solid
substances to be covered by a barrier wall. The wall must be
chemically inert to the content of the capsule and possess an
adequate stability to mechanical, thermal, or chemical influence.
Various barrier wall materials may be utilized during
encapsulation, which are dependent upon the application.
[0299] The Wurster process is a coating technique that is well
suited to uniformly coat or encapsulate individual particulate
materials. The Wurster process is an internationally recognized
coating technique for precision of film coat to particulate such as
powders, crystals, or granules.
[0300] The coating of pharmaceutical and/or nutraceutical
micro-encapsulations helps ensure and optimize stability and
prolong shelf life of reactive ingredients.
[0301] Capsules may be coated for improved barrier properties.
Coating is a most effective way of masking the taste or odor of a
particular ingredient, making products more palatable. Enteric
coatings can be adjusted most easily to controlled and/or timed
release for the maximum health benefits. In the food industry
micro-encapsulations are beneficial especially to encapsulate
vitamins, minerals, and functional food ingredients. Thin or
partial coatings are very effective in reducing the caking of
certain materials.
[0302] The Southwestern Reserve Institute has been a leader in
micro-encapsulation research, development, and prototype production
through most of its 51-year history. SwRI scientists and engineers
use physical and chemical encapsulation techniques along with
various coating materials that offer specialized microcapsule
release characteristics. During 1998, approximately 50
micro-encapsulation research projects were conducted for the food,
nutraceutical (health food), pharmaceutical, cosmetic, personal
care, consumer product, agrochemical, veterinary medicine, and
chemical industries.
[0303] Consumer products make up one of the largest market sectors
for the SwRI micro-encapsulation program. The Institute's
contributions in micro-encapsulation technology have led to
advances in detergents, bleaches, carpet cleaners, deodorants,
antiperspirants, toothpastes, and paints. Microcapsules prepared
for these applications range in size from less than a micrometer to
several thousand micrometers.
[0304] SwRI uses a variety of micro-encapsulation technologies to
produce edible coatings for food components. Encapsulation of
acidulates, aromas, bacteria, flavors, nutritional oils and
supplements, vitamins, minerals, dietary fibers, leavening agents,
and peroxides is used for improved taste and odor masking, for
controlled-release applications, or for improved thermal,
oxidative, and shelf-life stability.
[0305] SwRI scientists, working with Enviroquest Ltd. of Cambridge,
Ontario, Canada, successfully co-developed and co-patented a
microencapsulated medicament for ingestion by honeybees and other
beneficial insects. The product was tested in beehives against
tracheal mites. In the study, encapsulated menthol was delivered to
honeybees' blood (haemolymph) and killed the mites. The
encapsulated menthol also showed excellent shelf life. Additional
trials are scheduled, and U.S. Food and Drug Administration
approval is pending. SwRI will continue to assist in the
development and manufacture of the product.
[0306] SwRI scientists conduct micro-encapsulation research and
development for a variety of applications, including industrial,
agrochemical, food, and consumer products.
[0307] Bio Dar was established in 1984 as a United States and
Israeli joint venture now under LycoRed, Koor Group of Companies.
They are specialists in microencapsulated vitamins and minerals for
the fortification of food products. Their specialty extends to
technologies of how to keep the food additive particle from
imparting an undesirable taste to the surrounding ingredients. This
technology is most valuable for where the micro-encapsulations are
mixed in with the other ingredients and this technology is
critically important to this invention.
[0308] Further they deal with Carnetine, Amino Acids, Herbal
Extracts, as well as other nutritional components where the role of
micro-encapsulation is to avoid hygroscopicity, minimize
interactions, and eliminate the oxidation of these materials.
Further they have the ability to do multiplayer
micro-encapsulations for mainly drug delivery. U.S. Pat. No.
4,749,575 to Rotman, (Bio-Dar Ltd. IL), titled Microencapsulated
medicament in sweet matrix.
[0309] In addition to encapsulated, micro-encapsulated,
microparticled, digestive and systemic uses, enzymes can also be
used in fiber-water formulations containing encapsulated,
micro-encapsulated, micro-particled, herbals (extracts and/or the
like), vitamins, minerals, and various other diagnostics,
therapeutics, dietary supplements, nutraceuticals, pharmaceuticals,
and/or the like known to those skilled in the art, because, in
combination, they provide a number of unique opportunities,
including, but not limited to: [0310] (1) Improved absorption
[0311] (2) Improved bio-availability [0312] (3) Improved
stability
[0313] (4) Maximized activity [0314] (5) Balance the body various
systems (example; PH, hormones) [0315] (6) Diagnose Delivery
Sequencing:
[0316] Within the present invention, an "effective amount" of a
composition is that amount which produces a statistically
significant effect. For example, an "effective amount" for
therapeutic uses is the amount of the composition comprising an
active compound herein required to provide a clinically significant
Such effective amounts will be determined using routine
optimization techniques and are dependent on the particular
condition to be treated, the condition of the patient, the route of
administration, the formulation, and the judgment of the
practitioner and other factors evident to those skilled in the
art.
[0317] The dosage of the compounds of the invention will vary
according to the extent, and severity, of the need for treatment,
the activity of the administered compound, the general health of
the subject, and other considerations well known to the skilled
artisan. The inventor here is hoping, that through this invention
medicants and/or the like can be administered on a daily basis as
an oral dose.
[0318] While dietary oral administration may be preferable in most
instances (for reasons of ease, patient acceptability, and the
like), alternative methods of administration may be appropriate.
This can relate to any and/or all of this invention, which can be
administered by enteral feeding (naso-gastric tubes and/or
gastrostomy tube . . . detailed later). Additionally, it is
possible that there be a split between delivery vehicles on the
advice of a knowledgeable practitioner. For example it is possible
to, as an example need part of the formula in a different format
injected and then daily follow-ups orally . . . and/or the like
with any combinations known to this best skilled in the delivery of
such.
[0319] In another preferred method of the invention, the
administration of the invention conceived as to be part of the diet
(or as aforementioned in conjunction with another route), is
intermittent rather than continuous. Thus, preferred protocols may
include administering the invention once every other day, three
days, once every week, optionally, in varying amounts, at each time
of administration. Such forms of administration may be preferable
to daily administration, or to a "consistent", several times a day
dosage.
[0320] Thus, by "intermittent" administration is meant that the
invention with the compounds and/or compositions containing the
actives are provided to the subject only sporadically, with
substantial periods between dosages, or until the results are
assessed. Thus, there could be incremental intervals between
administrations.
[0321] There might be situations where there is alternation between
the administrations of one or more formulas designed to work in
consort. Or if only a single dose is administered, there might be a
substantial period, after dosage, until results are assessed. That
is, while one day 1 multiple dosages may occur (or only one) there
would be no dosage the next day, at least. Or if the dosage is on a
daily basis, a substantial interval is permitted to elapse before
results are assessed.
[0322] A single bolus dose is preferred over a multiplicity of
smaller dosages in some instances. Preferred "intermittent"
regimens would comprise administering the compounds or compositions
every other day, every two days, every five days, or on days
unevenly spaced but separated at least by a one day interval
between days on which a dosage occurred. In summary, by
"intermittent" dosage regime is meant either a single bolus dose or
multiple dosages that comprise only a small proportion of the
timeframe over which the subject is being treated. The timeframe
over which treatment is administered is measured by the time
between initial administration and assessment of the results. The
inventor feels the aforesaid most specifically refers to those that
are administered under the care of a medical professional and thus
classified as such. Additionally, they might not even appear in the
consumer marketplace, but be given directly by a health care
practitioner, in a healthcare facility, or under a prescription, or
under the advice of a healthcare practitioner as a medical food
(described in detain in this filing) and/or more than one of the
combinations above may best service the delivery.
[0323] The ability to manipulate substances in a carrier, such as
is invented here, leaves much room for further options of
controlling delivery. Just as an I.V. drip offers advantages so
does the ability to sip, over time, a drink. This, in its own
right, is considered a form of a continuous delivery.
[0324] Using this invention also provides the advantage of
continuous dosing of one or more ingredients, over time, which is
often preferred to intermittent bolus dosing. Two examples of
continuous delivery, other than an IV drip, would be the
implantable insulin pump, and subcutaneous and/or submucosal
patches such as the estrogen patch.
[0325] These are based on metering the delivery of a substance to
closely mimic the body's natural production of the said substance
(e.g. insulin) and/or another medicant. Further, and it has been
demonstrated that with the metered dose (given slowly over time) it
may not be necessary to give as much of a medication etc. as would
be necessary with a bolus dose ergo reducing and/or eliminating all
together and, if not all unwanted side effects which may present.
An understanding here is based on substances that, when
administered in a bolus dose, may be harmful at one end of the
spectrum and/or at the other end not as effective as compared to
administering a small continuous dose. An example would be
substances that may cause severe to mild gastric and/or metabolic
upset.
[0326] Vitamin C is a good example, as it is not stored in the
body, but instead excreted in the urine. Also if one is inclined to
look at the example of an endurance ingredient, like even a simple
sugar, whereby encapsulations (sized appropriate) will give a timed
release of the glucose into the blood stream hopefully avoiding a
rapid rise, and subsequent drop, of a blood sugar level. No doubt,
we need sugar for metabolism, but not so large a dose at one time,
which could upset the delicate insulin mechanism, by which the
sudden drop off (per individual) can defeat the initial purpose. By
encapsulating glucose you can get more of the effect of a slow
release carbohydrate in a different form. (The inventor is fully
aware that you cannot concentrate glucose, however later the
inventor addresses encapsulations, which are larger and resemble
beads, seeds, and/or the tapioca balls common in Asian drinks)
[0327] It is possible to have micro-micro-encapsulations within a
specific micro encapsulation. This would resemble a ball within a
ball. Each ball can be engineered so that it is contained within is
the same active, a different active, and/or a combination of one or
more actives.
[0328] In U.S. Pat. No. 5,209,978, to Kosaka et al. (Taisho
Pharmaceutical Co., Ltd. (JP) issued May 11, 1993, titled "Seamless
soft capsule and production of," we are taught that there now
exists an invention of a soft capsule composed of a plurality of
cells coalesced to each other and filling substances encapsulated
in the individual cells, the walls of at least one of the cells
being formed of a material different from a material forming the
wall of at least one of the other cells, and being seamless, thus
creating a soft capsule with a multi-cellular structure.
[0329] It is noted that the partitioning material is able to handle
substances, which might react unfavorably with each other if the
partitioning material was not properly adapted to the situation.
And additionally, by being seamless, there is not the opportunity
for leakage and/or air penetration, which would cause problems.
[0330] A multi-cellular soft capsule having its inside partitioned
by a film was recently proposed (see Japanese Laid-Open Patent
Publication No. 109520/1985). This patent document states that the
multi-cellular soft capsule is obtained by partitioning a soft
capsule shell composed of an upper film and a lower film, into two
cells by means of a partitioning film, and filling different drugs
into the two cells. As a result, two drugs, which do not mix, can
be stably included in a single soft capsule. By using materials
having different solubilities and dissolving speeds, it is possible
to cause one part of a single capsule to be released and absorbed
in the stomach and the other part, in the intestines. It is also
possible to make one part of the capsule fast-releasing and the
other part slow-releasing.
[0331] So to that end, and to those skilled in the art, and/or the
advancement of scientific skills, it is, or will be conceived that
there can be, more than just one ball inside another.
[0332] U.S. Pat. No. 6,022,500 to John et al., Feb. 8, 2000, (The
United States of America as represented by the Secretary of the
Army) titled; Polymer encapsulation and polymer microsphere
composites has claimed the ability to encapsulate an active enzyme.
The discovery is a novel method of encapsulating enzymes, other
solutes or nanoparticles in a polymer matrix. The present invention
relates to polymer microspheres suitable for the encapsulation,
stabilization and release of biologically active molecules such as
enzymes, drugs, biocides and the like. The present invention also
relates to advanced materials, especially composites of polymers
with organic or inorganic compounds. What is further most
interesting is that the polymers may exhibit a preparation of high
luminescent, (both photoluminescent and electroluminescent)
qualities.
[0333] Other patents of reference are U.S. Pat. No. 4,711,784
(Yang/Warner Lambert); U.S. Pat. No. 5,024,842 Edgren,
Theeuwes/Alza Corp.); U.S. Pat. No. 5,051,261 (Mc Ginity, Chang/FMC
Corp.); U.S. Pat. No. 5,009,819 (Popescu, Mertz/The Liposome
Company); U.S. Pat. No. 5,653,996 (Hsu/Genentech CA); U.S. Pat. No.
5,891,465 (Keller/Bio-Zone Laboratories Inc CA); U.S. Pat. No.
6,007,838 (Alving, Owens, Wassef, Nabila, U.S.A. Dept. of the Sec.
of the Army/Washington D.C.); U.S. Pat. No. 6,190,591 (van
Lengerich/General Mills MN); U.S. Pat. No. 5,922,350 (Janoff et
al./The Liposome Company NJ).
The Releasing of Encapsulations
[0334] It is further conceived, that this invention includes
encapsulations, and/or micro-encapsulations, that may be uniformly
released and/or timed released which may be in the form of
liposomes, and/or any other form that fits under the category of
encapsulations, and/or micro encapsulations. In addition,
flavoring, coloring, aromatics, pharmaceutical and/or nutritionally
active components can advantageously be encapsulated and/or
microencapsulated to ensure stability.
[0335] It is conceived that whether uniformly released or not,
controlled release, they may be nothing more than bursts of color
and/or flavoring. These as an example, might be especially
delightful to children. Encapsulations might separately, and/or
additionally, provide what might be termed as an entertainment
factor, especially if they are colored, and/or of different sizes,
and/or shapes. First, the color red may be released in the mouth,
then yellow, and resulting in a red-yellow and/or orange mix. This
can be fun and/or educational. Further, if a double membrane is
used then the encapsulations may be colored, varied, and/or
consistent. The "beads" locked between all or part of the walls of
the double membrane may or may not be fully transparent. Following
suit, the same can occur separately and/or in combination as
related to flavor. These encapsulations may follow all of the
claims here for encapsulations. If, as an example, the
encapsulation reacts with the saliva in the mouth then it is
possible to take in a liquid with no color, and suddenly you have a
colored mouth/tongue/even teeth. In this capacity it is possible to
have the liquid adhere to the teeth and ergo you can potentially
have a plaque disclosure functional fluid with or without
additional nutritive elements. (It is conceived that additional
internal diagnostically need substances can be consumed in the same
fashion) Most often timed release, or sometimes referred to as
controlled release, provides none of the aforementioned, and/or
any, and/or all, of the just aforementioned, whereby they
additionally may provide the ability to suspend the release of
active ingredients until they each the designated position along
the gastro-intestinal tract. This is most valuable in the deliver
of pharmaceuticals, nutraceuticals, OTC Drugs, diagnostics,
enzymes, pre-biotic and/or pro-biotic formulations and/or the
like.
[0336] Further, the encapsulations may be used to preserve and/or
better deliver the active ingredients to the aforesaid. Further,
they may, and/or may not, travel farther down the digestive tract
to the gut for release, all at one time, and/or over a
predestinated period. It is therefore to be claimed that any and/or
all of the just aforesaid may be included.
[0337] The microcapsules can be formulated to release their
contents when they are exposed to saliva either by fracturing
and/or dissolving. Alternatively, the microcapsules can be
formulated within the micro-beads, or other components whereby the
microcapsules then release their contents, even up to several hours
post ingestion, at a predetermined designated point along the
digestive tract. In this way it is possible to precisely deliver a
labile component.
[0338] Various and assorted encapsulated ingredients can be
included in one encapsulation regardless of form. This can mean
that there be several granules inside of one (1) encapsulation
and/or micro-encapsulations, which goes of inside of a larger
encapsulation. Encapsulation controls the stability, compatibility
etc. of ingredients, as well as the timing of ingredient release
etc. Again may be used for decorative purposes.
[0339] Encapsulations and swallowing: What must be kept in mind is
that particles must not interfere with ones ability to swallow the
liquid. Again, reminding that the viscosity altering gums and/or
the delivery of actives by encapsulations/micro-encapsulations for
swallowing purposes, and/or desirability, and/or necessity, is a
component of the invention. This includes but not limited to the
purpose of being swallowed in a way that will go virtually
unnoticed by the user.
[0340] However, it is possible, and might also be desirable, to go
noticed by the user by having a "swallowable" particle(s)
deliberately to enhance the texture of the liquid. This enhancement
of texture may also serve a valuable medical function addressing a
swallowing disorder, or in another context address those on diets
who need oral gratification of not just drinking but chewing to
feel satisfied.
[0341] There are beverages, and even in non visible to the eye
beverages, in cans in Asia. Additionally noted in Asia there are
beverages, which incorporate small seeds (chia, poppy, etc.), that
one swallows in conjunction with the ingested liquid For example,
in Asia there are beverages containing sesame seeds or other small
seeds, which are commonly consumed, and seem to present no problem
in swallowing. In the United States we have orange juice with pulp
and this, likewise, presents no problem to the consumer. If we look
at a thickened product we can project that there be many particle,
encapsulations or nit that bring forth nutritive ingredients. This
could resemble enriched noodles (like the alphabet) in soups.
[0342] However, the inventor has a range of intentions which will
present a much lesser feeling of "particles in liquid" than the
aforementioned, and certainly no greater than, or close to, the
size and texture of the aforementioned, unless so desired for a
specific use and under the guidance of those in the medical
profession. While other particles are to be considered an inclusion
in the invention, in this instance the inventor is specifically
referring to a "swallowable" encapsulation(s).
Encapsulations Present to Ensure the Bio-Availability of
Ingredients, in Integrity, to the User:
[0343] Often, delicate and unstable ingredients are not
bio-available to the user. Many actives, which are delivered to the
oral cavity, or directly into the stomach, are altered and/or
partially or wholly destroyed by the saliva and/or stomach acids
and therefore become, in part or in total, bio-unavailable to the
system or human system. Therefore, the process of specific design
and execution of the encapsulations becomes critically important.
Although the inventor may have an understanding and/or ideas in
relation to how best to circumvent technical problems there are
those skilled in the art of encapsulations and prior existing art,
which are far more qualified. The inventor has noted some of the
just said previously, but will include a list here of referenced
patents specifically addressing this technology and the variations
of. [0344] 1. U.S. Pat. No. 6,033,888 to Batich et al., (U. of FL.
Gainsville), titled Process for microencapsulating cells. This
patent addresses both the injectable and/oral administration of
encapsulations. The compositions and methods of the subject
invention are illustrated herein with reference to encapsulation of
certain bacteria. Bacteria, which produce a useful product can be
encapsulated and introduced into a human or other animal. The
encapsulation of bacteria is specifically exemplified herein by the
encapsulation of Oxalobacter formigenes. The encapsulated O.
formigenes can be introduced into a human or animal and the
bacteria continue to produce and release enzyme but are not subject
to attack from the immune system. For oral administration,
multi-encapsulated microspheres of cellulose acetate phthalate in
poly-2-vinylpyridine (pKa=3.5) were prepared to protect the enzymes
from gastric juices. Polymeric matrix micro-encapsulation of
microorganisms is a relatively new technology, which has
potentially major implications in the treatment of various
afflictions. Examples of afflictions in which treatment involving
microcapsules could be advantageous are diabetes and urinary stone
diseases. [0345] a. Insulin dependent diabetes mellitus (IDDM) is a
severe disease, which afflicts millions of Americans, causing
substantial disruption of lifestyle and often resulting in severe
health problems. The exact causes of IDDM have remained largely a
mystery, despite years of intensive research on this disease. It is
now widely recognized that IDDM is an autoimmune condition whereby
the body's natural immunological defenses destroy the .beta.-cells
of the pancreas. Beta.-cells are responsible for the production of
insulin, and, once a substantial portion of the .beta.-cells are
destroyed, those individuals afflicted with the disease must rely
on exogenous sources of insulin, usually in the form of injections.
The success of pancreas or islet cell transplantations is very
limited because of immune responses typically mounted by the
recipient against the foreign cells. [0346] Urolithiasis, or
urinary stone disease, is a common urinary tract problem afflicting
more than 10% of the U.S. population. Urinary tract stones are
usually classified according to their composition, with the most
frequently encountered (70%) being the calcium stone composed of
calcium oxalate alone or calcium oxalate mixed with calcium
phosphate. Although precipitation of calcium oxalate depends on a
urine saturated with both calcium and oxalate ions in a metastable
state, it has been argued that the oxalate ion concentration is
more significant in the formation of urinary calcium oxalate
stones. Thus, the management of oxalate in individuals susceptible
to urolithiasis would seem especially important. The majority of
oxalate in plasma and urine is derived from the endogenous
metabolism of ascorbic acid, glyoxylate, and to a lesser degree,
tryptophan. In addition, between 10% and 20% of the urinary oxalate
is absorbed from the diet, especially through ingestion of leafy
vegetables and plant materials, although there is disagreement in
the literature about the relative amounts of diet and endogenous
oxalate. Ingestion of ethylene glycol, diethylene glycol, xylitol,
and excess ascorbic acid can lead through metabolic conversions to
disorders of excess oxalate. Use of methoxyfluraneas an anesthetic
can also lead to oxalosis. Aspergillosis, infection with an
oxalate-producing fungus, can lead to production and deposition of
calcium oxalate. Other causes of excess oxalic acid include renal
failure and intestinal disease. It is believed that lowering the
oxalate levels in the plasma, and subsequently the urine, would
decrease the incidence of calcium oxalate stone formation.
Unfortunately, there are no known naturally occurring oxalate
degrading or metabolizing enzymes in vertebrates. Catabolism of
oxalic acid appears restricted to the plant kingdom. [0347] 2. U.S.
Pat. No. 5,571,441 to Mark Andon (The P&G Co. Cincinnati,
Ohio), tided Nutrient supplement compositions providing physiologic
feedback brings forth the importance of being able to add nutrition
to existing products. However this patent relies only on the novel
composition, not on the novel delivery into water, a water-like
composition, and in this case based on the patent issued on
fiber-water via encapsulations with the benefits and versatility
they bring forth. It is noted here that the inventor acknowledges
the stated invention but perceives that under her "novelty" if one
or more stimulants are added to a water composition water
composition that they be encapsulated and released at different
rates so that the consumer does not get that "buzz" or immediate
release effect and then the drop off, but instead a steady
controlled release overtime. [0348] a. (The inventor here,
Stillman, claims that while many substances have been encapsulated,
no one has encapsulated stimulants with the specific intent, shall
we say of preventing "the bolus dose jitters" and "unsteadyness"
commonly associated with the "all at once ingestion" of such
stimulants. (Also relating to caffeine which effects colon motility
it mau present an advantage to time release caffeine for that
reason as well) [0349] b. The importance in the Andon Patent is
that it references the following: "Vitamin and mineral supplements
for human and veterinary use are commonplace. Nutrient intake
surveys have shown large segments of the world's population
consumes substantially less than the recommended amounts of
numerous vitamins and minerals. For example, in the U.S.A. 60%, or
more, of females' age 20-29 years consume less than the recommended
dietary allowance of vitamins A, E, B-6, folic acid, and the
minerals calcium, magnesium, iron, and zinc. It is generally known
that some diets, heavy physical exercise and disease conditions may
require the intake of considerable quantities of vitamins and
minerals apart from those generally available from what is
considered a normal diet. Nutritional supplements are primarily
important for those who have inadequate diets, however, individuals
with a reduced ability to utilize or absorb vitamins and minerals
from food, e.g., the elderly, also need nutritional
supplementation. [0350] c. A physiological signal that many people
are accustomed to is the alertness response received by food-type
tonics or bracers, such as caffeine. These materials can be useful
for creating a perceived benefit and for establishing more regular
use of nutritional supplements. These natural bracers, and in
particular, the xanthine alkaloids (methylxanthines) are found in
various plants. The methylxanthines are obtained by extraction of
plants (e.g. coffee beans, cola nuts, tea plants). Plants
containing methylxanthines are known to those skilled in the art.
Preferred methylxanthines are 1,3,7-trimethylxanthine (caffeine),
1,3-dimethylxanthine (theophylline) and 3,7-dimethylxanthine
(theobromine). Many people establish a consistent pattern of
caffeine use due to its well-documented effects as a tonic. One or
more caffeine containing food or beverages-cocoa, chocolate,
coffee, tea, soft drinks--are consumed daily by most adults and
children. Cocoa and chocolate contain only small amounts of
caffeine and are not usually consumed for the same reason as
coffee, tea, and soft drinks. [0351] d. Although it is clear that
many people consume caffeine and other related tonics, there are
well-recognized problems with the usual caffeine containing foods.
Many people consume much affricated coffee in the morning. Coffee
is known to stimulate the gastric mucosa and increase stomach acid
secretions, which contributes to heartburn and irritation of
ulcers. Coffee is also bitter tasting, so some people consume
caffeine in the form of soft drinks. The high acid content of soft
drinks, phosphoric for colas and "pepper" type soft drinks and
citric acid for fruit flavored type beverages is well documented to
etch or erode the enamel of the tooth surface. In addition, cola
and "pepper" type soft drinks contributed greatly to the total
phosphorus intake of the diet which imbalances the calcium to
phosphorus ratio and can cause a negative effect on bone
metabolism. Tea is another widely consumed source of caffeine but
it also has some negatives associated with it. Tea contains
anti-thiamin factors, which stress the thiamin stores in the body
and can lead to poor thiamin nutritional status. In addition, teas
are often consumed with lemon and/or sugar. The lemon can increase
the risk of dental erosion due to etching of the teeth from the
high citric acid content and the sugar can provide a source of
fermentable carbohydrate to the oral bacteria, which increases the
risk of caries. Apart from the negative effect of caffeine
containing beverages, many people look for alternative ways to
provide alertness benefits. [0352] e. It would be desirable to
provide the sought after bracing effects of caffeine or other
similar ingredients in a composition, which eliminates the negative
effects of normal caffeine source carriers, and yet provides a
convenient and effective composition for promoting good health.
[0353] f. Thus, an object of the current invention is to provide
compositions of vitamins and/or minerals and a central nervous
system tonic in a convenient dose form. These compositions would
provide vitamin and mineral supplements with a noticeable
physiologic response and also the desired alertness effects without
the negative components associated with typical caffeine containing
beverages. It is an object of this invention to provide nutritional
supplements which provide the physiologically positive alertness
effects of a bracer." [0354] g. Some people avoid caffeine due to
health reasons, i.e. the effect of caffeine on elevating blood
pressure. It would be desirable, therefore, to have additional
nutritional supplements, which provide a physiological signal other
than those of methylxanthines. Green tea is believed to have a
relaxing benefit owing to the presence of flavanols (i.e., the
catechins and epicatechins). Green tea has had several physiologic
benefits attributed to it. It is believed to lower blood pressure
and have other soothing and healing effects. These benefits have
been attributed to flavanols. Black tea contains polymerized
flavanols, which do not impart the same degree of benefits of
catechins and epicatechins. [0355] h. Compositions comprising
vitamins and/or minerals and flavanols would be useful as a
convenient dose form for improving the diet while also providing a
physiologic response and combined benefits of flavanols with those
of vitamins and minerals to yield a more comprehensive product for
the promotion of health. [0356] i. It is further recognized that
certain individuals seek the benefits of caffeine or similar
ingredients, but closely control the amount of caffeine they ingest
due to sensitivity to caffeine or because of caffeine's undesirable
effects (i.e. the promotion of nervousness). For some people, the
negative effects of caffeine may eventually outweigh the positive
so that caffeine is avoided altogether. Tea contains caffeine.
However, the caffeine in tea does not appear to be as
physiologically available due to the presence of flavanols. It is
well known that the flavanols, in particular the unoxidized
flavanols, present in green tea, help to control the negative
effects of caffeine. See, for example, French Patent No. 2,586,532
issued to Balansard et al. [0357] j. Vitamin and mineral
supplements having unique compositions containing a bracer, such as
caffeine, along with the beneficial effects of flavanols or green
tea would be useful for improving nutritional status and providing
positive alertness benefits while limiting the negative effects.
[0358] k. Both caffeine and flavanol containing products are
primarily consumed in the morning to obtain an alertness effect.
Typically vitamins and minerals are also consumed in the morning.
It would be more convenient if the nutritional supplements,
methylxanthines and flavanols could be administered conjointly in a
form, which would provide nutritional supplementation and alertness
without negative effects. These nutrient supplement compositions
would be useful in providing a physiologically positive alertness
benefit while providing feedback beneficial in establishing more
regular use of a supplement. [0359] l. The uses of methylxanthines,
and/or flavanols are known in pharmaceutical and therapeutic
preparations. The methylxanthines have primarily been used to treat
various problems such as asthma, abdominal complications, and
migraine headaches. However methylxanthines and in particular,
caffeine, is used to counteract the adverse effects (i.e.
drowsiness) caused by other ingredients in the pharmaceutical
preparation. The flavanols, have been used for centuries to combat
numerous diseases and illnesses, both real and imaginary. While the
beneficial effects of methylxanthines and flavanols, in particular
caffeine and green tea are suggested by the literature, the use of
these materials in conjunction with vitamin and mineral supplements
or the co-administering of the materials with vitamins and minerals
in a convenient form is not known. [0360] m. It would be desirable,
therefore, to have vitamin and mineral supplements containing
flavanols and methylxanthines or flavanols alone wherein
physiological feedback is achieved. [0361] 3. U.S. Pat. No.
5,681,606 to Hutchison, et al. (R. P. Scherer, Troy, Mich.),
titled: Method of preparing a water-based beverage, it is noted, by
the inventor as documentation of how viable it is to encapsulate
ingredients to go into a water-based beverage. However, this is a
separate unit to be added to the water-based beverage and not
already present in the water-based beverage, as in Stillman,
whereby the actives will be released once ingested by the consumer.
This invention releases ingredients into the beverage, and makes a
valid point for releasing at the bottom of the beverage inside the
container, which in total concept is important in supporting, but
is not the invention of Stillman, as the encapsulated ingredients
release when in contact with the liquid. Extrapolation is as
follows: "A method is disclosed of preparing a beverage in the form
of a dilute aqueous solution, suspension or dispersion of an
encapsulated product. The capsule is added to a potable liquid, and
the capsule material breaks down when submerged in the liquid to
release its contents and itself dissolve. A primary advantage of
providing the product in this way is that it can be confined within
the capsule in liquid form, and can therefore disperse or dissolve
in water more readily. Additionally, the capsule would normally
sink to the bottom of the body of water before releasing its
contents, thereby ensuring that the contents are released within
the body of water, and not at the surface thereof. Overview of
Changing Viscosities and the Importance of
[0362] Viscosity is an internal property of a fluid that offers
resistance to flow. For example, pushing a spoon with a small force
moves it easily through a bowl of water, but the same force moves
mashed potatoes very slowly.
[0363] Viscosity changing additives, regardless of their source,
present many advantages previously addressed. (Viscosity changes,
especially in beverages, are also used for those with swallowing
difficulties. Viscosity changes give the consumers a feeling of
being full and will, in many cases, satisfy and/or ameliorate
hunger pangs. (A thicker product is a viable consideration for
dieters).
[0364] More noteworthy is the fact that several, viscosity-changing
additives are classified as fiber ergo boosting the amount of
health promoting and enhancing soluble dietary fiber. As an
example, the gums fall into this category. Then to notice with each
gum comes forth individual and/or overlapping healthful
value(s).
[0365] The inventor is looking at the entire range of gums, working
individually and/or in consort to achieve special qualities and
desired effects. As an example, in conjunction with gelatin, or as
a substitute for, additives, regardless of category may be
impregnated into the gummy by those qualified in the art and/or
encapsulations may be in held in the gummy (inventor's U.S. patent
application Ser. No. 09/936,209 CIP of PCT/US 01/09171 titled:
Method of Hydration: Infusion Packet System(s) Support Member(s)
Delivery System(s) and Method(s) with Business Model(s) and
Method(s). Gums, and gum systems, can improve mouth feel, content,
and suspend encapsulations, as they can any particle(s), fleck(s)
and/or the like. The same hold true for pulp (most commonly in
citrus juices). An example is [0366] 1. Novartis.RTM. guar gum,
Benefiber.RTM. which addresses bowel regularity. [0367] 2. Tic Gums
(Belchamp, Md.), as an example, offers a wide range of gums which
can be used alone and/or in combination such as: [0368] a. Agar is
produced from red seaweed and comes in two species: Graciliaria,
which forms firm gels, and, Gelidium, which forms soft gels. [0369]
b. Agaroid.RTM. [0370] Agaroid.RTM. RS, line of readily soluble
Agar systems, can be used to create gels and other textures.
Agaroid RS can replace gelatin in many applications and are
certified kosher. [0371] c. Alginate [0372] Alginate is a
gel-forming gum extracted from brown seaweed. [0373] d. Gum Arabic
[0374] Gum Arabic is used to encapsulate flavors, emulsify
beverages, boost soluble dietary fiber, coat candy shells, and
control water in baked goods. [0375] e. Aragum.RTM. [0376]
Aragum.RTM. gum systems are built on the foundation of dried gum
arabic and incorporate other gums to take advantage of unique
synergies. [0377] f. Caragum [0378] Our Caragum line consists of
gum systems specially designed to extend locust bean gum in a
variety of applications. [0379] g. Carrageenan [0380] Carrageenan
is extracted from red seaweed and is available in three different
forms: kappa (gelling), iota (gelling), and lambda (non-gelling).
Most often Carrageenan provides set to puddings, binds water in
meat products, and improves mouthfeel in milkshakes. [0381] h.
Colloids [0382] TIC Pretested.RTM. systems are formulated using
various gums to take advantage of the functional properties of each
individual ingredient as well as the synergies created when the
ingredients are combined. [0383] i. Freedom Gum [0384] Eliminate or
reduce the need for costly propylene glycol alginate in beverages
and salad dressings. [0385] j. Gum Acacia [0386] Brings forth
excellent emulsification and binding properties. Used as emulsifier
of flavor emulsion concentrates, used in formulation of "cloud"
emulsions, as a foam stabilizer in beer, as a clarifying agent in
wines. Additionally gum acacia functions to lower cholesterol. A
product recommendation from Tic Gums is their TIC PRETESTED.RTM.
Colloid 1004 "T" Powder which dissolves in Cold Water, used in
relation to citrus pulp which was developed for line of fruit
drinks containing Pulp & Fat (emulsifies coconut cream &
suspends pineapple pulp). Used at 0.15% to 0.30%. Heat Stable at
low pH. Drinks, Pulp Suspension [0387] k. Guarcel.RTM. [0388] The
Guarcel.RTM. offers relatively low-cost thickeners with the protein
reactivity of cellulose gum. Guarcel improves suspension and
stability characteristics. [0389] l. GuarNT.RTM. [0390] GuarNT.RTM.
Bland products offer the thickening benefits of Guar Gum, without
the grassy odor or mealy taste typically associated with Guar.
[0391] m. Locust Bean Gum [0392] Locust Bean Gum retains moisture,
reduces syneresis, and improves texture, and creates smooth
meltdown. [0393] n. Nutriloid.RTM. [0394] Boost the soluble dietary
fiber level, improves mouth feel, and modifies the texture of
functional foods, all-natural, non-GMO Nutriloid gums. I about 85%
soluble dietary fiber on a dry weight basis. [0395] o. Pectin
Extracted from the rinds of citrus fruit, TIC Pretested.RTM. Pectin
is an all-natural gelling agent usually used for jams and jellies,
stabilizes acidified milk products, and adds mouthfeel in
beverages. Both low methoxyl (LM) and high methoxyl grades of
pectin are available. [0396] p. Pre-Hydrated.RTM. [0397]
Pre-Hydrated.RTM. Gums disperse without lumping, even with minimal
agitation [0398] q. Saladizer.RTM. [0399] Improve mouth feel and
cling, stabilize emulsions, suspend spices, and reduce fat using
our specially designed gum systems. [0400] r. Ticagel.TM. [0401]
Specially formulated to yield distinct gelling and viscosity
characteristics, our Ticagel.TM. line of thickeners and gel formers
are used in a variety of applications. Current uses include
improving mouthfeel of acidified beverages. [0402] s. Ticaloid.RTM.
[0403] Our unique TIC Pretested.RTM. systems are formulated using
various gums to take advantage of the functional properties of each
individual ingredient as well as the synergies created when the
ingredients are combined. [0404] t. Ticalose.RTM. CMC [0405] Create
clear viscous solutions with our Ticalose.RTM. CMC. Also known as
cellulose gum or carboxymethyl cellulose, Ticalose CMC is available
in a range of viscosities and mesh sizes. Ticalose CMC thickens
reduced sugar table syrups, improves texture. [0406] u.
Ticaxan.RTM. Xanthan [0407] Produced using fermentation, our
Ticaxan.RTM. Xanthan is a multi-purpose thickener and stabilizer.
Commonly used in salad dressings, Xanthan gum is tolerant to
extreme heat, pH, and salt conditions. [0408] v. Tragacanth
Replacers [0409] TIC Gums has developed a full line of tragacanth
replacers, which offers superior emulsion stability. They are
relatively unaffected by pH and heat. Tragacanth replacers can
thicken and emulsify. [0410] NEED the gray boxes off to the left
off off off Understanding Viscosity
[0411] Perhaps the cart has been put before the horse however it is
most important to be well versed on viscosity. There are many ways
to measure viscosity, including attaching a torque wrench to a
paddle and twisting it in a fluid, using a spring to push a rod
into a fluid, and seeing how fast a fluid pours through a hole.
Then there is the exercise, which uses one of the oldest and
easiest ways: that is to simply see how fast a sphere falls through
a fluid.
[0412] In this invention all encapsulations are not necessarily
spheres, a sphere at this time shall serve as a good example. The
faster the sphere falls, the lower the viscosity. This makes sense:
if the fluid has a high viscosity it strongly resists flow, so the
sphere falls slowly. If the fluid has a low viscosity, it offers
less resistance to flow, so the ball falls faster.
[0413] The measurement involves determining the velocity of the
falling sphere. Dropping each sphere through a measured distance of
fluid, and measuring how long it takes to traverse the distance
accomplish this. Thus, you know distance and time, so you also know
velocity, which is distance/time.
[0414] The formula for determining the viscosity is impressive,
decorated with Greek letters and a squared term, but simply amounts
to multiplying some numbers and then dividing by some others:
viscosity = .eta. = 2 .times. ( .DELTA. .times. .times. .rho. )
.times. ga 2 9 .times. v ##EQU1## [0415] Delta p=difference in
density between the sphere and the liquid [0416] G=acceleration of
gravity [0417] A=radius of sphere [0418] V=velocity=d/t=(distance
sphere falls)/(time of it takes to fall)
[0419] This equation makes sense in that spheres that fall slowly
have low velocities. This makes the denominator small, so the
answer (viscosity) is large. Viscosity is measured in units of Pa s
(Pascal seconds), which is a unit of pressure times a unit of time.
This is not especially intuitive. How does it relate to flowing
liquids? One-way of looking at it is to realize that pressure is
force per square area. This makes a little more sense: force
applied to the fluid, acting for some length of time. [Note: the
exercise uses kilograms, meters, and seconds, rather than grams,
centimeters, and seconds. Viscosity can be measured in g-cm-s, with
the resulting unit called the poise; 10 poise=1 Pa s. You may
prefer those units to kg-m-s because densities are the more
familiar grams per cubic centimeters.]
[0420] It is also critical to look at the density of the
encapsulations (and/or any particles which may not contain
encapsulations) for which they may vary due to one or more factors.
Using spheres of different radii and densities and measuring the
viscosities of at least two liquids gives a good idea of this
unusual physical property and the power of an equation to predict
behavior. For example, if group A uses a marble (density of about
2800 kg/m) and group B uses a steel ball bearing (7800 kg/m.sup.3),
and both measure the viscosity of the same liquid, they will find
that the velocities differ, but the viscosities will be the same,
within the error of measurement. TABLE-US-00001 Viscosity of Water
Absolute Temp Viscosity Kinematic Viscosity .degree. F. Centipoises
Centistokes SSU ft.sup.2/sec 32 1.79 1.79 33.0 0.00001931 50 1.31
1.31 31.6 0.00001410 60 1.12 1.12 31.2 0.00001217 70 0.98 0.98 30.9
0.00001059 80 0.86 0.86 30.6 0.00000930 85 0.81 0.81 30.4
0.00000869 100 0.68 0.69 30.2 0.00000739 120 0.56 0.57 30.0
0.00000609 140 0.47 0.48 29.7 0.00000514 160 0.40 0.41 29.6
0.00000442 180 0.35 0.36 29.5 0.00000385 212 0.28 0.29 29.3
0.00000319
[0421] Understand viscosities as related to the valuables
associated with the encapsulations and with the relation to the
surrounding fiber-water is very critical in designing the to be
invented products. As can be noted in the above chart the
temperature of the liquid/water can change the viscosity. This will
be taken into consideration by those knowledgeable in the art. With
that understand the inventor will rely on the experts in such
technologies as deemed necessary to create exactness/consistency in
product(s).
[0422] With multiple viscosities in one clear container and each
having a different color, it is possible to layer a drink in a
container, best visible like a bottle, by filling it with layers of
different viscosities (best if colored) and even if put in all
together (or in a predetermined arrangement) with time the layers
will settle according to viscosities. If the layers are also
flavored, (the flavoring can or cannot be associated with the
color) then it is possible to have a drink where first you get the
red/cherry and then the orange/orange and then the yellow/lemon
etc. Or the red can be lemon etc. When the bottle is still for a
specific amount of time, the layers will sort out. Even a rainbow
can be layered. What fun for children to drink from this bottle
whereby they get all mixed up and then watch them settle again.
Additionally different layers can bring forth different
additives.
Understanding the "Lava Lamp" Concept as a Delivery System for a
Beverage
[0423] The main association here is that you do not change the
viscosity of the entire product, but selectively you use one or
more viscosities that do not necessarily stay in suspension but
move around at will, and/or in the hands of a consumer, as an
example, or both. It is conceivable that much remains clear, while
other portions may cloud, but all has a negligible taste factor.
The delivery is the action along with ancillaries such as color,
aroma etc. regardless of employed delivery system.
[0424] Aroma can come from the bottle cap the headspace/nitrogen
(PepsiCo patents as noted in this document later). Aroma is
certainly an important factor in appeal and not discounted at all
by this inventor.
[0425] Further, color can denote grades/strengths of fiber, or just
color for color's sake. Or the same holds true for viscosity
modules, encapsulations, etc. Color can denote what is in each
encapsulation(s) in terms of additives, quantities, and/or the
like. Any coding system can be used.
[0426] In the 1960 an Englishman developed what was to be called a
"Lava Lamp." To inventor Stillman this concept of float and
changing elements can now be shifted to reside inside a beverage
bottle serving to entertain and expanded so as to deliver added
health benefits, along with hydration, is most intriguing.
[0427] The commercial name "Lava Lamp" is used here as a
descriptive to presents a case whereby two contrastingly colored,
immiscible liquids are contained in a bottle-like chamber. However
the Lava Lamp needs a heat source, which was located in the base.
The heat from the source causes one of the two liquids to in effect
"boil," producing a slow but observable upward flow of large
globules of the one liquid relative to the other. Upon moving away
from the heat source, the globules cool and tend to settle toward
the heat source. Thermal currents in the liquids produce an
ever-changing geometry of the globules. Light directed through the
bottle-like chamber enhances the visual effect produced. When the
globules settle they are again reheated and the process repeats
itself producing a continuously changing display until the heat is
removed.
[0428] In the drink concept, here invented, the product in the
container can be heated, (or chilled), which will transpose to
affect the viscosities of the product inside. This will in effect
affect the "globulization" of the particle mass inside. Those
skilled in the art shall most efficiently design within the
confines of the manufacturing and honor the integrity of the
contained property.
[0429] Further it is conceived that the container, regardless of
the material be so designed, and/or adjusted using the laws of
physics, including but not limited to using the technologies
covering heat and cold, light and dark, gravitational forces, etc.
to "best fit" the intention of the movement.
[0430] The inventor notices that other devices utilize the
influence of gravity to produce visual effects. One such device is
of the type described in U.S. Pat. No. 3,564,740 to Calfee, in
which a multi-compartment display device is provided with liquids
of different specific gravities stored therein. The visual effect
produced by the relative movement of the liquids is obtained by
inverting the device like an hourglass to produce the gravity flow
of the heavier liquid in the downward direction with the consequent
upward displacement of a lighter liquid. The flow of liquids is
accomplished by a "valving", or porting arrangement in barriers or
partitions, which divide the several compartments of the display
device, one from the other.
[0431] In U.S. Pat. No. 4,034,493 to Ball (Whamo-O Mfg. Co., San
Gabriel, Calif.) titled; Fluid novelty device the inventor notices
that Ball compares his invention to that of Calfee as follows. The
relative flow of liquids of different specific gravities, utilized
in the Calfee, (U.S. Pat. No. 3,564,740) can be utilized by the
present invention, but with several important differences. In the
first instance the beading or droplet forming action is provided by
the liquids themselves as the heavier liquid flows around baffles
and obstructions in its flow path without the use of ports or
valves of any kind. In addition, because the invention utilizes a
pair of plates defining a narrow chamber for the liquids, the color
contrast and visual effect is maximized because each of the liquids
abuts the inside surfaces of the plates and are viewed directly
through the plates.
[0432] In Calfee one liquid flows through the other interiorly of
the container walls and the view thereof is obscured to the extent
that the line of sight to the drops of the first liquid passes
through said other liquid. In the Ball patent a display device,
consisting of a sealed chamber, defined by two closely spaced panes
or plates of a transparent or translucent material. Liquids of
different specific gravities and selected viscosities are located
in the chamber. In operation, the device is inverted and the liquid
of the heavier specific gravity flows through the liquid of the
lighter specific gravity in distinct, spaced apart beads or
droplets under the influence of gravity. The downward flow of the
heavier liquid causes the upward displacement of the lighter
liquid. A series of obstructions of various shapes and geometric
configurations are interposed in the flow path of the heavier
liquid to change its flow path and create the visual display.
[0433] It is also possible to add decoration to the drink, which
may, or may not, bring forth one or more healthful additive. These
may be in the form of dots, (not encapsulations) flecks, or
anything that would be considered a particle that is visible. It
may also be defined as a candy with or without the typical
characteristics of a candy. U.S. Pat. No. 6,416,800 to Weber et
al., issued Jul. 9, 2002, titled Fiber optic candy teaches an
edible fiber optic light source is combined with confectioneries,
in particular candy, to form a safe edible material possessing
unusual combinations of internally generated colors and optical
images. The basic design consists of a edible food pipes that may
be placed within various confectioneries or foodstuffs that elicits
light of various colors and intensities while standing untouched
and even as the product is ingested. This effect may be use for
frozen products, as the inventor has covered in fiber-water (U.S.
Pat. No. 6,248,390) Popsicle.RTM. and ice cubes and ergo they are
considered to be covered in this application as well.
Ingredient Categories:
[0434] In the present invention, the term "edible" means safe or
fit to be eaten. The term "digestible" means to transform into an
assimilable state.
Understanding Soluble Fiber
[0435] Fiber or "roughage" is a component of food that remains
undigested as it passes through the gastrointestinal system. The
vast majority of dietary fiber consists of polysaccharides of plant
origin. The most obvious fiber is the cellulosic wall that
surrounds plant cells. Many of these cells are actually called
"fibers", hence the name "fiber" for this dietary component.
However, there are actually two forms of fiber: insoluble
fiber--the classic cellulosic material, and soluble fiber--water
soluble polysaccharides that are not digested by human or carnivore
digestive systems. Both types of fiber bind considerable water and,
thus, have a softening effect on the stool. However, soluble fiber
may, depending on the precise polysaccharides involved, be
metabolized or partially metabolized directly by bacteria in the
colon. Both type of fibers tend to increase motility within the
gastrointestinal tract thus speeding transit time of wastes and
lowering the risk of acute and chronic medical problems. Like
water, fiber is essential for human health and is not metabolized
by humans.
[0436] It has been discovered that dietary fiber appears to
moderate the rate at which sugars and fats are absorbed from the
intestine. The exact reason for this effect is not completely
understood. In the case of simple sugars, slowed absorption
translates to a more gradual rise in blood sugar following eating.
This is important in the managing of diabetes and may also help
prevent adult onset diabetes. In the case of fats, the fiber seems
to help prevent damaging levels of cholesterol in the blood. This
seems to be due to a binding of bile salts and cholesterol to the
fiber so that these materials are excreted with the feces rather
than being absorbed or reabsorbed. Studies show adequate fiber
clearly lowers the risk of heart disease and tends to bind toxins,
including toxic metals, allowing them to exit safely from the
digestive system.
[0437] In fact, it has been suggested that deficiency in dietary
fiber is related to numerous disease states, including colon
cancer, heart disease, cerebral apoplexy, appendicitis, and
diabetes. This is apart from those diseases more closely linked to
constipation, such as intestinal toxemia, hemorrhoids, irritable
bowel syndrome (IBS), colitis, diverticulitis, varicocele, and
cholelithiasis (gall stones). It is believed that dietary fiber
performs various useful physiological functions including reduction
of serum cholesterol, limitation of insulin secretion, and
acceleration of bowel evacuation. All these factors make fiber a
very important nutrient substance, the sixth most important by some
commentators, although it is not actually metabolized.
[0438] Any water-soluble carbohydrate polymer can act as dietary
fiber as long as no human enzymes are capable of hydrolyzing these
polysaccharides into simple sugars. Preferentially, the polymers
should also not be readily metabolized by bacteria common in the
human gut so they can continue to provide a "bulking" effect.
However, some types of soluble fiber are metabolized by and do
promote growth of beneficial bacteria. This generally has a
positive effect, as the beneficial bacterial may also tend to
lubricate the stool and/or prevent the growth of other bacteria
that may release toxins (Prosky, Leon J. of AOAC Int'l. 82:223-35
[1999]).
[0439] Soluble fiber comes from a wide range of plant sources.
Water-soluble plant pectins and pectic materials, galactomannans,
arabanogalactans and water-soluble hemicelulose can act as soluble
fiber. Many plant "mucilages," gums, and soluble polysaccharides
found in grains, seeds, or stems such as psyllium, guar, oat (beta
glucans), astragalus (gum traganth), gum ghatti, gum karaya
(Sterculia gum), and gum acacia are also soluble fiber. Algal
polysaccharides such as agar or carrageenan also behave as soluble
fiber as do other indigestible carbohydrates, such as maltodextrins
or dextrins, produced by chemical or enzymatic digestion (e.g.,
partial hydrolysis) of starch, gums and other carbohydrate
polymers. Soluble cellulosic ethers and other derivatives such as
carboxymethyl cellulose behave as soluble fiber as do indigestible
carbohydrate polymers artificially prepared using bacterial
enzymes
[0440] In experimenting with various types of soluble fiber, the
inventor noticed that a number of the more refined materials, such
as lower molecular weight grades of inulin (for example see U.S.
Pat. No. 5,968,365 to Laurenzo, et al., issued Oct. 19, 1999,
titled Preparation of inulin products), specialized dextrins,
maltodextrins and partially hydrolyzed guar gums. The preferred
dextrins or maltodextrins are prepared by controlled hydrolysis of
vegetable starches (e.g. potato or corn) as is described in U.S.
Pat. No. 5,620,873 to Ohkuma et al., issued Apr. 15, 1997, titled
Process for preparing dextrin containing food fiber. The hydrolyzed
guar gum is of the type discussed in U.S. Pat. No. 5,260,279 to
Greenberg, Norman A., issued Nov. 9, 1993 (Sandoz now Novartis),
titled: Enteral nutrition and medical foods having soluble fiber
(available in the United States as BENEFIBER from Novartis
Nutrition of Minneapolis, Minn.; available in other countries as
SUN-FIBER from Taiyo of Japan).
[0441] Non-digestible storage carbohydrates such as inulin are also
important soluble fibers. A number of companies are now providing
an entire range of "soluble fiber" materials of food grade. For
example: TIC Gums of Belcamp, Md. provides gums which are
considered also as a soluble fiber, Novartis Nutrition of
Minneapolis, Minn., a guar gum trademarked in the U.S. as
Benefiber.RTM. and Imperial Sensus of Sugar Land, Tex. provides
inulin.
[0442] Any water-soluble carbohydrate polymer can act as dietary
fiber as long as no human enzymes are capable of hydrolyzing these
polysaccharides into simple sugars. Preferentially, the polymers
should also not be readily metabolized by bacteria common in the
human gut so they can continue to provide a "bulking" effect.
However, some types of soluble fiber are metabolized by and do
promote growth of beneficial bacteria. This generally has a
positive effect, as the beneficial bacterial may also tend to
lubricate the stool and/or prevent the growth of other bacteria
that may release toxins. (Prosky, Leon J. of AOAC Int'l.
82:223-35(1999)).
[0443] Soluble fiber comes from a wide range of plant sources:
water-soluble plant pectins and pectic mater, galactomannans,
arabanogalactans and water-soluble hemicelulose can act as soluble
fiber. Many plant "mucilages," gums, and soluble polysaccharides
found in grains, seeds, or stems such as psyllium, guar, oat (beta
glucans), astragalus (gum traganth), gum ghatti, gum karaya
(Sterculia gum), and gum acacia are also soluble fiber. Algal
polysaccharides such as agar or carrageenan also behave as soluble
fiber as do other indigestible carbohydrates, such as maltodextrins
or dextrins, produced by chemical or enzymatic digestion (e.g.,
partial hydrolysis) of starch, gums and other carbohydrate
polymers. Soluble cellulosic ethers and other derivatives such as
carboxymethyl cellulose behave as soluble fiber as do indigestible
carbohydrate polymers artificially prepared using bacterial
enzymes. Non-digestible storage carbohydrates such as inulin are
also important soluble fibers.
[0444] It is permissible and often advantageous to blend an
assortment of different soluble fibers to create any particular
fiber-water as the foundation for this invention. In fact this
invention may dictated the fiber(s) used and the quantity and/or
the delivery. It is believed that the various soluble fibers have
essentially identical properties when it comes to providing bulk
and hydration to the stools. However, it is not yet clear which
soluble fibers will prove superior in altering lipid or sugar
absorption, etc. Of the soluble fibers presently available the
indigestible dextrins, inulins and partially hydrolyzed guar gum
appear to provide the most water clear solutions. However, many
dextrins and inulins contain a small amount of a metabolizable
component and have a slight sweet taste. Therefore, there can be an
advantage of providing a portion of the soluble fiber in the form
of hydrolyzed guar gum or some other flavorless and totally
non-metabolizable compound. Even though some of these materials may
produce a less clear solution, a combination with a clear soluble
fiber can yield a solution that is both high in fiber and clarity
and low in sweetness or other taste. Other soluble fibers can be
combined to realize the advantages of the different fibers. Inulins
have a slightly sweet taste and while not appreciably metabolized
by humans, bacteria in the colon metabolize inulins. In some cases
such colonic metabolism may provide a distinct advantage and would
mitigate towards including inulins in the mixture. To be more
specific, pectins (and gums) form a gel in the gastrointestinal
track by absorbing water and swelling as much as 10 times its
weight. They slow down the passage of food and thus they give us a
feeling of being full. The "feeling full" feeling that they provide
aids weight loss, which will be covered later in fiber-water for
dieters. Pectins are good for diabetics because it slows down food
absorption after meals while further removing unwanted metals and
toxins from the body. Pectin is valuable during radiation therapy
or X-rays, and it helps lower cholesterol, ergo lessens the risk of
heart disease and gallstones.
[0445] An appropriate diet is an important part of the management
of diabetes mellitus. Later it will be covered in detail,
fiber-water for diabetics, whereby we want to keep any glucose
portion at the lowest concentration. The goal is to maintain blood
glucose levels as close to normal as possible and maintain normal
lipid levels. Diets for persons with diabetes do not have to be
sugar free. Dietary carbohydrates affect blood glucose levels more
than other foods and need to be eaten in consistent amounts at
meals and snacks each day. Diet-fiber-water and fiber-water for
diabetics, if administered throughout the day in metered amounts,
will aid in the targeted program and may even be packaged in 2, 4,
6, 8, or more self contained units thus creating a "water a day
program" with each water being time specific.
[0446] While it may seem out of order it is important here to touch
upon one of the objects of the invention briefly and that is to
create a pack a day be it 2 or more bottles designed to work in
consort. Basically more than one bottle of a water composition
(and/or a fiber-water composition) designed to be drunk throughout
the day. The bottles may be marked as with numbers, colors, naming
or the like. See object of the invention
[0447] Further, additional additives would be in support of the
diabetic needs for supplementation forming a solution or a vicious
appropriate (jelly like) beverage with or without encapsulations of
active ingredients.
[0448] Arabanoglactan (AG), a natural polysaccharide extracted from
already harvested Larch trees from Larex Incorporated, with
headquarters in St. Paul, Minn. markets several versions of their
arabinoglactan. They are as follows: [0449] 1. ClearTrac.TM. AG is
a natural prebiotic fiber which acts as a food source to stimulate
growth of the friendly bacteria (Bifidobacteria, Lactobacilli)
commonly found in the gastrointestinal tract (colon). [0450] 2.
ImmunEnhancer.TM. AG is a natural polysaccharide offering a number
of immunological stimulating properties related to the immune
system including: [0451] Natural Killer (NK) cell and Macrophage
activation [0452] Increased release of various cytokines including
interferon gamma (IFN gamma), tumor necrosis factor alpha,
interleukin-1beta (IL-1beta) and IL-6 [0453] Promotes healthy
limits to cell replication. [0454] 3. Fiber-Aid AG is a natural
pre-biotic fiber which acts as a food source to stimulate/promote
an increase in the Bifidobacteria, Lactobacilli (good bacteria)
found in the digestive tract/gastrointestinal tract (colon). In
addition to the promotion of friendly bacteria FiberAid.RTM. AG has
been shown to increase the production of short chain fatty acids
(SCFA). SCFA are important in the colon as they reduce colon pH and
help establish a beneficial colon environment. In particular
butyrate has been shown to support healthy cell division in the
colon. Also, a recent human clinical at the University of Minnesota
demonstrated cholesterol reduction in hyperlipidemic individuals.
[0455] 4. Larex.RTM. UF is Intended for biomedical applications and
is greater than 99% pure Arabinogalactan with applications in:
[0456] Biomedical Cell Separation-Used for density gradient blood
cell and/organelle separation. [0457] Drug Conjugation-Enhanced
drug delivery; Increases solubility, activity and delivery
effectiveness of various water insoluble drugs such as Amphotericin
B.
[0458] Celluloseis is good for hemorrhoids, varicose veins,
colitis, and diverticulitis. It is excellent for removal of
cancer-causing substances from the colon wall, constipation, and a
boost for weight loss.
[0459] Hemicellulose is good for weight loss, constipation, and
colon cancer. It fights carcinogens in the intestinal tract.
[0460] Lingnin is good for lowering cholesterol levels, protecting
against colon cancer and preventing gall stone formation. It binds
with bile acids to remove them. It is recommended for
diabetics.
[0461] Gums and Mucilages are known to regulate blood glucose
levels, aid in the lowering of cholesterol levels and help in the
removal of toxins.
[0462] Matsutani of Japan markets a maltodextrin, Fibersol-2.TM.,
which is a soluble dietary fiber (90% min dsb). Fibersol-2.TM. is
produced from cornstarch by pyrolysis and subsequent enzymatic
treatment (similar to the process to manufacture conventional
maltodextrins) to purposefully convert a portion of the normal
alpha-1,4 glucose linkages to random 1,2-, 1,3-, and 1,4-alpha or
beta linkages. The human digestive system effectively digests only
alpha 1,4-linkages; therefore the other linkages tender the
molecules resistant to digestion. Thus, Fibersol-2.TM. is GRAS as
maltodextrin, resistant to human digestion, and conforms to all
working industrial and scientific definitions of dietary fiber
[0463] Inulin
[0464] The carbohydrate inulin, which occurs in over 36,000 plants,
is all natural and non-digestible by the human digestive system.
Entire populations have consumed inulin, for centuries, as a main
staple in various food sources, such as onions, wheat, J.
artichokes, asparagus, and others.
[0465] However, current consumption from natural sources is not
large enough to provide an efficacious inulin dose (approximately 5
g/day minimum for improved physiological health) as a unique
soluble dietary fiber and preferred food for healthy intestinal
bacteria. (Good gut micro-flora such as bifidobacteria and
lactobacilli). [0466] 1. In addition; inulin provides a myriad of
health properties for which; under DSHEA, and further clarified by
the FDA Apr. 29, 1998 in 21 CFR Part 101 Food Labeling: Nutrient
Content Claims, Definition of Term: Healthy, statements of
structure or function may be made for mainstream inulin-containing
products, e.g. [0467] a. "Promotes growth of beneficial bacteria
such as bifidobacteria", "bifidogenic", [0468] b. "Helps to
maintain a normal, well balanced gut micro-flora", [0469] c. "Helps
maintain intestinal flora", [0470] d. "Stimulates natural Bifidus
flora", [0471] e. "Inulin is efficiently converted to short chain
fatty acid", [0472] f. "Helps maintain cardiovascular function and
a healthy circulatory system", [0473] g. "Helps promote urinary
tract health", [0474] h. "Helps maintain a healthy cholesterol
level", [0475] i. "Helps to regulate blood glucose level", [0476]
j. "Helps maintain regularity", [0477] k. "Helps improve mineral
bio-availability", [0478] l. "Supports the immune system", are
allowed. [0479] m. Further impressive literature is replete with
the benefits of inulin hailing its ability to: [0480] n. Suppress
pathogenic gut microorganisms and their toxins, [0481] o. Prevent
ulcerative colitis, [0482] p. and mal-absorption, [0483] q.
Demonstrates positive influences on blood sugar regulation [0484]
r. and also balance insulin for diabetics. [0485] 2. Further to
improved [0486] a. Calcium absorption for osteoporosis [0487] b.
and immune activation as related to disease prevention, [0488] c.
Anti-tumor effects, [0489] d. Reduction in food allergies, [0490]
e. and potential help for autoimmune diseases like [0491] i.
Crohn's and [0492] ii. Rheumatoid arthritis. [0493] 3. In recent
years, scientific evidence for reducing serum lipid levels in man,
and animals, using inulin has grown. (Shown to lower LDL and raise
HDL)
[0494] In food and/or beverage, inulin has neutral taste, odor, and
color, and is ideal to be incorporated into an infusion packet
blend.
[0495] The inventor has noted the following patents related to
inulin as relevant; U.S. Pat. No. 5,972,415 to Brassart, et al.,
issued Oct. 26, 1999, titled Nutritive composition (Nestec S.A.
CH); U.S. Pat. No. 5,792,754 to Green et. al., issued Aug. 11,
1998, titled Nutritional composition containing fibres (Nutricia
NL). Of most relevance is U.S. Pat. No. 5,721,345 to Roberfroid, et
al., issued Feb. 24, 1998, titled "Prevention Of Mammary
Carcinogenesis and Breast Cancer Treatment." U.S. Pat. No.
5,550,113 to Mann, issued Aug. 27, 1996, titled "Blood Sugar
Regulating Composition and Methods Relating Thereto."
[0496] Inulin is recommended sometimes for diabetics; it has a
mildly sweet taste, and is filling like starchy foods, but because
it is not absorbed, it does not affect blood sugar levels.
[0497] The inventor has just provided a short description, or some
of the most applicable, and noteworthy to date, soluble fibers.
[0498] Understanding Water and the Importance of Hydration
[0499] Although water is not metabolized, it is essential for
metabolism. Water serves a variety of functions in the body,
including regulating temperature, protecting and cushioning vital
organs, removing waste, and converting food into energy. A majority
of our body is water, serving as the solvent for the chemical
reactions of life. Thirst is one of the first signs of dehydration,
but one cannot rely on thirst to tell when you need more water.
Once dehydration begins, the thirst response becomes even less
effective, particularly in older people, who are less likely to
drink sufficient water. The reader's attention is drawn to
"Problem: thirst, drinking behavior, and involuntary dehydration"
by Dr. John E. Greenleaf, of NASA, (Medicine and Science in Sports
and Exercise, 24:645 (1992)).
[0500] It is generally agreed that the average adult person should
consume at least eight, 8 oz. glasses of water per day--more if the
individual is undergoing stress, exercising strenuously, ill, or in
very hot climates. Unfortunately, most people drink water only when
parched, not consuming enough to completely address and/or reverse
dehydration.
[0501] When the body is dehydrated, nutrients cannot be as readily
delivered to the cells, nor waste products be as readily removed.
With dehydration, viscosity of the blood is increased so that
efficiency of circulation is decreased. Such impaired circulation
can ultimately lead to vascular damage and disease. At the same
time, because the dehydrated body seeks to reverse this situation,
more water is removed from the bowel. This causes excessive
compaction and hardness of digestive residues with resulting
constipation and potential accumulations of toxins in the bowel
(which toxins may ultimately be absorbed into the blood stream).
Further, there is abundant evidence that constipation may lead to a
myriad of medical problems related to the gastrointestinal track
including colon cancer, possibly as a result of prolonged contact
between cells of the colon and toxin laden feces. It is critically
important to be able to regularly eliminate toxins from the body in
a healthy person and far more critical in those with health
challenges.
Understanding Mineral Waters
Definitions of Mineral Waters
[0502] Europeans as well as other cultures all over the world use
and experience the health benefits of not just bathing in mineral
waters, but additionally by drinking natural mineral waters. Over
two thousand years ago the Etruscans and Romans drew their water
from natural springs. In Europe drinking mineral water has been
part of the standard life style for centuries. The following brief
description of mineral waters, with some of their intrinsic health
benefits in addition to hydration, is necessary to better
understand the new and novel proposed invention, functional
fiber-waters.
[0503] The following is according to the Food and Drug
Administration (FDA) of the United States: [0504] "`Spring Water`
must be derived for an underground formation from which water flows
naturally to the surface of the earth. No particular
physical/chemical properties are required other than those normally
applied to drinking water". Spring waters are normally light waters
with minimal mineral taste. Total dissolved solids (TDS) are
allowed up to 249 mg/liter. The taste may vary depending on the
origin of the water. Based on the composition of the ground, this
will determine the amounts of mineral components that the water
collects on its way from the source. If, for instance, the soil is
rich in calcium and magnesium, it will result in hard water. On the
contrary, a high altitude mountain source that flows direct into a
bottling plant, will result in a pure and light water This such
water may be recommended for delicate organisms such as newborn
babies or people with sensitive kidneys. [0505] "`Mineral Water` is
Spring Water that contains at least 250 mg/liter to 500 mg/liter,
which we can classify this water as `Mineral--Low Mineral Content`
or `Light Mineral`. Recommended for anybody who wants to compromise
the refreshing taste with a moderate replenishment of minerals such
as athletes and/or outdoor workers. [0506] Above 500 mg/liter, the
water can be called just `Mineral`. These waters (TDS between 501
and 1000 mg/liter) are already heavy waters where the taste is
definitely affected by the chemical-physical content of the water.
Recommended for people with moderate mineral deficiencies. [0507]
`Mineral Water`--High Mineral Content (IDS above 1000 mg/liter are
heavy waters for people with stronger mineral deficiencies. In some
cases, administration under medical supervision is recommended.
[0508] It is important to the inventor to have an understanding of
ingredient categories that are especially sensitive to proper
handling. In most cases they cannot just be place at will, in a
liquid, and maintain their stability, bio-availability, ergo their
effectiveness and integrity.
Sweeteners
[0509] When one thinks of sweeteners one usually thinks of sugar or
fructose is from fruits/fruit sugar and lactose is from milk a
Milan sugar. Many sweeteners were discovered accidentally
Saccharin, Sucralose, Cyclamate, Acesulfame which has a sweet
taste; and some people experience a bitter-metallic aftertaste
(much like saccharin). Its onset of sweetness is rapid. The
sweetness potency relative to sucrose is about 200, Aspartame
(Nutrasweet.RTM., provides 4 calories per gram. Since it is about
180 times as sweet as sugar, the amount of aspartame needed to
achieve a given level of sweetness is less than 1% of the amount of
sugar required. Thus 99.4% of the calories can be replaced and the
list goes on.
[0510] The newest area of focus are the sweet proteins (Thaumatin
(Tayte and Lyle UK); Brazzein (University of Wisconsin); Miraculin
(BioResources Ind.) Mollein (University of Penna. Kirin
Brewery)
[0511] The discussion best saved for actual product development
future but to be included so that the practicing of (using) this
invention may include one, or a combination of more than one,
sweetener with a specific purpose, by design, as will be discovered
later.
Understanding Pro-Biotics and Pre-Biotics
[0512] For thousands of years man has used bacteria to preserve
food, but it was not until the end of the 17.sup.th century that
the existence of bacteria could be visually observed. The research
today we know that various micro-organisms have different
characteristics and can be applied for different purposes.
Microbial technology can now be used, for example, to vary the
nutrient content, flavor, consistency, and most valuable in keeping
the quality of food high.
[0513] Important in this area is the fact that basic research
during the last decades have demonstrated that the administration
of viable cultures of certain gastrointestinal tract organisms have
a positive effect on the recipient's health and well being. This
has been demonstrated for both humans and animals.
[0514] The common prerequisite for a pro-biotic organism to be
effective against various forms of gastrointestinal tract
disorders, and/or building a healthy GI tract are that they should
be able to pass through the acid barrier of the stomach, withstand
the effects of bile salts, and be able to colonize the intestinal
lining. A goal is to stimulate gastrointestinal epithelial cell
development, which would result in longer and healthier intestinal
villi, deeper crypts, and hence more efficient nutrient uptake.
[0515] Thus noting that both pro-biotics and pre-biotics are
delicate/sensitive and up until recently, have not been able to be
handled effectively long-term, without refrigeration.
[0516] With new encapsulation technologies available, we are now
able to handle these organisms successfully. Once again they are
not only valuable in human health but animal health as well.
[0517] Definition of pro-biotics, by Marcel B Roberfroid, From the
Department of Pharmaceutical Sciences, Universite Catholique de
Louvain, Brussels. [0518] "A pro-biotic is a viable microbial
dietary supplement that beneficially affects the host through its
effects in the intestinal tract. Important health-related effects
associated with pro-biotic administration include immune
enhancement, (enhance host resistance to a broad spectrum of
bacterial, viral, protozoal and physiological challenges) and the
alleviation of lactose intolerance and more have been reported in
human studies. Some evidence suggests a role for pro-biotics in
reducing the risk of rotavirus-induced diarrhea and especially
colon cancer (which makes an excellent case for combining
pro-biotics with soluble fiber which has been shown to bind to
toxins, ergo removing said toxins from the colon). [0519]
Pre-biotics are non-digestible food ingredients that benefit the
host by selectively stimulating the growth or activity of one or a
limited number of bacteria in the colon. Work with pre-biotics has
been with the inulin-type fructans, which have generated sufficient
data for thorough evaluation regarding their possible use as
functional food ingredients. Among the claims are constipation
relief, suppression of diarrhea, and reduction of the risks of
osteoporosis, atherosclerotic cardiovascular disease associated
with dyslipidemia and insulin resistance, obesity, and possibly
type 2 Diabetes. It is conceived that by combining a combination of
pro-biotics and pre-biotics that this combination might improve the
survival of the bacteria crossing the upper part of the
gastrointestinal tract, thereby enhancing their effects in the
large bowel. In addition, their effects might be additive or even
synergistic."
[0520] Pre-biotics are organisms and/or substances, which help to
improve the environment of the intestinal tract. Pre-biotics are
foods that contain live bacteria and are known to increase
digestibility, speed recovery from diarrhea (especially guar gum),
enhance immune function (arabinoglactan, a fiber, is a good
choice), reduce certain cancers, and lower blood cholesterol
levels, (again an excellent case for combining with fiber).
[0521] Pre-biotics are foods or nutrients that are used by specific
bacteria and can be added to the diet to increase the chances of
these particular bacteria growing and thriving in the
intestine.
[0522] The bacteria that live in the intestines make up a very
large, and very diverse population. The numbers of each kind of
bacteria change, depending on age, diet, health status, and use of
drugs and supplements. The bacteria that do thrive do so because
they are able to adhere to the intestinal wall, and use the
semi-digested food that is passing through the intestines. Because
some bacteria have specific nutrient requirements, it has been
proposed that adding these particular foods or nutrient to the diet
could be a way of increasing the numbers of specific bacteria.
[0523] Just as an example set forth here, the inventor calls
attention to U.S. Pat. No. 6,180,099 to Paul, (Metagenics, CA.),
titled, "Method of using immunoglobulin and fiber-containing
compositions for human health" identifies preferred and beneficial
human intestinal microorganisms such as Lactobacillus acidophilus,
L. bulgaricus, L. casei, L. fermentum, L. salivaroes, L. brevis, L.
leichmannii, L. plantarum, L. cellobiosus, Bifidobacterium
adolescentis, B. infantis, B. longum, B. thermophilum, and B.
bifidum. More preferably, the beneficial human intestinal
microorganism is selected from L acidophilus and B.
adolescentis.
Understanding Antioxidants
[0524] Antioxidants help to protect the body from the formation of
free radicals. Free radicals can cause damage to the cells,
impairing the immune system and leading to infections and various
degenerative diseases such as heart disease and cancer. Free
radical damage is thought by scientists to be the basis for the
aging process as well.
[0525] Antioxidants are defined as any substance inhibiting
oxidation. Oxidation reactions can occur anywhere in our body, in
any organ and/or cell. When oxidation reactions get out of control
and slip past the constraints of the body's own protective
mechanisms, this results in the formation of free radicals.
Antioxidants help prevent the formation of free radicals, stop the
domino effect of free radicals, and even repair, or "clean up",
after the damage has been done.
[0526] These reactive molecules that damage tissue can be
controlled through antioxidant supplementation. As with enzymes,
these antioxidants can be taken separately or in combination(s).
Taking anti-oxidants individually, as with enzymes might target
specific an area more intensely. At times this is more if not as
valuable as taking a combination of antioxidants that will affect
several tissues in the body, while individual antioxidants would
target specific areas. This invention acknowledges that both
approaches are set forth of which the inventor believes
necessary.
[0527] There are many antioxidants and more discovered as time and
science continue to make discoveries. The main proven antioxidants
are Vitamin C, Vitamin E, and Vitamin A. (.beta. carotene or a
cartinoid mixture which is substantially equivalent in vitamin
activity to quantity of .beta.carotene).
[0528] While Hoffman La Roche makes a water-soluble vitamin E that
has no taste, Vitamin C, ascorbic acid, does have a taste. Further,
too much Vitamin C at one time can cause gastric upset.
Additionally, Vitamin C is not stored in the body. Therefore it may
be of great advantage to encapsulate all or part of the ascorbic
acid and also to consider time releasing. Vitamin A is not
water-soluble and therefore in a fiber-water antioxidant
composition, which may include those just said, and others,
encapsulations once again, may be most desirable.
[0529] Airline travel as an example: It is a wide spread fact that
dehydration is a major factor in airline travel, and passengers are
urges to drink, hopefully 6-8 oz. It is advisable, that for every
hour in flight to prevent such dehydration, passengers follow the
guidelines aforesaid. It is not a wide spread fact that in the
cabins of airplanes many free radical scavengers are present. Long
flights especially wreck havoc on the body at best, and certainly
do not provide enough fiber when one evaluates the airline meals.
Ergo, not just fiber-water (which provides hydration and soluble
fiber) but a target specific antioxidant fiberwater for airline
travel, with or without supporting additional nutritional
supplementation, is ideal.
[0530] There are other stressful emergency situations for which
fiber-water is beneficial and now with additional additives is more
target specific. This is not to be confused with a general
population anti-stress situation but emergencies handled by the Red
Cross, FEMA and like such agencies governmental or privatized, or
non-profit).
[0531] In U.S. Pat. No. 6,248,390, inventor Stilman clearly states
the importance of such product(s). "When under stress humans and
animals are known to reduce their consumption of water. Yet when
the body is stressed by disease, additional water is required, yet
this is exactly when many reduce their fluid intake. Further stress
may influence people to prefer sugar-laden beverages (comfort food)
or caffeine beverages for alertness--these types of beverages
actually increase ones water requirement and may lead to
dehydration. Thus, it is beneficial to provide fiber-water as
opposed to plain water in emergency supplies to be used in case of
natural disaster--fire, flood, storm, earthquake, or hurricane and
it is suggested fiber-water be stocked by FEMA or its international
counterparts. During such a disaster people are stressed and are
often forced to move from their homes and everyday surroundings.
Emergency situations often dictate a shortage of food and water
and/or that food and water will be available at abnormal times.
This combined with the general shortage of fresh fruits and
vegetables, which are a key source of dietary fiber, during such an
emergency naturally leads to loss of regularity. Emergency food
drops rarely contain fresh fruits and vegetables. Having to deal
with the emergency is bad enough. Adding severe constipation and
dehydration simply makes a bad situation worse. Assuring ample
supplies of fiber-water is intended (what happened here?) to
alleviate many of these problems".
[0532] Anti-oxidants of importance include, but are not limited, to
the following: [0533] 1. Alpha-Lipoic Acid, helps to neutralize the
effects of free radicals. [0534] 2. Bilberry is a strong
antioxidant that keeps capillary walls strong and flexible.
Supports and strengthens collagen, inhibits growth of bacteria,
anti-inflammatory, anti-aging, anti-carcinogenic. [0535] 3.
Coenzyme Q10, is an immunological stimulant, increases circulation,
anti-aging, and beneficial for cardiovascular system. [0536] 4.
Cysteine, (an amino acid) detoxifier of alcohol, tobacco smoke, and
environmental pollutants. Anti-aging. [0537] 5. Glutathione,
defends against damage from smoking, exposure to radiation, cancer
chemotherapy, and toxins such as alcohol. A detoxifier of heavy
metals and drugs, it aids in the treatment of blood and liver
disorders. [0538] 6. Melatonin, is an antioxidant/free radical
scavenger [0539] 7. Selenium, guards the cells of blood, heart,
liver, and lungs. It stimulates antibody response to infection.
[0540] 8. Vitamin C, free radical scavenger. It increases the
synthesis of interferon (natural antiviral substance produced by
the body). [0541] 9. Vitamin E, prevents the oxidation of lipids
and protects the heart. Understanding Enzymes for the Purpose of
Encapsulating, with or without Viscosity Changes
[0542] Enzymes are the powerhouses of every living cell. They
either start chemical reactions, or they make them run faster.
[0543] Enzymes sustain life. The late Dr. Edward Howell, a
physician and pioneer in enzyme research, called enzymes the
"sparks of life". These energized protein molecules play a
necessary role in virtually all of the biochemical activities that
go on in the body. They are essential for digesting food, for
stimulating the brain, for providing cellular energy, and for
repairing all tissues, organs, and cells. Life as we know it could
not exist without the action of enzymes, even in the presence of
sufficient amounts of vitamins, minerals, water, and other
nutrients.
[0544] An enzyme is a complex protein molecule originating from
living cells and capable of producing certain chemical changes in
organic substances by catalytic action, such as in digestion. In
fact enzymes are best known for their ability to improve digestion
by breaking down proteins, fats, and carbohydrates in out food. In
this way, digestive enzymes improve health by allowing the
nutrients in our foods to be extracted, absorbed, and carried
through the bloodstream to the various organs and cells of the
body. This is why improving digestion can benefit so many
conditions that at first do not appear to have anything to do with
digestion (such as allergies, acne, aging, headaches, gout, etc.).
By augmenting the body's enzymes, supplemental digestive enzymes
free pancreatic enzymes to perform other health functions in the
body, such as boosting immune function, decreasing inflammation,
and improving circulation. Further, digestive enzymes are essential
for proper detoxification and for maintaining healthy flora in the
colon.
[0545] In the book, "The Complete Book of Enzyme Therapy," Dr.
Anthony Cichoke presents a practical guide to using the natural
power of enzymes to maximize health and combat a host of common
disorders, including, but not limited to, digestion. Dr. Cichoke is
a strong advocate of including plenty of water (on a daily basis)
while avoiding, coffee, soft drinks, alcohol, artificial fruit
drinks, and canned juices. (Page 436) On page 437, Dr. Cichoke
stresses the importance of safe water. Chlorinated or fluoridated
water in excessive amounts can kill the "good" bacteria living in
the intestinal tract which can also increase free-radical formation
in the blood, leading to tissue damage and accelerated aging.
[0546] Enzymes make digestion possible allowing the user to drink
the fiber-water enzyme composition before, during, or after a meal
with the specific intent of the invention being: "digesting fiber
enriching water". By the nature of the specific enzymes used to
break down food, especially protein, as in the popular Atkins
protein diet, the enzymes will help digest and break down the
proteins while providing hydration along with the fiber that these
diets so critically lack.
[0547] Enzymes go far beyond the breakdown of protein, being
essential for everything that occurs in the body, including, but
not limited to, digestion, breathing and circulation. Your body
uses enzymes to fight disease and inflammation and to slow the
aging process. Supplemental enzymes aid digestion, dissolve blood
clots, and fight back pain; however as we age the numbers of our
enzymes and their activity levels decrease.
[0548] Enzymes remain unchanged even after an action is complete,
and because they have so many applications, it is better to
classify enzymes based on what they do, what substances they act
upon (substrates) and the reaction they start or accelerate.
Enzymes are very substrate specific; some work best within a
specific pH range--a measure of acidity and alkalinity. There are
six main groups of enzymes, each having fundamentally different
activities: [0549] 1. Hydrolyses consists of [0550] a. Proteases
which breakdown the peptide bonds in proteins [0551] b. Amylases
break down carbohydrates, [0552] c. Lipases break down fats
(lipids), improves fat utilization, a digestive aid, [0553] 2.
Isomerases break down the rearrangement of chemical groups within
the same molecule. [0554] 3. Ligases catalyze the formation of a
bond between two substrate molecules through the use of an energy
source. [0555] a. Lyases split the double bonds between atoms with
the accumulation or disassociation of chemical groups. [0556] b.
Oxidoreductases make oxidation and reduction possible. [0557] c.
Transferases transfer chemical groups from one molecule to the
other. Again, enzymes are best known for their treatment in their
ability to aid digestion and ease digestive problems.
[0558] Systemic enzyme therapy takes the use of enzymes one step
further by allowing the enzyme to enter the blood stream intact and
be carried to every cell in the body in order to be effective. In
this way, systemic enzyme therapy can fight inflammation and
stimulate the body's own enzymatic processes, decrease pain and
swelling, combat free radicals, improve circulation, and bolster
immunity.
[0559] Systemic enzyme therapy is an integrative, holistic approach
to health and healing. When made for systemic use and are to be
taken orally (opposed to injection and/or topical application) they
are enterically coated or protected in some way so they can pass
through the acidic stomach intact. Microbial enzymes can be
designed and produced to be acid resistant and, therefore, can
resist the low pH of the stomach and pass onto the small intestine
to do their work.
[0560] There are at least three methods by which enzymes are
absorbed into the small intestine: [0561] 1. Pynocytosis, [0562] 2.
Transcellular absorption (persorption) and/or [0563] 3. Transported
by the lymphatic system.
[0564] Complete Book of Enzyme Therapy by Dr. Anthony Cichoke Avery
Press, 1999, pages 37-54. Dr. Cichoke says, "Enzyme depletion is
one of the greatest tragedies in today's society. If your food has
been cooked and/or processed, it is enzyme dead. Fewer than 10% of
Americans eat 2 servings of fruit or 3 servings of vegetables a
day."
[0565] Enzymes are amino acids. They are the structural units of
all proteins. There are approximately 20 different amino acids,
which occur in each enzyme in different numbers amounts and
combinations. The body can make many of these amino acids by
itself, but nine of these amino acids, called the essential amino
acids, cannot be made by the body and must be obtained from diet
and/or supplementation. Further, stress (including disease or
injury) may cause increased demand for certain amino acids. They
are: [0566] 1. Alanine: which can reduce cholesterol (when combined
with argine and glycine) effects the stabilization of blood
glucose, enhances fat metabolism [0567] 2. Arginine: fights
hypertension, (according to cardiologist Dr. John Cooke of
Stanford, about 9 grams of arginine a day are recommended. To that
end he has developed the "Heart Bar"--a medical food containing
significant grams of arginine). Additionally, arginine accelerates
wound healing, enhances thymus activity, increases fat metabolism,
aids insulin production and glucose tolerance. [0568] 3.
Asparagines: fights chronic fatigue, cirrhosis, and drug addiction.
[0569] 4. Aspartic acid: plays an important role in metabolism,
increases endurance, treats drug addiction, cirrhosis, fatigue.
[0570] 5. Cystein: promotes healing and improves disease
resistance, detoxifies the body. [0571] 6. Glutamic acid:
Influences brain health, detoxifies body. [0572] 7. Glutamine:
treats alcoholism, helps maintain gastrointestinal health, prevents
malabsorption. [0573] 8. Glycene, detoxifies liver, part of glucose
tolerance factor. [0574] 9. Histidine: needed for tissue growth and
repair and blood cell production, treats digestive disorders,
arthritis, and allergies. [0575] 10. Isoleucine: aids healing from
burns. [0576] 11. Leucine: aids healing from burns [0577] 12.
Lysine: fights herpes, aids calcium absorption, tissue repair, and
collagen formation, essential for growth in infants, maintains
nitrogen equilibrium, and in adults plays a role in enzyme,
hormone, and antibody production, treats cold sores. [0578] 13.
Methionine: helps prevent liver and artery fat build up, maintains
blood flow to kidneys, heart, brain, thus helps protect cells from
free radicals, detoxifies harmful agents, aids digestion, helps
prevent brittle hair, aids muscle weakness, fights osteoporosis and
allergies. [0579] 14. Phenylalanine: prevents and treats
depression, treats hyperactivity and attention deficit disorders,
produces neurotransmitters, improves memory, aids weight loss,
elevates mood, powerful pain reliever. [0580] 15. Proline: needed
for formation and maintenance of collagen and healthy skin. [0581]
16. Serine: involved in biosynthesis of pyrimidine, purine (uric
acid compounds), creatine (a nitrogen compound found mainly in
muscle tissue), and porphyrin (organic compounds), forms cystine
(an amino acid) with homocystine. [0582] 17. Threonine: aids
digestion, improves absorption and assimilation of nutrients,
important to formation of collagen and elastin, helps control
epileptic seizures. [0583] 18. Tryptophan: important in energy
production, glycolysis (the energy producing process in which sugar
is broken down to lactic acid) tissue respiration, and fat
synthesis, relieves pain, aids sleep, precursor of niacin and
seritonin. [0584] 19. Tyrosine: helps form antibodies and nourish
blood, treats Parkinson's disease, narcolepsy, and hypertension, a
melanin precursor, functions in a synthesis of hormones (tyrosine
and epinephrine), and neurotransmitters (norepinephrine, dopamine).
[0585] 20. Valine: speeds healing from burns, aids normal
metabolism, important to muscular coordination, mental energy, and
nervous system function.
[0586] The inventor envisions one or more amino acids which can be
encapsulated solely or in combination with other ingredients with
specific release times so that they are complimentary
[0587] Enzymes are often divided into two groups: systemic and/or
metabolic enzymes and digestive enzymes.
Digestive Enzymes
[0588] Digestive enzymes are secreted along the gastrointestinal
tract and break down foods so that the nutrients are more readily
absorbed into the bloodstream for use in various bodily functions.
There are three main categories of digestive enzymes: amylase,
protease, and lipase. Amylase, found in saliva and in the
pancreatic and intestinal juices, breaks down carbohydrates.
Different types of amylase break down specific types of sugars. For
example lactase breaks down milk sugar lactose), maltase breaks
down malt sugar (maltose), and sucrase breaks down cane and beet
sugar (sucrose). Protease, found in the stomach juices, and also in
the pancreatic and intestinal juices helps to digest protein.
Lipase, found in the stomach and pancreatic juices, also present in
fats in foods, aids in fat digestion.
[0589] Digestive enzymes are very important on a regular basis.
While the body manufactures a supply of enzymes, it can also obtain
enzymes from food. Unfortunately, enzymes are extremely sensitive
to heat. (Even low to moderate heat (118 degrees F. (48 degrees C.)
or above) destroys most enzymes in food, so to obtain enzymes for
food one must eat raw foods. Unfortunately, the eating of raw food
is not prevalent in out society today. Research has shown that as
we grow older, the body's ability to produce enzymes decreases. At
the same time, mal-absorption of nutrients, tissue breakdown, and
adverse health conditions increase.
[0590] The alternative is to take enzyme supplements, which reduce
the stress on the body, etc. Today digestive enzymes are available
over the counter in tablet, liquid, capsule, form.
[0591] It is the object of this invention to provide digestive
enzymes, separately and/or in combination with each other. If they
are micro-encapsulated there is a greater potential for stability
and potency. Further they may be combined with other ingredients to
compliment such as peppermint which is know to be good for
digestion.
Systemic Enzymes
[0592] Many people are familiar with enzymes as digestive aids. In
addition it is very important to include the systemic enzymes and
systemic enzymes in combinations because many enzymes can also be
used to treat a wide variety of conditions through systemic enzyme
therapy and/or through the aforesaid use of combinations.
[0593] Systemic enzymes can be taken in formulations made with any
and/or all sorts of dietary supplements such as: phyto-nutrients,
vitamins, minerals, herbs, anti-inflammatory agents nutraceuticals,
pharmaceuticals, etc. Again, development and combinations rely on
the technologies to best deliver, while ensuring stability and
bio-availability to the consumer. From the categories just
described and mainly those which are considered "nutritive",
(especially phyto-nutrients those coming from plants), in
combination with systemic enzymes form what is called and have been
described as Enzyme Absorption System Enhancers (EASE). These
combinations are beneficial as they improve the absorption and
bio-availability of other nutrients, maximize enzyme activity when
combined with these nutrients, reduce the drain of the bodies own
digestive enzymes, etc.
[0594] In systemic enzyme therapy, the enzymes are distributed
throughout the body to help restore the body to health. Some of the
conditions which can be treated with systemic enzyme therapy
include; arthritis (and other inflammatory conditions), back pain,
premature aging, circulatory problems, herpes, injuries, systemic
myofacial pain, multiple sclerosis (MS), skin problems,
gynecological problems, lupus, erythematosus, and other auto-immune
diseases, viruses, and weight problems.
[0595] There is much literature on the aforementioned coming from
Germany, Japan, and Italy, along with the U.S. on the use of enzyme
therapy. The inventor calls attention to the fact that in addition
to new applications, which are being discovered constantly in
systemic enzyme therapy, they are being discovered in all
categories whereby the delivery system becomes critical.
SUMMARY OF THE INVENTION
[0596] The inventor has called attention to the fact that this
invention goes in new and novel ways beyond fiber-water, and
therefore inventive additional aspects are here forth
created/products that are water-like, taste water-like
compositions, just like Fiber-Water, but with the addition of the
ability to change the viscosity, add encapsulations, particles
(flecks, dots, specks and/or the like) emulsify, suspend, create
special effects, all with the specific purpose of creating
"healthy" while creating visually appealing, "entertaining"
water-like fiber-waters (drinks), and/or the like, for general
desirability/use, and/or for specific use, dietary use and/or
medical use.
[0597] Of great importance to the inventor, and is present in all
her filings, is that there are sound scientific principle(s) behind
the inventiveness, the inventiveness will be consistent, and that
the intent of the inventiveness will be available and/or
bio-available to the user on a an individual, as well as a
"duplicatable" and "replicatable", basis.
[0598] With all the dollars spent on all aspects of media today the
inventor would be hard pressed to feel she could capture a portion
of the market place unless the products are so unique, valuable,
and/or distinguishable from what the media is promoting/telling
consumers that they should drink.
[0599] To this end the inventor, with this invention, is able to
combine "healthy" and in many instances added entertainment,
especially for children, in the water beverage category. If the
process is enjoyable to the consumer/user, as well as healthy, then
there is a chance to capture a consumer while making a difference.
It is a lofty goal to hope to reduce the number of soft drinks,
over-sugared drinks and juices, that are consumed at such a high
rate. Although there is hope and sales are beginning to reflect
this new trend. To that the inventor is encouraged.
[0600] So while this inventor has filed PCT WO 01/70591 A1 titled:
Infusion Packet with useful and decorative elements, Support
Member, and Delivery System she has also filed US CIP of
PCT/US01/09171 Method of Hydration, Infusion Packet System(s)
Support Member(s), Delivery System(s) and Method(s) with business
model(s) and Method(s). Sometimes it is not just the drink, but
also the way in which it is presented and/or delivered that
carries, along with the drink, just what it takes to capture a
consumer by looks, additives, and/or the like.
[0601] The inventor here understands what is involved, what it
costs a company to launch a new product(s) especially in Ready to
Drink (RTD) Form. Such drinks we often predominately select by what
is new, considered fashionable, and/or established (a brand) such
as a Coke or a Pepsi, Sprite, Mountain Dew, So-Be, Snapple, Mystic,
A&W Root Beer, just to name a few.
[0602] Drink selections now have bent towards adding ingredients
for which the company is hoping that the consumer will select by
the effect (stimulating, relaxing) that they promise the user.
Mentioned above, and further here, we note waters with caffeine,
nicotine, chlorophyll, and a myriad of vitamins, herbs, "other"
substances and additives (some considered nutritional) addressing
"a feeling" effect are coming to market. Vitamins seem to be a "hot
ticket", as if it is even desirable to get your vitamins in a water
product.
[0603] What the inventor has noticed, so prominently, is that major
companies like a Coca Cola, etc. launch different drinks in
different parts of the world. It is obvious that certain flavors,
"degrees of sweetness" etc. is more popular in certain areas of the
world. Sometimes this is due to ethnic preferences. Sometimes
certain ingredients are not always and/or readily available, or too
costly, especially when desirous to expand to distant regions. This
invention hopes to address much of the aforesaid by not really
having flavor, but by providing the foundational taste of water,
which is accepted worldwide. (Note: Under the guidelines of
flavoring water the FDA says it is still water if the flavor
constituent is 1% or less).
[0604] However, as flavor enhancers in a bottled drink there are
other technologies that come to the forefront. The company,
Sensations, has impregnated into the plastic sports cap, aromas
that align with flavor. U.S. Pat. No. 6,102,224 to Sun, (PepsiCo.
(NC), titled: Aroma release cap, whereby a method and apparatus is
described, so that when the bottle cap is removed from the bottle,
using scratch and sniff material/technology (creating friction),
aroma is released. Further PepsiCo also controls the technology to
add aroma to the nitrogen in the head-space of the bottle.
[0605] Clearly it is the goal of the inventor to bring forth a
whole new category of drinking, based on the invention fiber-water
called Hydraceuticals.TM. "Hydration with a Healthy Twist".TM..
General Overview of the Invention:
[0606] Just as the inventor has contemplated new and novel ways to
go beyond water with fiber-water, she now is dedicated to using
fiber-water as the base for new compositions whereby, creatively,
using encapsulations and viscosity modifications as delivery
vehicles so as design products targeting "specific desires" and/or
"special needs".
[0607] These new water compositions will include, but not be
limited to compositions addressing, as examples; obesity, diabetes,
heart health, improved general health and well being, stress,
depression, pain, fostering a healthy digestive tract, and the
binding and removing of toxins from the body, thus intending to
reduce the incidences of cancer etc. Further looking at immune
enhancing, anti-bacterial and anti-viral, compositions. Further
looking at products for babies, children, teenagers, seniors,
pregnant mothers, stress, athletic and sports needs, all based on
one, or a combination of soluble fibers delivered in pure, safe,
water. Integrity will be reflected by the choice of systems, how
they are integrated, and the additional scientifically researched
and developed active ingredients. Manipulating via viscosity
changes and encapsulations, mainly, will reflect and affect the
results. Most important to the inventor, is how to create within
the novelty and newness of this invention, "special added-value
Fiber-Waters" for humans and/or animals which may be drunk, used
for enteral feedings, and/or spooned.
[0608] The inventor realized that for those afflicted with a myriad
of health challenges (acute/chronic) there must be an easier answer
as to how to deliver target specific ingredients. Recognizing that
people by nature are lazy and want convenience and, also by nature,
individuals (users) don't take things that are good for them (look
at smoking), or if they do it is not on a regular basis. "Taking
with regularity" is critical for many supplements, even
fiber-water, which a consumer cannot gain the maximum benefit,
(although every little bit helps), in just one serving now and
then. Individuals procrastinate and there's always an excuse. That
is why the inventor chose to use water as the delivery system for
the fiber and beyond. Some individuals fear taking pills and
capsules, and/or find taking them is somewhat distasteful. Others
may have difficulty swallowing. Others find that the ingredients
are so strong that they come up on them, as in an acid reflux
situation. Another problem is that they look so ugly and
distasteful. Then too many ingredients, especially vitamins and
minerals, carry an undesirable odor and/or taste. Water is needed
by everyone daily to live, fiber to live healthier, and now
expanding to service an individual's needs and desires so that not
just life span, but health span will increase.
[0609] In such cases, for a product to be palatable, manufacturers
have resorted to using extra sweeteners, mainly sugar, and/or
chemical additives. Regardless of the havoc the sugar plays in the
body, all the extra calories alone are a major issue, along with
what this sugar does to your teeth. However, sometimes it is
necessary to add sweetener, but not to overwhelm. We think of
sweeteners as being sugar in one form or another. Sometimes a
sweetener (sugar/sugar substitute may be necessary to counteract
the use of organic and/or inorganic acids necessary for production
of a safe product with extended shelf life. Many new sweeteners
have recently come to market and shall be used as deemed
appropriate by those skilled in the art. The significance here is
that it is not the intention of the inventor to make a sugar loaded
product, when in fact it is the direct opposite. It is also factual
that great pains will be taken to accomplish the aforesaid.
[0610] For some of the drinks proposed, it is essential for the
condition that they are targeting to add glucose but that will be
done in moderation. It has been so far established the importance
of hydration and fiber, and now perhaps glucose in
"designed/designated and specific amounts", in accord with
achieving maximum benefits appropriate to specific conditions, and
including but not limited to other additives.
[0611] Using encapsulations and viscosity changes, along with the
presentation of additives, may be added to the drink without adding
significant taste and/or calories. Ramifications, including but not
limited to, preventing sharp rises and fall-offs in blood glucose
levels which are known to cause mood swings, depression, cravings,
headaches, hyperactivity (especially in children) and, most
particularly, significant calories which can lead to weight gain
and/or be a precursor for problematic health issues in the future
(e.g. diabetes), etc.
[0612] Many individuals who need to take supplementation on a
regular daily basis might and/or will gain more benefits from
taking the additive(s) throughout the day. How many people actually
take supplements with them when they leave home for the day? Even
if they do they are not always carried appropriately, and/or "go
stale" and unclean in a desk drawer at work. AND with what liquid,
and do they ingest enough water period, not considering the
importance of being sure that a substantial amount of safe water is
used to help these supplements travel through the system.
Interesting is that the inventor has observed individuals who may
take up to ten (10) or more supplements in the morning, and even
more when they get home in the evening. Others leave home and
forget their necessary and/or desired supplements? When they get
home, many times they are pre-occupied, and/or too tired, and/or
believe that they shouldn't take certain nutrients in the evening,
especially before bedtime.
[0613] A commitment of this invention is to avoid unnecessary
additives chemicals whenever possible, and most critically, use
small amounts of sugar (a durative of, in combination with any form
of sweetener) only when necessary and required for specific use.
Thus the invention, functional water(s) or water(s) for specific
dietary use, and/or medically recognized conditions is designed to
be safe, convenient, purposeful, and as ethical as possible in the
area of medically sensitive or reactionary effects.
[0614] The inventor is presenting a radically new, completely
shelf-stable, ready-to-drink totally nutritional functional
fiber-water product. Functional fiber-waters for specific use(s)
and/or medical use(s) is revolutionary in the realm of the buying
public's ability to finally gain access to ethical functional water
products designed for the users specific desires, dietary
supplementations, and/or medical use, with one or more additives,
with a specific intent, along with encapsulations, viscosity
changes, and/or both. Not only is fiber-water, and fiber-water
extensions, for humans, but also for their pets, some of who may
need this product as much, if not more, than their human
counterparts.
[0615] By providing in addition to safe water and soluble fiber,
the addition of various popular, safe and completely approved
functional ingredients, a product of exceptional value and
versatility is created for consumers. Then by varying that ability,
once again, to include various additional elements/components along
with one or more functional ingredients, the existing fiber-water
invention is enhanced. Then again, the variations offer the basic
same product for multiple usages by varying their process
conditions, including, but not limited to, viscosity changes and
encapsulations. Now in doing all of the above, various such water
products can be obtained that specifically target the nutritional
and health goals, as well as needs and/or be condition specific as
related to health improvement and/or challenges, in both healthy
individuals and those needing health improvement in humans, and/or
animals.
[0616] Diet refers either to the types of foods a person eats or
the practices they use to control the types and amounts of food
eaten to promote weight control, as to gain or loss, good health,
or to help control or reverse disease. A healthy diet contains all
the energy, protein, vitamins, minerals, and other essential
nutrients, including fiber, and fluids, and most essentially,
water, the single most critical ingredient the body needs on a
daily basis and cannot do without . . .
[0617] The invention (U.S. Pat. No. 6,248,390), fiber-water, is
quintessential to the Continuation In Parts (CIP) titled:
"Functional Fiber-Waters, Waters for Specific Dietary Use and
Medical Use." The word "function" used herein, as described in
Webster's Dictionary, means: [0618] 1. The kind of action or
activity proper to any person or thing; [0619] 2. The purpose for
which something is designed or exists. [0620] 3. It is further
denoted to mean, a relation between two or more elements in which
one or more elements are assigned to one or more other
elements.
[0621] While it is conceived that these products be available
mainstream in the same bottles and packages that mainstream waters,
juices, and sodas are found in, and may be found for purchase in
the same locations, it is also conceived that they be packaged
differently/accordingly and sold in, or by, medical institutions,
and/or establishments. Further they may even be sold under a
doctor's request (medical food) and/or by prescription. As just one
example Fiber-water, with the additional focus on diet control, is
reflected in this present application concerning a water
composition, more specifically water and fiber, and encapsulated
related ingredients, with or with out a minimal amount of
sweetener, designed to assist humans and/or animals with their diet
specific needs and goals. There are additives, known by those in
the art of weight control, that are not commonly used and/or
approved for use except under medical supervision, ergo the correct
labeling and product distribution channels will be followed.
[0622] Water has a viscosity of 3 centipoises, as opposed to orange
juice or milk, which may have centipoises between 50-100. By
increasing the viscosity of the fiber-water with a low viscosity
fiber (permits using more fiber) along with the gelling qualities
of pectin or guar gum, or the addition of one or more other kinds
of soluble fiber, gelling agent(s), the fiber-water will gain more
substance, which to many users be more appealing, and in some
cases, easier to ingest (swallowing problem than a liquid with the
viscosity of water itself). It may even be "spoonable". If colored
and/or decorated etc. the preparation will have greater consumer
appeal yet it is really almost just like water, fiber-water.
[0623] While gelatin can be used, carrying with it known specific
beneficial properties, (e.g. Knox gelatin by The Nabisco Company,
claiming that gelatin provides building blocks for collagen--the
chief structural protein in cartilage and bone and also claims to
enhance for fingernail strength, it is not without its
disadvantages. For example, gelatin is expensive, sets up rather
slowly, and water products containing gelatin could be undesirable
for some religions, such as Jews and Moslems as it is often
manufactured from pig products. In U.S. Pat. No. 5,002,934 to
Norton et al., issued Mar. 26, 1991, titled; Aqueous gel comprising
carrageenan, it is demonstrated that without the use of gelatin,
relatively strong low melting gels can be made.
[0624] It is also conceivable that some thickeners may be
appropriate by themselves, and/or in combination with gelling
agents, so long as they comply with the integrity of the invention.
Thickeners include, but are not limited to, propylene glycol
alginate, xanthan gum, starch, modified starch, gellan gum and
carboxyethyl cellulose. These additives certainly contribute, among
other qualities, to a more food-like substance, and can actually
be, and/or perceived as being, more filling when ingested.
[0625] This inventor, and therefore this invention, will be most
sensitive to babies, children, teens, adults, seniors, and those,
regardless of age, with specific health desires, challenges, and/or
needs.
[0626] Compositions with encapsulations, viscosity changes, or both
may be packaged in expected bottles (glass or plastic), box,
plastic, paper, pouches, and/or the like. The addition of color,
flavor, aroma and shape of the product within its specifically
designed contained confinement, attractive packaging using target
specific graphics, would be most effective for inducing an
individual to maintain needed fiber and water (hydration) and
additives of value on a daily basis.
[0627] This invention can further deliver additional active
ingredients, desired and/or needed, so that an individual does not
have to take a tablet, capsule, soft-gel, etc., which may create
discomfort in swallowing and, separately but additionally, lower
the risk of not drinking enough safe, water at the same time. Often
noted: people will toss back into their mouths handfuls of
supplements, and/or medications, sometimes with no water at all, or
only enough to allow them to enter the stomach. This practice can
be very dangerous in general, and may lead to choking, or other
adverse medical conditions.
OBJECT OF THE INVENTION
[0628] We have established early on the importance of fiber in
addressing many areas of health. Best to review here with examples
of specific combination of potential fiber-water compositional
product. This, in total is a huge market as we look at the unique
selling positions and the loyal consumers who choose to, need to,
or both address their health and/or the health of one under their
direct care. The inventor is aware that it is most frustrating at
best for those who are becoming educated, knowledgeable, and
willing, not to have ethical products be made available. One size
does not always fit all. It has been estimated that about one in
nineteen individuals in our society has a health condition that
definitely requires special attention. This is a loyal and
dedicated consumer. In many cases this makes the need for adequate
fiber and water even more important to these individuals, along
with the specific additions, and in the novel delivery methods. Due
to modern medicine's success in combating disease, and with a
better understanding of aging, and our ability to medically and
dietarily address the aforesaid, we are living longer. But can we
live healthier? The inventor's goal is to provide those
opportunities through safe fresh pure water, and make them ethical
as well as attractive in greater hopes that consumers will comply.
[0629] 1. The object of the invention is to present a fiber-water
composition with added encapsulations regardless of size, shape,
color, material(s) and/or all, and/or the like, simultaneously with
hydration. [0630] To present such encapsulations regardless of
composition(s) releasing potential(s) capability that will serve to
protect sensitive ingredients, direct their release, visible and/or
non visible to the eye, yet "swallowable" and/or "spoonable".
[0631] 2. The object of the invention is to present a fiber-water
composition with one, or more than one, viscosity changes,
simultaneously with hydration. [0632] 3. The object of the
invention is to present a fiber water composition employing both
encapsulations and viscosity changes, simultaneously with
hydration. [0633] 4. The object of the invention is to present a
fiber-water composition using encapsulations, viscosities, and/or
both which move around in the bottle (a lava lamp effect) using
such possibilities as the introduction of heat/cold, light/dark,
shaking rolling, stirring to create different effects and
combinations, simultaneously with hydration. This can be done for
delivery purposes and/or entertainment purposes. [0634] 5. The
object of the invention is to present a fiber water composition
that contain particles, flecks, and/or any "descriptive" of the
like, that add active substances and/or decorative elements to the
product, simultaneously with hydration. The just said may be in
suspension and/or settle and move when the bottle is moved in any
direction and/or by any means [0635] 6. The object of the invention
is to present a fiber-water composition with additives in a bottle
with a form such as a character, which does not pass through the
bottle into the drinkers/"spooners" mouth to be considered
dangerous (except if small enough and designed as such {alphabets
in alphabet soup}), and/or does not block the opening from drinking
and/or pouring of that is the chosen pathway of delivery,
simultaneously with hydration. [0636] The objects may be
representational, and/or just a shape(s), and/or may be more than
one. One might think of a ship in the bottle, or a snow filled
paperweight with an affixed character(s) and moving particles
surrounding separately and/or simultaneously. [0637] If one
considers a "spoonable" product, like a Jello.RTM. or a soup then
these particles may have meaning like in alphabet soup, or be tiny
characters, miniatures, whereby they are not drunk but spooned and
possibly chewed, and/or the like. [0638] 7. The object of the
invention is to present a fiber-water composition that addresses
airline travel, beyond just the needed water (hydration) and fiber,
(Example: deplete in airline foods) with specific anti-oxidants,
(mainly A, C, and E) needed to counteract the free radicals in the
cabins for flight personnel and passengers a like, Fiber-Water PLUS
for Airline travel, simultaneously with hydration. [0639] 8. The
object of the invention is to present a fiber-water composition
with enhanced additives under the guidelines of this invention that
is most useful in emergency (stress) situations serviced by such
institutions as the Red Cross, FEMA, and/or the like,
simultaneously with hydration. [0640] While it is to be noted that
there is an enhanced fiber-water for general stress this
composition specifically addresses emergency situations. [0641]
Besides, universal use as a hydrating and fiber providing material,
fortified fiber-water with the additives will be even more helpful
as a single product and especially useful in situations of stress.
It is believed that stress, both physiologically and
psychologically wrecks havoc on the body and alters or effects
bowel regularity as well as other bodily functions. [0642] When
under stress humans and animals are known to reduce their
consumption of water. Yet when the body is stressed by disease,
additional water is required, yet this is exactly when many reduce
their fluid intake. Further stress may influence people to prefer
sugar-laden beverages (comfort food) or caffeine beverages for
alertness--these types of beverages actually increase ones water
requirement and may lead to dehydration. [0643] Thus, it is
beneficial to provide fiber-water and/or the fortified
fiberwater(s) (more categorically target specific) as opposed to
plain water in emergency supplies to be used in case of natural
disaster--fire, flood, storm, earthquake, or hurricane and it is
suggested fiber-water be stocked by FEMA or its international
counterparts. [0644] During such a disaster people are stressed and
are often forced to move from their homes and everyday
surroundings. Emergency situations often dictate a shortage of food
and water and/or that food and water will be available at abnormal
times. This combined with the general shortage of fresh fruits and
vegetables, which are a key source of dietary fiber and other
important nutrients, during such an emergency naturally impacts
health status, animals too. [0645] It is also conceivable as for
any part of the invention to have a vial of fortifications to the
basic fiberwater and that they may be mixed in. These may present
in vials and/or the like. It certainly allows more product
versatility to a posing situation. (In the inventors infusion
packet filing this is in depth but this is not in dry form but in a
liquid vial, packet etc and specifically for the base product
fiber-water. [0646] 9. The object of the invention is to present a
fiberwater composition designed to specifically address digestive
support, simultaneously with hydration: Digestive Support
FiberWater [0647] a. The importance of addressing digestive
disorders: [0648] i. The inventor is concerned with the over
abundance of degenerative digestive conditions so prevalent in the
US. Today, 70 million American suffer from digestive diseases, 15
percent on a daily basis (NIDDK 1997). An even larger population,
approximately 118 million, experience heartburn or are afflicted
with gastro-esophageal reflux disease (GERD) at least once a month.
Even more potentially alarming is the projected 35 percent increase
in the number of adults 50-64 who will be afflicted with digestive
problems. It is estimated in America that 90 million people use
antacids or other stomach relief medicines (Euromonitor, 1998).
Next to headaches stomach problems are one of the most self-treated
ailments in the U.S. (American Pharmaceutical Assoc., 1997). [0649]
ii. A principal function of the gastrointestinal tract is to
process and absorb food. The stomach, which is both a storage and
digestive organ, works to optimize the conditions for the digestion
and absorption of food in the small intestine. Following the
stomach, is the large bowel (colon), then is the small intestine,
which comprises three regions: the duodenum, jejunum, and ileum. A
major function of the small intestine is one of absorption of
digested nutrients. [0650] iii. The passage of a meal through the,
gastrointestinal tract, which leads to digestion and absorption of
nutrients, is controlled by a complex system of inhibitory and
stimulatory motility mechanisms which are set in motion by the
composition of the meal ingested. Specific receptors for fats, and
proteins, and the osmolality, acidity and particle size of the meal
activate propulsive and inhibitory reactions, which modulate
transit and thus absorption. The rate of passage through the small
intestine is of great significance for the rate and extent of
absorption from the small intestine. [0651] iv. Disruption of the
normal digestive and absorptive processes frequently manifests as a
variety of syndromes, such as, for example malnutrition, weight
loss, diarrhea, steatorrhea, vitamin deficiency, electrolyte
imbalance, and the like. [0652] v. The small intestine is also an
important site for the absorption of pharmacological agents. The
proximal part of the small intestine has the greatest capacity for
absorption of drugs. Intestinal absorption of drugs is influenced
to a great extent by many of the same basic factors that affect the
digestion and absorption of nutrients, water and electrolytes.
[0653] vi. While many of the fibers address digestion and improve
and support gastrointestinal health the inventor chooses to go
beyond their sole ability alone to contribute to better digestion
and the improving and/or sustaining a healthy gut. [0654] vii.
Further, one of the strongest health links for nutraceuticals is to
treat digestive problems. [0655] viii. So as to gain a better
perspective, and a more layman appreciation of a portion of the
invention, the inventor presents a water composition which not only
hydrates along with delivering soluble fiber (some fibers are more
inclined to benefit good gut health such as inulin/those which act
as a pre-biotic/pro-biotic {to be discussed in depth}), but now to
enhance with encapsulated ingredients specifically designed to
supply additional additives that promote a healthy gut.
Additionally also targeted at addressing the symptoms of gastro
intestinal upset/indigestion, best in a natural way however
pharmaceutically if deemed necessary. [0656] ix. The inventor has
covered digestive and systemic enzymes and their delicate nature,
yet important function in the body. There are other ingredients
that are known in the art to support digestion and/or aid in
indigestion. Those may be encapsulated as well so that the taste
may be masked as needed. In the cases of indigestion known helpful
additives include, but are not limited to the following: alfalfa,
aloe, anise, catnip, chamomile, fennel, fenugreek, goldenseal,
ginger, peppermint, hydrochloric acid (sometimes), garlic, B
complex especially B1 and B12, L Glutamine, to list just but a few.
[0657] x. Further, by time releasing the encapsulation(s) all at
the same time and/or sequencing, be they the same ingredient or
different ingredients this will allow the ingredients to be
delivered to a specific targeted area of the Gastrointestional
Tract. [0658] xi. U.S. Pat. No. 5,977,175 to Lin (Cedars-Sinai
Medical Center Los Angeles Calif.), issued Nov. 2, 1999, titled:
Methods and compositions for improving digestion and absorption in
the small intestine. The abstract as follows; "The present
invention provides methods and compositions for slowing
gastrointestinal transit and prolonging residence time to optimize
presentation and absorption of ingested nutrients and/or
pharmacologically active agents in the small intestine to prevent
and/or reduce ineffectiveness thereof due to mal-absorption. The
present invention further provides methods and compositions for
enhancing the bio-availability and therapeutic effectiveness of
pharmacologically active agents. What Lin points out is critical in
relation to soluble fiber which is known to slow transit time
through the colon not just to allow the binding of toxins so as to
remove them from the colon but to slow the transit time for the
absorption of the additive, "drug" and/or the like. Encapsulations
and/or viscosity changes in the deliver system may further enhance
target specific delivery. [0659] xii. The size as well as the
components, perhaps in the form of particles inside of particles
then inside of said components, (whether they are considered
encapsulations or not) is in the inventiveness here described in
this filing (with or with out viscosity changes or not) will depend
on many factors and known to those skilled in the art of
structuring, composing, and formulation. [0660] xiii. Promoting
good gut health U.S. Pat. No. 5,605,697 to Asano (Fujisawa Pharm.
C., Ltd. Osaka JP.), issued Feb. 25, 1997, titled: Bifidobacterium
growth promotant. Abstrct teaches as follows follows: This
invention relates to a bifidobacterium growth promotant comprising
gluconic acid, a nontoxic salt thereof and/or
glucono-.delta.-lactone as an active ingredient. The
bifidobacterium growth promotant of this invention has selective
bifidobacterial growth promoting-activity and, at the same time,
inhibits growth of deleterious bacteria. Moreover, its rate of
digestion and absorption in the upper alimentary tract is so low
that the promotant has very satisfactory characteristics as a
bifidus factor. Therefore, the bifidobacterium growth promotant of
this invention can be used per se or as an additive for various
foods and drink to provide functional foods and drinks, thus being
of great value from the standpoint of health improvement. This
prior art proves the new finding that an organic acid has the
activity to promote the growth of bifidobacteria. [0661] xiv.
Additionally U.S. Pat. No. 5,698,437 to Masuda, issued Dec. 16,
1997, titled Agent for proliferation of bifidobacterium is
noteworthy. [0662] 10. The object of the invention is to present a
fiberwater composition designed to specifically address overweight
(appetite suppression, obesity and/or "dieting"), simultaneously
with hydration: Diet Support Fiber-Water [0663] a. Fiber-Water
composition with enhanced abilities designed to specifically
address appetite suppression/weight loss/weight control. [0664] i.
First to note is how mind boggling it is to know that literally
over a billion dollars annually is spent on pharmaceutical drugs,
over the counter supplements (OTC) medications, with their guarded
"all natural promises", shakes and herbal concoctions, along with
each diet Guru's claim to have the ultimate answer in league with
their philosophy of "why" and "how" to lose weight. We are
bombarded with presentations everywhere including but not limited
to the advertisements on television (infomercials) print
advertisements, direct marketing and/or the like, all costing an
enormous amount of money to produce. They may also provide the plan
by which to accomplish a weight loss goal and, in many instances,
have available products under their name produced. (Robert Atkins
as one who purports a low carb/no carb diet for weight loss. In
fact 35,000,000 Americans are on such diets. Additionally, another
80,000,000 Americans are on some sort of weight loss diet at any
one time.
[0665] ii. There are organizations worldwide like Weight Watchers,
and Jenny Craig along with a domestic chain of about 2,500
locations (US), centers, called Diet Centers. [0666] iii. The
inventor is most concerned with "general population obesity", but
with a "special" focus on childhood obesity (CO). CO may not just
catapult into adult obesity, but set the child up for major health
problems later in life, such as: diabetes, heart problems, stress
fractures, psychological abuse etc. The biggest rise in childhood
obesity has been in the US, but European countries are following
the trend. About one in seven children in France, and one in five
children in Italy, is now overweight. To understand this problem,
and how significant it is the inventor calls attention to the
following: [0667] (1) 61 percent of U.S. adults overweight. Dec.
15, 2000. [0668] (2) The condition of being overweight is due to
excess body fat. Strictly speaking, the term obesity is used to
denote body weight that is 20 percent, or more, over the ideal
weight as determined from life insurance company statistics for
age, body-type, gender, and height. If a person's weight is not
considered normal for his, or her, height and gender, he or she
should try to lose weight to improve health. Weight loss of 10
percent of total body weight is associated with improvements in
health. [0669] (3) It has been demonstrated that babies who are fed
excessive amounts of food become fat, often remain overweight into
adulthood. [0670] (4) Further many babies, children, and/or adults
have been given food to feel better, or told that if they want to
feel better they should eat more, and the inventor says "notice"
EAT MORE NOT DRINK MORE. [0671] (5) Obesity has contributed greatly
to one of the major health challenges today in humans and animals,
weight control including weight loss, reduction of obesity, and
weight maintenance. [0672] (6) This inventor is concerned with the
many potentially serious health hazards in being overweight, as
mentioned and also includes looking at the potential for being at
greater risk for coronary thrombosis and stroke because of
arteriosclerosis. Such high-risk people are more likely to develop
diabetes mellitus and high blood pressure or hurt themselves
seriously in accidents, develop osteo-arthritis, particularly of
the knees hips, and ankles, and have complications following
surgery, such as venous thrombosis and chest infections. [0673] (7)
Obesity increases the risk of diabetes and cardiovascular disease
and causes severe social and psychological problems in millions of
Americans. [0674] iv. Therefore it is the belief, and goal, of the
inventor to use an easy to administer effective "obesity addressing
solution" (fiber-water {U.S. Pat. No. 6,248,390} addresses this
problem), and now by this addition to the just said invention the
inventor, will provide enhancement(s) for this purpose thus
allowing more versatility to the treatment with the delivery
systems of encapsulations and viscosity changing abilities,
independent and/or in consort). [0675] v. While psychological
factors may, or may not, play an important role in gaining and/or
loosing weight, they must be considered as well. There has become a
tremendous focus on oral gratification as a part of addressing this
issue. For many they just need to have "their mouth going". It is
even noted that when smokers give up smoking they put on weight.
Drug addicts go to smoking and/or eating. However, it is well
established that although disciplinary dieting may result in weight
loss, such loss is rarely long lasting due to hunger, or more so to
the "drive to eat". This drive may be accompanied by the need for
oral gratification. In the beginning a mother's breast, or the
bottle, gave us nourishment, oral gratification, and satisfaction.
By providing a functional water, or functional water program,
especially for those addressing the problem of weight loss and/or
weight maintenance, it is possible to also address this need for
oral gratification. [0676] (1) With that in mind it is not just the
additives to the fiber-water via the methodologies described, but
the very fact that the dieter is given something that is pleasing,
while playing to, and ergo appealing to this "oral gratification
needy population". [0677] (2) A slightly thicker viscosity, which
basically goes un-noticed, or slightly noticed, or very noticeable
as planned, is one way. Who would want to drink, and/or spoon thick
water . . . perhaps one would say "yuck". But it is here that the
inventor cannot emphasize enough that, and covered in her issued
fiber-water U.S. Pat. No. 6,248,390, fiber-water, and now this
novel enhanced fiber water, is also used for imbibing and
reconstituting other products. Direct quotation for the abstract is
as follows: "A shelf stable, ready to use, essentially tasteless
and odorless water-like fluid for humans/animals comprised of safe
water and a significant quantity of one or more water-soluble
dietary fibers. Fiber-water, is intended to be consumed by
drinking, or by enteral feeding alone, and/or in combination. The
inventive liquid may be consumed directly hot or cold or after use,
at any required temperature, in the preparation/reconstitution of
beverages or liquid food product (e.g. coffee, tea, concentrates
such as "HAWAIIAN PUNCH..RTM.", frozen concentrates such as
lemonade/orange juice, soups and pet food). It can be used to
enrich foods with soluble fiber through cooking, moistening,
reconstituting or imbibing dried foods (e.g. oatmeal, rice, dried
fruits, powdered soups, powdered beverages, powdered milks,
nutritional shakes, "GATORADE..RTM./TANG..RTM./KOOL-AID..RTM.."
products, gelatins, custards, puddings, and pet food). Fiber-Water
can be consumed in the frozen state either indirectly by adding it
to a beverage as a cube or crushed "ice", or directly by licking a
frozen "POPSICLE..RTM." product). Fiber-water is safe water fiber
enriched intending to be a replacement and/or adjunct to other
water to ensure proper hydration while at the same time provide
significant soluble fiber." [0678] (3) So in addition to the
formula(s) for addressing obesity, additional fiber-water formulas
might not just be supportive but necessary. Categorically, an
example would be a stress reducing formula, a mood improver, an
anti-depressant, and/or the like. [0679] (4) U.S. Pat. No.
6,013,622 to Bruno et al. (Nutriceutical Technology Corporation
(Bridgewater, N.J.); Research Foundation of State University of New
York (Stony Brook, N.Y.), issued Jan. 11, 2000, titled Method of
regulating appetite and metabolism [0680] (5) U.S. Pat. No.
4,784,861 to Gori (CCA Indust. Inc. (East Rutherford, N.J.), issued
Nov. 18, 1988, titled: Weight-control formulation, which
additionally goes extensively into the benefits of fibers. [0681]
(6) By helping control appetite we now may have discovered a way to
address and control childhood and adult obesity as disclosed in
U.S. Pat. No. 5,505,981 Method for Imparting Ability of Preventing
Obesity and Imparting Glucose Tolerance to Foods and Sugar
Preparations Exhibiting Such Preventative Effects. [0682] vi. By
designing a plan of action to sip, and/or at the other extreme
spoon fiber-water, an enhanced functional fiber-water(s) throughout
a protracted period of time, there exists the likely hood that the
dieting individual will have something to hold (keeping roaming
hands free from selecting food) and additionally, something
addressing oral gratification. This is separate from the actual
effect of the contents upon the individual, which again, used
frequently throughout the day, brings forth additional merit. In
many instances the additional functional ingredients may work
better in a constant delivery mode, as opposed to a "bolus" dose
taken hours apart and/or skipped in par, and/or even forgotten.
[0683] While it is a separate subject, the inventor is most
sensitive to those with eating disorders. [0684] It may benefit
individuals with such known eating disorders as anorexia or bulimia
since these individuals typically drink water because it fills them
up without providing calories. [0685] Hopefully by these additions
to Fiber-water they would serve to not only help preserve proper
functioning of the gastrointestinal tract while other treatment is
hopefully undertaken, but additionally add other needed nutrients.
[0686] vii. Those with eating disorders often from sever
dehydration and/or are constantly drink water to ameliorate the
hunger pains and satisfy. If in any conceivable way the practice of
this invention addresses this disorder by providing hydration,
nutrition, even if not providing the calories needed, it is still a
step towards improvement, and should be taken as serious, and
valuable. [0687] viii. The inventor has looked closely at the
following, and is hopeful that with not just these waters in this
invention, but with her infusion packets in PCT/US01/09171 and/or
her infusion packets in formulation with Fiber-Water (U.S. Pat. No.
6,248,390) and/or these new and novel "consistency regulated"
invented waters, with or without the encapsulated additives, will
tend towards making a significant impact on the health of our
population in general, and especially with our younger. [0688] (1)
To the inventor the following should drive home the importance of
this invention, along with, perhaps even more alarming statistics
and findings: [0689] (a) Obesity rates have risen in tandem with
soft-drink consumption. (The National Institutes of Health
recommends that people who are trying to lose or control their
weight should drink water instead of soft drinks with sugar). The
Problematical Increased Prevalence of Sugar in the American
Diet
[0690] The big food companies and fast food chains still produce
beverages and food products with an enormous amount of sugars, and
most of all soda pop adds unnecessary, non-nutritious calories to
the diet.
[0691] In fact America is drowning in sugar.
[0692] WASHINGTON--The Center for Science in the Public Interest
(CSPI) and dozens of leading health experts and/organizations today
petitioned the Food and Drug Administration (FDA) to require that
food labels declare how much sugar is added to soft drinks, ice
cream, and other foods.
[0693] The petition also asks the FDA to set a maximum recommended
daily intake (Daily Value) for added sugars and require labels to
disclose the percentage of the Daily Value a food provides.
[0694] Michael Jacobson, executive director of CSPI, said today at
a Washington press conference, "Sugar consumption has been going
through the roof. It has increased by 28% percent since 1983,
fueling the soaring obesity rates and other health problems. It's
vital that the FDA require labels that would enable consumers to
monitor--and reduce--their sugar intake."
[0695] Marion Nestle, chair of the Department of Nutrition and Food
Studies at New York University, said, "Because sugary foods often
replace more healthful foods, diets high in sugar are almost
certainly contributing to osteoporosis, cancer, and heart disease.
It's high time that the food label informed consumers of a food's
contribution to a recommended limit for added sugars." Nestle was
managing editor of the 1988 Surgeon General's Report on Diet and
Health.
[0696] United States Department of Agriculture (USDA) surveys show
that sugar consumption has increased almost every year since 1982.
Most of that sugar came from cane and beet sugar and corn syrup and
corn sugar. Much of the increase was due to the consumption of soft
drinks.
[0697] "Health officials must take prudent action to stem the
dilution of the American diet with sugar's empty calories.
Declaring on food labels the amount of added sugars would help
consumers cut the sugar and improve their diets," said Mohammad
Akhter, the executive director of the American Public Health
Association.
[0698] USDA advises people who eat a 2,000-calorie healthful diet
to try to limit themselves to about 10 teaspoons of added sugars
per day. In fact, the average American does not eat a healthful
diet, but consumes 20 teaspoons of added sugars per day.
[0699] A teenage male who eats a healthful diet could eat about 18
teaspoons of added sugars, according to USDA. Most teenage males do
not eat a healthful diet, because they consume an average of 34
teaspoons of sugar per day.
[0700] CSPI is asking the FDA to adopt USDA's figure of 10
teaspoons (40 grams) as the Daily Value for added sugars. Daily
Values are used on Nutrition Facts labels to indicate the
recommended maximum intakes of fat, sodium, and other
nutrients.
[0701] Many individual foods provide large fractions of the USDA's
Re-commended sugar limits. For instance, a typical cup of fruit
yogurt provide 70% of a day's worth of added sugar; a cup of
regular ice-cream provide 60%, a 12-ounce COLA provides 103%, a
large McDonald's Shake 120 percent, a large Mr. Misty Slush at
Dairy Queen 280%
[0702] One of the biggest problems with high-sugar foods is that
they are replacing more foods that are healthful. According to USDA
data, people who eat diets high in sugar get less calcium, fiber,
foliate, vitamin A, vitamin C, vitamin E, zinc, magnesium, iron,
and other nutrients. They also consume fewer fruits and
vegetables.
[0703] "If you're drinking soda pop instead of low fat milk or
orange juice, or eating a candy bar instead of a piece of fruit,
you're missing a chance to cut your risk of osteoporosis, cancer,
or heart disease," said Bonnie Liebman, CSPI nutrition
director.
[0704] Liquid Candy, as soft drink are called are harming America's
Health. The inventor also believes that all the sugar laden new age
beverages such as the So Be Drink line and many of the flavored
teas, botanicals, and the like are just as guilty as the soft
drinks. Granted they do not have the phosphoric acid of the colas
but the sugar level is just as high if not higher.
[0705] In 1997, Americans spent over $54 billion on soft drinks.
The industry produced 14 billion gallons of soft drinks, twice as
much as in 1974. That is the equivalent to 576, 12-ounce servings
per year, or 1.6 12-ounce cans per day for every man, woman, and
child.
[0706] 12- to 19-year-old boys who consume soda pop drink an
average of 2 12-ounce sodas per day (868 cans per year). Girls
drink about one-fourth less.
[0707] Bigger serving sizes spur consumption. In the 1950s,
Coca-Cola sold only a 61/2-ounce bottle. That grew into the
12-ounce can, which is now being supplanted by 20-ounce bottles ( .
. . and then there's 7-Eleven's 64-ounce 600-calorie Double
Gulp--the "Pop Belly Special").
[0708] Soda pop is Americans' single biggest source of refined
sugars, providing the average person with one-third of all sugar.
Twelve- to 19-year-old boys get 44% of their 34 teaspoons of sugar
a day from soft drinks. Girls get 40% of their 24 teaspoons of
sugar from soda. Because some people drink little soda pop, the
percentages are higher among actual drinkers.
[0709] Soft drinks provide the average 12- to 19-year-old male with
about 15 teaspoons of sugar a day and the average female with about
10 teaspoons a day.
[0710] In 12- to 19-year-olds, soft drinks provide 9% of boys'
calories and 8% of girls' calories. Those percentages are triple
(boys) or double (girls) what they were in 1977-78. Those figures
include teens, which consumed little or no soda pop.
[0711] As teens have doubled, or tripled their consumption of soft
drinks, they drank 40% less milk. Twenty years ago, boys consumed
twice as much milk as soft drinks, and girls consumed 50% more milk
than soft drinks. Now, boys and girls, consume twice as much soda
pop as milk.
[0712] Teenage girls consume only 60% of the recommended amount of
calcium, with soda-pop drinkers consuming almost one-fifth less
calcium than non-drinkers. It is crucial for females in their teens
and twenties to build up bone mass to reduce the risk of
osteoporosis later in life. Preliminary research suggests that
drinking soda pop, instead of milk, can contribute to broken bones
in children and adolescents.
[0713] Among frequent consumers, regular soft drinks promote tooth
decay because they bathe the teeth with sugar-water for long
periods of time.
[0714] Diets high in carbohydrate may promote heart disease in
"insulin resistant" people by raising triglyceride levels in blood.
Sugar, such as that in soda pop, has a greater effect than other
carbohydrates.
[0715] Soft drinks may increase the recurrence of kidney stones.
The National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK) includes cola beverages on a list of foods that
doctors may advise patients to avoid.
Nutritional Harm of Soft Drinks
[0716] Heavy soft-drink consumption also correlated with low intake
of magnesium, ascorbic acid, riboflavin, and vitamin A. Calcium
continued to be a special problem for female soft-drink
consumers.
[0717] Dietary surveys of teenagers found that in 1996: [0718] Only
34% of boys and 33% of girls consumed the number of servings of
vegetables recommended by USDA's Food Pyramid. [0719] Only 11% of
boys and 16% of girls consumed the recommended amount of fruit.
[0720] Only 29% of boys and 10% of girls consumed the recommended
amount of dairy foods. [0721] Most boys and girls did not meet the
recommended amounts of grain and protein foods.
[0722] Those surveys also found that few 12- to 19-year-olds
consumed recommended amounts of certain nutrients, including:
[0723] calcium: only 36% of boys and 14% of girls consumed 100% of
the Recommended Dietary Allowance (RDA). [0724] vitamin A: only 36%
of boys and 31% of girls consumed 100% of the RDA. [0725]
magnesium: only 34% of boys and 18% of girls consumed 100% of the
RDA.
[0726] Colas provide male teens in the 90th-percentile of
soft-drink consumption with as much caffeine as is in 11/2 cups of
coffee; for females the figure is one cup. Caffeine, a mildly
addictive stimulant drug, is added to most Colas, Dr Pepper, some
orange sodas, and other soft drinks. Caffeine's addictiveness may
be one reason why six of the seven most popular soft drinks contain
caffeine. However the inventor notes that caffeine has specific
use, and may be used with specific intentions and not just put into
beverages, indiscriminately to addict consumers to their product.
Caffeine does not contribute to the taste factor in the inventor's
opinion and presents, in fact as bitter.
[0727] The artificial sweetener saccharin, which is now used only
in a few brands, has been linked in human studies to
urinary-bladder cancer and in animal studies to cancers of the
bladder and other organs. Several cancer experts have questioned
the safety of acesulfame-K, which is used in the new Pepsi One.
[0728] ix. It is the object of this invention to present additional
benefits to fiber-water, which in and of itself, by the nature of
soluble fiber(s) addresses appetite suppression/feeling of
fullness, ergo weight control and/or dieting while simultaneously
satisfying hydration requirements especially important to dieters.
[0729] x. In weight loss, weight management, or weight maintenance,
diet fiber-water(s) would be water providing adequate hydration,
adequate fiber, and perhaps, a minimal amount of a "sugar" and/or a
sweetener, and/or a combination of both. The
glucose/sugar/sweetener would be for the purpose of modulating
glucose levels wherein significant fluctuations in blood sugar can
now be kept at bay. In other words, "take the edge off of hunger".
Certainly when ones blood sugar falls the symptoms including, but
not limited to, extreme hunger, ergo most likely results in
overeating and/or food bingeing. (The inventor here is not
referring to those who eat for psychological reasons) [0730] xi. A
minimal amount of glucose added to the fiber in water is valuable
and even to be considered necessary for many reasons, including,
but not limited to, a feeling of satisfaction when
ingesting/digesting, in helping to support/regulate blood glucose
levels during a weight loss, or maintenance program. Also to aid
with feelings of depression, stress (a hint of sweet brings
satisfaction), and to ensure that, as in fiber-water, adequate
water and fiber are consumed. By varying the ratios of both caloric
(to accomplish the aforesaid), low caloric, and non-caloric
sweeteners, the inventor provides "formulation room" to effect
taste and therefore relating affirmatively to the consumer's,
perceived and/or actual, satisfaction. [0731] xii. Further, to
maintain a functional water-like drink with very low inclusion of
glucose it is necessary to take into consideration the taste of the
additional ingredients. It is to this end that encapsulations be
included following the guidelines of this invention and the
abilities of the art. The viscosity, and/or more than one
viscosity, as mentioned, of the fiber-water-glucose/sweetener
composition may be altered to better support the desired
response(s), with or without encapsulations, or for other commonly
known reasons, including but not limited to individuals with
swallowing difficulties. [0732] xiii. A swallowing disorder may be
caused by allergies, anxiety, bacterial infection, cancer of the
esophagus, fear, genetic problems, goiter, hiatial hernia, hormone
imbalance, nervous disorder, stress, swollen lymph nodes, thyroid
disorder, tonsillitis etc. Further, Jello.RTM. like beverages have
a great appeal to children and even the elderly as they enjoy the
texture and possibility of flavors and colors. A thickening and/or
gelling agent to give an enhanced body to the water for the purpose
of creating a more food like or filing feeling` is especially
desired by those on a weight loss program. Some of these thickening
agents and/or gelatins have, by their intrinsic nature, nutritional
value. Knox.RTM. gelatin by Nabisco.RTM. was mentioned earlier but
to note that, in addition to fingernails, gelatin provides building
blocks for collagen, the chief structural protein in bone and
cartilage. [0733] xiv. The present inventor is concerned with
providing a composition that can be extremely beneficial to humans
(animals too) who are looking to reduce their weight. Then at
formulating a plan as to how to implement that plan, including but
not limited to the selection of a "functional water" specially
deigned to meet the needs and desires. This may readily be a
platform for a daily individual, (large container/bottle of one
litter or more in contents) to be drunk throughout the day and/or
an integrated, multi-bottled/packaged (Two (2) or more containers
synergistically functioning in consort) water program. This is also
for those who have already started a weight loss program and/or
wish to maintain life long regimen of healthy drinking. It is
believed that plus or minus 1-5 gr. of sugar (dextrose, sucrose,
fructose etc.) will only add 4 calories per gram to the liquid, in
this case 8 oz. (240 ml.). Therefore a total of plus or minus 4 to
20 calories per 8 oz. is what is considered reasonable, but may
exceed by design. (Sugar is often referred to as in Brix. One
degree Brix is equal to 1% sugar solution per 100 ml.) [0734] xv.
With the further addition of flavoring(s), aroma(s), and
coloring(s), a diet-fiber-water that includes scientifically
studied additives for this specific use, is considered far more
ethical than drink selections consisting of water and sugar laden
liquid diet supplements that add fat too many calories, for one
thing, and actually contribute to one, or more than one,
potentially serious dietary problems, rather than alleviate them.
(The inventor, personally, does not advocate nutritionally
fortified diet beverages for continued use, as one must eat meals
and regulate the body normally accordingly) However if it is in dry
form, to be reconstituted, then with this invention it may be
meritorious. [0735] xvi. With the proper administration of a fiber,
water, glucose/sweetener composition consumed throughout the day,
and on a daily basis, positive results have been observed noting a
sufficient reduction in appetite along with and a more
regulated/even metabolism. [0736] xvii. U.S. Pat. No. 5,344,824 to
Ohkuma et al., issued Sep. 6, 1994, titled; Method for reducing
insulin secretion . . . A method for reducing insulin secretion
without negatively affecting/influencing blood glucose levels in an
animal Abstract: A food composite for saving insulin secretion
comprising a refined product of pyrodextrin obtained as an active
ingredient through a process of decomposing starch or starch
hydrolyzate by heating in the presence of an acid or without acid.
[0737] xviii. U.S. Pat. No. 5,505,981 to Wakabayashi et al., issued
Apr. 9, 1996 titled; Method for imparting ability of preventing
obesity and impaired glucose tolerance to foods and food sugar
preparations exhibiting such preventative effects. [0738] xix. It
is the goal of this invention to provide the vehicles/delivery
system relating to the placement of additives in order to produce a
most scientific and ethical product, while giving the consumer the
highest in quality, consistency, appeal, and value. [0739] xx.
While this invention purports that the addition of said functional
components will reside within the encapsulations, it is also
conceived that one or more than one of the non-active/active
components, in addition to the fiber, will reside in the liquid
itself, outside of the encapsulations. The value in doing the
aforementioned is multi-purposeful. As an example some minerals
might enhance the flavor of the water regardless of the total
dissolved solids and/or salts but for a certain specific need, more
of that mineral might be needed. If put in the "general water" aka
"background water" the taste would not be acceptable, ergo
encapsulating that mineral would allow more to be delivered without
changing the taste. In the case of Astroade, (Dr. John Greenleaf
NASA), the re-hydration drink of the astronauts, which is very high
in sodium, this could provide a viable solution. Further, some of
the (in this example) minerals could be timed release while some
could be used immediately upon ingestion. In the case of some
minerals as an example, the water composition would still taste
like water (even if you went into a higher mineral category [above
a TDA of 500]) and the minerals will enhance the taste and provide
nutritive value as well. Note: The inventor has already discussed
fiber (including but not limited to the gums) as in relation to
what she would define as a "more textured" water composition.
[0740] xxi. It is also a part of this invention in total, and not
just for the fiber-water for weight loss purposes, that the
encapsulations/micro-encapsulations while they may be released in
the mouth, they may also be coated to drop within 60-240 minutes,
(1-4 hours) post ingestion, thus allowing the active ingredients to
be placed farther down along the gastrointestinal tract. In the
case of a diet fiberwater, ingredients known in the art to
ameliorate hunger and/or give a feeling of fullness ergo having
extra value if they are not just immediately released but released
at timed intervals. Qualities of mood regulating waters, stress
addressing waters, relaxing waters, etc. may be incorporated into
the program in the same packages container and/or multiple
containers packaged together and/or selected by the choice of the
consumer. [0741] xxii. It is even possible to encapsulate small
amounts of sugar(s) to be released in this fashion, however they
would be larger in size and most likely visible to the eye (perhaps
even colorful) that could address fluctuations in blood sugar
levels ergo would help ameliorate mood swings, hunger, and/or the
like conditions resulting from blood sugar "lows" with or without
other additives which have been recognized/endorsed/prescribed by
health care professionals and supporting science has validated.
[0742] xxiii. Other additives, which are contemplated by the
inventor have been well researched with sound ethical, and
recognizable, scientific studies behind them and deemed
"functional" and known to support weight loss without side effects
include but are not limited to: [0743] (1) Chromium Picolinate
reduces sugar cravings by stabilizing the metabolism of simple
carbohydrates. [0744] (2) Vitamin C necessary for glandular
function, speeds up a slow metabolism. [0745] (3) Choline and
insitol help the body burn fat. [0746] (4) Gamma-aminobutyric acid
(GABA) suppresses cravings and has antidipressant qualities. [0747]
(5) L. Arginine. L'Ornithine plus L'Lysine are amino acids which
are known to decrease body fat and best combined with 50 mg. B6 and
100 mg. Vitamin C for better absorption. [0748] (6) L'Carnitine has
the ability to break up fat deposits and aids in weight loss.
[0749] (7) L'Glutamine lessens carbohydrate cravings. [0750] (8)
L'Phenylalanine is an appetite suppressant which tells your brain
that you are not hungry [0751] (9) L'Tyrosine suppresses cravings
and has anti-depressant qualities [0752] (10) Zinc enhances the
effectiveness of insulin and boosts immune function. [0753] xxiv.
U.S. Pat. No. 6,403,657 to Hinz, issued Jun. 11, 2002, titled:
Comprehensive pharmacologic therapy for treatment of obesity
abstracts the following: The comprehensive pharmacologic therapy
for treatment of obesity is a procedure which involves the
administration of a desired therapeutic range of Diethylpropion
and/or Phentermine in combination with a SSRI medication and
nutritional supplementation for brief and long durations which may
be 12 months or more. The preferred procedure involves the
administration of drugs in combination which are identified as:
Citalopram (Celexa) and Phentermine; Citalopram (Celexa) and
Diethylpropion; Citalopram (Celexa), Phentermine, and
Diethylpropion. In addition nutritional supplementation such as a
multivitamin, 5-Hydroxytryptophan, vitamin B6, vitamin C, Tyrosine,
Calcium, and Lysine may be used to enhance the performance of the
weight loss treatment program. (The inventor here is specifically
interested in the encapsulations of the nutritional supplementation
of the aforesaid). [0754] 11. The object of the invention is to
present a fiber-water composition designed to support heart health,
simultaneously with hydration: Hearth Healthy Fiber-Water. [0755]
a. If one has elevated cholesterol, for which statistics have shown
one (1) in every five (5) adults has, fiber-water (U.S. Pat. No.
6,148,390) with its inclusion of significant soluble fiber has been
shown to be of great benefit in lowering such an elevated level.
[0756] i. Studies also show that adequate fiber clearly lowers the
risk of heart disease and tends to bind toxins, including toxic
metals, allowing them to exit safely from the digestive system.
[0757] ii. Further, and of major significance, is that in the case
of fats the fiber seems to help prevent damaging levels of
cholesterol in the blood. This seems to be due to a binding of bile
salts and cholesterol to the fiber so that these materials are
excreted with the feces, rather than being absorbed or reabsorbed.
[0758] iii. Additionally, if we address a way of lowering
cholesterol, in addition to soluble fiber/fiber-water as a way to
reduce cholesterol level, some natural additions should be
considered, and presented within the confines of the "new and
novel" of this invention. In the same alternative one can give
consideration to a pharmaceutical addition, but the inventor here
prefers to use nutritional enhancing additives where ever and when
ever possible due to many of the consequences that go with
pharmaceuticals. Such nutritive enhancing agents include but are
not limited to the following: [0759] (1) Coenzyme Q10, which has
been shown to oxygenate heart tissue. [0760] (2) Calcium and
magnesium are important in the proper functioning of the cardiac
muscle (The inventor is impressed with the magnesium gluconate and
the calcium lactate gluconate both by Glucona America, (Janesvile
Wis.). They go readily into solution without imparting a taste at
recommended levels. It is therefore possible that they can go into
fiber-water (U.S. Pat. No. 6,248,390) and fall within the limits of
that patent (TDS). In this filing they do not have to be
encapsulated and may reside in the foundational liquid itself, with
or without a viscosity change. (Note; If additional palatable
and/or non-palatable, water soluble or non-soluble forms of
calciums and/or magnesiums are used they will have to be
encapsulated most probably . . . Again referencing a previous
example "if a significantly higher amount is needed, an amount is
best delivered in time release fashion, and/or whereby Taste
becomes an important factor encaspsulations are a consideration".
[0761] (3) Garlic (now exists the odorless varieties) lower blood
pressure and thins the blood. [0762] (4) Vitamin E (water soluble
by Hoffman La Roche, CH) does not affect the taste of water, and
may be used in the basic fiberwater (U.S. Pat. No. 6,248,390)
itself without changing the taste of the composition. Vitamin E
strengthens the heart muscle, improves circulation, it is also an
anti-oxidant [0763] (5) Niacin, lowers cholesterol and improves
circulation. [0764] (6) L'Carnatine has been shown to reduce fat
and triglycerate levels in the blood. Increases oxygen uptake and
stress tolerance.
[0765] (7) Additionally, in therapeutic doses potassium, selenium,
lecithin, Superoxide dismutase (SOD), taurine, Melatonin, and all
the B vitamins are just some of the nutrients that affect the heart
in a positive way if used propetly.8.The object of the invention is
to present a fiber-water composition designed specifically for
diabetics. In the case of simple sugars, slowed absorption
translates to a more gradual rise in blood sugar following eating.
This is important in the managing of diabetes and may also help
prevent adult onset diabetes. [0766] iv. U.S. Pat. No. 5,612,026 to
Diehl, (P&G Co. Cincinnatti, Ohio), issued Mar. 18, 1997,
titled: Cholesterol lowering drink-mix compositions. In this patent
a gum, specifically xanthin gum, is used as the cholesterol
lowering agent/gum. (Xanthan Gum Xanthan gum is a polysaccharide
gum produce by the bacterium Xathomonas compestris. Xanthan gum is
a cream-colored, free-flowing, odorless powder, which dissolves in
water to provide highly viscous solutions at low concentrations.
The Merck Index, Tenth Edition, published by Merck & Co., No.
9868, (1983). Xanthan gum is available commercially under the
tradename Keltrol..RTM., by the Kelco Division of Monsanto &
Co., San Diego Calif.) The art teaches that: a drink mix
composition comprising a therapeutically effective dose of an anion
exchange resin; from about 0.05 g to about 1.25 g of xanthan gum;
and from about 0.3 g to about 1.75 g of edible, water soluble salt
at a level (wherein the gelation rate of the drink mix composition
in an aqueous solution is reduced; and wherein further the
compositions are in a form mixable with a liquid to form a
suspension of the anion exchange resin, xanthan gum and edible,
water soluble salt) has a positive effect on cholesterol lowering.
[0767] 12. The object of the invention is to present a fiber-water
composition designed especially for diabetics, simultaneously with
hydration: Fiber-Water for Diabetics [0768] a. Obesity is a major
cause of a dramatic rise in diabetes. Perhaps because of widespread
obesity in the US, diabetes has increased dramatically over the
past decade, a new nationwide study has found. Between 1990 and
1998, diabetes increased by 70% among individuals aged 30 to 39, by
40% among those aged 40 to 49, and by 31% among those aged 50 to
59, the findings indicate. Diabetes increased across all regions,
demographic groups and nearly all states, according to the
researchers. [0769] b. It has been discovered that dietary fiber
appears to moderate the rate at which sugars and fats are absorbed
from the intestine, thus providing the ability to stabilize the
blood sugar. This stabilization is extremely valuable to those
hoping to achieve and maintain weight loss. [0770] c. U.S. Pat. No.
5,505,981 is an invention, which presents to a method for the
ability of preventing obesity and impaired glucose tolerance to
ingested foods and preparation exhibiting such preventative
effects. There have been developed various agents for inhibiting an
increase in the blood-sugar levels and excess insulin-secretion for
preventing healthy people from suffering from obesity and/or
diabetes or for treating patients requiting the control of blood
sugar level such as those suffering from diabetes. As such agents,
there have been known, for instance, Acarbose (available from Bayer
Yakuhi Ltd.) and AO-128 (available from Takeda Chemical Industries
Ltd.) which are substances having an effect of inhibiting the
gastrointestinal absorption of sugar and starch and inhibitors for
enzymes involved in digestion, however, both of them are medicines
and the ingestion or intake thereof for the preventive purpose
becomes a cause of various problems. For instance, they suffer from
a problem of safety, since they would be dangerous because of
possible side effects, including, but not limited to, elongating
coagulation time. The invention of said patent teaches us that the
prevention of obesity and impaired glucose tolerance can be insured
through the inhibition of increases in blood sugar level and
insulin-secretion in response to the oral ingestion of sugary
substances such as sugars and starches. The inventors of this
invention have demonstrated to us that indigestible dextrin is
excellent for this purpose. The dosage give would be 1 g to 30 gr.
per unit of food of 8 oz. to 12 oz. Therefore for this purpose we
would adapt that range. [0771] d. A study conducted and reported in
the New England Journal of Medicine, May, 2000 encourages all type
2 Diabetics to have at least 50 grams of fiber a day. [0772] e.
Critically important may be the effect of fiber-water(s) on both
type one, type two (adult onset and juvenile) and/or borderline
diabetics as disclosed in U.S. Pat. No. 5,344,824, titled: Method
for Reducing Insulin Secretion. [0773] f. Beside reducing obesity
these additives are helpful additives for diabetics: [0774] i.
L'Carnitine which mobilizes fat [0775] ii. Chromium Picolonate
which improves insulin's efficiency which lowers blood sugar levels
[0776] iii. Taurine aids in the release of insulin [0777] iv. All
the B vitamins, along with Vitamins A, C, and E. [0778] v. Calcium
for Ph balance [0779] vi. Magnesium important for Ph balance and
enzyme systems [0780] vii. Maganese is needed for repair of the
pancreas. Also a co-factor in key enzymes of glucose metabolism
[0781] viii. Garlic stabilizes blood sugar [0782] ix. Alpha lipoic
acid: A powerful anti-oxidant has been shown to improve diabetic
neuropathy and to improve insulin sensitivity. (600 mg. One to
three times as day) [0783] x. Brewers Yeast (BY) As far back as
1853, reported yet still today that chromium rich BY can be useful
(9 grams per day) [0784] xi. Evening Primrose Oil, improve nerve
function and relieve pain symptoms. [0785] 13. The object of the
invention is to present a fiber-water composition designed to
support bone and/or joint health, simultaneously with hydration:
Bone and/or Joint Supporting Fiber-Water. [0786] a. Osteoporosis is
a progressive disease in which the bones gradually become weaker
and weaker, causing changes in posture and making the individual
more susceptible to bone fractures. Osteoporosis is an age related
condition that causes a loss of bone mass and increased brittleness
in the remaining bone tissue. Osteoporosis currently affects 25
million Americans. Osteoporosis affects 15-20 million Americans and
in people over the age of 50 it is linked to 1.5 million fractures
a year. The cost of this disease is thought to surpass $18 billion
a year and is on the rise. The older you are, the greater your
risk. Bone mass--the amount of mineral in the bone begins to become
less dense as you age. [0787] b. Because of the physiological,
nutritional, and hormonal differences between males and females,
osteoporosis primarily affects women. Also women are at a greater
risk also because women have less bone tissue and lose bone more
rapidly because of the changes associated with hormones/menopause.
Caucasian and Asian women are even more prone to the disease.
Small-boned, thin women are also at increased risk. Lifestyle plays
an important role as well. Smoking, excessive consumption of
alcohol, inadequate consumption of calcium, and little, or no,
weight bearing exercise increases risk. The National Osteoporosis
Foundation (NOF recommends 1000 mg of calcium a day for men and
pre/postmenopausal women taking ERT, and 1500 mg a day for
post-menopausal women not on Hormone/estrogen replacement therapy
(ERT) and for all men and women over age 65. [0788] c. Bone is
subject to constant breakdown and resynthesis in a complex process
mediated by osteoblasts, which produce new bone, and osteoclasts,
which destroy bone. The activities of these cells are regulated by
a large number of cytokines and growth factors, many of which have
now been identified and cloned. [0789] d. There is a plethora of
conditions, which are characterized by the need to enhance bone
formation. Perhaps the most obvious is the case of bone fractures,
where it would be desirable to stimulate bone growth and to hasten
and complete bone repair. Agents that enhance bone formation would
also be useful in facial reconstruction procedures. [0790] e. Other
bone deficit conditions include bone segmental defects, periodontal
disease, metastatic bone disease, osteolytic bone disease and
conditions where connective tissue repair would be beneficial, such
as healing or regeneration of cartilage defects or injury. Also of
great significance is the chronic condition of osteoporosis,
including age-related osteoporosis and osteoporosis associated with
post-menopausal hormone status. Other conditions characterized by
the need for bone growth include primary and secondary
hyperparathyroidism, disuse osteoporosis, diabetes-related
osteoporosis, and glucocorticoid-related osteoporosis. [0791] f.
U.S. Pat. No. 6,410,521 to Mundy, et al. (OsteoScreen, Inc., San
Antonio, Tex.), issued Jun. 25, 2002, titled: Nutritional
supplements for stimulating bone growth This art presents a food or
food supplement which comprises a compound that enhances bone
growth in vertebrates wherein the food or foodstuff is formulated
so as to provide the desired bone growth enhancing effect using red
yeast rice. The ultimate goal of the methods and compositions of
the invention is to treat or ameliorate bone disorders in
vertebrate subjects, particularly mammals, and more particularly
humans. [0792] As used herein, "treat" or "treatment" include a
postponement of development of bone deficit symptoms and/or a
reduction in the severity of such symptoms that will or are
expected to develop. The terms further include ameliorating
existing bone or cartilage deficit symptoms, preventing additional
symptoms, ameliorating or preventing the underlying metabolic
causes of symptoms, preventing or reversing bone resorption and/or
encouraging bone growth. Thus, the terms denote that a beneficial
result has been conferred on a vertebrate subject with a cartilage,
bone or skeletal deficit, or with the potential to develop such
deficit. By "bone deficit" is meant an imbalance in the ratio of
bone formation to bone resorption, such that, if unmodified, the
subject will exhibit less bone than desirable, or the subject's
bones will be less intact and coherent than desired. Bone deficit
may also result from fracture, from surgical intervention or from
dental or periodontal disease. By "cartilage defect" is meant
damaged cartilage, less cartilage than desired, or cartilage that
is less intact and coherent than desired. "Bone disorders" includes
both bone deficits and cartilage defects. [0793] Representative
uses of the compounds of the present invention include: repair of
bone defects and deficiencies, such as those occurring in closed,
open and non-union fractures; prophylactic use in closed and open
fracture reduction; promotion of bone healing in plastic surgery;
stimulation of bone in growth into non-cemented prosthetic joints
and dental implants; elevation of peak bone mass in pre-menopausal
women; treatment of growth deficiencies; treatment of periodontal
disease and defects, and other tooth repair processes; increase in
bone formation during distraction osteogenesis; and treatment of
other skeletal disorders, such as age-related osteoporosis,
post-menopausal osteoporosis, glucocorticoid-induced osteoporosis
or disuse osteoporosis and arthritis, or any condition that
benefits from stimulation of bone formation. The compounds of the
present invention can also be useful in repair of congenital,
trauma-induced or surgical resection of bone (for instance, for
cancer treatment), and in cosmetic surgery. Further, the compounds
of the present invention can be used for limiting or treating
cartilage defects or disorders, and may be useful in wound healing
or tissue repair. [0794] g. Additionally there is nutritional
support, which can be most helpful in addition to the known
effectiveness of calcium and/or to support calcium uptake in
addition to magnesium and boron. [0795] i. L'Lysine and L'Arginene
aid calcium absorption and help support connective tissue strength.
[0796] ii. Sulfur is necessary for calcium uptake and also serves
to increase bone and connective tissue strength. [0797] iii.
Vitamins A, E, D, important in retarding the aging process [0798]
iv. Zinc Important for calcium uptake and immune function [0799] v.
Chromium Picolonate; Improves insulin efficiency, which improved
bone density [0800] vi. Maganese; Vital in mineral absorption
[0801] vii. Vitamin C; Important for collagen and connective tissue
formation [0802] Addressing joint health the inventor will not go
into a lengthy dissertation, but just to mention that there are
supplements, with sound science, that if taken regularly, which is
problematic in and of itself, (and covered in this writing) not
just joint pain, but the joint quality and joint socket can be
addressed as well. Nutritive substances that can help include but
not limited to balanced supplementation of minerals, Since the
body's connective tissue and cartilage include a natural compound
called glucosamine, Glucosamine has been clinically studied to
build joint cartilage. Glucosamine sulfate is the preferred form of
supplemental glucosamine as it has been shown to be up to 98%
absorbable, so more glucosamine reaches the joint structures.
Devil's Claw Complex contains standardized extracts of devil's claw
root, which supports joint health and acts as an antioxidant;
nettle leaf, which supports circulation; and ginger root, which has
antioxidant effects. Cherries are a source of flavonoids, natural
compounds that contribute to the integrity of capillaries, collagen
structures, eyes, joints, and arteries. The anthocyanidin and
proanthocyanidin flavonoids in cherries also have antioxidant
properties to help disarm free radicals, which can damage healthy
cells. [0803] 14. The object of the invention is to present a
fiber-water composition designed to support the immune system:
Immune Enhancing Fiber-Water, simultaneously with hydration. [0804]
a. Our bodies are constantly at war, under assault 24-hours a day
from infection and toxins. The fact that we survive at all is due
to our immune system--a fascinating network of chemicals and cells
that protect the body. The immune system is your body's defense
against invaders. It can be divided into two sub-groups--the innate
immune system (which covers three areas) and the adaptive immune
system. [0805] i. The Innate Immune system [0806] (1) The skin and
mucosal membranes. The skin and the lining of the body cavities
that open to the outside must provide a protective barrier. The
entrance to the organs like the gut and the reproductive tract
needs to prevent invasion by any pathogenic micro-organisms. The
oil or `sebum produced by the skin keeps its pH slightly acidic
which controls the growth of any organisms on the skin. The mucosal
membranes secrete a variety of fluids, such as saliva by the
gastro-intestinal tract and mucus in the respiratory tract, which
provide a defense against pathogenic micro-organisms. The body
carries its own natural
`flora` of micro-organisms. [0807] (2) Secreted soluble proteins:
These proteins and enzymes, such as lysozyme, c-reactive protein,
interferons and the complement system, are present in the body
secretions and fluids and attack different micro-organisms in a
variety of ways, often by dissolving their protective layer [0808]
(3) Cells: Most of the white blood cells, called granulocytes
(including neutrophils, basophils and eosinophils), alongside
others called macrophages, mast cells and natural killer (NK)
cells, have a role in initial defense. They arrive at the site of
damage or infection and either eat up the invading organisms (known
generally as `antigens`) by a process called phagocytosis, or
release chemicals toxic to the invader. Some of them also play a
part in killing abnormal cells or tidying up the debris after such
a fight. The Adaptive Immune system [0809] ii. The adaptive immune
system: is more complex and has the ability both to recognize
different `antigens` by a group of proteins across its cell surface
(a bit like a chemical fingerprint) and to retain a memory of them
so that the next time the antigen invades the fighting response is
quicker. Every organism will have its own individual group of
proteins, known as the major histocompatability complex (MHC).
Human cells have their own, also known as the HLA (human leucocyte
antigen complex) and this is the `tissue typing` which is done when
you need to be matched to someone for an organ transplant. [0810]
(1) Cells called lymphocytes include: Plasma cells and B cells--The
plasma cells secrete and the memory cells `wear` molecules called
immunoglobulins or antibodies. These molecules are grouped either
as IgG, IgA, IgM, IgE and IgD depending on their exact function and
location in the body. They act by passing messages about the
invader to other cells, which will then attack it, or by attaching
themselves to the antigen itself. T cells--these particularly help
in the fight against intracellular pathogens such as viruses and
also help to prevent the growth of `altered self` cells such as
cancer cells. They work by recognizing the MHC and the antigen.
There are a variety of different T cells including helper T cells,
cytotoxic cells and memory cells. [0811] (2) Antigen-presenting
cells: These are cells that have begun to process antigens and
include macrophages and B cells. They then present the antigen to
the T cell, which will continue the attack. [0812] (3) Secreted
chemicals: Chemicals such as antibody, complement and cytokines are
secreted by different cells around the body and have a role in the
complex recognition and attack on antigens. The lymphocytes are
produced by lymphoid tissue around the body. The primary lymphoid
organs are the bone marrow and the thymus, providing the
development and maturation of the lymphocytes. The lymphoid tissue
is connected by the `lymphatic drainage system`--a system of
vessels, which allow the lymph fluid to drain back to the venous
blood system via the `lymph nodes`. These nodes provide somewhere
for the lymphocytes, along with other cells, to attack the
antigens. It is these nodes, which you notice as being `swollen
glands` when, for example, you have a throat infection. The bone
marrow and the thymus, the primary lymphoid organs, are responsible
for the development and maturation of the lymphocytes. The
secondary lymphoid tissues are the lymph glands, spleen and the
`mucosal associated lymphoid tissue` (MALT), which includes the
tonsils appendix and `Peyers patches` in the intestine. There is
also some very diffuse lymphoid tissue in the wall of the intestine
and in the lungs.http://www.bbc.co.uk/health/immune/-top [0813] b.
Modern conventional medicine battles diseases directly by means of
drugs, surgery, radiation, and other therapies, but true health,
believed by the inventor, can be obtained by maintaining a properly
functioning immune system. (This will include anti-bacterial,
anti-viral compositions separately and/or combined) [0814] c. U.S.
Pat. No. 6,328,967 to Rivera (Allergenics Inc. San Francisco
Calif.), issued Dec. 11, 2001, titled: Delivery System to modulate
immune response. This invention is directed generally to a method
of selecting and/or selectively modulating an immune response by
administering a microencapsulated immunogen. [0815] i. An
immunogenic response is most predictably induced by using a protein
as the immunogen. In immunotherapy, the protein is frequently
administered parenterally, for example by injection. While
injections are inconvenient and uncomfortable to many patients,
they have heretofore been a common route of administration because
protease enzymes, and acid in the stomach, and enzymes in the small
intestines degrade orally administered protein. It has been
demonstrated that oral administration of a soluble protein such as
the model antigen ovalbumin (OVA) results in the induction of
immune tolerance, characterized by the loss of either antibody or T
cell response to the protein antigen. Here presented is a method of
better selecting and selectively modulating a particular immune
response from the complex immune repertoire to better respond to
different antigenic stimuli in different conditions requiring
treatment. This invention provides methods and compositions to
induce an enhanced general or selective immune response. An
Immynogen delivery system comprises a microsphere of an immunogen
bound to an inert particle having a mesh size greater than about 35
mesh. The microsphere is administered to the small intestine of a
mammal. The microsphere is preferably administered orally and
contains one or more enteric coatings and may be administered in a
gel capsule. In one embodiment the inert particle has a mesh size
greater than about 40 mesh and may be a nonpareil, a silica powder,
a salt crystal or a sugar crystal. [0816] d. Soluble fiber is known
to bind to heavy metals, and other toxins, and remove them from the
body. However, while that is a start, this invention goes beyond
just that. It is the purpose here to deliver prescription
medications if needed (including Over the Counter {OTC} products as
well), but most important is to strengthen the immune system,
whether it is damaged as a result of disease, stress, inadequate
nutrition, poor living habits, chemotherapy, or a combination of
one or more of these factors. [0817] i. Vitamin A is the best
anti-infection vitamin and very important in defending he health of
the organism. (If used properly, and in moderation it is not toxic)
[0818] ii. Vitamin C is considered by this inventor to be the most
important vitamin for the immune system. It is essential for the
formation of adrenal hormones and the production of lympocytes. It
also has a direct effect on bacteria and viruses. Vitamin C, if
taken as a supplement, and in this case used in the enhanced water
for increasing immunity it should be augmented with bioflavinoids
(natural plant substances that enhance the absorption and reinforce
the action of this vitamin. [0819] iii. Zinc boosts the immune
response and promotes the healing of wounds when used in the
appropriate dose (100 milligrams or less a day, over that may
depress the immune system). Zinc also helps protect the liver.
[0820] iv. Geranium is a trace mineral that is beneficial to the
immune system, [0821] v. Pro-biotics and pre-biotics are important
bacteria to restore and protect [0822] vi. Co-enzyme Q10 supports
the immune system [0823] vii. Garlic stimulates the immune system
[0824] viii. Amino acids and antioxidants for which literature is
replete [0825] 15. The object of the invention is to present a
fiber-water composition designed to reduce bad breath, body odors,
and fecal odors, simultaneously with hydration: Odor reducing
Fiber-Water [0826] a. Volatile sulfur compounds, mainly H.su.2S and
CH. sub.# SH, generated in the oral cavity have been documented to
be among the cause of bad breath. Generally, the presence of these
compounds is most noticeable after long periods of reduced saliva
flow and abstinence from food or liquids, resulting in morning
breath. Typically, serious dieters have the same problem and
additionally when in a state of ketosis, their breath smells like
soured juicy fruit gum. Therefore it is a well-intended extension
of the diet-fiber-water for weight loss to include an ingredient(s)
with proven science to address this condition. Personal motivation
for the ingestion of this functional water may be more to address
bad breath and/or body odors than the fore-mentioned reasons.
[0827] b. Nabisco, Inc., (Parsippany, N.J.) U.S. Pat. No. 6,030,605
to D'Ameila et al., issued Feb. 29, 2000, titled: Breath freshening
compositions and methods using them, teaches us that a physically
acceptable zinc compound, including zinc salts). The preferred zinc
compounds for use in accordance with the present invention are zinc
gluconate and zinc lactate. U.S. Pat. No. 5,405,836 to Richar et
al. (Nabisco.RTM.), issued Apr. 11, 1995, titled: Pet foods with
water-soluble zinc compound coating for controlling malodorous
breath, uses a water-soluble zinc coating in pet foods to control
malodorous breath. [0828] c. U.S. Pat. No. 5,900,251 to Raissen et
al. (Breath Assure.RTM., Inc., Calabasas, Calif.), issued May 4,
1999, titled: Internal breath freshener and digestive aid, provides
an herbal or herbal extract for the control and treatment of breath
odors and with the added benefit of improving digestion. The
ingredients selected are ginger, licorice, chamomile, parsley seed
oil, and sunflower seed oil in a delivery system. Persimmons have
been use for the purpose of addressing foul breath also. [0829] d.
The most exciting to date and for which the inventor is including
is Champex.RTM. by Ricom of Japan, Maypro.RTM. US distributor (NY)
is a mushroom derivative which has been demonstrated to reduce
breath, body and fecal odors. Mushroom (Agaricus bisporus) has
enjoyed a long association with food culture and cuisine throughout
the world over the centuries and it has a long history of being
cultivated for human consumption for more than 2,000 years. In
fact, annual consumption per nation amounted to be approximately
526,060 tons in the USA 220,428 tons in Germany, 139,536 tons in
France. World production of A. bisporus in 1980 was reported
884,000 tons per annum and it is estimated that current production
is over 1,000,000 tons. [0830] Given that A. bisporus has been
consumed world wide, there should be no doubt as to its safety as a
daily food. The safety of A. bisporus has been confirmed by an oral
chronic study entitled "Carcinogenicity examination of A. bisporus,
edible mushroom, in rats", in which a diet containing a 30% dry
powder of A. bisporus was given to CD rats for 500 days. Champex is
made from the extract of A. bisporus with other inert natural
ingredients. Champex, the natural extract derived from a white
mushroom (Agalicus bisporus) reduces mouth, body and fecal odors by
suppressing putrid substances in the intestine. At the recent
study, it has also determined that Champex retards the progression
of renal failure by detoxifying the blood. [0831] i. There are two
major causes of mouth odors. One is decaying food debris between
the teeth, on the mucous membrane or in the esophagus. This type
(odors in the mouth cavity) is generated as time elapses. Another
is the foul odor that is absorbed from the intestinal tract into
the blood, then breathed out from the lungs as foul breath. In
other words, foul mouth odors are a mixture of odors from the mouth
and intestines. [0832] ii. The cause of body odors . . . These
odors are composed of putrid intestinal chemicals that are absorbed
into the blood and excreted through the sweat glands. [0833] iii.
The cause of fecal odors . . . More than 100 trillion bacteria
exist in the intestines. They create foul-smelling chemicals by
decomposing the proteins and fats in ingested foods. Major
representative putrefaction bacteria are Welch bacillus and
Escerichia coli, which create such foul-smelling chemicals as
ammonia, indoles, skatoles, triptamine, mercaptan, hydrogen
sulfide, and amines. Fecal odors originated from the rotten odors
caused by such putrid chemicals. [0834] iv. Delivering Champex;
while encapsulation is not always necessary it may be most
desirable and efficient in larger doses and/or with timed releasing
activity do to the aforesaid and the to be said. [0835] v.
Supression of the 3 catagories of odors . . . Consumed internally,
Champex reacts with odor-causing chemicals in the mouth as well as
in the intestines to suppress foul breath, body odors, and fecal
odors. [0836] vi. It is also noted that Champex cleans the blood .
. . Champex suppresses those putrid substances in the intestines
that are transmitted from the intestinal canal into the blood,
thereby preventing the blood from being tainted. [0837] vii.
Physiological activity. Champex reduces functional burdens on the
kidneys and liver, suppressing the progression of renal failure and
hyperammonemia, while toning and improving them. Champex has been
determined to suppress the progression of renal failure and hepatic
encephalopathy. It also suppresses the generation of active oxygen
and the allergen leucotriene, both of which are closely associated
with disease and aging. Champex reduces functional burdens on the
kidneys and liver, suppressing the progression of renal failure and
hyperammonemia, while toning and improving them. Champex has been
determined to suppress the progression of renal failure and hepatic
encephalopathy. It also suppresses the generation of active oxygen
and the allergen leucotriene, both of which are closely associated
with disease and aging. [0838] viii. Beauty nutrition ingredients .
. . Champex contains many of the minerals and amino acids that
people tend to lack these days, as well as glucide such as nucleic
acid, mannitol, hemi-cellulose that act as physiological activators
to develop proper immunity. Many of these components are unique to
mushrooms and are considered effective in dissolving cholesterol,
lowering blood pressure, and bolstering immunity against viruses.
[0839] 16. The object of the invention is to present a fiberwater
composition for the removal of toxins from the body, support the
immune for preventative measures, address existing cancer,
simultaneously with hydration: Toxin Cleansing Fiber-Water. [0840]
a. Two in five people will be affected by cancer at some stage in
their lives. In the US one person dies from cancer every minute and
another 3,000,000 have cancer. Cancer is not one disease but many,
all with some similar features but all with distinctive
characteristics, which varies according to the cancer's type and
location. There are over 200 types of cancer, but all start in the
same way. The control signals in a normal cell in the body go
wrong, resulting in an abnormal cell. Cells normally divide in a
controlled way, but abnormal cells keep on dividing and dividing
and this forms a lump. This cluster of abnormal cells is called a
tumor. Some tumors are benign, or harmless, and often don't need
treatment. But malignant tumors
--the cancers--can spread. They may be dangerous because they can
invade nearby parts of the body and stop them working properly.
Cells from malignant tumors can break away and travel to other
parts of the body, where they can form new groups of abnormal
cells, called secondary growths. The cells grow and spread and this
varies from person to person. [0841] b. Soluble fiber binds to
heavy metals and, along with toxins, removes then from the body.
[0842] i. High fiber diet can cut cancer risk by 40%: study Jun.
26, 2001 London, (Reuters)--A high fiber diet can slash the risk of
developing deadly cancers by as much as 40%, scientists said
Saturday. Results from the biggest ever study into diet and cancer,
involving 400,000 people from nine countries and presented at an
international conference in France, showed fiber was particularly
important in reducing cancer of the colon and rectum." These are
the first positive results for the benefits of fiber from such a
large group. We placed 400,000 people on the study into five sets
according to their consumption of fiber," Professor Sheila Bingham
of the Dunn Human Nutrition Unit at Cambridge University said in a
statement released in London." The group eating the most fiber
reduced their risk of colorectal cancer by as much as 40%," she
added. The findings were part of the EPIC (European Prospective
Investigation of Cancer and Nutrition) study that was reported at
the European Conference on Nutrition and Care in Lyon, France.
Medical experts believe up to 30% of all cancers in the developed
world are associated with nutritional factors and could be avoided
by better-balanced diets. The People are advised to eat five
portions of fruit and vegetables a day to achieve optimum health
and avoid cancer. "These finding are important because of the sheer
scope of the EPIC study. They put fiber firmly back on the menu as
an important part of a healthy diet," said Professor Gordon McVie,
the director general of the Cancer Research Campaign, which
sponsored Bingham's research. [0843] Carcinogenesis and Immune
Response in Cancer The body is composed of billions of cells, which
are all subject to free radical damage and mutations caused by
various carcinogens. Free radicals and carcinogens cause cells to
become mutated and abnormal. The immune surveillance system plays a
critical role in prevention of cancer by recognizing the formation
of these abnormal cells. T-cells in particular are valuable for
their ability to distinguish the mutated cells from normal cells.
Yet, when the immune system is suppressed, the mutated carcinoma
cells are not recognized by the immune surveillance system and the
cells grow uncontrollably and become cancerous. Cancer cells
release several kinds of immune suppressive factors, which inhibit
antigen and macrophage activity. T-cells in a suppressed immune
system do not recognize cancer cells. The suppressed macrophage
cells fail to produce IL-12 and thus the Th0 cells cannot
proliferate or differentiate into Th1/Th2 cells. The suppressed Th1
cells cannot exert their anti-tumor effects which include
production of IL-2 and IFN-?. Finally, the anti-cancer immune
response fails when the proliferation of CTL, LAK or NK cells
fails. Cancer is a disease of the immune system whereby immune
suppression allows cancerous cells to not be recognized and grow
uncontrollably. Thus, reversing and restoring the suppressed immune
system should be a very important part of cancer treatment. [0844]
The inventor presents qualified research to show the connection
between obesity and cancer. As has been addressed fiberwater
addresses obesity as well as demonstrating that soluble fiber binds
to toxins and removes them from the colon. Now additionally the
next generation, new and novel fiberwater(s) with their viscosity
changes and encapsulated ingredients. [0845] ii. On the connection
between obesity and cancer Americans Don't Know Obesity Increases
Cancer Risk and, Researchers Express Alarm at New Survey Findings:
WASHINGTON, DC--Speaking at a press conference at the AICR/WCRF
International Research Conference on Food, Nutrition and Cancer,
Professor W. P. T. James, chairman of the International Obesity
Task Force, said, "We are used to thinking about the obesity
epidemic on one hand and the cancer epidemic on the other. We need
to think of them as linked." A new survey commissioned by AICR,
however, indicates that although Americans are deeply concerned
about both obesity and cancer, remarkably few are aware of the link
between the two. Asked to name major risk factors for developing
cancer, only 6 percent of 1,025 Americans surveyed mentioned
overweight and obesity. They were more likely to mention exposure
to certain chemicals (22 percent), high-fat diets (18 percent),
exposure to the sun (18 percent), family history (11 percent) and
alcohol (7 percent). Later in the survey, Americans were read a
list of chronic diseases and specifically asked which ones are
significantly affected by overweight and obesity. The great
majority were able to identify heart disease (89 percent) and
diabetes (86 percent) as conditions made more likely by being
overweight or obese. Only 25 percent, however, were aware that
overweight and obesity increase cancer risk. Citing a report issued
by the International Agency for Research on Cancer, an agency of
the World Health Organization, James estimated that being
overweight and inactive accounts for one-quarter to one-third of
worldwide cases of breast cancer, colon cancer, endometrial cancer,
kidney cancer and esophageal cancer. "That's somewhere between
102,000 and 135,000 cases in the U.S. alone," he said. This link is
important, James noted. "People need to be aware of it if they are
to take steps to reduce their risk of getting cancer," he said.
Conversely, the rapid increase in the number of people who are
obese in the U.S. and worldwide could have a dire long-term effect
on cancer rates. Unless people take the necessary steps, James
said, we are headed for a steep escalation in cancer cases. James
reported that one billion people are overweight (Body Mass Index
over 25) and, of that group, 300 million are obese (Body Mass Index
over 30) worldwide. According to the Centers for Disease Control
and Prevention, 61 percent of American adults are now classified as
overweight or obese and 27 percent are considered obese. Conducted
between Jun. 27 and Jun. 30, 2002, the Harris survey entailed
polling 1,025 adults aged 18 and over, using an unrestricted Random
Digit Dialing technique that significantly reduces bias and ensures
that respondents with both listed and unlisted telephone numbers
are reached. The margin of error for the total sample is 3.1
percent. The American Institute for Cancer Research (AICR) is the
nation's third largest cancer charity, focusing exclusively on the
link between diet and cancer. The Institute provides a wide range
of education programs that help millions of Americans learn to make
dietary changes for lower cancer risk [0846] c. This inventor,
institutions worldwide, private researchers, as well as The
European Conference on Nutrition and Cancer, is looking at the
impact of different types of food/supplements as related to the
disease. The nutritional support listed are to be considered for
those who have been diagnosed with the disease as well as, or even
more so, for those in which cancer is in their family genetically,
and/or to enhance their chances of avoiding the condition. Using
fiberwater as a base, and with controlling the viscosities as well,
with the dosage released via encapsulations, along with supportive
scientific supplementation given, which by this invention is
protected so as to be stable and bio-available to the user, the
following is a mere suggestion of such supplementation: [0847] i.
Commonly known include: Coenzyme Q 10, Dimethylglycine (DMG),
garlic, Melatonin, Natural Beta Carotine or cartenoid complex,
Proteolytic enzymes, Selenium, Shark Cartledge, Superoxide
dismutase (SOD), Vitamin A (People with cancer require a higher
amount emulsion safer at higher doses) Vitamin B Complex, Vitamic C
with bioflavnoids (promotes the production of interferon in the
body) Grape Seed extract), Taurine (Functions as a foundation for
tissue and/organ repair) L Carnitine, and more it is important to
note that the inventor believes that the form of delivery is very
important to efficacy) [0848] ii. Not as commonly known include:
[0849] (1) Active Hexose Correlated Compound (AHCC) (Ricom, Japan)
is an extract of the mycelia from several species of basidiomycete
mushrooms. It is derived from a highly specialized manufacturing
process allowing for optimal bioavailability (due to its low
molecular weight). [0850] (a) Research Association symposiums.
Clinical studies have shown AHCC to significantly increase immune
response, activate macrophage activity, NK and LAK cells, increase
production of cytokines including TNF-, IFN-, IL-1, IL2, &
IL-12. Studies show AHCC increases the quality of life for patients
with: cancer, AIDS, chronic fatigue, and other immune disorders.
Decreases viral loads by 85% or more in Hepatitis C patients (Fred
Pescatore, MD in NY & TX, and Lawrence Kempf, MD in NY have
noticed these benefits in as little as 2-3 months.) [0851] (b) AHCC
decreases white blood cell reduction and anemia seen during
chemotherapy. [0852] (c) AHCC restores and reverses a suppressed
immune status by stimulating and activating the immune system and
finally wiping out cancerous cells. [0853] (d) The Institute for
Genetic Medicine at Hokkaido University found that the macrophage
population harvested from AHCC peritoneal treated rats increased
twice as much as rats in the control group, for both normal rats
and in tumor-bearing rats. This result demonstrated that AHCC
increased the proliferation and activation of macrophages. (The 4th
Symposium of AHCC Research Association, June 1997). [0854] (e) In
summary, the results of the basic and clinical research indicated
AHCC is a powerful anti-tumor substance, which works by activating
and enhancing the cells of the immune system. The powerful immune
regulating effects of AHCC could be used in a variety of immune
related diseases. Since 1986, the AHCC Research Association has
been examining and discussing the effects of AHCC on cancer,
hepatitis, and ailments involving immune dysfunction. Research is
now underway at more than 150 institutes, including national
research centers and university hospitals in Japan and the US. Each
year since 1994, over 300 medical doctors and researchers have
gathered in Sapporo, Japan for the AHCC conference. AHCC has been
the subject of some 325 clinical studies conducted at prestigious
Japanese institutions such as Hokkaido University, Kyorin
University, and Teikyo University. More clinical trials will be
completed at Harvard University, University of California at Davis,
Columbia Presbyterian University, Thomas Jefferson University, and
NY Medical College. Over 700 hospitals and medical centers in Japan
recommend AHCC as part of an ongoing immune enhancement program.
[0855] iii. Genistine Concentrated Polysaccharide (GCP) (Amino UP
Chemical Co., Ltd. Japan) is a natural anti-tumor substance.
GCP.TM. is a nutritional supplement made by the Amino Up Chemical
Company in Sapporo, Japan. It is a mixture of a mushroom and
soybean extract. Research on GCP.TM. has shown it can reduce
prostate cancer cell growth and the formation of blood vessels in
prostate tumors. GCP is a novel functional health additive produced
by fermination of soybean isoflavone extracts with basidiomycetes.
[0856] d. U.S. Pat. No. 6,410,061 to Moore et al. (Purdue Research
Foundation Lafayette Ind.), issued Jun. 25, 2002, titled: Tea
catechins as cancer specific proliferation inhibitors abstracts:
The invention described herein encompasses a methods and
compositions of treating cancer or solid tumors comprising the
administration of a therapeutically effective amount of catechins,
a group of polyphenols found in green tea, to a mammal in need of
such therapy. Compositions of catechins include but not limited to,
epigallocatechin gallate (EGCg), epicatechin (EC), epicatechin
gallate (ECG), epigallocatechin (EGC). The unique compositions of
the invention contain various combinations of the catechins, alone
or in combination with each other or other therapeutic agents and
are used to treat primary and metastatic cancers in humans. The
invention also encompasses the varying modes of administration of
the therapeutic compounds. [0857] 1. The invention described herein
encompasses a method of treating cancer or solid tumors comprising
the administration of a therapeutically effective amount of
catechins, a group of polyphenols found in green tea, to a mammal
in need of such therapy. [0858] ii. In accordance with the present
invention, the catechins can be used alone or in combination with
other known therapeutic agents or techniques to either improve the
quality of life of the patient, or to treat cancer or solid tumors.
The catechins can be used before, during, or after the
administration of one or more known chemotherapeutic agents,
including antitumor agents. [0859] iii. In addition, the catechins
can be used before, during, or after radiation treatment. [0860]
iv. In another embodiment, the compositions of the invention are
sterile pharmaceutical compositions suitable for intravenous
injection or infusion. In another embodiment, the invention
encompasses a composition suitable for oral delivery, comprising
catechins and a pharmaceutically acceptable excipient or carrier. A
preferred embodiment comprises a sustained release composition to
maintain the circulating levels of said composition at a certain
minimum level for therapeutic efficacy over a specified time
period. [0861] 17. The object of the invention is to present a
fiber-water composition designed for addressing general stress:
Anti-Stress Fiber-Water, simultaneously with hydration. [0862] a.
It is the object of this functional Fiber-water to provide
anti-stress (calming) agents, which can address the situation as
best as possible considering that there are no known drugs that are
able to fundamentally inhibit or reduce stress. There are drugs,
such as anti-anxiety agents and sleeping pills for temporarily
alleviating somatic reactions when exposed to stress and are
considered to be an effective means of dealing with stress. Also
there are various relaxation techniques for the mind and body which
been proposed as ways of effectively controlling stress so prevent
destruction of the body's homostasis. Stress disorders and other
related disorders are believed to comprise a condition in which
stress destroys the ability to maintain homeostasis by the body.
[0863] b. Stress is quite prevalent in modern society, and those
diseases caused by stress, namely somatic disorders as well as
stress disorders such as neurosis and depression, are increasing.
In modern society, people under go various kinds of stress caused
by being exposed to highly advanced and complicated scientific
technology, or drastically changing social circumstances.
Particularly, in the internationalized and industrialized and
computerized society, complex human relationships are formed,
causing mental stress. It has been reported that a variety of
symptoms are caused by mental stress.
[0864] It is also recognized that mental stress has a great
influence on all the systems of the body especially the circulatory
system. Further stress affects the immune system. [0865] c. Various
drugs have been developed and marketed for this and overlapping
conditions however not with our serious side effects, acute,
chronic or even temporary. They can cause both physical and
psychological dependence. Regular use over a long period of time
may result in tolerance, which means people have to take larger and
larger doses to get the same effects. When regular users stop using
large doses of these drugs suddenly, they may develop physical
withdrawal symptoms ranging from restlessness, insomnia and
anxiety, to convulsions and death. When users become
psychologically dependent, they feel as if they need the drug to
function. Finding and using the drug becomes the main focus in
life. [0866] d. Sedative-hypnotics are drugs, which depress or slow
down the body's functions. Often these drugs are referred to as
tranquilizers and sleeping pills or sometimes just as sedatives.
Their effects range from calming down anxious people to promoting
sleep. Both tranquilizers and sleeping pills can have either
effect, depending on how much is taken. At high doses or when they
are abused, many of these drugs can even cause unconsciousness and
death. [0867] e. Barbiturates and benzodiazepines are the two major
categories of sedative-hypnotics. The drugs in each of these groups
are similar in chemical structure. Some well-known barbiturates are
secobarbital (Seconal) and pentobarbital (Nembutal). Diazepam
(Valium), chlordiazepoxide (Librium), and chlorazepate (Tranxene)
are examples of benzodiazepines. A few sedative-hypnotics do not
fit in either category. They include methaqualone (Quaalude),
ethchlorvynol (Placidyl), chloral hydrate (Noctec), and mebrobamate
(Miltown). All of these drugs can be dangerous when they are not
taken according to a physician's instructions. [0868] i.
Barbiturates are often called "barbs" and "downers." Barbiturates
that are commonly abused include amobarbital (Amytal),
pentobarbital (Nembutal), and secobarbital (Seconal). [0869] (1)
Small amounts produce calmness and relax muscles. Somewhat larger
doses can cause slurred speech, staggering gait, poor judgment, and
slow, uncertain reflexes. Barbiturate overdose is a factor in
nearly one-third of all reported drug-related deaths. These include
suicides and accidental drug poisonings. Accidental deaths
sometimes occur when a user takes one dose, becomes confused and
unintentionally takes additional or larger doses. [0870] (2) With
barbiturates there is less difference between the amount that
produces sleep and the amount that kills. Furthermore, barbiturate
withdrawal can be more serious than heroin withdrawal. These
effects make it dangerous to drive a car or operate machinery.
Large doses can cause unconsciousness and death. [0871] f. Other
sedative-hypnotics which are abused include glutethimide (Doriden),
ethchlorvynol (Placidyl), and methaqualone (Sopor, Quaalude).
[0872] g. Methaqualone ("Sopors," "ludes") was originally
prescribed to reduce anxiety during the day and as a sleeping aid.
It is one of the most commonly abused drugs and can cause both
physical and psychological dependence. The dangers from abusing
methaqualone include injury or death from car accidents caused by
faulty judgment and drowsiness, and convulsions, coma, and death
from overdose. [0873] h. There are also pills manufactured to look
like real sedative-hypnotics and mimic their effects. Sometimes
look-alikes contain over-the-counter drugs such as antihistamines
and decongestants, which tend to cause drowsiness. The negative
effects can include nausea, stomach cramps, lack of coordination,
temporary memory loss, becoming out of touch with the surroundings,
and anxious behavior. [0874] i. Alcohol and sedative-hypnotics
taken together, alcohol can kill. The use of barbiturates and other
sedative-hypnotics with other drugs that slow down the body, such
as alcohol, multiplies their effects and greatly increases the risk
of death. Overdose deaths can occur when barbiturates and alcohol
are used together, either deliberately or accidentally. [0875] j.
Babies born to mothers who abuse sedatives during their pregnancy
may be physically dependent on the drugs and show withdrawal
symptoms shortly after they are born. Their symptoms may include
breathing problems, feeding difficulties, disturbed sleep,
sweating, irritability, and fever. Many sedative-hypnotics pass
through the placenta easily and have caused birth defects and
behavioral problems in babies born to women who have abused these
drugs during their pregnancy. [0876] k. The inventor is hopeful
that unless absolutely necessary and under a doctors care the
public will turn to more natural means totally or at least at a
first go around. Foods/beverages by category and then the
ingredients in these products have been have been developed for the
purpose of preventing and reducing stress or fatigue as related to
stress. Typical examples of these include the category of: [0877]
i. Sports drinks: They do not prevent or reduce stress and fatigue
directly. [0878] ii. Tonics, on the other hand, contain extracts
from several medical plants in addition to vitamins and amino
acids. These are expected to have physiological effects such as
central nervous system stimulation, increased blood flow, cardiac
effects and activation of endocrine system. However, many of the
physiological effects of these natural drugs are based on old
legends, and none are known, on a scientific basis, to prevent or
reduce stress. [0879] (Formulation into a tonic, a concentrate, a
decoction, an elixir, and/or the like are all to be considered as a
form of delivery for this invention and covered later in this
writing.) [0880] l. More recently, there have been numerous
reports, which stated that stress affliction, and numerous mental
disorders are all pronounced emotional disorders, indicating
research results that show that these disorders are closely linked
with decreased immunological function of the body. Although the
concept of mental anguish being a cause of illness is itself quite
old, only recently has attention been focused on this concept in
scientific fields as well. [0881] m. Considerable immunological
research has been conducted on the relationship between stress and
cancer in particular. However, there are no known specific
compounds that inhibit the onset, and metastasis, of cancer caused
by stress. [0882] However, long-term efforts will most likely be
required due to fulfill the social demand as mentioned above, which
can be taken repeatedly throughout the day and/or daily and/or as
part of a program without any problems with safety, and which can
mitigate and hopefully prevent mental and physical symptoms caused
by stress. [0883] n. U.S. Pat. No. 6,410,685 to Masuyama, et al.
(Calpis Co. Ltd., Toyko, JP), issued Jun. 25, 2002, titled:
Antistress agents and functional foods, reports that when one
undergoes stress, angiotensin II increases, and intracorporeal
sodium due to sodium reabsorbancy becomes excess, which causes rise
in blood pressure (Osamu Mobara et al.: Taisha, 28, 2, 323, 1991).
Based on such findings, studies have been made on the effect of
enalapril and alacepril, which are angiotensin converting enzyme
inhibitors and used as antihypertensive agents, on hypertension
caused by stress (The American Journal of Cardiology; 68, 15,
1362(1991), Internal Medicine; 32, 9, 691(1993)). However, it is
considered that suffering stress not only causes rise in blood
pressure, but also influences various factors to cause stomach
ulcer, ischemic heart diseases, cerebrovascular diseases,
hyperlipemia, or the like. Therefore, though stress is regarded as
one of the causes of hypertension, it is not believed that the
anti-stress effect is achieved merely by suppressing the rise in
blood pressure. [0884] o. U.S. Pat. No. 6,265,450 to Asami et al.
(Suntory Limited Osaka JP.) (Itano Foods (Tokushima, J P.), issued
Jul. 24, 2001, titled Anti-stress composition presents an
anti-stress composition having for its active ingredient
astaxanthin and/or its ester. This composition can be in the form
of a pharmaceutical, functional food, or beverage and/or so forth.
[0885] 18. The object of the invention is to present a fiber-water
composition designed for regulating mood: Fiber-water for mood
regulations, simultaneously with hydration. [0886] a. Soluble fiber
is known to moderate the pos-prandial rise in blood sugar levels,
ergo prevent mood swings in those who tend to have repetitive peaks
and valleys in their blood glucose levels. It is desirable to add
additional ingredients to the fiber-water to enhance this effect.
(moderating moods with small amounts of glucose is considered
invented), however, sometimes just a sweetener fools the body into
believing that there is sugar (aka a placebo effect) and that is
also invented. [0887] b. If encapsulated and/or regulations with
viscosity (or both) changes (with or without glucose and/or
sweetener) so that the affect of the fiber and the affect of the
viscosity (be it the property of the fiber or no, or both) and the
"releasability", differentials of the encapsulations (if deemed
appropriate to this formulation) all serve to present formulators
the delivery variables (delivery systems) which in turn has the
capabilities of making a most desired and needed product. [0888] c.
U.S. Pat. No. 6,410,522 to Ruenberg (Heifa,IL), issued Jun. 25,
2002, titled: Anti-depressant, stress suppressor and mood improver;
calls attention to the present invention which relates to a
composition having an effect of alleviating symptoms associated
with depression and mental and emotional stress. [0889] d. A method
for improving symptoms of depression, mental & emotional stress
and mood in a subject in need thereof by reducing the blood
cortisol level and serotonin reuptake in the brain of said subject,
comprising administering an effective amount of the composition to
said subject. [0890] e. Herein presented a pharmaceutical or
nutritional composition for treating depression, for suppressing
mental & emotional stress and for improving mood comprising
Phosphatidyl-L-serine and Phosphatidic acid or salts thereof as the
effective ingredients, comprising at least 20% (w/w)
Phosphatidyl-L-serine out of the total phospholipid content of the
composition and at least 3% (w/w) of Phosphatidic acid out of the
total phospholipid content of the composition, wherein the
Phosphatidyl-L-serine and Phosphatidic acid have a structural fatty
acid chain derived from at least one raw material lecithin selected
from the group consisting of soy bean lecithin, rapeseed lecithin,
and egg yolk lecithin, and which is produced by reaction with
Phospholipase-D. [0891] f. As an agent for preventing and
mitigating mental and physical symptoms caused by stress,
chemically synthesized medicaments such as a tranquilizer, an
anti-anxiety agent, and sleeping pills are presently used. However,
these medicaments have habituation and side effect problems, so
that it is not preferable to use them daily for the purpose of
preventing mental and physical symptoms caused by stress.
Accordingly, an anti-stress agent that can be taken repeatedly and
daily without any problems with safety, and that can mitigate and
prevent mental and physical symptoms caused by stress are desired
and are under development. [0892] g. For example, there are
proposals such as an anti-stress agent containing as an effective
ingredient L-theanine contained in tea leaves (Japanese Laid-open
Patent Application No. 6-100442), an anti-stress composition
containing imidazole compounds such as anserine, valenine,
n-methylhistidine, or r-methylhistidine [0893] h. (Japanese
Laid-open Patent Application No. 9-20660), and anti-stress food
containing a composition of glutathione and antioxidant (Japanese
Laid-open Patent Application No. 8-275752). [0894] i. There is also
a report on stress reducing effect of fragrance (Fragrance Journal:
1991-11, p 44-49). However, there has not been reported that a
tripeptide has the effect of mitigating and preventing mental and
physical symptoms caused by stress. [0895] j. This inventor
believes in aromatherapy and the fact that certain aromas have be,
back to ancient times, associated with moods. Lavender is
especially known to be considered relaxing and stress [0896] 19.
The object of the invention is to present a fiber-water composition
to increase alertness focused on delivering a stimulating effect:
Stimulating Fiber-Water, simultaneously with hydration. [0897] a.
Stimulants were a name originally given to several groups of drugs
that tend to increase alertness and physical activity. The groups
include pharmaceuticals such as amphetamines and the street drugs
commonly called "uppers" or "speed," and cocaine. (Cocaine's recent
notoriety belies the fact that the drug has been used as a
stimulant by people for thousands of years. Its properties as a
stimulant have led people in the past to use it in a number of
patent medicines and even in soft drinks). [0898] i. The more
widely abused stimulants are amphetamines and cocaine. Cocaine has
limited commercial use and its sale and possession are strictly
controlled. [0899] ii. Amphetamines are sometimes prescribed by
physicians therefore their availability makes them prime candidates
for misuse. Used properly, amphetamines increase alertness and
physical ability. They are often prescribed to counter the effects
of narcolepsy, a rare disorder marked by episodes of uncontrollable
sleep, and to help children with minimal brain dysfunction.
Amphetamines increase the heart and respiration rates, increase
blood pressure, dilate the pupils of the eyes, and decrease
appetite. Other side effects include anxiety, blurred vision,
sleeplessness, and dizziness. Abuse of amphetamines can cause
irregular heartbeat and even physical collapse. Amphetamines are
psychologically addictive. Users become dependent on the drug to
avoid the "down" feeling they often experience when the drug's
effect wears off. This dependence can lead a user to turn to
stronger stimulants such as cocaine, or to larger doses of
amphetamines to maintain a "high". [0900] iii. That boost we get
from that morning cup of coffee is the result of the caffeine that
naturally occurs in coffee. Caffeine is a common stimulant and is
found not only in coffee and tea, but also in soft drinks and other
foods. It can also be bought over-the-counter in tablet form. Too
much caffeine can cause anxiousness, headaches, and the "jitters."
Caffeine is also addictive and a person who abruptly stops drinking
coffee may experience withdrawal symptoms. HERE COMES CAFFEINATED
WATER: Caffeinated waters have been on the market for several years
under such names as
"Water Joe" and "H2O ZIP" etc., which dispurse the caffeine
throughout the water. While there are some who sip water, the
inventor has noticed that when caffeine is in the water the drinker
tends to guzzle the entire bottle for the "NOW" stimulation effect.
Coffee drinkers on the other hand seem to "sip" which may be due to
the fact that it is too hot to drink all at once, the same with
tea. [0901] iv. This inventor perceives that there is a place for a
stimulant including but not just limited to caffeine, yet caffeine
is exampled here. [0902] v. (1) To have a sustained release form of
caffeine it is here invented that all or a portion, (some of the
caffeine be in solution in the fiberwater), of the caffeine be
encapsulated with one or more release timed advantages. Ergo
caffeine can be released even over a multiple of hours if coated as
such. [0903] (2) Further and so invented here is the ability to use
caffeine fiber-water most advantageous combined with fiber-water to
support colon motility. Caffeine increases colon motility, thus
combined with fiber and used for a specific condition
(gastrointestinal track related) this fiber-water caffeine
water-like drink can have healthy benefits for general and/or
specific humans and/or animals on a continuous regular and/or an as
needed basis. [0904] b. There are many herbs and/or herbal
combination that can stimulate and act in the same way that the
consumer perceives caffeine to act. Some are thermogenic and speed
up the body's metabolism. Ephedra, and Ma Hung, have both been used
extensively in basically weight loss products and considered
controversial, however Dr. Alan Fleischner, (reputation: Albert M.
Fleischner, Ph.D., has a doctorate in Pharmaceutical Chemistry from
Rutgers University and has had over thirty years experience in the
pharmaceutical industry with firms such as Schering Corporation,
Lehn & Fink Division of Sterling Drugs, Bradley Pharmaceutical
Corporation, Amerchol Division of CPC and the Goen Group companies,
has a number of published papers and two previously granted patents
and has several patents pending) in his U.S. Pat. No. 6,420,350 to
Fleischner; Albert M. (Goen Group Inc. Cedar Knolls N.J.), issued
Jul. 16, 2002, titled weight loss product, abstract: Supplement
compositions designed to support weight loss and increase energy
teaches that the combination of ephedrine and caffeine increases
fat loss, maintains muscle mass, prevents the fall of HDL
cholesterol during weight loss, increases insulin sensitivity,
reduces lipogenesis and is safe. With the addition of glucosamine
sulfate, the new and useful formula is further enhanced. [0905] c.
U.S. Pat. No. 6,416,806 to Zhou, issued Jul. 9, 2002, titled:
Herbal caffeine replacement composition. This invention will give
the same effect but will not have the same drawbacks. The invention
relates to a caffeine replacement composition and various food
products such as beverages and the like, which incorporate the
same. [0906] i. As set forth above, a wide variety of food products
include caffeine, which is desirable to many people for the
alertness enhancing affect of the caffeine. In light of the
well-documented disadvantages of caffeine and caffeine addiction,
the present invention is intended to provide an herbal replacement,
which provides similar alertness enhancement without the
disadvantages. Further, compositions are provided as coffee
replacement compositions, both in concentrated and diluted or
beverage-strength form, which possess substantially the same flavor
characteristics as coffee and provide substantially similar
alertness benefits through a combination of herbal extracts
selected according to the invention. [0907] ii. In accordance with
the present invention, the two critical ingredients to the caffeine
replacement composition are Ginkgo biloba extract and kudzu extract
which, in appropriate proportions and ratios to each other, serve
to advantageously enhance alertness of a person consuming same,
typically for approximately the same period of time as an equal
serving of caffeine. [0908] iii. Ginkgo biloba is known to provide
improved memory and cerebral circulation, and is also advantageous
as an anti-oxidant. However, Ginkgo biloba does not provide any
rapidly occurring alertness enhancement. Further, Ginkgo biloba has
a very bitter taste and in high doses cannot be tolerated as an
ingredient in beverages. For example, in a six-ounce beverage, no
more than about 20 milligrams of Ginkgo biloba can be tolerated in
terms of taste. Kudzu, which is also known as Pueraria, has a
friendly taste and provides almost instant enhancement to
alertness. However, this enhancement diminishes quickly and,
depending upon the dose, can lose effect within about one half hour
to one hour. [0909] iv. It has now been found in accordance with
the present invention that a combination of Ginkgo biloba and kudzu
advantageously serves to moderate the bitter flavor of Ginkgo
biloba, and the combination serves to provide for an instant and
sustained improvement in alertness. The composition according to
the invention in typical strengths provides for enhanced alertness
for about 2 to 6 hours. This makes the composition surprisingly
well suited for use as a caffeine replacement in various food
products, especially in a coffee replacement beverage. [0910] 20.
The object of the invention is to present a fiber-water composition
containing nicotine (Nicotine Fiber-Water), simultaneously with
hydration. [0911] a. Nicotine is also now delivered in water in a
product called Nico-Water.TM.. Once again it is in solution, and
the drinkers observed consuming this product tend to guzzle the
entire container. Worse they may choose to guzzle consecutive
bottles, as might also occur with caffeinated water. By
encapsulating all, or part of these type of ingredients we reduce
the potential of unwanted side effects and also moderate the
delivery. [0912] b. It is well known in the literature that it is
beneficial to take 25 mg. of Vitamin C with every cigarette as
nicotine depletes vitamin C. Ergo we have the invention fiber-water
with nicotine and vitamin C. Again we can time release at
pre-determined intervals and for very similar and/or different
distinctive reasons and advantages [0913] i. So invented here is to
have a sustained release form of nicotine (encapsulated) with one
or more release timed advantages. Ergo nicotine can be released
even over a multiple of hours if coated as such. Or some of the
nicotine may be present in the solution (fiberwater), itself while
additional nicotine it is here invented. Either form may include
antioxidants, especially Vitamin C to counteract the negative
effects of the nicotine. The antioxidants may be present in the
general Fiber-water solution, or encapsulated, or both. [0914] c.
The inventor calls attention to the following intellectual
properties for which the use of nicotine, positively, be is
physiologically or psychologically advantageous. [0915] The recent
discoveries of the benefits of nicotine are referenced in the
following: [0916] i. U.S. Pat. No. 4,953,572 to Rose, et al.,
issued Sep. 4, 1990, titled: Method and apparatus for aiding in the
reduction of incidence of tobacco smoking. This intellectual
property stresses the potential of nicotine poisoning and discusses
several techniques, which can be used to control the rate of
absorption on nicotine by the body. The inventor here feels that
encapsulation in fiber-water alone and/or following the same
delivery as above described in relation to putting caffeine in
fiberwater, [0917] ii. U.S. Pat. No. 5,810,018 to Monte, issued
Sep. 22, 1998, titled: Method, composition and apparatus for
reducing the incidence of cigarette smoking calls attention to the
ability of how to uses nicotine and caffeine together in an oral
spray device. Quoting Monte, "While scopolamine or any other
alkaloid or stimulant can be utilized in the practice of the
invention, caffeine is presently preferred because it is often less
likely than other alkaloids or stimulants to become habit forming.
[0918] (1). The liquid carrier in the spray solution is water,
alcohol, or any other desired liquid. The liquid carrier is,
however, typically an aqueous solution. When caffeine is the
stimulant utilized in conjunction with nicotine, the liquid carrier
is preferably an alcohol-water mixture because caffeine is at its
maximum solubility in such a mixture. The sequence of solutions
preferred in the use of the invention gradually decreases the
amount of nicotine in each solution and increases the amount of
caffeine. Eventually, a solution is used which contains only
caffeine and does not contain nicotine. Solutions, which contain
only caffeine and do not contain nicotine do not include a
sequestering agent and also preferably include ascorbic acid, which
improves the solubility of the caffeine. The amount, by weight, of
ascorbic acid used is preferably over twice the amount, by weight,
of caffeine present in the liquid solution". Using fiber-water and
nicotine as a program to reduce the nicotine craving is if one were
to look at a series of 10 or more single servings of a product that
gradually reduced the quantity of nicotine over time while also
supplying additional nutritional support. It is possible to use the
encapsulations, with their controlled release to gently and
progressively be of help to those desirous of kicking the nicotine
habit. [0919] iii. There are also other means of addressing
nicotine withdrawal known in the art. U.S. Pat. No. 4,778,677 to
Ebbesen, issued Oct. 18, 1988, titled: Method for treatment of
nicotine craving teaches that a combination of glucose, potassium
and caffeine may be a method for treating the cravings of nicotine.
[0920] By using fiber-water as a carrier and other supporting
nutritional ingredients, particularly in the solution fiberwater,
with encapsulations in a controlled release form, the inventor can
present a product and/or also an entire program to replace the
nicotine. Again Vitamin C is important along with other
antioxidants. [0921] 21. The object of the invention is to present
a fiber-water composition designed for those with fatigue,
simultaneously with hydration: Fatigue reducing Fiber water (also
addressing Fatigue Syndrome (CFS), and/or the symptomology (the
general feeling of fatigue/CFS and not diagnosed). [0922] a. The
inventor is very aware of fatigue, (tiredness) and that fatigue
comes from and/or is associated with many conditions, which in some
instances are overlapping. Tiredness is not uncommon to dieters. It
can be due to restricted calories/nutrients and/or both. However
there are many reasons for fatigue such as lack of sleep and/or
proper sleep, stress, a myriad of psychological reasons, and a
myriad of physical conditions. Pain drains energy and causes
exhaustion as another example. [0923] b. CFS, which has become an
epidemic, is on the rise. Since this is one of the disorders that
require at least 8 (8 oz) glasses of water everyday fiber-water and
ir fiber-water with additional additives is ideal. In general, in
order to receive a diagnosis of chronic fatigue syndrome, a patient
must satisfy two criteria: [0924] i. Have severe chronic fatigue of
six months or longer duration with other known medical conditions
excluded by clinical diagnosis, and [0925] ii. Concurrently have
four or more of the following symptoms: substantial impairment in
short-term memory or concentration, sore throat, tender lymph
nodes, muscle pain, multi-joint pain without swelling or redness,
headaches of a new type, pattern or severity, un-refreshing sleep,
and post-exertional malaise lasting more than 24 hours. [0926] iii.
A variety of vitamin supplements, medications, and other substances
have been described as having potential therapeutic benefits for
chronic fatigue syndrome (CFS) patients. Since no cause for CFS has
been identified, the therapies for this disorder are directed at
relief of symptoms. The physician, together with the patient, will
develop an individually tailored program that provides the greatest
perceived benefit, based on some combination of the therapies
discussed in this section. [0927] 22. The object of the invention
is to present a fiber-water composition designed for relaxation:
Relaxing Fiber-Water, simultaneously with hydration. [0928]
Fiber-water with additives that can relax, as opposed to those that
stimulate, have their place in the market. This is especially
important to those Type A personalities as well as those with
stress, stressful psychological conditions, and health challenges.
Weight loss and weight management diets do cause nervousness and
stress alone. Additional nutritional support is most beneficial to
our overstressed population. While there are herbs and other
botanicals that are known to support this specific area of concern,
the inventor is most interested in L-Theonine, or Theonine, an
amino acid derived from green tea. The product Sun Theonine.RTM. by
Taiyo is considered the best choice for the practice of the
invention. Due to the somewhat "off taste" of theonine, especially
in higher concentrations, along with the amount that is desired for
effect encapsulations are ideal. [0929] 23. The object of the
invention is to present a fiber-water composition addressing bowel
regularity, simultaneously with hydration. [0930] a. Fiber-water
for bowel regularity/maintenance. Fiber is known to affect the
bowels. In fact to most consumers today there minds still are
focused on the fact that fiber effects bowels. The inventor does
acknowledge that this is so, and that it must be given attention
although in the next area covered, gastro-intestinal tract health,
the inventor makes it clear that she does not wish to go into "more
conditions" and all their definitions. Best to just call attention
to: [0931] b. In patent literature we are aware of U.S. Pat. No.
4,834,990 to Amer, issued May 30, 1989, titled: Non-dairy liquid
health food. Here we are taught that soluble fibers include plant
gums, plant derivatives such as gum Arabic, locust bean gum, citrus
pectins, logum tragacanth, agar, carrageenan, xanthan gum and/or
other soluble fibers are beneficial. [0932] i. U.S. Pat. No.
5,380,717 to Ohkuma et al., issued Jan. 10, 1995, titled: Food
composite for performing function of large bowel regulation and
improvement in constipation. This patent uses maltodextrins as the
soluble fiber. [0933] ii. U.S. Pat. No. 5,260,279 to Greenberg,
Norman A., issued Nov. 9, 1993 (Sandoz now Novartis), titled:
Enteral nutrition and medical foods having soluble fiber. The
fibers used here are hydrolyzed guar gum and pectin. [0934] iii.
U.S. Pat. No. 5,558,897 to Goldman, issued Sep. 24, 1996, titled:
Milk Composition containing fiber and method for making the same,
also uses hydrolyzed guar gum. [0935] iv. U.S. Pat. No. 6,004,610
to Wang, et al., issued Dec. 21, 1999 titled Composition of dietary
fiber rich and low viscosity beverages uses fiber blend with the
guar gum adding arabinoglactan.
[0936] 24. The object of the invention is to present a fiber-water
composition to improve the health of the gastrointestinal tract; GI
FiberWater, simultaneously with hydration. [0937] a. Once in the
mouth food/beverges/"ingestibles" (regardless of their
constituents) start their journey through the body. This follows
what is called transit time. What we take in effects the entire
organism/body/human/animal. [0938] b. The gastrointestinal tract
pertains to the mouth, stomach small and large intestines, colon,
rectum, liver, pancreas, and gallbladder. There are many disorders
that can affect the health of that specific portion. Some are
genetic, others come from the ways in which we treat and/or care
for the body, and some just come as a natural part of the aging
process. Certainly filling this portion with conditions such as
gastritis (inflammation of the stomach lining), gastroenteritis
(inflammation of the mucous lining of the stomach and the
intestines), colitis (inflammation of the colon), constipation,
diarrhea would take volumes. Further just looking at intestinal
support, the "friendly", bacteria essential for digestion and/or
the metabolism of certain nutrients speak volumes. [0939] c.
Earlier in this writing the inventor pointed out the 70,000,000
people in the US alone who have gastric upset. It is almost beyond
imagination, if we look at the entire digestive system and break it
down (matrix style), what numbers we would come up with who have
needs, desires, challenges and so forth. Sometimes even more than
one. (this can be addressed with the ingestion of a daily preset
program by a professional and/or by the individual making personal
selections for himself/user be they human or animal. [0940] d. In
noting the just said it is not important to deviate anymore than
with the examples already given from this invention. So, while many
ideas and suggestions have been noted/covered, and even by topics
such as condition being addressed (chronic or
acute/temporary/permanent), age of the user, etc., the essence of
the patent is using the invention fiber-water (U.S. Pat. No.
6,248,390) as the foundation delivery system for adding/fortifying
enhancing agents (other delivery vehicles (encapsulations) and/or
vehicles (viscosity {s} to manipulate the delivery receiving site
and rate. [0941] e. The inventor calls attention to U.S. Pat. No.
6,120,803 to Wong et al. (Alza Corp. Palo Alto Calif.), issued Sep.
19, 2000, titled: Prolonged release active agent dosage form
adapted for gastric retention abstracts the present invention which
is directed to an active agent dosage form which is adapted for
retention in the stomach and useful for the prolonged delivery of
an active agent formulation to a fluid environment of use. The
active agent dosage form is a polymer matrix that swells upon
contact with the fluids of the stomach. A portion of the polymer
matrix is surrounded by a band of insoluble material that prevents
the covered portion of the polymer matrix from swelling and
provides a segment of the dosage form that is of sufficient
rigidity to withstand the contractions of the stomach and delay
expulsion of the dosage form from the stomach until substantially
all of the active agent has been dispensed. [0942] f. This patent
goes beyond, what is considered "encapsulations" by further
controlling release rates into the stomach and then following the
trickling down effect. Taking this to the next level it is
conceived that within this matrix are encapsulations which then can
drop and do their job farther down the GI tract in combination with
the below information provided by the "Alza" patent. [0943] g.
Controlled release dosage forms that provide for prolonged delivery
of active agent formulations to the environment of use have found
application for increasing numbers of active agents. However, with
respect to pharmaceutical and veterinary active agent formulations,
there has been a need not only to provide for prolonged delivery of
the active agent over time, but also to provide prolonged delivery
of the active agent at a particular location or locations in the
environment of use, such as in the stomach. [0944] h. Certain
active agents are absorbed primarily from the small intestine.
Generally, the time of passage of different particles through the
small intestine does not vary significantly, and passage is
generally independent of food intake and particle size. Thus,
active agent dissolved in liquid, solid active agent dispersed in
liquid and relatively larger delivery units of active agent, such
as microcapsules and the like, will traverse the length of the
small intestine in substantially the same time frame, usually about
3-5 hours. For active agents that are not easily absorbed by the
small intestine or that do not dissolve readily, the window for
active agent absorption in the small intestine may be too short to
provide a desired therapeutic effect. This fact often creates a
need for frequent dosing of active agent in order to provide and
maintain adequate levels of active agent in blood plasma. The need
for frequent dosing presents compliance problems and is often
inconvenient for the user as well. [0945] i. Since it has been
found difficult to alter the transit time of active agent through
the small intestine, some emphasis has been placed on attempting to
control the transit time of active agents in the stomach. Most
active agents are not well absorbed in the stomach, but even in
those instances where the active agent is not well absorbed, the
continuous release of active agent in the stomach over a prolonged
time period will dispense active agent over that same period of
time to the small intestine where it can be absorbed. [0946] 25.
The object of the invention is to present a fiber-water composition
designed for those experiencing pain: Pain Addressing/Relieving
Fiber-Water, simultaneously with hydration. [0947] a. There are
many conditions for which the body experiences pain so this is just
to serve as an isolated window to understand what a very valuable
product in the consumer marketplace world-wide it would be to have
a fortified fiber-water to address pain, in general, and/or by
specific categories. [0948] b. Stress exacerbates pain in most
every situation. It is important in fibromylgia, as well as other
stress related diseases to reduce the stress. When some people,
and/or animals are sick or are in pain they refuse to eat or drink.
It is at these times that hydration is essential. (a discussion
relating to a stress reduction fiberwater/relaxing fiber-water is
in the context of this filing) [0949] Fibromylgia, by some
professionals, been deemed to be closely related to chronic fatigue
syndrome (CFS). Additional symptoms of this chronic condition may
include sleep problems numbness and/or tingling, irritable bowel
syndrome (IBS) etc., which all can be considered in any formulation
and/or a derivative of that formulation. [0950] c. The constant
drinking (sipping) of water with the fiber to speed the elimination
of toxins and toxic metals is ideal. With the addition of glucose
to normalize the blood glucose level patients may feel more "even",
and more relaxed. [0951] d. With the further addition of a natural
relaxant that is water-soluble such as theonine, could be of great
benefit to patients with arthritis both rheumatoid and osteo as
both conditions are painful. (Note: that theonine comes from green
tea and the fact that the drinkers sip, and many times multiple
cups throughout the day it may have a cumulative effect in this
manner. [0952] e. The inventor, throughout all these enhanced
fiber-waters acknowledges the "cumulative effect" as opposed to
bolus dosing, regardless if it is a prescriptive, nutraceutical,
dietary supplement and/or the like. [0953] i. The inventor calls
attention to Nonsteroidal Antiinflammatory Drugs: These drugs may
be used to relieve pain. Some are available as over-the-counter
medications. Examples include naproxen (Aleve, Anaprox, Naprosen),
ibuprofen (Advil, Bayer Select, Motrin, Nuprin), and piroxicam
(Feldene). These medications are generally safe when used as
directed, but can cause a variety of adverse effects, including
kidney damage, gastrointestinal bleeding, abdominal pain, nausea,
and vomiting. The inventor believes that delivered in a liquid
medium such as fiber-water and/or enhanced fiber-water will
potentate the pain addressing effect of the medication and at the
same time assure that plenty of fluids are simultaneously taken so
as to avoid many of the side effects of "that pill sitting in the
stomach" with too little fluid. [0954] ii. Other supplements of
value for CFS maybe in the form of Vitamins, Coenzymes, Minerals,
such as; adenosine monophosphate, coenzyme Q-10, germanium,
glutathione, iron, magnesium sulfate, melatonin, NADH, selenium,
1-tryptophan, vitamins B12, C, and A, and zinc. [0955] iii. Plants
are known sources of pharmacological materials. Herbal preparations
that have been claimed to have benefit to CFS patients include:
astralagus, borage seed oil, bromelain, comfrey, echinacea, garlic,
Ginkgo biloba, ginseng, primrose oil, quercetin, St. John's wort,
and Shiitake mushroom extract. Some herbal preparations, notably
comfrey and high-dose ginseng, have recognized harmful effects,
ergo low dose and continuous supplementation is advocated. [0956]
iv. All the above points to a very valuable product in the consumer
marketplace world-wide [0957] 26. The object of the invention is to
present a fiber-water composition designed for experiencing gout,
simultaneously with hydration. [0958] a. Gout, which is a form of
arthritis, is a specific condition for which water is essential. It
is critically important to dilute the urine and promote the
excretion of uric acid. In fact it is recommended by Anne Simmons
M.D. that individuals with gout consume 8 oz. of water with each
meal and at least 8 oz. between each meal and after supper. [0959]
i. If overweight it is essential to loose those extra pounds and
therefore diet fiber-water-glucose is ideal. (Weight loss reduces
uric acid levels) [0960] ii. Gout can lead to kidney stone
formation and must be taken seriously [0961] iii. All the above
points to a very valuable product in the consumer marketplace
world-wide. [0962] 27. The object of the invention is to present a
fiber-water composition designed for those experiencing depression:
Mood Elevating and/or Anti-depression Fiber-Water, simultaneously
with hydration. [0963] a. By the year 2020, depression is projected
to become the second most common cause of disability among persons
of all ages and both genders worldwide. In any given one-year
period, 9.5 percent of the population, or 18.8 million American
adults, suffer from some form of depression. Women in the U.S.
experience depression about twice as often as men. Women buy more
bottled water than men. [0964] b. Regardless of the cause of
depression it can cause a slowdown of the entire digestive track.
Therefore specific fibers may be called for to help counteract this
along with other constituents (especially water). [0965] c. There
are pharmaceuticals with address depression such as: serotonin
reuptake inhibitors such as fluoxetine (Prozac), sertraline
(Zoloft), and paroxetine (Paxil); venlafaxine (Effexor); trazodone
(Desyrel); and bupropion (Wellbutrin). [0966] d. One of the
additional ingredients used today is St. Johns Wort. It is far
better, and with less side effects than taking prescription drugs.
In fact this herb has been called a natural Prozac. However the
public by and large does not know how to take this herb. It is
essential that St. Johns Wort, as is true with many herbs, it must
be taken daily and throughout the day whereby over time benefits
are recognized. [0967] e. Sam-e [0968] In a nutshell, SAM-e (short
for s-adenosylmethionine) is formed from the essential amino acid
methionine and adenosine triphosphate (ATP). SAM-e can be found in
every living cell, and is a methyl donor in over 100 different
reactions catalyzed by methyltransferase enzymes. Via enzymatic
transmethylation, SAM-e plays a role in the formation, activation,
or metabolism of neurotransmitters, hormones, proteins, and
phospholipids. [0969] As a mood enhancer, SAM-e functions by
donating its methyl group to CNS acceptors through transmethylation
and increases the activity of neurotransmitters like dopamine and
serotonin. It also improves receptor function linked to
phospholipid methylation. [0970] i. SAM-e is shown to be an
effective antidepressant without the side effects often associated
with several prescription treatments such as weight gain, dry
mouth, loss of libido, insomnia, etc. [0971] ii. SAM-e is shown to
reduce depressive symptoms in as little as 7 days [0972] iii. SAM-e
levels in the blood increase in relation to the degree of mood
improvement in depressed patients, regardless of the type of
treatment [0973] iv. SAM-e is shown to be effective in reducing or
relieving the signs and symptoms of postpartum psychological
distress [0974] v. SAM-e is shown to be effective in treating
depressed postmenopausal women [0975] vi. SAM-e is shown to be
effective in reducing prolactin levels in depressed patients--high
prolactin levels are associated with decreased libido [0976] vii.
SAM-e is shown to be effective in treating depression in patients
with Parkinson's disease [0977] viii. SAM-e is shown to be
effective in treating depression in patients with HIV [0978] ix.
Thus fiber-water-glucose is ideal. If to make the most tasteless
and effectual product possible the science of encapsulations might
best serve this purpose. [0979] x. All the above points show that
this variation alone can be a most valuable and profitable product
in the consumer marketplace in the United States, world-wide as
well as the inventor is looking at the approximate 18,000,000
Americans suffering from depression alone (non related to any
specific condition as exampled with those above (under Sam-e which
are HIV positive, Parkinson's, Women who are post-partum, and also
women who are post-menopausal)). Conclusion Statement as Related to
Health Issues
[0980] There are a myriad of other specific health conditions that
can be addressed by putting additives into fiber-water ergo
creating new and novel fiber-waters with the enhanced deliver
systems. Fiber-water, and now delivering additives, using the
versatility of these deliver systems within the invention, namely
encapsulations and viscosity changes. Ingredients can be delivered
through water with fiber(s) and the conditions to be addressed
categorically are huge. Besides what is listed here the following
are to be included as thoughts but not just limited to these:
allergies, headaches, eye problems, PMS, menapause, Lupus, MS, MD,
cancers, Menieres, Raynauds, shingles, Wilsons, celiac, those
easily bruised, parasite and yeast infections, edema, and more . .
.
Segmentations of Markets by Age:
[0981] Focus of The inventor is most focused in the next section on
children, as they grow from babies through maturing teenagers, as
well as the needs of pregnant and/or lactating mothers eventually
our aging population known most commonly as seniors. The inventor
notes the following:
[0982] Infants also have distinct fiber requirements. Until
recently, no specific guidelines for dietary fiber in children were
available. Recommendations have recently been developed, based on
age, weight and height of the child. It is now recommended that
children older than two years consume a minimum amount of fiber
equal to the age plus five grams a day. The recommended safe dose
is between this and age plus ten grams a day. Above that symptoms
of excess fiber (e.g., loose stool) may become apparent.
[0983] It is the intent of the inventor to provide in addition to
various grades of fiber-water the enriched fiberwater, which will
serve the basic fiber-water intent, and then magnify/amplify
additional added benefits.
[0984] Since infants and small children are generally unable to
directly tell us of their digestive distress, constipation and
other results of inadequate fiber are often exhibited as fussiness
or similar undesirable behavior. (This is especially true when
infants are just being weaned from fiber-free milk to a fiber
containing diet. There can be significant advantage to providing a
fiber source in the water along now with additional specifically
designed functional additives to be consumed by the infant).
[0985] Infants and many small children cannot tell us of their
feelings either but they learn quickly that if they cry know if
they cry Because infants have a constant requirement (not
necessarily a desire) for water, the addition of fiber-water with
the enhancements to the typical diet can provide a more constant,
even source of nutrition and condition addressing additives while
ensuring adequate hydration and fiber given.
[0986] Further the use of fiber-water can ensure adequate fiber
without adding significant calories--an inevitable consequence of
other fiber sources. Consistent dietary fiber can provide for a
"more even" operation of the infant's digestive tract while the
additives and the viscosity changes serve their purpose. In
contrast, a more traditional infant diet that alternates between
low fiber formula and high fiber adult foods may have, as an
example, an uneven or cramping effect.
[0987] A useful amount of soluble fiber is 1/4-1 gram per 8 oz
(considerably lower concentration than for the adult
fiber-water).
[0988] Sometimes we don't think that babies and young children have
stress in their lives also. Changes in custodial care, baby
sitters, new sibling (s), and/or a step-parent, changes due to
normal childhood illnesses, colds, flu, teething, fever, measles,
mumps, chicken pox, etc. While these illnesses may not be the
direct cause of constipation they may be the indirect cause. With
illness come changes in eating, sleeping, behaviors, and habits.
Travel--when a babies environment is changed, from going to
grandparents to international travel, sensitivities to the new, can
throw off a system that is used to regularity. International travel
bears with it the dehydration of long hours on an airplane etc. The
future holds even more stressing travel such as space travel.
Dysfunctional homes where there is divorce, alcoholism, family
abuse etc., may be noted in the babies, or young child's, refusal
to eat, defecate, crying spells etc.
[0989] Water probably can be given as early as one month, although
usually started between 2-4 months after birth. Fiber-water with
the added nutrients and their delivery methodology further can
serve as a great pacifier and satisfy the babies need to suck
and/or be fed. This is especially valuable during off feeding
hours: or in place of hard plastic and/or rubber pacifiers that may
cause harm.
[0990] Of major importance is the fact that many babies who are
given water are given water that is unsafe. This invention insures
that the water is safe. Diarrhea, which is often caused by
contaminated water supplies, can be life threatening to infants.
Therefore, there are great advantages to using safe bottled water
for any infant and/or infant formula, etc. In the case of the fat
baby this invention may well do more than provide a low or non
caloric-hydrating agent. The soluble fiber in fiber-water alone
without additives (such as increasing the viscosity) has been show
to slow the absorption of fats and sugars (see U.S. Pat. No.
5,505,981).
[0991] At every stage of life, fiber is vital to proper health,
growth and development. Infants and toddlers require a regular and
controlled source of fiber as well as other nutrients. After babies
cease to breast-feed or use liquid formulas and move on to more
varied adult solid foods, they often suffer a number of painful
digestive episodes which makes them fussy and difficult. Because
fiber-water, itself, and with this invention provides an ideal
source of hydration, fiber, and other additives for such infants,
it may be added to commercial formulas and/135-1 or used alone.
[0992] Therefore, not only does it ensure adequate hydration, it
also provides a consistent fiber source to guarantee regularity. It
should be kept in mind that typical commercial baby foods may vary
widely in the amount of fiber provided and also the nutrition they
provide generally yet alone when specifics are called for. This
invention provides an opportunity to lay the foundation of good
habits and additionally, it may be beneficial to add to commercial
baby food if deemed appropriate.
[0993] As the infant becomes a toddler and moves towards more a
more adult diet, the requirement for fiber and other additives
increases and/or changes and this inventor is sensitive to that.
[0994] 28. The object of the invention is to present a fiber-water
composition designed for babies, Enhanced Baby Fiber-Water,
simultaneously with hydration. [0995] At certain times babies want
to be fed more frequently than at other times. This could be due to
growth spurts, the good feeling of mother (using mother as a sort
of pacifier), and/other possibilities including but not limited to
illness etc. There it is important to have an alternative yet
healthy addition and/or substitution for the breast/bottle. [0996]
Fiber-water is an excellent choice but in this invention where we
go beyond the inventor lists some additional enhancements using
encapsulations, viscosity changes or a combination of both. [0997]
a. Babies who are hungry all the time and/or need oral
gratification can now have a slightly thicker fiber-water whereby
they have to draw harder on the nipple (although the nipple hole
can be enlarged) which will not just give them a feeling of
fullness but will tire their little mouth and jaw muscles. [0998]
b. In order to get a well-balanced nutritional delivery to babies
who are not breast fed formula is used (or in combination with
breast feeding). While this is desirable and important often
nutrition is needed without the calorie contributing additions. By
encapsulating (micro-encapsulating) supportive health additives,
with or without viscosity changes, and/or with or without a small
addition of glucose, a baby can receive beneficial nutrition to
support development. [0999] i. Calcium is a good example and can be
added to the enhanced fiber-water, with or with out viscosity
changes and/or encapsulations. (Babies, and through about age three
(3), 500 mg. of calcium is needed daily) [1000] ii. Fluoride for
the eventual eruption of teeth [1001] iii. Doctors prescriptives
[1002] iv. Any enriched fiberwater may be used in any proportion to
dilute, augument a formula. [1003] Additionally, there have been
many new discoveries in more than just nutritionally enhancing
infant formula. U.S. Pat. No. 6,399,090 to Shehadeah, Insotech,
(IL), issued Jun. 4, 2002, Again it is important to notice the
effect that sodas, and drinks which are extremely high in sugar,
have negative effects on the body. Further, giving children so much
sugar at an early age sets up their taste buds to crave sweets and
therefore select more sugary foods. It is also noted that excess
amounts of sugar on a continuous basis at an early age can set the
metabolism towards a diabetic-prone posture later in life.
Hyperactivity along with other unfavorable conditions in children
has been caused by an over load of sugar laden foods and beverages
that act like "liquid candy". Fruit juices are also very high in
sugar, although they may contain a different kind of sugar. Even
those new age beverages with their fancy names and deluxe
packaging, for the most part, are mostly sugar water. [1004] v.
U.S. Pat. No. to Shehadeah, Insotech, (IL) titled: Insulin
supplemented infant formula teaches an infant formula in a powder
or solution form including those important nutritional components
along with an insulin supplement. According to one aspect of the
present invention is such that when the infant formula is fed to an
infant a chance of the infant of developing diabetes is reduced.
(wherein said insulin is in a concentration range of about 1,000 to
100,000 micro units/100 ml of solution or 8,000 micro units/100
grams of powder) [1005] 29. The object of the invention is to
present a fiber-water composition designed for toddlers and young
children, simultaneously with hydration. [1006] The inventor again
must remind the reader of her adversity to sugar. Again it is
important to notice the effect that sodas, and drinks which are
extremely high in sugar, have negative effects on the body.
Further, giving children so much sugar at an early age sets up
their taste buds to crave sweets and therefore select more sugary
foods. It is also noted that excess amounts of sugar on a
continuous basis at an early age can set the metabolism towards a
diabetic-prone posture later in life. Hyperactivity along with
other unfavorable conditions in children has been caused by an over
load of sugar laden foods and beverages that act like "liquid
candy". Fruit juices are also very high in sugar, although they may
contain a different kind of sugar. Even those new age beverages
with their fancy names and deluxe packaging, for the most part, are
mostly sugar water. [1007] a. It has been documented that soluble
fiber is important for children of all ages. Now with the next
level of development of fiber-waters one can readily see the value
of a line extension for this age group and further considering this
to be a very valuable product in the consumer marketplace
world-wide. [1008] b. Additions for young children would include
calcium (ages 4-8 years 800 mg. is recommended and 9 years upward
1,200 mg. is the recommendation. The just said is just one example
of a value added enriched-fiberwater for children. [1009] c. Other
than growing healthy, addressing health challenges such as illness
and disease there are other conditions that are considered. Over
and over literature is replete, addressing concentration by school
age children. While some of them have been diagnosed as having
Attention Deficit Disorder (ADD) others as hyperactive, diet is
believed to play an important role. [1010] d. By the
caretaker/mother becoming more aware of the essential needs, on a
daily basis for water and fiber and good nutrition it is the hope
of this inventor that this awareness will continue, and pass to the
child who eventually will make part then in total his/her own
choices and decisions as he or she grows and develops. It may also
be noted that the father, possible siblings along with other family
members and friends become more aware of this invention, and so by
this invention it is the goal of this inventor to create healthier
people. [1011] e. While enhanced fiber-water may be packaged in any
container and under the conditions designated by governmental
health standards the inventor considers the packaging of such
fiber-water and/or an enhanced formulation for children, especially
young children, to be packaged in flexible pouches or laminate
boxes for several reasons, including the dangers of glass
containers, or the less likely to spill of a wide mouth cup.
Additionally, the child is less likely to put potentially dangerous
ingredients and/or small objects into a wide-mouth drinking
container thus creating potential dangers in swallowing the just
mentioned. [1012] f. As with any fiber-waters, it is advantageous
to provide the infant and child (any age) fiber-waters in a number
of strengths so that the amount of fiber administered can be
readily monitored and appropriately adjusted on an individual
basis. Again, it may be advantageous to add identifying color so
that it is clear to the parent/caregiver (or the user) precisely
which grade of fiber-water is being used. In the case of children
especially, (actually anyone) the color may be so inherently
appealing therefore may mitigate in favor of using transparent
packaging so that the child can appreciate the color of the
fiber-water being consumed. A popular noted expression has to do
with fooling the eye (trompe-l'oeil) and here the inventor believes
that color is distracting, especially very vivid, and may override
taste. [1013] g. It is also conceivable that if the container is
not transparent that a transparent straw may show the color, or
that specific graphics and/or color on the container will relate to
the strength (apart from the aesthetic appeal of the color or
graphics). [1014] 30. The object of the invention is to present a
fiber-water composition designed for teenagers simultaneously with
hydration. [1015] a. The importance of creating a fiber-water with
additives for teenagers cannot be overlooked. This is especially
true if they have significant health issues. The inventor would be
remiss if she did not at least mention this concern about what this
age group consumes. This age group, in their search for their
independence, are most inclined to make their own selections, and
additionally much of their drinking is away from home. They are
most influenced by media and peers. A strong effort should be made
to provide color, essences, and packaging to address this age group
in their language. [1016] b. Teenagers especially are known not to
eat much fiber and/or to hydrate with water. Many times they skip
meals, especially breakfast, and so with the drop in blood sugar
they cannot function well in school. On the opposite end of the
spectrum teenagers consume too much sugar. (see obesity and
diabetes) Many behavior problems are due to too much sugar and/or
too little glucose. Schools now allow students to keep a container
of water at their desk. Fiber-water and/or this invention is most
suitable/perfect for those students. Specific areas of concern for
this population includes, but is not limited to the following.
[1017] c. Pimples and acne are embarrassing and cause much stress.
While some 85% of teenagers between 12 and 25 experience acne most
outgrow the condition over time. Pimples and acne are not just a
condition of the teenagers, but some 10% of Americans between 25
and 44 have the same problem. Several population studies suggest
that eating more fiber can help with this condition by improving
the conditions within the body and eliminating toxins. [1018] i.
For those with acne zinc has been shown to have a significant
benefit. In one study people who took 135 milligrams of zinc
everyday for 12 weeks saw 85% of their blemishes disappear. Zinc
works by reducing blood levels of the male sex hormone
dihdrostestosterone (DHT). Small amounts of zinc added to the
invention and with multiple bottles of water consumed daily so as
not to exceed 30 milligrams of zinc daily (without doctors
permission) it is conceivable that there could be a reduction in
blemishes. [1019] ii. Eczema, a serious skin condition, has been
known to be helped by the regular addition of zinc to the daily
diet. [1020] iii. All the above points to a very valuable product
in the consumer marketplace world-wide [1021] 31. The object of the
invention is to present a fiber-water composition designed for
seniors and looking at the anti-aging market, simultaneously with
hydration. [1022] a. While there has been a great focus in relation
to children and the younger generation, this invention no way
limits itself to that marketplace. Infants, young children
teenagers pose need/desire/compliance friendly challenges and the
aging population, senior citizens, "seniors" another. As related to
seniors: [1023] i. Aging seniors who do not want to take so many
pills, etc, [1024] ii. With aging comes the loss of ones thirst
mechanism ergo seniors may not get enough hydrating liquid. [1025]
iii. Many seniors are use to bottled products ergo recognition
(just as they do with in tea bags under the inventors PCT) So
herein lies the opportunity to add all the extra benefits, to
fiber-water governed under this invention to the just mentioned
familiar bottle, can, pouch box and/or the like . . . easily
recognizable object. [1026] iv. Now it is not only possible, but
often desirable, to use this invention. As a psychological
advantage, a patient might not feel as if they are so ill as when
they have to take so many medications. Also whereas if they were
directed by a health care professional to take a pill, they would
not do so and/or pretend to do and hide, or flush it down the
toilet, etc. just like a child. While the inventor believes that
information is important many just can't absorb it and become
fearful, especially the aging. To prevent confrontation and tension
in this age group as well, care-givers hope for delivery systems,
in which there is the opportunity to mask not just the taste but
the active ingredient(s) so as to reduce questioning by the
patient. The inventor has first hand experience with her 91
year-old Mother in relation to on going cardiovascular, urinary,
depression, problems needing attention daily. [1027] b. Using
further, seniors have problems often times with gastric upset and
other digestive disorders whereby in the wrong from and/or too much
entering the stomach too quickly without adequate fluid may be
problematic. [1028] 32. The object of the invention is to present a
fiber-water composition designed for those participating in
strenuous activities/athletics Sport Fiber-Water Snapshot.TM.,
simultaneously with hydration. [1029] a. It is conceivable that
their be a formula with, and one without, glucose that may have
encapsulations, viscosity changes, and/or both. Minerals largely
make up the isotonic meaning and they really do not, for the most
part taste good and/or may, in some forms be taste acceptable but
not in the form most desired for this intention [1030] b. Several
decades ago French scientists formulated the hypothesis that
fatigue is caused by inefficient energy metabolism at the cellular
level. They believed that enriching the cellular environment with
the appropriate substrates and co-factors could promote greater
metabolic efficiency and thereby reduce the subjective symptom of
fatigue. The potassium and magnesium salts of aspartic acid were
considered ideal for this purpose. [1031] i. Potassium is involved
in energy metabolism and in repolarization of muscle cells. [1032]
ii. Magnesium is required for synthesis of ATP and it also enhances
transport of potassium into cells. [1033] iii. Aspartic acid (AA)
is converted intracellularly, in a series of steps, into
oxaloacetate, an important substrate in the energy producing Krebs
cycle. Potassium and magnesium aspartates thus appear to provide
several essential co-factors for energy production. [1034] c.
Designing a sports form with fiber-water as the base will rely on
encapsulations, viscosity changes (and maybe more than one) and the
importance of hydration. [1035] i. There is much supporting science
documenting isotonic beverages and that science is to be considered
when formulating here. [1036] ii. Further what is known is that it
is important to keep up the blood glucose and extend by
encapsulations and/or with the fiber(s) used/blended the
post-prandial rise in the just said. [1037] iii. The formulations
may be divided into gender specific products and/or by weight
and/or by age. [1038] iv. The formulation may be mixed in any ratio
with a Ready to Drink Sports Drink, such as Powerade.RTM.
Gatorade.RTM. All Sport.RTM. etc. This may be a way to formulate
for individual who weigh less and/or are younger.
[1039] d. While it would be very intense if Sports FiberWater was
added to reconstitute a powdered formulation of the just said, or
another in the category by having ingredients encapsulated for
later/delayed time release this would prevent the "all at once"
dosing upon drinking. [1040] e. It is also possible to use any
ratio of this enhanced fiber-water, pure water and the concentrate
to form a custom drink. This allows the consumer to have a broad
range of choice as is evident [1041] f. All the above points to a
very valuable product, and spin off products, in the sports drink
category, which is of major importance in the consumer marketplace
world-wide [1042] 33. The object of the invention is to present a
fiber-water composition designed for pregnant mothers, "Mama to Be"
Fiber-Water, simultaneously with hydration. [1043] a. In pregnancy
nutrients, hormones, toxins can have a profound effect. Folic acid
has been shown, as an example of a vitally important nutrient in
pregnancy to prevent a significant reduction of neural tube
difficulties including spina biffida. Folic acid needs to be
present at the moment when an embryo's cells curve over one another
to create the neural tube. 400 micrograms is what is recommended
and as experts advise should be a daily supplement for every woman
of child-bearing age. [1044] b. In the first 12 weeks of pregnancy
is critical to have more than the required 8 glasses of water. The
current recommendation is 10 glasses. [1045] i. Mothers-to-be
sometimes suffer from nausea and vomiting. It is important to be
sure to replace with water if fluids are lost. This is also true to
some degree with the addition of a small amount of glucose
especially if the mother-to-be is vomiting extensively as glucose
levels are affected by vomiting. A special diet-fiber-water-with
glucose for pregnant women who need to increase their water and
fiber intake along with foods to support both maternal and fetal
needs and ensure a healthy baby and mother. [1046] c. It is also
most critical to remove toxins on a regular basis for her health
and the health of her yet to be born baby. The fiber-water
invention will aid in the removal of such toxins. Further, with the
addition of small amounts of glucose to the water and fiber we can
best assure the "evenness" of blood glucose levels for both mother
and fetus as mentioned. Of specific importance to pregnant and then
lactation mothers is a strong immune system, the expediting of the
removal of toxins from the body. It is very important to give the
pregnant mother natural ingredients that will accomplish the just
mentioned without the addition of chemicals for, more than, obvious
reasons. [1047] d. All the above points to a very valuable product
in the consumer marketplace world-wide [1048] 34. The object of the
invention is to present a fiber-water composition for lactating
mothers, simultaneously with hydration. [1049] Breast feeding
fiber-water for new Mothers. [1050] a. Specific water for lactation
is important to provide nutrients to the newborn through breast
milk and for the care of the mother postpartum. Women who are
breast-feeding need to drink fluids especially safe water. Since
both with pregnancy and lactation the mother is usually somewhat
restricted in exercise the soluble fiber enrichment becomes even
more significant, especially if ingested regularly as suggested
throughout the day and on a regular basis. [1051] b. There are
mothers who use a breast pump to extract the breast milk for later
feeding. This may take on a new position if one looks carefully at
combining said breast milk with fiber-water and/or an enhanced
fiberwater with specific intents such as: enhancing nutrition
addition hydration cutting down on calories [1052] c. All the above
points to a very valuable product in the consumer marketplace
world-wide as noted by all the children being born, and the
continued belief that breast milk offers many benefits that a
commercial formula doesn't . . . most important is the immune
enhancing abilities. [1053] 35. Object of the Invention is to
present a series of Animal and Pet Products, simultaneously with
hydration. [1054] a. Animals, mostly domestic pets, are often
forgotten when it comes to supplying, as an example, healthier
alternatives. This is not always intentional especially with tight
budgets and time restrictive schedules of "working" owners or in
the case of large families etc. The ability to bring to market
products just for human consumption alone is most difficult yet
alone for pets and/or other animals. Then too it is noticed how
many individuals take better care of their animals than they do
themselves. [1055] b. Animals, especially personal pets, and
additionally all the "aid dogs" (for the blind, police K9 dogs,)
etc. are a major part of our society bringing help, joy, pleasure,
companionship, etc. to the lives of young and old alike. [1056] c.
Some pets have become so much a part of the family that they even
sleep in the same bed, travel with, and/or the like with their
owners. Further, now pets are even being brought into hospitals and
other institutions to visit patients. [1057] d. Pet health is very
important, however at the same time it is big business. As a
business, and to bring to the marketplace well-studied ethical
nutritional products one is faced with many of the same problems
that face the people population. Sometimes even more, because there
are many categories, which compose the annual kingdom, and this
invention is not limited to what is normally considered being just
the ordinary household pet. [1058] e. While it is true that pets
might have some fickle tastes along with individual preferences
when it comes to their food they still need nutrition and care in
relation to specific conditions. [1059] f. To get medication
including but not limited to even some vitamin preparations one
only has to look at what it takes to get this into a pet. Pills
have been buried in bits of food more often than not. Besides it is
very difficult to offer a trip to Disneyland.RTM. to your dog.
[1060] g. The inventor has noticed a great sensitivity to pet
nutrition by many companies especially the lams Company.RTM.
(Dayton Ohio) with reference to the following U.S. patents: U.S.
Pat. No. 6,039,952 to Sunvold, et al., issued Mar. 21, 2000, titled
Composition and method for improving clinical signs in animals with
renal disease; U.S. Pat. No. 6,204,291 to Sunvold, et al., issued
Mar. 20, 2001, titled Process for promoting weight loss in
overweight dogs; U.S. Pat. No. 6,180,131 to Sunvold et al., issued
Jan. 30, 2001, titled Process for improving glucose metabolism,
satiety, and nutrient absorption in companion animals; U.S. Pat.
No. 5,776,524 to Reinhart, issued Jul. 7, 1998, titled Process for
treating small intestine bacterial overgrowth in animals; U.S. Pat.
No. 6,133,323 to Hayek, issued Oct. 17, 2000, titled Process for
enhancing immune response in animals using .beta.-carotene as a
dietary supplement. [1061] h. Additionally, U.S. Pat. No. 5,968,569
to Cavadidi et al. (Nestec S. A., (Vevey C H), issued Oct. 19,
1999, titled Pet food product containing probiotics; [1062] i. U.S.
Pat. No. 5,294,458 to Fujimori (Maruha Corp. Tokyo JP), issued Mar.
15, 1994, titled Pet food--where this invention contains
lactosucrose to keep the intestines of the pet in order, provide a
good taste and a great effect on deodorizing feces and urine
discharged by the pet. [1063] j. The importance of fiber-water for
animals has been stated (U.S. Pat. No. 6,248,390) and this
invention for animals is to provide an enhanced fiber/water/liquid
following the guidelines as for humans while providing hydration
along with other active and/or non-active ingredients. [1064] k.
This invention for animals relates to the ability to directly give
enhanced fiber-water. Additionally and perhaps more common might be
the ability to give in-directly (mixed in food) an enhanced
fiber-water following the guidelines of the invention ergo creating
a superior product addressing desires and/or needs, and/or both for
the animal. This beneficial liquid (unlike adding liquid vitamins
and/or the like) will increase hydration with the added feature of
one or more beneficial agents to treat a specific condition,
performance desire, promote general health and/or the like. [1065]
l. Animals have many of the same problems as humans as far as the
following: viral and/or bacterial infections, and/or inflammatory
conditions, and/or the like. Additionally certain animals, such as
dogs, as well as humans, sometimes suffer from diabetes, or have an
impaired ability to regulate blood sugar levels. Once diagnosed,
they have to be closely controlled by diet, medication and/or both.
[1066] m. Certain animals also have a tendency towards excess
caloric intake, which increases, as in humans, the risk of the
animal developing not just diabetes but other chronic diseases. It
would be more than just desirable to manage caloric intake through
dietary means so that the animal would become sated after meals but
without excessive caloric intake. [1067] n. Animal by and large do
not eat for social purposes nor do they follow the psychological
(often pathological) patterns so associated with humans and their
food behaviors. Therefore, by this invention much can be offered to
the animal kingdom. [1068] o. Additionally there are numerous, and
far too many well-designed examples of all sorts of additives being
used for animals which are, and/or do produce food for humans and
other animals. (e.g. chickens, cows, pigs etc.) Careful
consideration must be given to animals, which are "eaten" and also
of the food that they produce for eating (eggs) and/or both. [1069]
p. Further there exists a special group of nutritionally engineered
products for, what the inventor calls, competitive animals such as
racehorses, polo ponies, greyhounds (comparable to human athletics
as just an example) etc. An extension would be show animals of all
types, and working animals on ranges and farms. Further would be
animals specifically for breeding. With the encapsulations much
nutritional fortification is possible. [1070] q. In our zoos and
circuses we have in captivity many wild animals, birds, etc. for
which humans are responsible for their nutrition. [1071] r. With a
consciousness towards the best way to deliver, in all the
categories of supplementation as described for humans (people), one
is reminded that animals do drink everyday. It is also noted that
quite often liquid is needed to wet animal food by necessity,
design, or both . . . ergo imbibing the food with additional
liquid. To use such products to mix in animal food is a most
lucrative market. (Any packaging is applicable) [1072] s. For a
better explanation is . . . more specifically, pet foods for dogs
and cats, as an example, is usually classified into [1073] i. a dry
type, a semi-moist and often called a soft dry type and a wet type.
In all these instants, liquid can be added. The dry type pet foods
include, as an example, a moisture content of below 10%-12% in
forms such as kibble, biscuits, flakes, crumbles (granules). [1074]
ii. Semi-moist usually have a moisture content ranging from 25%-35%
and are in the form of hamburger, ground meats, fowl, and/or the
like. [1075] iii. The wet type food includes food having high
moisture content of 70%-85%, whereby many canned foods and, those
that have undergone a retort process method fall into this
category. There are oatmeal type foods comprising of meat and fish,
as well as those that have additionally added vegetables and
vitamins, and/or the like added additionally. [1076] (1) If the
liquid has a flavor in it, which will mask the unappealing tastes
of many of the aforementioned ingredients and/or elements as
described for humans with and/or without encapsulation(s) and/or
viscosity changing technologies then there exists a greater chance
of compliance. [1077] (2) If the encapsulation are large (example
like a gummy ball to be chewed) then not only can they carry
additional fiber (with the benefits of) but within this invented
large encapsulation, many additional encapsulations (with one or
more active ingredients) which can be immediately released and/or
timed released (according to the digestive tract of the particular
animal/pet/species/size/weight and/or the like), are considered
invented. [1078] (3) Further, even animals have fragrance
preferences by nature and/or learned. For a cat one could envision
a fish smelling water the inventor just doesn't know what kind of
fish as of yet. Conceptually this can extend throughout the animal,
bird, and even reptile communities. [1079] (4) It was a real
learning experience for the inventor to study animal habits,
preferences and pet food products for the specific goal of
inventing/designing for this enormous category good tasting
nutritious healthy product(s)/additives. Again it is important to
note that the members of the animal kingdom do not require fancy
packaging for which so much extra monies are spent, and therefore
most profitable to the producing/owning entity while providing the
best in nutrition/supplementation for the user. [1080] (5)
Addressing bowel regularity to ensure hydration and regularity
again of domestic animals--primarily cats and dogs. However, any
carnivore or omnivore should benefit from the invention. Herbivores
have very different gut bacteria and may be able to metabolize the
soluble fiber. Therefore, these animals must be tested on a
case-by-case basis. Domestic animals, particularly cats and dogs,
also suffer from problems with hydration and constipation. Dogs are
omnivorous and will naturally consume some fruits and vegetables.
However, refined dog foods tend to be remarkably deficient in
vegetable fiber. Administering a source of fortified fiber-water
daily (with additional additives addressing the GI Tract) using
water as the delivery system, since dogs etc. generally drink
offered water can readily alleviate this problem. [1081] iv. The
inventors experiments showed that by adding just the fiber water to
dry kibble (or as an example, the gravy forming type) or even
stirred into canned dog food have shown that it has gone unnoticed
by dogs, cats, and other animals. [1082] v. Cats also have serious
dehydration and constipation problems. Cats are obligate carnivores
and generally will not knowingly consume fruits or vegetables
(other than valuable houseplants). Kidney failure is a common
malady of geriatric cats resulting, in part, from inadequate
hydration. Constant vomiting is a common feline problem brought on
by their grooming during which they ingest significant quantities
of fur. In the wild, cats ingest sufficient indigestible matter
(bones, cartilage and tendons) to provide non-vegetable fiber. With
pet cats the owners are expected to mix fiber generally psyllium)
with the cat's food or administer petroleum-based laxatives.
Neither alternative is particularly ideal. Thus this invention, as
well as Fiber-water, can be given as
"water", or mixed with the cat's food to provide sufficient fiber
to prevent both hairballs and constipation thus solving significant
feline problems. It appears that reduction in vomiting positively
contributes to the hydration of cats. [1083] 36. Daily water
program and/or incremental enhanced fiber-water, or any liquid
delivery program by design for humans and/or animals: (regardless
of the desire(s)/need(s)/condition(s)), simultaneously with
hydration: [1084] The inventor has covered bolus dosing as well as
spreading out the deliver of actives through the day as being, in
may instances, advantageous. [1085] a. Presented here in specifics
is a daily and/or incremental program, regardless of the category
addressing (user . . . desire/need/condition . . . matrix
appropriate), whereby delivery may be: [1086] i. in multiple sets
as with, example, a 2, 4, 6, or more 4 set/pack with a specific
daily purpose and always including hydration as a main goal) as
example they may include different but not related and/or different
but related (as exampled with a daily supply of RDA vitamins and
minerals which might be served/spread over a designated period of
time (e.g. 12 to 24 hours). [1087] ii. An integrated program for
weight loss might include but not be limited to [1088] (1) A
multi-pack (regardless of containers) rising water for the first
thing in the morning, one or more throughout the day, then the
retiring water . . . the last before bedtime. (The amount and/or
the constituents may vary) Separate containers might be even the
same formula but easier to transport . . . and/or again might be
packaged in separate containers if the formulations are different
[1089] (a) Color coded for changes of the time of day, or the
ingredients within [1090] (b) Viscosity changes for the time of
day, for a dieter especially, with or without encapsulations
(thicker may mean more fiber and/or different fibers, or thicker
but not with fiber, any with or without encapsulations [1091] (c)
Glucose supplementation (which the inventor knows can be
manipulated to taste like water with, as an example, offsetting
with one or more acidulates, and/or acid plus other ingredients, or
other ingredients with no acid known in the art of formulation.
[1092] (2) Multiple servings might be in one large bottle [1093]
(3) Perhaps there might be 2 bottles, one to last as an example 6
hours and the second to be sipped over the next 6 hours. Can be the
same or different formulas. [1094] iii. For children especially
creativity is important, and for business bringing on not just the
sale of product, but the opportunity for licensing and cross
promotions with major entertainment and/or "like entertainment"
companies etc. can be enormously profitable as well as responsible.
The inventor calls attention to the following example; [1095] (1)
In relation to a "fireman theme" by packing small individual
bottles/containers/(containers that have graphics are more
attractive to children . . . but clear is suggested if there is to
be a reaction in the packaging that the child will want to observe)
in a fire station and/or in a fire-truck, and/or in a fire-truck in
the fire station as a double incentive. [1096] (2) Now we are
starting to notice that with one unit it is possible but with more
than one it brings in the toy element, games, collectables,
tradeables etc. which can be made of any material, shape, design,
indicia, etc. If a treasure to be kept then it is conceivable that
there be electronics, lights, noise, etc. added. All considered as
part of the creativity and ergo the "inventivness". [1097] (3) The
drinks can be different colors for specific reasons . . . Red for
fire . . . . If with a story blue means that you put the fire out.
(Perhaps even included information about firemen and/or the
department. [1098] (4) Again of note is that if it for multiple
units are packed with the reconstituting liquid regardless of
portion size per bottle the container for the unit(s) does not have
to be metal or plastic; graphics on a paperboard box and/or a
paperboard box tray is also envisioned. Further; if it is presented
in a tray like form as opposed to a "closed carton", it could be
with or without a continuation of the concept printed on the
plastic covering. [1099] iv. It also provides the opportunity for
additional literature, advertising and/or the like. Literature of
all sorts, not just as related to the theme may be included in any
form, promotion, game, contest and/or the like. [1100] v. The size
may be one serving and/or more based on 8 oz. per serving and/or
perhaps scaled down appropriately for a child as in relation to
age. (e.g., in lots of 4, 6, 12, 24, etc. whatever to be used
through out the day, week, month. [1101] vi. Even a case a week or
a month club with a different theme and can be delivered as a
business method for the home delivery companies and/or sold off of
the internet. It can work as "pay as you go" and/or on a revolving
charge. [1102] vii. They also can be of the same nature and/or an
assortment of different containers with different natures with
and/or without the same intent and/or interrelated intent like.
[1103] 37. The object of the invention is to present other forms of
the liquid, simultaneously with hydration, which might fall
(classified by some) into one or more of the following categories
known by the descriptives: Concentrates. Needs reducing; Elixirs,
Usually a sweetened medicinal solution; Tonics, Usually considered
to be anything that refreshes. In different parts of the world
references are different. The inventor for this purpose uses the
word "LIQUID" to include all of the just mentioned and/or the like.
[1104] 38. The use of coloring agents, flavorings, and/or the like,
simultaneously with hydration. It may also be desired and/or
advantageous/useful to add colors: [1105] a. To denote
grade/strength of one or more ingredients so as to be can be
identified at a glance. [1106] b. To denote product content [1107]
c. For decoration color can be use to attract and/or enhance
desirability. [1108] d. Color may be functional/nutritive. Those
colorings with nutritive values include but are not limited to
colorings from pumpkin, cacti, lycopene from tomatoes, berries, and
cartinoids from the fruit of red pepper. [1109] e. It is also the
object of the invention to use colors of food grade quality so that
when the drink is spilled, the color is not permanent. It has been
possible to do this with most colors up until now with the
exception of green. U.S. Pat. No. 5,993,880 to Frost, et al.,
issued Nov. 30, 1999 (Kraft Foods Inc.) presents a new form of
green color prepared by specially treating copper chlorophyllin.
Other colorings of unique value and nutritional value with sound
scientific evidence shall be sought and included in the inventive
compositions. [1110] 39. It is the objective of this invention
simultaneously with hydration to incorporate Imbibing and
Reconstituting Objectives [1111] a. It is also a feature of the
invention that it can also be used to add the compositions to food.
For example, any packaged food and/or beverage can be reconstituted
so as to yield an enhanced food and/or beverage with additional
elements as herein described. [1112] i. This means that (and in
certain instances to those knowledgeable in the art, as might be
with encapsulations) extreme heating is not advisable/possible but
it is foreseeable in many instances that if the enhanced
fiber-water is used these foods will also become enhanced. [1113]
ii. If dried or concentrated fruits, vegetables, etc. are soaked in
the product, they will become imbibed, as well as softened, and
ergo more digestible due to the absorption of liquid. [1114] iii.
Fiber and the specific added enrichments to the liquid can readily
be added to all types of packaged food including gelatin products
and to canned concentrated foods such as soups (mainly those not
requiring heat). [1115] iv. In addition, the liquid can be frozen
to provide enriched healthy ice cubes, crushed ice, pops, etc.
[1116] 40. An object of the invention is to prevent a diagnostic
fiberwater simultaneously with hydration: Fiber-waters for
diagnosing for one or more conditions [1117] Fiber-water with
enhanced fortified substances that are delivered with hydration for
beneficial and/or diagnostic agents with the intent and/or designed
specifically for permitting such administration with or without
functional and/or decorative elements. The deliver of such may be
in the background liquid, the viscosity, the encapsulations or any
combination of the just said. They may be colored denoting use
and/or for decorative purposes and/or both. [1118] a. Diagnostics,
as teeth disclosure of plaque [1119] b. Radioactivity diagnostics
[1120] c. Diagnostic agents with health-enhancing component(s),
[1121] d. and/or a combination of one or more of the above with or
without colors, decorative elements and/or the like [1122] 41.
Objectives for specific conditions: [1123] a. Natural catastrophes
and emergencies are certainly a source of stress as are medical
problems. Numerous and varied medical conditions, both short term
and long term, may require feeding an individual through a tube.
The two types of tubes used most commonly are the naso-gastric tube
and the gastrostomy tube. In either case nutriment is supplied
directly into the stomach. The present inventor is a named inventor
on U.S. Pat. Nos. 4,315,513 and 4,393,873 for a percutaneous
transport tube with a one-way valve for gastric feeding, and is an
expert on the subject of conditions and problems related to tube
feeding. [1124] b. Great efforts have been made by major
corporations to provide balanced nutritional formulations for
specific medical conditions to be used for tube feeding. Depending
on the specific medical condition, the severity of the problem,
and/or a moment in time, multiple needs may be met including the
soluble fiber on which this invention is built. [1125] i. One of
the major short-comings of commercial premixed products is that
they do not readily contain enough fiber and/or other necessary
additives. There are continuing on going efforts to create
tube-feeding formulas that will address this problem. As an example
Novartis Nutrition has created IMPACT with Fiber. This product
contains 250 calories per 250-ml can and only 2.5-mg of fiber.
Also, liquid foods capable of passing through a tube are frequently
high in calories and low in fiber and other desired additives might
not be appropriate. [1126] (1) Fiber is important as has been said
because patients on tube feedings usually do not get the optimal
opportunity, nor amount of physical activities. Such activity is
important in stimulating proper functioning of the digestive tract.
Therefore one can certainly surmise the additional importance of
fiber in the diets of these individuals. The inventor also notes
that some patients may have a high requirement for fiber whereas
others do not. Therefore, one may administer excess calories in an
attempt to provide adequate fiber (and/or other ingredients).
[1127] (2) Depending on the design of the particular tube, it may
be expected that the viscosity of the feeding liquid may be a
problem, however encapsulations will not present a problem. The
inventor has demonstrated the 35 g of soluble fiber mixed with 2
ounces of safe water presents no problem in passing through the
aforementioned-patented tube. With the consideration that her
inventions possess a one-way valve it is far more difficult to use
a viscous product than with the conventional latex tubes which have
the additional options of using gravity flow techniques. [1128] (3)
Additionally, one must take into serious consideration the fact
that nasal-gastric fed patients are more sensitive to being fed
continuously, and/or more frequently by the tube. Problem also may
occur when the formulation is more viscous. This is especially true
in traumatized and overly sensitive patients. Extensive feedings
through these tubes may often irritate the throat. This has been
addressed and taken most seriously by the inventor. [1129] (4)
Whether it is for hospital, home, or travel like situations the
ultimate solution for tube fed patients is to supplement the
feeding regime with enriched fiber-water based products along with
and/or to replace plain pure water. [1130] (5) Fortified fiber
waters, as described herein, are: [1131] (a) Simple and accurate to
administer. [1132] (b) Perfect for designing an individual product
especially if they are packaged inn vials [1133] (c) The resulting
liquid can be used as a stand-alone product or mixed with a given
formula before delivering it to the patient as a single unit.
[1134] (d) Further, the liquid can be added to the tube line in
tandem with other supplementation (see U.S. Pat. No. 5,531,734 to
Geckle, et al., issued Jul. 2, 1996, Method of Altering Composition
of Nutritional Product During Enteral Tube Feeding, and U.S. Pat.
No. 5,533,973 to Piontek, et al., to Jul. 9, 1996, Alteration of
Nutritional Product During Enteral Tube Feeding). [1135] (e) The
inventor contemplates that the ingredients, other than the fiber
(and not just for tube feedings but for the general consumer
marketplace) may remain consistent/the same, but the grades and
blends of fiber change. This can be denoted by changes in the color
of the liquid and/or the packaging, markings, etc [1136] (f) It is
further contemplated that not only will color denote the strengths
and/or types of fiber and/or additives, but to note, that color has
often been denoted to coincide with flavor. Thus, to a tube fed
patient this addition of color might be pleasing, especially to a
child patient, and provide a distraction from an unpleasant
situation. Further, since these tubes are not always permanent, and
if the liquid colored or whatever liquid experience should mean to
the user accomplishes the designed intent, and is both convenient
and pleasant the inventor is hopeful that on going use of such
fluid will continue on a regular basis. The value of said fluid(s)
will be carried forward to promote good health for life. [1137] 42.
An object of the invention is to enhance the looks "appeal" of
drinking water for those who do not like to drink. While the fiber
is tasteless, and it tastes just like water some people find that
boring, ergo do not drink enough. It is possible then that, as with
the additives, the final product presents as fiberwater with
decorations. Festive looks such as ribbons, bubbles, dots,
recognizable shapes at random or arranged (licensing) and/or the
like are most appealing. The inventiveness is to decorate the
contents. [1138] a. One does not often think of "decorative" as an
additive of value but is considered to be most definitely here.
While container decorations and label decorations are to often
attract and, as an example, colored waters attract if they have no
other value added enhancements they are of value because the value
might be solely for the purpose of:
[1139] i. Attracting a consumer [1140] ii. Promoting a positive
image [1141] iii. Changing the perceptions of a consumer [1142] iv.
Promoting the "sale" [1143] v. Differentiating from the competition
etc. [1144] b. The inventor has conducted "look" studies with
mainly children using hand sanitizers and hair preparations, which
have bubble looking "identifiables", visuals" inside the bottle.
[1145] c. These look good objects may or may not have functions
beyond looks. [1146] d. Decorating liquids would be a proper
verbiage and visuals count. [1147] e. This invention includes any
indicia, or more than one, as in duplicating and/or as in more than
one representation, in the container, actives/nutritive and/or
decorative for brand recognition, advertising purposes, licensing,
cross promotions and/or the like. [1148] i. Most likely this would
be in a container whereby the indicia can be viewed through at
least one side. [1149] ii. If not viewable the when the liquid is
poured then it/they will become visible in the drinking container.
[1150] iii. Or both. [1151] 43. It is an object of the invention to
provide an adhesive system whereby any portion of the invention
(the liquid itself without the companion, the companion, or both)
that goes through the oral cavity may stick to the teeth, gums, or
any area of the aforementioned cavity and provide the continuous
release of one or more active ingredients that may work
independently and or in consort to medicate, nourish, support,
heal, and/or the like. The delivery system used adheres. [1152] a.
As an example it is possible to provide an anti-bacterial to remain
in the pockets of the gums, plaque remover to the teeth in such a
way that the "washing over the teeth" will provide ingredients and
delivery systems that will stick to the teeth and break down
plaque, or even tatter, over a protracted period of time. [1153] b.
As we develop more and more "good guy" organisms to fight the "bad
guy" organisms beginning their work in the oral cavity better
health will follow. [1154] c. Certainly this inventiveness can be
combined with oral disclosing of plaque, visually, as well as other
enhancements working in consort or independently. [1155] 44. An
object of the invention is to develop a fiber-water with the
aforementioned control factors, mainly encapsulations and viscosity
changes relating to those with hypoglycemia, acute and/or chronic
as a carbohydrate metabolic disorder and/or whatever the cause.
Fiber-Water for Hypoglycemics. [1156] a. Glucose, a form of sugar,
is the body's main fuel. Hypoglycemia, or low blood sugar, occurs
when blood levels of glucose drop too low to fuel the body's
activity. [1157] b. Carbohydrates (sugars and starches) are the
body's main dietary sources of glucose. During digestion, the
glucose is absorbed into the blood stream (hence the term "blood
sugar"), which carries it to every cell in the body. Unused glucose
is stored in the liver as glycogen. [1158] c. Hypoglycemia can
occur as a complication of diabetes, as a condition in itself, or
in association with other disorders. [1159] d. The normal range for
blood sugar is about 60 mg/dL (milligrams of glucose per deciliter
of blood) to 120 mg/dL, depending on when a person last ate. In the
fasting state, blood sugar can occasionally fall below 60 mg/dL and
even to below 50 mg/dL and not indicate a serious abnormality or
disease. This can be seen in healthy women, particularly after
prolonged fasting. Blood sugar levels below 45 mg/dL are almost
always associated with a serious abnormality. [1160] e. The amount
of glucose in the blood is controlled mainly by the hormones
insulin and glucagon. Too much or too little of these hormones can
cause blood sugar levels to fall too low (hypoglycemia) or rise too
high (hyperglycemia). Other hormones that influence blood sugar
levels are cortisol, growth hormone, and catecholamines
(epinephrine and norepinephrine). [1161] f. The pancreas, a gland
in the upper abdomen, produces insulin and glucagon. The pancreas
is dotted with hormone-producing tissue called the islets of
Langerhans, which contain alpha and beta cells. When blood sugar
rises after a meal, the beta cells release insulin. The insulin
helps glucose enter body cells, lowering blood levels of glucose to
the normal range. When blood sugar drops too low, the alpha cells
secrete glucagon. This signals the liver to release stored glycogen
and change it back to glucose, raising blood sugar levels to the
normal range. Muscles also store glycogen that can be converted to
glucose. [1162] g. A person with hypoglycemia may feel weak,
drowsy, confused, hungry, and dizzy. Paleness, headache,
irritability, trembling, sweating, rapid heartbeat, and a cold,
clammy feeling are also signs of low blood sugar. In severe cases,
a person can lose consciousness and even lapse into a coma. [1163]
h. Hypoglycemia as related to diabetes [1164] i. The most common
cause of hypoglycemia is as a complication of diabetes. Diabetes
occurs when the body cannot use glucose for fuel because either the
pancreas is not able to make enough insulin or the insulin that is
available is not effective. As a result, glucose builds up in the
blood instead of getting into body cells. [1165] ii. The aim of
treatment in diabetes is to lower high blood sugar levels. To do
this, people with diabetes may use insulin or oral drugs, depending
on the type of diabetes they have or the severity of their
condition. Hypoglycemia occurs most often in people who use insulin
to lower their blood sugar. All people with type 1 diabetes and
some people with type 2 diabetes use insulin. People with type 2
diabetes who take oral drugs called sulfonylureas are also
vulnerable to low blood sugar episodes. [1166] iii. Conditions that
can lead to hypoglycemia in people with diabetes include taking too
much medication, missing or delaying a meal, eating too little food
for the amount of insulin taken, exercising too strenuously,
drinking too much alcohol, or any combination of these factors.
People who have diabetes often refer to hypoglycemia as an "insulin
reaction." [1167] iv. Managing Hypoglycemia in Diabetesis critical
and people with diabetes should consult their health care providers
for individual guidelines on target blood sugar ranges that are
best for them. The lowest safe blood sugar level for an individual
varies, depending on the person's age, medical condition, and
ability to sense hypoglycemic symptoms. A target range that is safe
for a young adult with no diabetes complications, for example, may
be too low for a young child or an older person who may have other
medical problems. [1168] v. Because they are attuned to the
symptoms, people with diabetes can usually recognize when their
blood sugar levels are dropping too low. They can treat the
condition quickly by eating or drinking something with sugar in it
such as candy, juice, or a non-diet soda. Taking glucose tablets or
gels (available in drug stores) is another convenient and quick way
to treat hypoglycemia. [1169] vi. People with type 1 diabetes are
most vulnerable to severe insulin reactions, which can cause loss
of consciousness. A few patients with long-standing
insulin-dependent diabetes may develop a condition known as
hypoglycemia unawareness, in which they have difficulty recognizing
the symptoms of low blood sugar. For emergency use in patients with
type I diabetes, physicians often prescribe an injectable form of
the hormone glucagon. A glucagon injection (given by another
person) quickly eases the symptoms of low blood sugar, releasing a
burst of glucose into the blood. [1170] vii. Emergency medical help
may be needed if the person does not recover in a few minutes after
treatment for hypoglycemia. A person suffering a severe insulin
reaction may be admitted to the hospital so that blood sugar can be
stabilized. [1171] viii. People with diabetes can reduce or prevent
episodes of hypoglycemia by monitoring their blood sugar levels
frequently and learning to recognize the symptoms of low blood
sugar and the situations that may trigger it. They should consult
their health care providers for advice about the best way to treat
low blood sugar. Friends and relatives should know about the
symptoms of hypoglycemia and how to treat it in case of emergency.
Hypoglycemia in people who do not have diabetes is far less common
than once believed. However, it can occur in some people under
certain conditions such as early pregnancy, prolonged fasting, and
long periods of strenuous exercise. People on beta-blocker
medications who exercise are at higher risk of hypoglycemia, and
aspirin can induce hypoglycemia in some children. Drinking alcohol
can cause blood sugar to drop in some sensitive individuals, and
hypoglycemia has been well documented in chronic alcoholics and
binge drinkers. [1172] i. To diagnose hypoglycemia in people who do
not have diabetes, the doctor looks for the following three
conditions: [1173] i. The patient complains of symptoms of
hypoglycemia [1174] ii. Blood glucose levels are measured while the
person is experiencing those symptoms and found to be 45 mg/dL or
less in a woman or 55 mg/dL or less in a man [1175] iii. The
symptoms are promptly relieved upon ingestion of sugar. [1176] j.
For many years, the oral glucose tolerance test (OGTT) was used to
diagnose hypoglycemia. Experts now realize that the OGTT can
actually trigger hypoglycemic symptoms in people with no signs of
the disorder. For a more accurate diagnosis, experts now recommend
that blood sugar be tested at the same time a person is
experiencing hypoglycemic symptoms. [1177] k. Reactive Hypoglycemia
[1178] i. A diagnosis of reactive hypoglycemia is considered only
after other possible causes of low blood sugar have been ruled out.
Reactive hypoglycemia with no known cause is a condition in which
the symptoms of low blood sugar appear 2 to 5 hours after eating
foods high in glucose. [1179] ii. Ten to 20 years ago, hypoglycemia
was a popular diagnosis. However, studies now show that this
condition is actually quite rare. In these studies, most patients
who experienced the symptoms of hypoglycemia after eating
glucose-rich foods consistently had normal levels of blood
sugar--above 60 mg/dL. Some researchers have suggested that some
people may be extra sensitive to the body's normal release of the
hormone epinephrine after a meal. [1180] iii. People with symptoms
of reactive hypoglycemia unrelated to other medical conditions or
problems are usually advised to follow a healthy eating plan. The
doctor or dietitian may suggest that such a person avoid foods high
in carbohydrates; eat small, frequent meals and snacks throughout
the day; exercise regularly; and eat a variety of foods, including
whole grains, vegetables, and fruits. [1181] l. Rare Causes of
Hypoglycemia [1182] i. Fasting hypoglycemia occurs when the stomach
is empty. It usually develops in the early morning when a person
awakens. As with other forms of hypoglycemia, the symptoms include
headache, lack of energy, and an inability to concentrate. Fasting
hypoglycemia may be caused by a variety of conditions such as
hereditary enzyme or hormone deficiencies, liver disease, and
insulin-producing tumors. [1183] ii. Hereditary Glycogen Storage
Disease [1184] (1) The treatment for all glycogen storage diseases
is aimed at prevention. Treatment needs to be started as soon as
the disorder is diagnosed. For GSD type 1a, diet is the cornerstone
of treatment. The brain can only use glucose for energy. To avoid
low blood sugar, it is therefore essential for the person to
constantly have a source of energy that their body can use. Since
it is impossible to be eating all the time, people with this type
of GSD usually: [1185] (a) have tube feedings while they sleep, or
[1186] (b) wake up in the night to take cornstarch, or [1187] (c)
take cornstarch between meals [1188] (i) Cornstarch takes a long
time for the body to break down and is therefore available as an
energy source during periods of fasting. [1189] (2) Untreated
glycogen storage disease type 1a can lead to: [1190] (a) Very low
blood sugar, which can be life-threatening [1191] (b) enlarged
liver [1192] (c) muscle wasting [1193] (d) high levels of
cholesterol [1194] (e) blood clotting problems [1195] (f)
susceptibility to infections [1196] (g) stunted growth [1197] (h)
bone problems (osteoporosis) [1198] (i) liver problems [1199] (3)
Kidney problems: People with GSD type 1a who are in good metabolic
control through diet management can prevent low blood sugar. They
also have fewer symptoms and long-term complications. [1200] iii.
In hereditary fructose intolerance, a disorder usually seen in
children, the body is unable to metabolize the natural sugar
fructose. [1201] (1) Giving glucose and eliminating fructose from
the diet treat attacks of hypoglycemia, marked by seizures,
vomiting, and unconsciousness. [1202] iv. Galactosemia, a rare
genetic disorder, hampers the body's ability to process the sugar
galactose. [1203] (1) An infant with this disorder may appear
normal at birth, but after a few days or weeks of drinking milk
(which contains galactose), the child may begin to vomit, lose
weight, and develop cataracts. [1204] (2) The liver may fail to
release stored glycogen into the blood, triggering hypoglycemia.
[1205] v. A deficiency of growth hormone causes increased
sensitivity to insulin. [1206] vi. This sensitivity occurs because
growth hormone opposes the action of insulin on muscle and fat
cells. [1207] (1) For this reason, children with growth hormone
deficiency sometimes suffer from hypoglycemia, which goes away
after treatment. [1208] m. After citing the above information it is
noted that, by the action of the fiber(s) and with the proper
ratio, along with the features of the invention one is hopeful that
many of the symptoms of hypoglycemia may be reduced and/or
ameliorated. [1209] n. Further adding medication and the
controlling of the release of the active ingredients enhance the
invention. [1210] o. It is to be again noted that many people do
not take medication at all, miss doses, and look for excuses. It is
necessary to drink water everyday to live. So it then becomes a
very unique and sophisticated delivery system. [1211] 45. An object
of the invention is to look at a "more than one delivery" system
and/or vehicle working in consort for the desired outcome/result.
[1212] a. Covered thoroughly in this invention is the basic fact
that water, in U.S. Pat. No. 6,248,390, to this inventor is the
delivery system for fiber and with enrichments being delivered
through viscosity changes, encapsulations, and or both there now
exists more than one delivery system within the container. [1213]
i. The delivery systems may also have by nature and or by employing
scientific technologies the ability to sustain and or control the
release of the significant ingredient(s).
[1214] b. It is to be considered, by this inventiveness, that
additional delivery systems be offered which will work in consort
with the enhanced fiberwater, and/or realistically with any
container of liquid (even soup and/or soup like) that has a
designated purpose . . . even water to hydrate . . . which are not
in the container. [1215] i. A dual compartment container may be
used for this purpose whereby one part contains the fiberwater,
fiberwater enhanced with additives and/or the like [1216] (1) Two
or more compartments may exists in a companion to the liquid
container [1217] ii. They may be in the same form as in the
container (liquid or the like), or a different form (gel, dry form)
[1218] iii. The important factor here is to be able to deliver
bio-available ingredients/enhancements to the consumer whereby to
be effective/results obtained, the amount(s) of the active cannot
"fit" within the parameters of the drink. For an example to get the
significant ingredients one might have to take more than one drink
and that might not be practical and/or could even present
"negatives". This may employ [1219] (1) using the digestive system
(by mouth) [1220] (2) or without having to use the digestive
system, such delivery systems include but are not limited to:
[1221] (a) Trans-dermal (patch) [1222] (b) Trans-mucousal (patch)
[1223] (c) Sublingual [1224] (d) Topical; to be used on the skin
(ratioed to density of the skin along with particle size
appropriate to absorption) . . . in such form as a salve, a cream,
a lotion, and/or the like [1225] (i) As an example, an athlete who
presents out of doors, it is possible to present a sports drink
with amino acids (which may relieve fatigue as an example). The
amino acids may be part of the drink, or in a creme with or without
sun protection (SPF rating), which will serve to provide and/or
support one or more targets. [1226] (e) Rectal [1227] (f)
Injectable [1228] (g) Subcutanesous [1229] iv. Such additives are
not designed to go into or combined with the liquid, but are
presented in such fashion as to be taken with the liquid drink
and/or soup. [1230] (1) They may present in one or more of the
following forms . . . and taken, used, or both in consort with the
liquid. [1231] (a) Pill, capsule, tablet form to be swallowed with
the liquid [1232] (b) Gel, gu form and packaged as an example like
the well known, and well received, mustard, catsup, mayonnaise
packets to be taken with the liquid [1233] (c) Vials [1234] (d)
Packets in any other form than #2 above . . . these may present in
a candy like form, granules, liquid, lozenge, beads, and/or the
like which may or may not include another delivery system such as
encapsulations (regardless of size, shape, color, visible and or
non-visible) [1235] v. They may also have a relationship with the
liquid, regardless of form, that is time sensitive [1236] (1) This
is best described as a time frame exact, approximate, or both
whereby you have a prescribed interval as related to ingesting,
ingesting and using the companions [1237] vi. Likely situations
would include, but not be limited to, a metered portion of the
companion(s) to fiberwater (as the example), that would be packaged
in one of the following manners and sold [1238] (1) As a unit with
the product/container regardless of the packaging [1239] (2) Sold
separately in one or more units, which are targeting the same
function and/or varied functions. [1240] vii. Business models
[1241] (1) This section of inventiveness allows companies to
enhance the value of their existing products with out changing the
basis product, which presents a value to the consumer and
information to the marketer/producing company etc. [1242] (2) The
public is a giant feed back machine. Basically the public does not
buy, once and/or continuously, what they do not want. Or if tied
with a promotion or a bonus the feed back will sort out by the
obvious [1243] viii. This inventiveness serves as a vehicle to test
market new production technologies, methodologies, products, and/or
the like [1244] (1) As the just mentioned advances new
opportunities become available . . . new equipment as an example.
This will allow companies to put more additives inside the liquid.
What to put in will be important and if the company has feed back
as to what the public will select this is a valuable test-marketing
tool. (It is to be noted that the inventor's CIP to her PCT as
related to infusion packets/business models is used in the same way
and described in further detail). [1245] ix. This inventiveness
also works with this inventors vending and distribution models in
her CIP to her PCT Titled: Method of Hydration: Infusion Packet
System(s), Support Member(s) Delivery System(s) and Method(s); with
Business Model(s) and Method(s), whereby through vending, fast food
chains, restaurants, stadiums, concert halls, food and beverage
concessions, street carts, and/or the like the public directly has
the ability to acquire a companion product in one or more formats
to be used with the liquid. [1246] x. It is conceived that the
companion product be present in more than one chamber of the
packaging, with more than one exit portals to be opened
simultaneously or in consort.
[1247] Having presented extensive information thus far on the
benefits of adding ingredients to fiber-water with the novelties
herein invented, the inventor wishes that it be understood that we
can make a difference by taking responsibility, and that
additionally and hopefully, in the future health problems may be
addressed more readily and effectively through safe products based
on sound and reputable science.
[1248] Companies, formulations, inventors must make a tremendous
responsibility for our health. Certainly one sees that the carrot,
the orange, the broccoli, etc. proudly stand on their own. But we
are designing, and promoting, "not occurring natural foods".
However we are delivering them through naturally occurring
water.
[1249] With that being said the inventor is hopeful that she may
humbly and graciously provide the next generation of liquids with
new and novel delivery systems and these will deliver the best
possible additives, ergo playing a most significant role in
designing the future, whereby the ingestion of the components of
this invention and the ingredients they deliver through water . . .
that one essentially needed element to live, on a daily basis will
ameliorate, delay, make more livable, or altogether prevent, many
health challenges. Live longer and live healthier . . .
[1250] In addition to the equivalents of the claimed elements,
obvious substitutions now or later known to one with ordinary skill
in the art are defined to be within the scope of die defined
elements. The claims are thus to be understood to include what is
specifically illustrated and described above, what is conceptually
equivalent, what can be obviously substituted and also what
essentially incorporates the essential idea of the invention. Those
skilled in the art will appreciate that various adaptations and
modifications of the just described preferred embodiment can be
configured without departing from the scope and spirit of the
invention. The illustrated embodiment has been set forth only for
the purposes of example and that should not be taken as limiting
the invention. Therefore, it is to be understood that, within the
scope of the appended claims, the invention may be practiced other
than as specifically described herein.
* * * * *
References