U.S. patent application number 12/355465 was filed with the patent office on 2009-05-14 for packaged satiety enhancing composition.
Invention is credited to Alan R. Hirsch.
Application Number | 20090123524 12/355465 |
Document ID | / |
Family ID | 27668684 |
Filed Date | 2009-05-14 |
United States Patent
Application |
20090123524 |
Kind Code |
A1 |
Hirsch; Alan R. |
May 14, 2009 |
PACKAGED SATIETY ENHANCING COMPOSITION
Abstract
Compositions for enhancing satiety and weight loss in an
individual, assays for assessing a tastant for enhancing satiety
and weight loss, and methods of using the composition to suppress
appetite and enhance weight loss are provided.
Inventors: |
Hirsch; Alan R.;
(Riverwoods, IL) |
Correspondence
Address: |
BRYAN CAVE, LLP
211 N. BROADWAY, SUITE 3600
ST. LOUIS
MO
63102
US
|
Family ID: |
27668684 |
Appl. No.: |
12/355465 |
Filed: |
January 16, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10306198 |
Nov 27, 2002 |
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12355465 |
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60334401 |
Nov 30, 2001 |
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Current U.S.
Class: |
424/439 |
Current CPC
Class: |
A61P 3/04 20180101; A23L
33/30 20160801; A23L 33/20 20160801; Y10S 514/909 20130101; Y10S
435/81 20130101 |
Class at
Publication: |
424/439 |
International
Class: |
A61K 9/16 20060101
A61K009/16; A61P 3/04 20060101 A61P003/04 |
Claims
1. An article of manufacture, comprising a unit amount of a satiety
enhancing composition contained within a packaging material, the
satiety enhancing composition comprising a tastant and a carrier,
the composition being in the form of a free-flowing powder or
granules that can be sprinkled onto a foodstuff, the packaging
material including instructions to sprinkle the composition on the
food to enhance satiety or suppress appetite, the unit amount of
the satiety enhancing composition being a one-day or one-month
supply of the composition when used as instructed.
2. The article of claim 1 wherein the carrier is selected from the
group consisting of maltodextrin, dextrin, starch, methylcellulose,
sodium carboxymethylcellulose, and lactose.
3. The article of claim 1 wherein the person is instructed to
sprinkle a composition comprising a tastant having a sweet flavor
quality onto primarily sweet foods.
4. The article of claim 1 wherein the person is instructed to
sprinkle a satiety enhancing composition comprising a tastant
having a salty flavor quality onto primarily salty foods.
5. The article of claim 3 wherein the tastant is a sweet tastant
selected from the group consisting of almond (benzaldehyde), anise,
carob, cinnamon, cocoa (natural cocoa nibs), malt, peanut
(roasted), pecan, pistachio (natural), peppermint, spearmint, fruit
tastants, and combinations thereof.
6. The article of claim 4 wherein the tastant is a salty tastant
selected from the group consisting of artichoke, asparagus,
avocado, basil, broccoli, celery seed, cucumber, fennel, garlic,
horseradish, mushroom, mustard (seed), onion, parmesan, pizza,
ranch, spinach, taco, white cheese, yellow cheese, and combinations
thereof.
7. The article of claim 1 wherein the unit amount is a one-day
supply when used as instructed.
8. The article of claim 1 wherein the unit amount is a one-month
supply when used as instructed.
9. The article of claim 2 wherein the unit amount is a one-day
supply when used as instructed.
10. The article of claim 2 wherein the unit amount is a one-month
supply when used as instructed.
11. The article of claim 3 wherein the unit amount is a one-day
supply when used as instructed.
12. The article of claim 3 wherein the unit amount is a one-month
supply when used as instructed.
13. The article of claim 4 wherein the unit amount is a one-day
supply when used as instructed.
14. The article of claim 4 wherein the unit amount is a one-month
supply when used as instructed.
15. The article of claim 5 wherein the unit amount is a one-day
supply when used as instructed.
16. The article of claim 5 wherein the unit amount is a one-month
supply when used as instructed.
17. The article of claim 6 wherein the unit amount is a one-day
supply when used as instructed.
18. The article of claim 6 wherein the unit amount is a one-month
supply when used as instructed.
19. An article of manufacture comprising a set of two individually
packaged satiety enhancing compositions, the article comprising a
unit amount of each of the two compositions, one of the
compositions comprising a primarily sweet tastant and a carrier,
the other of the two compositions comprising a primarily salty
tastant and a carrier.
20. The article of claim 19 wherein each of the compositions is in
the form of a free-flowing powder or granules.
21. The article of claim 20 wherein the carrier is selected from
the group consisting of maltodextrin, dextrin, starch,
methylcellulose, sodium carboxymethylcellulose, and lactose.
22. The article of claim 19 wherein the primarily sweet tastant is
selected from the group consisting of almond (benzaldehyde), anise,
carob, cinnamon, cocoa (natural cocoa nibs), malt, peanut
(roasted), pecan, pistachio (natural), peppermint, spearmint, fruit
tastants, and combinations thereof.
23. The article of claim 19 wherein the primarily salty tastant is
selected from the group consisting of artichoke, asparagus,
avocado, basil, broccoli, celery seed, cucumber, fennel, garlic,
horseradish, mushroom, mustard (seed), onion, parmesan, pizza,
ranch, spinach, taco, white cheese, yellow cheese, and combinations
thereof.
24. The article of claim 20 wherein the primarily sweet tastant is
selected from the group consisting of almond (benzaldehyde), anise,
carob, cinnamon, cocoa (natural cocoa nibs), malt, peanut
(roasted), pecan, pistachio (natural), peppermint, spearmint, fruit
tastants, and combinations thereof.
25. The article of claim 20 wherein the primarily salty tastant is
selected from the group consisting of artichoke, asparagus,
avocado, basil, broccoli, celery seed, cucumber, fennel, garlic,
horseradish, mushroom, mustard (seed), onion, parmesan, pizza,
ranch, spinach, taco, white cheese, yellow cheese, and combinations
thereof.
26. The article of claim 21 wherein the primarily sweet tastant is
selected from the group consisting of almond (benzaldehyde), anise,
carob, cinnamon, cocoa (natural cocoa nibs), malt, peanut
(roasted), pecan, pistachio (natural), peppermint, spearmint, fruit
tastants, and combinations thereof.
27. The article of claim 21 wherein the primarily salty tastant is
selected from the group consisting of artichoke, asparagus,
avocado, basil, broccoli, celery seed, cucumber, fennel, garlic,
horseradish, mushroom, mustard (seed), onion, parmesan, pizza,
ranch, spinach, taco, white cheese, yellow cheese, and combinations
thereof
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of U.S. patent application
Ser. No. 10/306,198, filed Aug. 7, 2003, which claims the benefit
of U.S. Provisional Application Ser. No. 60/334,401, filed Nov. 30,
2001.
FIELD OF THE INVENTION
[0002] The present invention relates generally to appetite
suppression and weight loss, and more particularly to a composition
that enhances satiety during a meal and methods of using the
composition to achieve body weight loss.
BACKGROUND OF THE INVENTION
[0003] With a third to a quarter of the American population
overweight, obesity is rampant in contemporary society. At any
given time, 40% of women and 24% of men are trying to lose weight
and of these, 84% of women and 76-78% of men are dieting for this
purpose. In the USA, losing weight has become a national obsession.
Over 30 billion dollars are spent each year devising a plethora of
new diets and methods for losing weight, none of which have been
demonstrated to be effective over a long term (2 years).
[0004] Obesity is one of the most pervasive health problems in our
society. The physical and psychological consequences have an impact
on the afflicted in countless ways.
[0005] Almost all overweight people suffer derision and ridicule,
but the worst prejudice is reserved for and directed towards obese
women. We need only look at television commentators, politicians,
and other public life to realize that overweight men do not
experience the same degree of discrimination that obese women
suffer.
[0006] States of hunger and satiety are known to be of crucial
importance in the regulation of weight, and the perception of
hunger is multivariate; environmental stimuli, psychological
substrate, and internal physiology all contribute a share. Everyday
experiences attest to the influence of ambient aromas on our
appetites; we salivate at the smell of freshly baked cookies and
feel nauseated at a whiff of sewer gas. When we are hungry, foods
smell better and therefore, taste better. Conversely, olfactory
ability wanes when we are satiated, lessening the hedonics of
further ingestion.
[0007] Anatomic connections of the olfactory bulb to the
ventromedial nucleus of the hypothalamus, the satiety center,
authenticate these observations, as does the presence of
cholecystokinin, a gastic satiety factor, as a neurotransmitter in
the olfactory bulb. The fact that patients with acute anosmia often
gain weight suggests that a failure of the olfactory-satiety
feedback mechanism may be involved.
[0008] In a study to assess the effect on inhalation of certain
aromas upon weight control, overweight subjects were given an
inhaler containing a blend of odorants and instructed to inhale
three times in each nostril whenever feeling hungry. New inhalers
containing a new blend of odorants were supplied each month over a
period of six months. Data indicated that those subjects with
normal olfactory abilities and who inhaled certain odorants, used
their inhalers frequently, ate two to four meals a day, felt bad
about overeating but not about themselves, lost nearly five pounds
or two percent of body weight per month over the six-month
period.
[0009] This procedure has several drawbacks including the need and
inconvenience of using an inhaler prior to a meal to inhale the
odorants, the conspicuous nature of the inhaler, and the need to
carry the inhaler around.
[0010] Therefore, it would be desirable to provide a more effective
and convenient appetite suppression technique.
SUMMARY OF THE INVENTION
[0011] The present invention relates to a composition for enhancing
satiety, assays for assessing a tastant for enhancing satiety, and
methods of using the composition to suppress appetite.
[0012] The invention is based, in part, on the discovery of a
specific role for tastant substances in appetite suppression and
body weight loss.
[0013] In one aspect, the invention provides a satiety enhancing
composition. The composition comprises a tastant, which when
applied to or admixed with food, is effective to enhance satiety
(i.e., feeling of fullness), resulting in reduced food (caloric)
intake during the meal. The satiety enhancing composition is
preferably a dry, free-flowing powder form that can be sprinkled
onto a foodstuff to be consumed. In one embodiment, the satiety
enhancing composition comprises a primarily sweet tastant. In
another embodiment, the composition comprises a primarily salty
tastant. The tastant type is preferably used in conjunction with
foodstuffs most appropriate to that taste type.
[0014] In another embodiment, the satiety enhancing composition
comprises an amount of at least one tastant in combination with a
carrier, and optionally with an anti-caking agent, a coloring
agent, or both, which amount is effective to effect an average
weight loss of about 0.5 lb. or more per month over an about
6-month period, when the composition is applied to and ingested
with a foodstuff on a daily basis over the about 6-month
period.
[0015] In another aspect, the invention may provide a method of
enhancing satiety and suppressing appetite. In one embodiment, the
method comprises applying a satiety enhancing composition to a
foodstuff, the composition comprising an amount of a tastant which,
when applied to a foodstuff and ingested, is effective to reduce
caloric intake during a meal; and administering the food to a
person for ingestion. In another embodiment, the method comprises
selecting a satiety enhancing composition comprising a tastant;
applying the satiety enhancing composition to a foodstuff; and
administering the foodstuff to an individual for ingestion. In yet
another embodiment, a method for controlling appetite in an
individual includes selecting a tastant based on a foodstuff to be
ingested and effectiveness of the tastant to enhance satiety;
preparing a satiety enhancing composition comprising an amount of
the tastant effective to reduce appetite when applied to and
ingested with a foodstuff; applying an effective amount of the
satiety enhancing composition to the foodstuff; and administering
the foodstuff to a subject for ingestion, wherein the intake of
food by the subject is reduced.
[0016] In another embodiment, a method for promoting weight loss in
a person involves applying a satiety enhancing composition to a
food to be ingested, the amount of tastant in the composition
effective to cause a reduction in the intake of food by the person;
and administering the food to the person for ingestion. The effect
of the satiety enhancing composition can be measured, for example,
by a reduction in body weight over a set time period, for example a
1-month period. Preferably, the application of the satiety
enhancing composition to foodstuffs on a daily basis will effect a
body weight loss of at least about 0.5 pound (lb.) per month,
preferably at least about 1 lb. per month, preferably at least
about 3 lbs. per month, to up to about 5 lbs. per month, preferably
up to about 10 lbs. per month, preferably up to about 15 lbs. per
month, and preferably about 5 lbs. to up to about 20 lbs. over an
initial 6-month period, preferably up to about 25 lbs., preferably
up to about 35 lbs.
[0017] In yet another embodiment, a method of promoting weight loss
according to the invention involves combining an effective amount
of a satiety enhancing composition with substantially each food
portion to be consumed, on a daily basis over a one-month period,
the composition comprising either a primarily sweet tastant or a
primarily salty tastant as appropriate to the food type, and
preferably, the same two tastant compositions being used over the
month period, to effect a monthly weight loss of at least about 0.5
lb. to up to about 15 lbs. and, optionally, continuing such
application of a satiety enhancing composition to substantially
each food portion to be consumed over consecutive one-month periods
for up to 6-months or longer to effect an about 5 lb. to an about
35 lb. weight loss over an about 6-month period, wherein the two
compositions (i.e., comprising a primarily salty tastant or
primarily sweet tastant) utilized during a subsequent one-month
period comprise different tastants than the two compositions
utilized in the preceding one-month period.
[0018] In another aspect, the invention provides a foodstuff
comprising a food combined with a satiety enhancing composition
according to the invention. In one embodiment, the foodstuff
comprises an admixture of a primarily sweet food, and an amount of
a satiety enhancing composition comprising a primarily sweet
tastant effective to enhance satiety and/or suppress appetite
resulting in reduced food intake upon ingestion of the foodstuff.
In another embodiment, the foodstuff comprises an admixture of a
primarily salty food and an effective amount of a satiety enhancing
composition comprising an effective amount of a primarily salty
tastant.
[0019] In yet another aspect, the invention provides a method for
assaying tastants for a satiety enhancing effect and appetite
suppression, or weight loss enhancing effect, when applied to or
admixed with a foodstuff and ingested. In one embodiment, the assay
method comprises selecting a tastant; formulating a composition
consisting essentially of the tastant, a carrier, and optionally an
anti-caking agent, a coloring agent, or both; applying an amount of
the composition to a foodstuff; administering the foodstuff to the
individual for ingestion; and assessing the effectiveness of the
composition to reduce caloric intake during meals as measured, for
example, by a reduction in body weight.
[0020] In another embodiment, a method of assaying a tastant for
effecting weight loss of an individual, comprises the steps of:
selecting a tastant based on a food to be ingested, the tastant
selected from the group consisting of a primarily salty tastant or
a primarily sweet tastant; formulating a composition consisting
essentially of the tastant, a carrier, and optionally an
anti-caking agent, a coloring agent, or both; combining the
composition with each food to be ingested by an individual to form
a foodstuff; wherein a composition comprising a primarily salty
tastant is combined with a primarily salty food, and a composition
comprising a primarily sweet tastant is combined with a primarily
sweet food; administering each of said foodstuffs to the individual
for ingestion; repeating the combining and administering steps on a
daily basis for an at least one month period; and assessing the
effectiveness of the composition to effect weight loss according to
a change in weight of the individual. A preferred tastant is one
that effects an average weight loss of about 0.5 lb. or more per
month over an about 6-month period.
[0021] In another aspect, the invention provides an article of
manufacture. In one embodiment, the article of manufacture
comprises a unit amount of the satiety enhancing composition
according to the invention contained within a packaging material,
optionally with instructions for the use of the composition to
enhance weight loss, or enhance satiety or suppress appetite for a
resultant body weight loss, for example.
DETAIL DESCRIPTION OF THE INVENTION
[0022] In the current application, the term "tastant" is generally
understood to include substances having a flavor quality (i.e.,
salty, sweet, sour, bitter) combined with an aromatic quality. All
percentages are by weight based on the total composition, unless
otherwise indicated.
[0023] The satiety enhancing composition of the invention can be
formulated with one or more "sweet" tastants that impart a sweet
taste, or one or more "salty" tastants that impart a salty or
non-sweet taste. Examples of sweet tastants that can be used to
achieve the benefits of the invention include almond
(benzaldehyde), anise, carob, cinnamon, cocoa (natural cocoa nibs),
malt, peanut (roasted), pecan, pistachio (natural), peppermint,
spearmint, and fruit type tastants including apple (natural apple),
banana, fig, kiwi, orange (sweet orange peel) peach, raisin,
raspberry and strawberry, and the like, and mixtures or blends
thereof. Examples of salty tastants that can be utilized according
to the invention include artichoke, asparagus, avocado, basil,
broccoli, celery seed, cucumber, fennel, garlic, horseradish,
mushroom, mustard (seed), onion, parmesan, pizza, ranch, spinach,
taco, white cheese (e.g., Romano), yellow cheese (e.g., cheddar),
and the like, and mixtures or blends thereof.
[0024] The tastant can be a naturally-derived material or
synthetically produced, according to methods known and used in the
art. The tastant can be derived from concentrating the flavor
components (extracts) of naturally occurring plants and herbs, and
parts thereof. For example, the tastant can be extracted with a
solvent (e.g., an alcohol/water mixture), and the extractant dried
by spray drying or evaporation. The tastant can comprise a blend of
natural or synthetic flavors.
[0025] Examples of formulations for the composition include
crystalline, microcrystalline, particles, granules, powder,
spray-dried, lyophilized, and the like, forms that will admix with
a foodstuff to which it is applied, and dissolve or undergo
disintegration or dissolution in the presence of fluids in the
mouth, stomach and/or intestine. Preferably, the composition is in
the form of a free-flowing powder or granules, and contains less
than about 5 wt-% of moisture. The composition can also be in the
form of an oil which is sprayed onto a carrier such as magnesium
carbonate.
[0026] In a preferred form, the satiety enhancing composition is a
powder or granular mixture of the tastant and a suitable finely
divided solid (powder, granules) base or carrier, which is odorless
and tasteless, compatible with other ingredients of the
formulation, and not harmful to the recipient. Examples of such
carriers include maltodextrin, dextrin, starch, methylcellulose,
sodium carboxymethylcellulose, lactose, and the like, with
maltodextrin being preferred.
[0027] The composition can further include an anti-caking agent
such as tricalcium phosphate, and silicon dioxide (e.g., Flo-Gard
AB silica), preferably in an amount of up to 2% by weight, based on
the total weight of the composition. A compatible colorant and
suitable for food (e.g., FD&C dyes) such as FD&C Yellow #5
(Alum Lake 24-28%) and carmine (Alum Lake based on carminic acid),
can also be added, preferably in an amount of about 0.5% by weight
or less, based on the total weight of the composition.
[0028] Other additives and adjuvants that can be included in the
composition include effective but minor amounts of preservatives
such as ascorbic acid and sodium ascorbate; and anti-microbial
agents such as sodium benzoate, potassium benzoate, potassium
sorbate, parabens, and the like.
[0029] The satiety enhancing composition can be prepared by dry
mixing a solid form (e.g., powder or granules) of the tastant with
a finely divided solid carrier, and optional ingredients as
desired. The components of the composition can be admixed as is
known in the art and formulated according to standard procedures.
Preferably, each of the components of the composition is a FDA-GRAS
approved food additive.
[0030] The satiety enhancing composition generally comprises the
tastant in an amount of about 50% by weight up to about 99.98% by
weight, based on the total weight of the composition. Typically,
the tastant is included in an amount of about 50% to about 60% by
weight, with the balance being a carrier and, optionally as
desired, minor but effective amounts of an anti-caking agent and/or
coloring agent. The amount of the tastant in the composition
depends, at least in part, on the form of the tastant, and the
strength of the desired taste, and the hedonic quality of the
tastant. The composition generally comprises 0 to up to 0.5% by
weight coloring agent, typically about 0.01% to about 0.03% by
weight when included, and 0 to up to about 2% by of an anti-caking
agent, typically about 0.5% to about 1% by weight when included,
and about 40% to about 50% by weight carrier, based on the total
weight of the composition. An exemplary satiety-enhancing
composition comprises about 50% to about 60% by weight tastant (dry
powder form), about 40% to about 50% by weight maltodextrin
(granulated), 0 to about 1% by weight tricalcium phosphate, and 0
to about 0.03% by weight colorant, based on the total weight of the
composition.
[0031] The satiety enhancing composition can be conveniently
provided in discrete packaged amounts, for example, an amount to be
used in a daily intake of food, or over a 1-month period of time.
For example, the composition can be packaged as a powder form in
hard or soft gelatin capsules, cartridges, blister packages,
envelopes, tubes, vials, ampoules, bottles, lidded cylinders, a
shaker-type container with holes for dispensing the composition,
among other containers.
[0032] The amount of the tastant in a composition required for use
in enhancing satiety may be varied or adjusted according to the
particular application, the potency of the tastant selected, and
the taste and olfactory threshold of the individual. An amount of
the composition applied to each portion of food to be ingested in a
day is effective in diminishing appetite and enhancing satiation,
resulting in reduced calorie intake during the meal, as evidenced
by body weight loss over a set time period. In general, a
sufficient amount of the composition to provide the benefits of the
invention for an average adult human is in an amount of about 1/16
tsp. to about 1 tsp. or more, typically about 1/16 tsp. up to about
1/2 tsp., per about 8 oz. of food (wet or dry weight), depending on
the particular application. On average, an adult person consumes up
to about 20 meals or snacks per day, and the composition is
preferably applied to each food portion that is eaten on a daily
basis. The upper amount of the composition that is added to the a
food portion is generally limited by the taste preference and
tolerance of the individual.
[0033] In use, a satiety enhancing composition comprising a tastant
most appropriate to the taste type of the foodstuff (i.e., sweet or
salty) is applied to (e.g., sprinkled onto), and optionally admixed
with, the foodstuff, which is then consumed. Either a composition
comprising a primarily salty tastant or tastant blend or a
composition comprising a primarily sweet tastant or tastant blend
can be used, depending on whether the foodstuff to be consumed is
classified as a primarily "sweet" food or "salty" (non-sweet) food.
The satiety enhancing composition is applied to or admixed with the
foodstuff in an amount effective to extend the satiation effect of
that foodstuff, and achieve appetite suppression and a reduction in
caloric intake.
[0034] Examples of primarily "sweet" edible foodstuffs include
sweet baked goods, cake, pudding, cookies, candy, pies, and the
like. Examples of primarily "salty" edible foodstuffs include
breads, baked goods, meats, poultry, seafood, stews, casseroles or
baked dishes, potatoes, vegetables, cereal, potato chips, cheese
curls, pretzels, crackers, and the like.
[0035] The satiety enhancing composition taken orally with a
foodstuff results in the individual being satiated with a lower
caloric intake. The satiety enhancing composition can be used with
a weight loss program or diet to reduce appetite for food, and/or
as a weight loss maintenance system. Preferably, the ingestion of
the satiety enhancing composition with the foodstuff effectively
suppresses food intake by about 10% to about 30%, which can be
demonstrated by an associated body weight reduction over a set time
period, for example, a 1-month period or more, over which a weight
loss of about 0.5 lb. to up to about 5 lbs. or more per month can
occur, preferably about 1 lb. to up to about 10 lbs. or more per
month, preferably about 3 lbs. to about 15 lbs. per month, and up
to about 20 lbs. over a 6-month period, preferably up to about 25
lbs., preferably up to about 35 lbs. over a 6-month period.
[0036] In a preferred use of the satiety enhancing composition to
promote weight loss, a set of two satiety enhancing compositions
are utilized continuously over a one-month period, the first
comprising a primarily sweet tastant, and the second comprising a
primary salty tastant, and applied to each food item that is
consumed on a daily basis over the one-month period. Preferably,
the procedure is continued over consecutive months, preferably up
to at least about 6 months, utilizing a different set of two
compositions containing a different sweet tastant or salty tastant
than the preceding month. Preferably, such application of the
compositions results in a body weight loss of at least about 0.5
lb. per month, preferably at least about 1 lb. per month,
preferably at least about 3 lbs. per month, to up to about 5 lbs.
per month, preferably up to about 10 lbs. per month, preferably up
to about 15 lbs. per month, and about 5 lbs. to up to about 35 lbs.
over an about 6-month period. The same set of compositions is
preferably utilized over an entire month period. As such, a tastant
not traditionally used on a particular foodstuff can be applied.
For example, a peppermint tastant can be combined with a breakfast
cereal, or a horseradish tastant with pizza, etc.
[0037] The satiety enhancing composition can be provided as an
article of manufacture comprising a unit amount of the composition
contained within the packaging material, wherein the composition
comprises a tastant or blend of tastants in an amount effective to
enhance satiety or suppress appetite. The packaging material is
preferably a water impervious material. Exemplary packaging
materials include a box, cylinder, cartridge, vial, ampoule,
container with openings (covered) for dispensing the composition
(i.e., a shaker), bottle, tube, blister package, envelope, hard or
soft gelatin capsules, and the like. The packaging material
includes instruction means that indicate that the satiety enhancing
composition can be mixed with food and consumed to enhance satiety
or suppress appetite. Suitable instruction means include printed
labels, printed package inserts, tags, cassette tapes, CDs,
computer discs, and the like.
EXAMPLE 1
[0038] An open label study can be conducted as follows to assess
the effect of individual tastants to induce body weight loss of an
individual participant. An exemplary study group can include 15,000
adults based on the following criteria.
[0039] Inclusion/Exclusion Criteria
[0040] Inclusion criteria can be as follows: [0041] 1. Beyond ideal
weight and not obese (body mass index (BMI) less than or equal to
30 kg m.sup.2) (Mokdad et al., The continuing epidemics of obesity
and diabetes in the United States, JAMA 286:1195-1200 (2001)).
[0042] 2. Age 18-64 [0043] 3. Likes to eat between meals [0044] 4.
Does not exercise on a regular basis [0045] 5. Likes pickles or ice
cream (separately)
[0046] Exclusion criteria can be as follows: [0047] 1. Pregnancy
[0048] 2. Planning to become pregnant in the next 6 months. [0049]
3. Breast feeding [0050] 4. Perceived poor ability to taste [0051]
5. Uncontrolled hypertension, diabetes, or Sjorgren's syndrome
[0052] The following satiety enhancing composition can be
formulated with tastants in the amounts indicated.
TABLE-US-00001 TABLE 1 Composition Tastant % by weight Natural
Apple Flavor Blend natural apple flavor (Sensient)) 60 Roasted
Peanut Flavor natural and artificial peanut butter flavor, 60 Blend
powder (Gold Coast) natural peanut flavor (Sensient) 2 Raspberry
Burst Flavor natural and artificial raspberry flavor (Gold 50 Blend
Coast) Blended Cinnamon Flavor artificial cinnamon flavor, powder
(Flavor 50 Concepts) Pistachio Flavor Blend natural and artificial
pistachio flavor (Sensient) 60 Cool Spearmint Flavor natural and
artificial spearmint flavor (Gold 50 Blend Coast) Rich Cocoa Flavor
Blend natural cocoa nibs flavor, powder (Carmi 50 Flavor) Banana
Shake Flavor Blend natural and artificial banana flavor (Gold 50
Coast) Horseradish Kick Flavor natural horseradish powder
(SpiceTec-USF) 70 Blend Supreme Garlic Flavor natural garlic flavor
(Sensient) 60 Blend Sharp Cheddar Cheese natural and artificial
cheddar cheese flavor 60 Flavor Blend (Gold Coast) Romano Cheese
Flavor natural and artificial Romano cheese flavor 60 Blend (Gold
Coast) Yellow Onion Flavor onion powder 99.975 Sharp Cheddar Cheese
natural and artificial cheddar cheese flavor 50 (Gold Coast) Sweet
Apple Flavor natural apple flavor powder WONF (Carmi 65 Flavor)
[0053] Methodology
[0054] A demographic questionnaire that documents, for example,
age, race, sex, marital status, religion, employment status,
alcohol consumption, smoking habits, drug usage, food preferences,
eating habits, and so forth, can be completed by each
participant.
[0055] Tastants and other ingredients of the tastant compositions
are preferably FDA/GRAS approved. Compositions comprising an
individual tastant or blends of tastants can be packaged in
individual containers and labeled as either "salty" or "sweet", and
coded such that the identity of tastant (or blend) in the
composition is not revealed to the participant.
[0056] Each month, a participant can be given a one-month supply of
two different satiety enhancing compositions, one containing a
primarily sweet tastant (or blend thereof), and one containing a
primary salty tastant (or blend thereof). The participant can be
instructed to, each day, sprinkle an amount of the composition on
all food, similar to how she/he would use salt or sugar, using a
sweet tastant composition on primarily sweet foods, and a salty
tastant composition on primarily salty foods. Participants can be
told not to deviate from their usual diet and exercise habits. Two
new test compositions can be provided each month for a period of 6
months. On initiation, subjects can complete written questionnaires
regarding height and weight, hedonics (i.e., food preferences),
demographics, and outlook (self-perception). The participants can
be weighed monthly. Each month, two new tastant compositions can be
provided, a questionnaire on weight, hedonics and outlook can be
completed, and weight loss can be assessed as it relates to the
tastants being tested and hedonics for the tastants.
[0057] The particular tastant composition, and frequency of the use
of the compositions can be correlated with the amount of weight
loss. Data can be analyzed, for example, using Pearson Correlation
coefficients and I tests. Data can also be analyzed using Signed
Rank Test, Wilcoxin Rank Sum Test, and Spearman's Rank Correlation
Coefficient (T. Colton, Statistics in Medicine, Little Brown &
Co., Boston, Mass. (1974); E. L. Lehmann, Nonparametrics:
Statistical Methods Based on Ranks, Holden-Day, New York, N.Y.
(1975)).
[0058] The expected results are a reduction in body weight and
increase in self-esteem for the participant. In addition, the
effectiveness of the different tastants that are tested can be
assessed and rated.
EXAMPLE 2
[0059] An open label study was conducted according to the protocol
described in Example 1.
[0060] The Test Group included 92 adults: 73 females (79%) and 19
males (21%).
[0061] The Control group included 100 adults: 75 females (75%) and
25 males (25%).
[0062] Demographics. Each of the participants initially filled out
a questionnaire regarding age, race, height, weight, amount of
exercise per day and food preferences. The participants weighed
themselves, and their body mass index was determined.
[0063] For the Test Group participants, the age range was 18 to 64
years old, with an average of 48 years of age. Race was reported as
74 Caucasians (80%), 14 African Americans (15%), 2 Hispanic (2%),
and 2 "Other" (2%). The average amount of exercise per day was 15
minutes. The weight of the participants ranged from 130 to 348
pounds, with the average initial weight being 197 pounds. The body
mass index (BMI) of the participants ranged from 25 to 49, with the
average being a BMI of 31.
[0064] For the Control Group participants, the average initial
weight was 192 lbs. and the average body mass index (BMI) was
30.
[0065] Protocol. Each of the Test Group participants were provided
with two tastants compositions per month for a six month period, as
shown below in Table 2.
[0066] The Test Group participants were instructed to sprinkle an
amount of the tastant composition on all food each day, similar to
how she/he would use salt or sugar, using a sweet tastant
composition on primarily sweet foods, and a salty tastant
composition on primarily salty foods. The participants weighed
themselves monthly, and completed a questionnaire on hedonics of
the tastant compositions.
[0067] The Control Group participants did not ingest tastant
compositions with their food over the monitoring period.
TABLE-US-00002 TABLE 2 (Test Group) Weight Change (lbs) Salty Sweet
Average Average Month # Tastant Tastant Weight Change Range Initial
-- -- 197 -- -- 1 Cheddar Coca Flavor 193.7 -3.3 -7 to +5 Cheese
Flavor 2 Onion Flavor Spearmint 191.2 -2.5 -11 to +3 Flavor 3
Horseradish Banana 191.1 -0.1 -7 to +6 Flavor Flavor 4 Ranch
Strawberry 190.8 -0.3 -5 to +12 Flavor Flavor 5 Taco Flavor
Raspberry 191.4 +0.6 -6 to +9 Flavor 6 Parmesan Malt Flavor 191.4
-0.0 -1 to +1 Flavor Final 191.4 -5.6 (-2.8%) (-34 to +6)
[0068] Results. The monthly average weight loss of the Test Group
ranged from 0 lbs. (month 6) to -3.3 lbs. (month 1). The overall
6-month average weight change of the Test Group was a loss of -5.6
lbs., or an average weight loss of about -3%.
[0069] By comparison, the overall 6-month average weight change of
the Control Group was a gain of +1.1 lbs., or an average weight
gain of +0.6%.
[0070] This indicates an average overall improvement in the Test
Group of -6.7 lbs. (from -5.6 lbs. to +1.1 lbs.).
[0071] The Test Group also had an average -2.8% change in body mass
index (from an average BMI of 31 to 28.2), while the Control Group
showed substantially no change.
[0072] Discussion. The results show that tastants (flavorants) may
be used as a way of inducing weight loss in those attempting to
lose weight, and can be integrated into a comprehensive weight loss
program.
[0073] The invention has been described by reference to detailed
examples and methodologies. These examples are not meant to limit
the scope of the invention. It should be understood that variations
and modifications may be made while remaining within the spirit and
scope of the invention, and the invention is not to be construed as
limited to the specific embodiments disclosed. The disclosures of
references cited in the application are incorporated by reference
herein
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