U.S. patent application number 10/260993 was filed with the patent office on 2003-01-30 for soy formulations and their use for promoting health.
Invention is credited to Tabor, Aaron.
Application Number | 20030021859 10/260993 |
Document ID | / |
Family ID | 26786272 |
Filed Date | 2003-01-30 |
United States Patent
Application |
20030021859 |
Kind Code |
A1 |
Tabor, Aaron |
January 30, 2003 |
Soy formulations and their use for promoting health
Abstract
The present invention provides novel soy formulations comprising
3-23 milligrams of at least one isoflavone per gram of the
formulation. The soy formulations may additionally comprise 0.4 to
1.2 grams of protein per gram of the formulation. In another
aspect, the present invention provides novel soy formulations
comprising diadzin, genistin and glycitin in a ratio of 3:1:2 to
3:4.5:1, preferably approximately 2:1:1 such that diadzin is a
major isoflavone component. The present invention further provides
dietary supplements and food products comprising a soy formulation
of the present invention. In another aspect the present invention
provides pharmacological compositions comprising a soy formulation
of the present invention. The pharmacological compositions may
additionally comprise a medicinal composition. Also disclosed are
methods for promoting the health of an individual, preferably
utilizing the soy formulations, dietary supplements, food products
and/or pharmacological compositions of the present invention.
Inventors: |
Tabor, Aaron;
(Winston-Salem, NC) |
Correspondence
Address: |
Charles W. Calkins
Kilpatrick Stockton LLP
1001 West Fourth St.
Winston-Salem
NC
27101
US
|
Family ID: |
26786272 |
Appl. No.: |
10/260993 |
Filed: |
September 30, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10260993 |
Sep 30, 2002 |
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09356167 |
Jul 16, 1999 |
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6482448 |
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60092985 |
Jul 16, 1998 |
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60105797 |
Oct 27, 1998 |
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Current U.S.
Class: |
424/757 ; 514/27;
514/456 |
Current CPC
Class: |
A61K 31/47 20130101;
A23L 11/07 20160801; A23L 33/185 20160801; A23V 2002/00 20130101;
A61K 31/7048 20130101; A61K 31/47 20130101; A61K 31/7048 20130101;
A23V 2002/00 20130101; A23V 2002/00 20130101; A61K 31/35 20130101;
A23V 2250/1618 20130101; A61K 2300/00 20130101; A61K 2300/00
20130101; A61K 2300/00 20130101; A23V 2250/1614 20130101; A23V
2250/2116 20130101; A23V 2250/1578 20130101; A23V 2250/16 20130101;
A23V 2250/5488 20130101; A23V 2250/2116 20130101; A23V 2250/5488
20130101; A61K 2300/00 20130101; A61K 31/352 20130101; A61K 31/352
20130101; A23L 33/105 20160801; A61K 31/35 20130101; A23L 33/40
20160801 |
Class at
Publication: |
424/757 ; 514/27;
514/456 |
International
Class: |
A61K 035/78; A61K
031/7048; A61K 031/353 |
Claims
1. A natural soy formulation comprising 3 to 23 milligrams of at
least one isoflavone per gram of the formulation.
2. The natural soy formulation of claim 1 wherein the soy
formulation comprises 5 to 15 milligrams of at least one isoflavone
per gram of the formulation.
3. The natural soy formulation of claim 2 wherein the soy
formulation comprises 6 to 9 milligrams of at least one isoflavone
per gram of the formulation.
4. The natural soy formulation of claim 1 wherein the isoflavone
comprises diadzin.
5. The natural soy formulation of claim 4 wherein the soy
formulations comprises a plurality of isoflavones comprising
diadzin, genistin and glycitin.
6. The natural soy formulation of claim 5 wherein the diadzin to
genistin to glycitin ratio is between 3:1:2 and 3:4.5:1.
7. A natural soy formulation comprising isoflavones diadzin,
genistin and glycitin wherein the diadzin to genistin to glycitin
ratio is between 3:1:2 and 3:4.5:1.
8. The natural soy formulation of claim 7 wherein the diadzin to
genistin to glycitin ratio is approximately 2:1:1.
9. The natural soy formulation of claim 7 wherein the isoflavones
comprise their glycone forms.
10. The natural soy formulation of claim 7 wherein the isoflavones
comprise their aglycone forms.
11. A natural soy formulation comprising: 3 to 23 milligrams of at
least one isoflavone; and 0.4 to 1.2 grams protein; per gram of the
formulation.
12. The natural soy formulation of claim 11 wherein the soy
formulation comprises 5 to 15 milligrams of at least one isoflavone
per gram of the formulation.
13. The natural soy formulation of claim 12 wherein the soy
formulation comprises 6 to 9 milligrams of at least one isoflavone
per gram of the formulation.
14. The natural soy formulation of claim 11 wherein the soy
formulation comprises 0.4 to 0.9 grams protein per gram of the
formulation.
15. The natural soy formulation of claim 13 wherein the soy
formulation comprises 0.4 to 0.9 grams protein per gram of the
formulation.
16. The natural soy formulation of claim 11 wherein the isoflavone
comprises diadzin.
17. The natural soy formulation of claim 15 wherein the isoflavone
comprises diadzin.
18. The natural soy formulation of claim 15 wherein the soy
formulations comprises a plurality of isoflavones comprising
diadzin, genistin and glycitin.
19. The natural soy formulation of claim 18 wherein the diadzin to
genistin to glycitin ratio is between 3:1:2 and 3:4.5:1.
20. A natural soy formulation produced by combining a first portion
of higher isoflavone concentration soy product produced from the
heart of the soy bean and a second portion of lower isoflavone
concentration soy product produced from the whole soy bean to
achieve a soy formulation comprising 3 to 23 milligrams of at least
one isoflavone per gram of the formulation.
21. The natural soy formulation of claim 20 wherein the soy
formulation further comprises 0.4 to 1.2 grams protein per gram of
the formulation.
22. The natural soy formulation of claim 20 wherein the soy
formulation comprises 6 to 9 milligrams of at least one isoflavone
per gram of the formulation.
23. The natural soy formulation of claim 21 wherein the soy
formulation comprises 6 to 9 milligrams of at least one isoflavone
per gram of the formulation.
24. The natural soy formulation of claim 23 wherein the soy
formulation comprises 0.4 to 0.9 grams protein per gram of the
formulation.
25. A dietary supplement comprising the soy formulation of claim 1
wherein the amount of the soy formulation in the dietary supplement
is sufficient to provide greater than 60 milligrams of at least one
isoflavone per serving.
26. A dietary supplement comprising the soy formulation of claim 7
wherein the amount of the soy formulation in the dietary supplement
is sufficient to provide greater than 60 milligrams of at least one
isoflavone per serving.
27. A dietary supplement comprising the soy formulation of claim 11
wherein the amount of the soy formulation in the dietary supplement
is sufficient to provide greater than 60 milligrams of at least one
isoflavone per serving.
28. A food product comprising the soy formulation of claim 1
wherein the amount of the soy formulation in the food product is
sufficient to provide greater than 60 milligrams of at least one
isoflavone per serving.
29. A food product comprising the soy formulation of claim 7
wherein the amount of the soy formulation in the food product is
sufficient to provide greater than 60 milligrams of at least one
isoflavone per serving.
30. A food product comprising the soy formulation of claim 11
wherein the amount of the soy formulation in the food product is
sufficient to provide greater than 60 milligrams of at least one
isoflavone per serving.
31. A pharmcological composition comprising the soy formulation of
claim 1 wherein the amount of the soy formulation in the
pharmacological composition is sufficient to provide greater than
60 milligrams of at least one isoflavone per dose.
32. The pharmacological composition of claim 31 further comprising
a medicinal composition in an amount per dose sufficient to produce
a desired therapeutic effect.
33. The pharmacological composition of claim 32 wherein the
medicinal composition comprises: Premarin; Fosamax; Raloxifene;
Tamoxifen; or an SERM.
34. A pharmcological composition comprising the soy formulation of
claim 7 wherein the amount of the soy formulation in the
pharmacological composition is sufficient to provide greater than
60 milligrams of at least one isoflavone per dose.
35. The pharmacological composition of claim 34 further comprising
a medicinal composition in an amount per dose sufficient to produce
a desired therapeutic effect.
36. The pharmacological composition of claim 35 wherein the
medicinal composition comprises: Premarin; Fosamax; Raloxifene;
Tamoxifen; or an SERM.
37. A pharmcological composition comprising the soy formulation of
claim 11 wherein the amount of the soy formulation in the
pharmacological composition is sufficient to provide greater than
60 milligrams of at least one isoflavone per dose.
38. The pharmacological composition of claim 37 further comprising
a medicinal composition in an amount per dose sufficient to produce
a desired therapeutic effect.
39. The pharmacological composition of claim 38 wherein the
medicinal composition comprises: Premarin; Fosamax; Raloxifene;
Tamoxifen; or an SERM.
40. A method for promoting the health of an individual comprising
having the individual ingest greater than 60 milligrams of at least
one isoflavone per day.
41. The method of claim 40 wherein the method comprises having the
individual ingest 120 to 200 milligrams of at least one isoflavone
per day.
42. The method of claim 40 wherein the step of having the
individual ingest greater than 60 milligrams of at least one
isoflavone per day comprises having the individual ingest a soy
formulation of claim 1.
43. The method of claim 40 wherein the step of having the
individual ingest greater than 60 milligrams of at least one
isoflavone per day comprises having the individual ingest a soy
formulation of claim 7.
44. The method of claim 40 wherein the step of having the
individual ingest greater than 60 milligrams of at least one
isoflavone per day comprises having the individual ingest a soy
formulation of claim 11.
45. The method of claim 40 wherein the step of having the
individual ingest greater than 60 milligrams of at least one
isoflavone per day comprises having the individual ingest a
pharmacological composition of claim 32.
46. The method of claim 40 wherein the step of having the
individual ingest greater than 60 milligrams of at least one
isoflavone per day comprises having the individual ingest a
pharmacological composition of claim 35.
47. The method of claim 40 wherein the step of having the
individual ingest greater than 60 milligrams of at least one
isoflavone per day comprises having the individual ingest a
pharmacological composition of claim 38.
49. The method of claim 40 wherein the promoting of the health of
the individual comprises reducing menopausal like symptoms.
50. The method of claim 49 wherein the menopausal like symptoms
comprise hot flashes, vaginal itching, vaginal dryness,
irritability, insomnia, night sweats, headaches and/or mood
swings.
51. The method of claim 40 wherein the promoting of the health of
the individual comprises soothing menstrual problems.
52. The method of claim 40 wherein the promoting of the health of
the individual comprises decreasing fatigue.
53. The method of claim 40 wherein the promoting of the health of
the individual comprises reducing the effects of Alzheimer's type
dementia.
54. The method of claim 40 wherein the promoting of the health of
the individual comprises reducing the risk of breast cancer.
Description
STATEMENT OF RELATED APPLICATIONS
[0001] The present application claims priority from U.S.
provisional patent application serial No. 60/092,985, filed Jul.
16, 1998 and U.S. provisional patent application serial No.
60/105,797, filed Oct. 27, 1999. The disclosure of each provisional
application is hereby incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The present invention relates to soy formulations, dietary
supplements comprising the soy formulations and food products which
include the soy formulations and/or the dietary supplements. The
present invention also relates to pharmacological compositions
comprising the soy formulation that may additionally comprise a
medicinal composition. The present invention further relates to
processes for producing soy formulations. In addition, the present
invention relates to methods for promoting the health of an
individual utilizing the soy formulations, dietary supplements,
food products and/or pharmacological compositions of the present
invention.
BACKGROUND
[0003] Soybeans include natural plant estrogens, known as
phytoestrogens or isoflavones. These isoflavones are thought to
bind to estrogen receptors and thus exert an estrogenic response.
Medical studies have shown that isoflavones in soy protein have
many beneficial interactions with a variety of human tissues, are
safe, cause no significant side-effects, and are the primary reason
for many health benefits. Research has discovered in Asian
countries like Japan, where the traditional diet is high in soy
protein, very few women complain about menopausal symptoms, for
example only 9% of Japanese women complain about hot flashes. In
addition, younger women have fewer menstrual periods per year, and
occurrences of some cancers (breast and endometrial), heart
disease, and other chronic diseases are very low. It has been
reported that Japanese women consume up to 200 mg of isoflavones in
their daily diet and have a lower incidence of perimenstrual and
menopausal symptoms than women in other cultures consuming less
daily dietary isoflavones. Previous studies using isoflavone
dosages of 76 mg per day report a 45% reduction in hot flashes in
women after 12 weeks.
[0004] In addition to providing isoflavones, soybeans provide a
source of protein. It is believed that the benefits from soy come
from the phytoestrogens (isoflavones) other compounds such as
lignans and saponins, the soy protein itself and undoubtedly
undiscovered compounds.
[0005] Several soy protein formulations are commercially available.
Formulations produced exclusively from the whole soy bean generally
include 1-5 milligrams isoflavone per gram of the formulation and
may be up to 90% protein. Formulations produced exclusively from
the heart (center) of the soy bean generally include 24-36
milligram isoflavone per gram of the formulation. Although tablets
with concentrations of 100-750 milligram isoflavones per gram are
available, formulations having concentrations greater than 36 mg
isoflavones per gram of the formulation are chemically extracted
and modified and therefore are not considered natural.
[0006] Dietary levels of 60 milligrams, in particular 120-200
milligrams of isoflavones are difficult to achieve utilizing
currently available natural soy protein formulations. To achieve a
dietary level of greater than 60 milligrams, and in particular
120-200 milligrams of isoflavones from soy formulations produced
utilizing the whole soy bean could require ingesting greater than
60 grams, in particular up to 120-200 grams of soy protein. Intake
of soy protein at this volume level tends to cause digestive side
effects such as bloating and constipation. To achieve a dietary
level of greater than 60 milligrams, preferably 120-200 milligrams,
of isoflavones from soy formulations produced utilizing the heart
of the soy bean may require ingesting only 3 to 8 grams of soy
protein. However, with soy protein levels this low, the person
ingesting the formulation would be receiving minimal benefits and
nutritional value from soy protein itself.
[0007] Accordingly, it would be advantageous to have a natural soy
formulation having a milligram isoflavone to gram of the
formulation ratio falling between the ratios of natural soy
formulations produced from the whole soybean and natural soy
formulations produced from the heart of the soy bean.
[0008] It would also be advantageous to have dietary supplements
that include the natural soy formulations. In particular, it would
be advantageous to have dietary supplements which when ingested in
reasonable amounts provide dietary isoflavone levels of greater
than 60 milligrams, preferably greater than 120 milligrams, for
example 120-200 milligrams or higher, e.g. greater than 200
milligrams. For certain applications it may be advantageous to have
dietary supplements or soy formulations that provide dietary
isoflavone levels as high as 1500-2200 milligrams, or greater.
[0009] Further, it would be advantageous to have food products that
include the natural soy formulations and/or the natural dietary
supplements. In particular, it would also be advantageous to have
food products which when ingested in reasonable amounts provide
dietary isoflavone levels of greater than 60 milligrams, preferably
greater than 120 milligrams, for example 120-200 milligrams, or
higher, e.g. greater than 200 milligrams, up to 400-900 milligrams
or greater. For certain applications it may be advantageous to have
food products, dietary supplements or soy formulations that provide
dietary isoflavone levels as high as 1500-2200 milligrams, or
greater.
[0010] These and other advantages are achieved by the present
invention.
SUMMARY OF THE INVENTION
[0011] The present invention provides soy protein formulations (soy
formulations), dietary supplements and food products (including
medical foods) comprising the soy formulations and/or dietary
supplements. The present invention also provides pharmaceutical
compositions.
[0012] A soy formulation of the present invention includes a higher
concentration of natural plant estrogens, referred to as
isoflavones or phytoestrogens, per gram of the formulation, than
currently available in a natural product. The soy formulation may
further include protein, therefore providing a higher concentration
of isoflavones per gram of the formulation, and per gram of protein
in the formulation, than currently available in a natural
product.
[0013] The isoflavone component of the soy formulation of the
present invention may comprise naturally occurring isoflavones,
including, but not limited to: diadzin, genistin, and glycitin. In
another aspect, the present invention provides soy formulations
having diadzin as a major isoflavone component.
[0014] A dietary supplement of the present invention comprises a
soy formulation of the present invention. The dietary supplement
may further comprise ingredients such as enzymes, a fiber source,
vitamins and the like.
[0015] A food product of the present invention comprises a soy
formulation of the present invention and/or a dietary supplement of
the present invention. The food product may further comprise
additional ingredients.
[0016] A pharmaceutical composition of the present invention
comprises a soy formulation of the present invention in a
pharmacologically effective amount. The compositions may
additionally comprise prescription medicines. The combination may
advantageously produce one or more of the following effects:
[0017] 1) additive and/or synergistic benefits;
[0018] 2) reduction of the side effects and/or adverse effects
associated with use of the prescription medicine in the absence of
the soy formulation; and/or
[0019] 3) the ability to lower the dosage of the prescription
medicine in comparison to the amount of prescription medicine
needed in the absence of the soy formulation. Further advantages
and possible embodiments of a drug formulation of the present
invention are discussed in detail below.
[0020] The soy formulations, dietary supplements, food products
and/or pharmaceutical compositions of the present invention may
advantageously be utilized in methods for promoting the health of
an individual. The soy formulations, dietary supplements, food
products and pharmaceutical compositions of the present invention
may provide higher concentrations of isoflavones than currently
available soy products in a readily digestible and absorbable
form.
[0021] The soy formulations, dietary supplements, food products and
pharmaceutical compositions of the present invention may also
provide protein. The isoflavones and/or protein provided by the soy
formulations, dietary supplements, food products and pharmaceutical
compositions of the present invention may provide numerous health
benefits to an individual. In particular, the soy formulations,
dietary supplements, food products and pharmaceutical compositions
of the present invention may be ingested in amounts that provide
greater than 60 milligrams, and in certain embodiments greater than
200 milligrams, or greater than 1800 milligrams, and that may
additionally provide greater than 20 grams of protein, without the
unpleasant side effects individuals have experienced with prior
products.
[0022] Further details and advantages of the present invention are
provided in the following more detailed description.
DETAILED DESCRIPTION OF THE INVENTION
[0023] In one aspect, the present invention provides a soy
formulation which includes a higher concentration of natural plant
estrogens (referred to as isoflavones or phytoestrogens) per gram
of protein than previously available. A soy formulation of the
present invention comprises 3 to 23 milligrams of at least one
isoflavone per gram of the formulation. Preferably a soy
formulation of the present invention comprises 5 to 15 milligrams
of at least one isoflavone per gram of the formulation, more
preferably, 6-9 milligrams of at least one isoflavone per gram of
the formulation.
[0024] In this aspect, the present invention provides a natural soy
formulation comprising 3 to 23 milligrams of at least one
isoflavone per gram of the formulation. In embodiments of the
present invention the natural soy formulation may comprise 5 to 15
milligrams of at least one isoflavone per gram of the formulation,
or 6 to 9 milligrams of at least one isoflavone per gram of the
formulation.
[0025] The isoflavone component of the soy formulation of the
present invention preferably comprises naturally occurring
isoflavones, including, but not limited to: diadzin, genistin,
and/or glycitin.
[0026] In another aspect, the present invention provides a soy
formulation comprising diadzin, genistin and glycitin and having a
diadzin to genistin to glycitin ratio of between 3:1:2 and 3:4.5:1.
In other words, in this aspect the soy formulation comprises 3
parts diadzin; 1 to 4.5 parts genistin; and 1 to 2 parts glycitin.
Preferably a soy formulation of the present invention has a ratio
of diadzin to genistin to glycitin of near or approximately 2:1:1,
respectively, such that diadzin is the major isoflavone
component.
[0027] Although the isoflavones discussed herein are discussed with
reference to their glycone forms, the present invention may utilize
aglycone forms of isoflavones which may be digested and/or absorbed
more easily by an individual. The aglycone form refers to glycone
after cleavage of the glucose subgroup.
[0028] In a further aspect, the soy formulations of the present
invention comprise 0.4 to 1.2 grams, preferably 0.4 to 0.9 grams,
more preferably 0.6 to 0.8 grams of protein per gram of the
formulation. Thus, an embodiment of a soy formulation of the
present invention comprises:
[0029] 3 to 23 milligrams, preferably 5 to 15 milligrams, more
preferably, 6-9 milligrams of at least one isoflavone; and
[0030] 0.4 to 1.2 grams, preferably 0.4 to 0.9 grams, more
preferably 0.6 to 0.8 grams protein; per gram of the
formulation.
[0031] The soy formulation may further include a plurality of
isoflavones, including diadzin, genistin and glycitin. In an
embodiment the soy formulation has a diadzin to genistin to
glycitin ratio of between 3:1:2 and 3:4.5:1. More preferably the
soy formulation may have a ratio of diadzin to genistin to glycitin
of near or approximately 2:1:1, respectively, such that diadzin is
the major isoflavone component.
[0032] In yet a further aspect, the present invention provides a
soy formulation produced by combining a first portion of higher
isoflavone concentration soy product produced from the heart of the
soy bean and a second portion of lower isoflavone concentration soy
product produced from the whole soy bean to achieve a soy
formulation comprising 3 to 23 milligrams of at least one
isoflavone per gram of the formulation, preferably 5 to 15
milligrams of at least one isoflavone per gram of the formulation,
more preferably, 6-9 milligrams of at least one isoflavone per gram
of the formulation. The isoflavone(s) may comprise diadzin,
genistin and glycitin. The soy formulation thus obtained may
further comprise 0.4 to 1.2 grams, preferably 0.4 to 0.9 grams,
more preferably 0.6 to 0.8 grams protein; per gram of the
formulation. It is further preferred that the soy formulation
include the diadzin-genistin-glycitin ratios discussed above.
[0033] A soy formulation of the present invention may take many
forms. For example, the soy formulations of the present invention
may be in powder form. Alternatively, the soy formulations may be
in tablet or liquid form. In addition, the soy formulations of the
present invention may be included within a dietary supplement, or
within food items, such as nutrition bars, liquid drinks, cereals
etc., in a food product of the present invention.
[0034] The soy formulations of the present invention may be
utilized in dietary supplements. In one aspect, a dietary
supplement of the present invention comprises a soy formulation of
the present invention. The dietary supplement may comprise a soy
formulation having one or more of the features described above. The
amount of soy formulation utilized in a dietary supplement of the
present invention will depend on the level of isoflavones desired
per serving or dose of the dietary supplement. As further explained
below, it is generally desirable for the dietary supplement to
provide greater than 60 milligrams of at least one isoflavone per
serving or dose. Thus, for example, a serving of a dietary
supplement of the present invention could comprise 10 grams of a
soy formulation of the present invention comprising 7 milligrams of
at least one isoflavone per gram of the formulation, to provide 70
milligrams of isoflavones. To achieve higher levels of isoflavones,
the dietary supplement could include additional amounts of a soy
formulation and/or a soy formulation having a higher level of
isoflavones per gram.
[0035] Thus an embodiment of a dietary supplement comprises: a soy
formulation comprising 3 to 23 milligrams, preferably 5 to 15
milligrams, more preferably 6-9 milligrams of at least one
isoflavone per gram of the formulation wherein the amount of the
soy formulation is sufficient to provide greater than 60 milligrams
of at least one isoflavone per serving.
[0036] In another embodiment, a dietary supplement of the present
invention comprises: a soy formulation comprising 3 to 23
milligrams, preferably 5 to 15 milligrams, more preferably, 6-9
milligrams of at least one isoflavone per gram of the formulation;
and 0.4 to 1.2 grams, preferably 0.4 to 0.9 grams, more preferably
0.6 to 0.8 grams protein; per gram of the formulation; wherein the
amount of the soy formulation is sufficient to provide greater than
60 milligrams of at least one isoflavone per serving.
[0037] In a further embodiment, a dietary supplement of the present
invention comprises: a soy formulation produced by combining a
first portion of higher isoflavone concentration soy product
produced from the heart of the soy bean and a second portion of
lower isoflavone concentration soy product produced from the whole
soy bean to achieve a soy formulation comprising 3 to 23 milligrams
of at least one isoflavone per gram of the formulation, preferably
5 to 15 milligrams of at least one isoflavone per gram of the
formulation, more preferably, 6-9 milligrams of at least one
isoflavone per gram of the formulation wherein the amount of the
soy formulation in the dietary supplement is sufficient to provide
greater than 60 milligrams of at least one isoflavone per
serving.
[0038] The isoflavone components and/or their ratios include those
discussed above with reference to the soy formulations of the
present invention. In particular embodiments of a dietary
supplement of the present invention the amount of soy formulation
utilized may be an amount sufficient to provide well above 60
milligrams of at least one isoflavone per serving. In particular
embodiments of a dietary supplement the amount of soy formulation
utilized may be an amount sufficient to provide 120-200 milligrams
of at least one isoflavone per serving; greater than 200 milligrams
of at least one isoflavone per serving; 400 to 900 milligrams of at
least one isoflavone per serving; greater than 1800 milligrams of
at least one isoflavone per serving; or 1800 to 2200 milligrams of
at least one isoflavone per serving.
[0039] In a still further embodiment, a dietary supplement of the
present invention comprises: a soy formulation comprising diadzin,
genistin and glycitin and having a diadzin to genistin to glycitin
ratio of between 3:1:2 and 3:4.5:1. Preferably the soy formulation
has a ratio of diadzin to genistin to glycitin of near or
approximately 2:1:1, respectively, such that diadzin is the major
isoflavone component. In this embodiment, the dietary supplement
may provide any milligram level of at least one isoflavone per
serving, thus differing amounts of the soy formulation may be
utilized in the dietary supplement. In specific embodiments
according to this aspect of a dietary supplement of the present
invention the amount of soy formulation utilized is sufficient to
provide greater than 60 milligrams of at least one isoflavone per
serving. In particular embodiments of this dietary supplement the
amount of soy formulation utilized may be an amount sufficient to
provide 120-200 milligrams of at least one isoflavone per serving;
greater than 200 milligrams of at least one isoflavone per serving;
400 to 900 milligrams of at least one isoflavone per serving;
greater than 1800 milligrams of at least one isoflavone per
serving; or 1800 to 2200 milligrams of at least one isoflavone per
serving.
[0040] In another aspect, a dietary supplement of the present
invention comprises a soy formulation of the present invention and
is further characterized by comprising: 40 to 90%, preferably 70 to
90%, by weight, protein; 1 to 10%, preferably 1 to 5%, by weight,
fat; and 1 to 59%, preferably 1 to 25%, by weight, carbohydrate.
The analysis of protein, carbohydrate and fat levels may be
accomplished utilizing conventional techniques.
[0041] In another aspect, a dietary supplement of the present
invention further comprises one or more of the following
ingredients: digestive enzymes, fibers, sweeteners, preservatives,
vitamins, minerals and the like, including but not limited to
calcium phosphate, soy lecithin, salt, potassium, chloride,
artificial and/or natural flavorings, carragenenen,
carboxymethylcellulose, xantham gum, or milk solids. Suitable
digestive enzymes include, but are not limited to: alpha
galactosidase. Suitable fiber sources include, but are not limited
to: psyllium. Suitable sweeteners include, but are not limited to,
natural sweeteners, including sucrose, dextrose, fructose and the
like; artificial sweeteners including sucralose (Splenda),
aspartame, saccharin and SinetK (acesulfurame K) and the like; and
plant derived sweeteners including stevia. The amounts of the one
or more additional ingredients are such that the dietary supplement
maintains the protein, carbohydrate and fat ratios set forth
above.
[0042] A dietary supplement of the present invention may be in any
digestible form, including a powder, a tablet or in liquid form. A
dietary supplement of the present invention may also be
agglomerated and/or otherwise treated to improve solubility,
digestibility or other aspects of the dietary supplement.
[0043] As will be understood by those of ordinary skill in the art,
a dietary supplement of the present invention may also include
ingredients similar to those set forth below with respect to a food
product of the present invention.
[0044] In a further aspect the present invention provides a
digestible food product which includes greater than 60 milligrams
of at least one isoflavone per serving. In particular embodiments
of this dietary supplement the amount of soy formulation utilized
may be an amount sufficient to provide 120-200 milligrams of at
least one isoflavone per serving; greater than 200 milligrams of at
least one isoflavone per serving; 400 to 900 milligrams of at least
one isoflavone per serving; greater than 1800 milligrams of at
least one isoflavone per serving; or 1800 to 2200 milligrams of at
least one isoflavone per serving.
[0045] In one aspect, a food product of the present invention
comprises a soy formulation of the present invention. The dietary
supplement may comprise a soy formulation having one or more of the
features described above. The amount of soy formulation utilized in
a food product of the present invention will depend on the level of
isoflavones desired per serving of the food product. As further
explained below, it is generally desirable for the food product to
provide greater than 60 milligrams of at least one isoflavone per
serving. Thus, for example, a serving of a food product of the
present invention could comprise 8 grams of a soy formulation of
the present invention comprising 9 milligrams of at least one
isoflavone per gram of the formulation, to provide 72 milligrams of
isoflavones. To achieve higher levels of isoflavones, the food
product could include additional amounts of a soy formulation
and/or a soy formulation having a higher level of isoflavones per
gram.
[0046] Thus an embodiment of a food product comprises: a soy
formulation comprising 3 to 23 milligrams, preferably 5 to 15
milligrams, more preferably 6-9 milligrams of at least one
isoflavone per gram of the formulation wherein the amount of the
soy formulation is sufficient to provide greater than 60 milligrams
of at least one isoflavone per serving.
[0047] In another embodiment, a food product of the present
invention comprises: a soy formulation comprising 3 to 23
milligrams, preferably 5 to 15 milligrams, more preferably, 6-9
milligrams of at least one isoflavone per gram of the formulation;
and 0.4 to 1.2 grams, preferably 0.4 to 0.9 grams, more preferably
0.6 to 0.8 grams protein; per gram of the formulation; wherein the
amount of the soy formulation is sufficient to provide greater than
60 milligrams of at least one isoflavone per serving.
[0048] In a further embodiment, a food product of the present
invention comprises: a soy formulation produced by combining a
first portion of higher isoflavone concentration soy product
produced from the heart of the soy bean and a second portion of
lower isoflavone concentration soy product produced from the whole
soy bean to achieve a soy formulation comprising 3 to 23 milligrams
of at least one isoflavone per gram of the formulation, preferably
5 to 15 milligrams of at least one isoflavone per gram of the
formulation, more preferably, 6-9 milligrams of at least one
isoflavone per gram of the formulation wherein the amount of the
soy formulation in the food product is sufficient to provide
greater than 60 milligrams of at least one isoflavone per
serving.
[0049] The isoflavone components and/or their ratios include those
discussed above with reference to the soy formulations of the
present invention. In particular embodiments of a food product of
the present invention the amount of soy formulation utilized may be
an amount sufficient to provide well above 60 milligrams of at
least one isoflavone per serving. In particular embodiments of a
food product the amount of soy formulation utilized may be an
amount sufficient to provide 120-200 milligrams of at least one
isoflavone per serving; greater than 200 milligrams of at least one
isoflavone per serving; 400 to 900 milligrams of at least one
isoflavone per serving; greater than 1800 milligrams of at least
one isoflavone per serving; or 1800 to 2200 milligrams of at least
one isoflavone per serving.
[0050] In a still further embodiment, a food product of the present
invention comprises: a soy formulation comprising diadzin, genistin
and glycitin and having a diadzin to genistin to glycitin ratio of
between 3:1:2 and 3:4.5:1. Preferably the soy formulation has a
ratio of diadzin to genistin to glycitin of near or approximately
2:1:1, respectively, such that diadzin is the major isoflavone
component. In this embodiment, the food product may provide any
milligram level of at least one isoflavone per serving, thus
differing amounts of the soy formulation may be utilized in the
food product. In specific embodiments according to this aspect of a
food product of the present invention the amount of soy formulation
utilized is sufficient to provide greater than 60 milligrams of at
least one isoflavone per serving. In particular embodiments of this
food product the amount of soy formulation utilized may be an
amount sufficient to provide 120-200 milligrams of at least one
isoflavone per serving; greater than 200 milligrams of at least one
isoflavone per serving; 400 to 900 milligrams of at least one
isoflavone per serving; greater than 1800 milligrams of at least
one isoflavone per serving; or 1800 to 2200 milligrams of at least
one isoflavone per serving.
[0051] In another aspect a food product of the present invention
may preferably comprise:
[0052] 20 to 40%, by weight, protein, preferably provided by a soy
formulation of the present invention;
[0053] 10 to 80%, by weight carbohydrate; and
[0054] 1 to 10%, by weight fat.
[0055] The food product may further comprise additional components
including preservatives, flavorings, vitamins, minerals and the
like, including but not limited to calcium phosphate, soy lecithin,
salt, potassium, chloride, artificial and natural flavors,
carragenenan, carboxymethylcellulose, xantham gum, water or milk.
Among the carbohydrates suitable for use in the present invention
are included fructose, glucose, dextrose, maltodextrin and corn
syrup solids.
[0056] A food product of the present invention may also be produced
in a lower calorie form by substituting an artificial sweetener for
all or a portion of the sugars. Suitable artificial sweeteners
include sucralose (Splenda ), aspartame, saccharin and SinetK
(acesulfurame K). Plant derived sweeteners such as stevia are also
suitable.
[0057] A food product of the present invention may take many forms,
including a powder for dispersing in a liquid, a tablet, a bar,
liquid drinks, a cereal etc. By way of example, a powdered food
product of the present invention may comprise:
[0058] 30 to 32%, by weight a soy formulation of the present
invention;
[0059] 55 to 57%, by weight carbohydrate;
[0060] 3 to 5%, by weight fat;
[0061] 0.2 to 1%, by weight calcium;
[0062] 0.2 to 1%, by weight phosphorous;
[0063] 0.1 to 0.7%, by weight sodium;
[0064] 0.2 to 1%, by weight potassium; and
[0065] include ingredients such as fructose, sugar, cocoa,.calcium
phosphate, maltodextrin, soy lecithin, salt, potassium chloride,
artificial flavor, carrageenan, carboxymethyl cellulose and xanthan
gum, wherein the food product provides greater than 60 milligrams,
preferably 120-200 milligrams of at least one isoflavone per
serving, preferably a plurality of isoflavones in the ratios
discussed above.
[0066] A food product of the present invention may further include
vitamins and minerals in an amount of up to 100% or more of the
recommended daily allowance for each vitamin. In a preferred
embodiment, a food product of the present invention may include
20-40% of the recommended daily allowance of most minerals.
[0067] In a further aspect, the present invention provides a
pharmacological composition comprising a soy formulation of the
present invention. The amount of soy formulation utilized in a
pharmacological composition of the present invention will depend on
the level of isoflavones desired per dose of the pharmacological
composition. As further explained below, it is generally desirable
for the pharmacological composition to provide greater than 60
milligrams, preferably greater than 200 milligrams, more preferably
greater than 1800 milligrams, of at least one isoflavone per dose.
Thus, for example, a serving of a pharmacological composition of
the present invention could comprise 9 grams of a soy formulation
of the present invention comprising 7 milligrams of at least one
isoflavone per gram of the formulation, to provide 63 milligrams of
isoflavones. To achieve higher levels of isoflavones, the
pharmacological composition could include additional amounts of a
soy formulation and/or a soy formulation having a higher level of
isoflavones per gram.
[0068] Thus an embodiment of a pharmacological composition
comprises: a soy formulation comprising 3 to 23 milligrams,
preferably 5 to 15 milligrams, more preferably 6-9 milligrams of at
least one isoflavone per gram of the formulation wherein the amount
of the soy formulation is sufficient to provide greater than 60
milligrams, preferably greater than 200 milligrams, more preferably
greater than 1800 milligrams, of at least one isoflavone per
dose.
[0069] In another embodiment, a pharmacological composition of the
present invention comprises: a soy formulation comprising 3 to 23
milligrams, preferably 5 to 15 milligrams, more preferably, 6-9
milligrams of at least one isoflavone per gram of the formulation;
and 0.4 to 1.2 grams, preferably 0.4 to 0.9 grams, more preferably
0.6 to 0.8 grams protein; per gram of the formulation; wherein the
amount of the soy formulation is sufficient to provide greater than
60 milligrams, preferably greater than 200 milligrams, more
preferably greater than 1800 milligrams, of at least one isoflavone
per dose.
[0070] In a further embodiment, a pharmacological composition of
the present invention comprises: a soy formulation produced by
combining a first portion of higher isoflavone concentration soy
product produced from the heart of the soy bean and a second
portion of lower isoflavone concentration soy product produced from
the whole soy bean to achieve a soy formulation comprising 3 to 23
milligrams of at least one isoflavone per gram of the formulation,
preferably 5 to 15 milligrams of at least one isoflavone per gram
of the formulation, more preferably, 6-9 milligrams of at least one
isoflavone per gram of the formulation wherein the amount of the
soy formulation in the pharmacological composition is sufficient to
provide greater than 60 milligrams, preferably greater than 200
milligrams, more preferably greater than 1800 milligrams, of at
least one isoflavone per dose.
[0071] The isoflavone components and/or their ratios include those
discussed above with reference to the soy formulations of the
present invention. In particular embodiments of a pharmacological
composition of the present invention the amount of soy formulation
utilized may be an amount sufficient to provide well above 60
milligrams of at least one isoflavone per dose. In particular
embodiments of a pharmacological composition the amount of soy
formulation utilized may be an amount sufficient to provide 120-200
milligrams of at least one isoflavone per dose; greater than 200
milligrams of at least one isoflavone per dose; 400 to 900
milligrams of at least one isoflavone per dose; greater than 1800
milligrams of at least one isoflavone per dose; or 1800 to 2200
milligrams of at least one isoflavone per dose.
[0072] In a still further embodiment, a pharmacological composition
of the present invention comprises: a soy formulation comprising
diadzin, genistin and glycitin and having a diadzin to genistin to
glycitin ratio of between 3:1:2 and 3:4.5:1. Preferably the soy
formulation has a ratio of diadzin to genistin to glycitin of near
or approximately 2:1:1, respectively, such that diadzin is the
major isoflavone component. In this embodiment, the pharmacological
composition may provide any milligram level of at least one
isoflavone per dose, thus differing amounts of the soy formulation
may be utilized in the pharmacological composition. In specific
embodiments according to this aspect of a pharmacological
composition of the present invention the amount of soy formulation
utilized is sufficient to provide greater than 60 milligrams,
preferably greater than 200 milligrams, more preferably greater
than 1800 milligrams, of at least one isoflavone per dose. In
particular embodiments of this pharmacological composition the
amount of soy formulation utilized may be an amount sufficient to
provide 120-200 milligrams of at least one isoflavone per dose;
greater than 200 milligrams of at least one isoflavone per dose;
400 to 900 milligrams of at least one isoflavone per dose; greater
than 1800 milligrams of at least one isoflavone per dose; or 1800
to 2200 milligrams of at least one isoflavone per dose.
[0073] As discussed above, and in detail below, a particular
advantageous feature of the present invention is that in another
aspect the present invention provides a pharmacological composition
comprising a soy formulation of the present invention and further
comprising a medicinal composition. Suitable medicinal compositions
include, but are not limited to the medicinal compositions, drugs
and/or prescription drugs utilized in estrogen replacement therapy;
hormone replacement therapy; cholesterol lowering therapy; bone
strengthening therapy; endometrial therapy; cancer therapy,
including chemotherapy; alzeheimer's therapy; ulcer therapy;
prostrate therapy; skin therapy; renal therapy; blood therapy;
lymphatic therapy; lung therapy; nervous system therapy; diabetes
therapy; eye therapy and the like. These medicinal compositions
include, but are not limited to, Premarin; Fosamax; Raloxifene;
Tamoxifen; SERM's (selective estrogen receptor modulators) and
other drugs known to those of ordinary skill in the art.
[0074] The amount of the medicinal composition utilized in this
embodiment of a pharmacological composition of the present
invention is an amount sufficient to achieve the desired
therapeutic effect while minimizing side or adverse effects. In
general the amount of the medicinal composition utilized in a
pharmacological composition of the present invention will be the
same or less than the amount utilized in conventional therapy in
the absence of the soy formulation of the present invention.
[0075] An advantage of a pharmacological composition of the present
invention comprising a soy formulation of the present invention and
a medicinal composition is that the combination may have
synergistic effects. Therefore it may be possible to use a lesser
amount of the medicinal composition in a pharmacological
composition of the present invention than the amount traditionally
utilized in the absence of a soy formulation of the present
invention, while achieving substantially the same desired
therapeutic effects. This feature also may provide an additional
advantage of reducing side or adverse effects caused by the
medicinal composition due to the lower amount of the medicinal
composition utilized.
[0076] Further details, and specific examples of possible uses of
pharmacological compositions of the present invention that comprise
a soy formulation of the present invention and a medicinal
composition are set forth below with reference to the methods of
the present invention.
[0077] Thus, an embodiment of a pharmacological composition
comprises: a soy formulation comprising 3 to 23 milligrams,
preferably 5 to 15 milligrams, more preferably 6-9 milligrams of at
least one isoflavone per gram of the formulation wherein the amount
of the soy formulation is sufficient to provide greater than 60
milligrams, preferably greater than 200 milligrams, more preferably
greater than 1800 milligrams, of at least one isoflavone per dose;
and a medicinal composition wherein the amount of the medicinal
composition is sufficient to achieve a desired therapeutic
effect.
[0078] In another embodiment, a pharmacological composition of the
present invention comprises: a soy formulation comprising 3 to 23
milligrams, preferably 5 to 15 milligrams, more preferably, 6-9
milligrams of at least one isoflavone per gram of the formulation;
0.4 to 1.2 grams, preferably 0.4 to 0.9 grams, more preferably 0.6
to 0.8 grams protein; per gram of the formulation; and a medicinal
composition wherein the amount of the soy formulation is sufficient
to provide greater than 60 milligrams, preferably greater than 200
milligrams, more preferably greater than 1800 milligrams, of at
least one isoflavone per dose and wherein the amount of the
medicinal composition is sufficient to achieve a desired
therapeutic effect.
[0079] In a further embodiment, a pharmacological composition of
the present invention comprises: a soy formulation produced by
combining a first portion of higher isoflavone concentration soy
product produced from the heart of the soy bean and a second
portion of lower isoflavone concentration soy product produced from
the whole soy bean to achieve a soy formulation comprising 3 to 23
milligrams of at least one isoflavone per gram of the formulation,
preferably 5 to 15 milligrams of at least one isoflavone per gram
of the formulation, more preferably, 6-9 milligrams of at least one
isoflavone per gram of the formulation wherein the amount of the
soy formulation in the pharmacological composition is sufficient to
provide greater than 60 milligrams, preferably greater than 200
milligrams, more preferably greater than 1800 milligrams, of at
least one isoflavone per dose; and a medicinal composition wherein
the amount of the medicinal composition is sufficient to achieve a
desired therapeutic effect.
[0080] The isoflavone components and/or their ratios include those
discussed above with reference to the soy formulations of the
present invention. In particular embodiments of a pharmacological
composition of the present invention the amount of soy formulation
utilized may be an amount sufficient to provide well above 60
milligrams of at least one isoflavone per dose. In particular
embodiments of a pharmacological composition the amount of soy
formulation utilized may be an amount sufficient to provide 120-200
milligrams of at least one isoflavone per dose; greater than 200
milligrams of at least one isoflavone per dose; 400 to 900
milligrams of at least one isoflavone per dose; greater than 1800
milligrams of at least one isoflavone per dose; or 1800 to 2200
milligrams of at least one isoflavone per dose.
[0081] In a still further embodiment, a pharmacological composition
of the present invention comprises: a soy formulation comprising
diadzin, genistin and glycitin and having a diadzin to genistin to
glycitin ratio of between 3:1:2 and 3:4.5:1; and a medicinal
composition wherein the amount of the medicinal composition is
sufficient to achieve a desired therapeutic effect. Preferably the
soy formulation has a ratio of diadzin to genistin to glycitin of
near or approximately 2:1:1, respectively, such that diadzin is the
major isoflavone component. In this embodiment, the pharmacological
composition may provide any milligram level of at least one
isoflavone per dose, thus differing amounts of the soy formulation
may be utilized in the pharmacological composition. In specific
embodiments according to this aspect of a pharmacological
composition of the present invention the amount of soy formulation
utilized is sufficient to provide greater than 60 milligrams,
preferably greater than 200 milligrams, more preferably greater
than 1800 milligrams, of at least one isoflavone per dose. In
particular embodiments of this pharmacological composition the
amount of soy formulation utilized may be an amount sufficient to
provide 120-200 milligrams of at least one isoflavone per dose;
greater than 200 milligrams of at least one isoflavone per dose;
400 to 900 milligrams of at least one isoflavone per dose; greater
than 1800 milligrams of at least one isoflavone per dose; or 1800
to 2200 milligrams of at least one isoflavone per dose.
[0082] Embodiments of a pharmacological composition of the present
invention may further comprise a biologically compatible inert
carrier composition comprising one or more of the following
ingredients: a gel composition; a cellulose composition; a starch;
a glycol composition; hydroxypropyl methylcellulose;
microcrystalline cellulose; polyethylene glycol; and/or sodium
lauryl sulfate. Other ingredients known in the art may also be
utilized in the carrier composition.
[0083] Among the advantages of the soy formulations, dietary
supplements, food products and pharmacological compositions of the
present invention are that the soy formulations, dietary
supplements, food products and pharmacological compositions may be
utilized in the methods of the present invention to promote the
health of an individual. In addition, the soy formulations, dietary
supplements and food products provide a dietary means for providing
beneficial amounts of an isoflavone, or a plurality of isoflavones,
and protein to an individual, without requiring the individual
ingests unpalatable or difficult to digest amounts of protein.
[0084] In addition to the soy formulations, dietary supplements,
food products and pharmacological compositions discussed above, the
present invention provides methods for promoting the health of an
individual. A method of the present invention for promoting the
health of an individual comprises having the individual ingest
greater than 60 milligrams, preferably greater than 120 milligrams,
more preferably 120-200 milligrams of at least one isoflavone per
day. Embodiments of a method of the present invention may further
comprise having the individual ingest greater than 200 milligrams
of at least one isoflavone per day.
[0085] Preferably the individual will ingest the isoflavones by
ingesting a soy formulation of the present invention, by ingesting
a dietary supplement of the present invention, by ingesting a food
product of the present invention, or by ingesting a pharmacological
composition of the present invention. Thus, it is preferred that in
a method of the present invention an individual ingests a soy
formulation, a dietary supplement, food product and/or
pharmacological composition including a soy formulation, comprising
3 to 23 milligrams of at least one isoflavone per gram of the
formulation, more preferably 5 to 15 milligrams of at least one
isoflavone per gram of the formulation, even more preferably, 6-9
milligrams of at least one isoflavone per gram of the formulation.
The soy formulation utilized in a method of the present invention
may further comprise 0.4 to 1.2 grams, preferably 0.4 to 0.9 grams,
more preferably 0.6 to 0.8 grams protein; per gram of the
formulation. The isoflavone(s) may comprise diadzin, genistin
and/or glycitin. It is also preferred that in a method of the
present invention an individual ingest the isoflavones in a diadzin
to genistin to glycitin ratio of between 3:1:2 and 3:4.5:1,
preferably a ratio of diadzin to genistin to glycitin of near or
approximately 2:1:1, respectively, such that diadzin is the major
isoflavone component.
[0086] The present invention also provides methods for enhancing
health which include digesting a soy formulation of the present
invention, and/or dietary supplements and/or food items and/or
pharmacological compositions which include a soy formulation of the
present invention.
[0087] A method of the present invention may be utilized to promote
the health of an individual by reducing menopausal like symptoms,
including hot flashes, pains and the like being experienced by the
individual, for example as the result of a hysterectomy, breast
cancer or a recent pregnancy. A method of the present invention may
be utilized to promote the health of an individual by providing a
dietary means of achieving the effects achieved by estrogen
therapies.
[0088] Methods of the present invention may also be utilized to
promote the health of an individual by reducing hot flashes,
vaginal itching/dryness, irritability, mood swings, insomnia, night
sweats, nervousness, headaches, and painful intercourse; soothing
menstrual problems like cramping, bloating, irritability, and
weight gain and to increase the time between menstrual periods
(i.e., fewer periods per year); decreasing fatigue by boosting
energy levels and mood; maintaining healthy breast tissue,
endometrial tissue, and other tissues; preserving a strong and
healthy skeletal system (bones and joints); and helping support a
healthy heart, cardiovascular system, and cholesterol levels.
Methods of the present invention may further be utilized to promote
the health of an individual by minimizing the effects of
Alzheimer's type dementia, age-related loss of cognitive function,
and alcoholism. Other potential uses of the methods of the present
invention include: birth control (at higher doses); hormone
replacement therapy in combination with mammalian estrogens; breast
cancer preventative; prostate cancer preventative; prevention
and/or treatment of headaches and migraine headaches; prevention
and/or treatment of acne and other skin conditions; improvement of
sexual function; lessening effects of chronic fatigue syndrome; and
weight loss.
[0089] As noted above, and in further detail below, methods of the
present invention may be utilized to produce health benefits in an
individual by alleviating or minimizing symptoms of the following
conditions and/or providing health benefits in the following
areas:
MENOPAUSE/PMS
[0090] Menopause symptoms like hot flushes, vaginal
itching/dryness, irritability, mood swings, insomnia, night
sweats.
[0091] Menopause-like symptoms.
[0092] Post-partum hot flushes.
[0093] Surgically-induced menopause symptoms (ie.
oophorectomy).
[0094] PMS symptoms.
[0095] Normal menstrual complaints like cramping, bloating,
irritability, and weight gain.
[0096] Abnormal vaginal bleeding of any cause.
[0097] Endometriosis, fibroids or other diseases where blocking
estrogen could be beneficial.
[0098] In a particular embodiment of a method of the present
invention for minimizing or alleviating symptoms of menopause/pms,
the method comprises having an individual ingest a pharmacological
composition of the present invention wherein the pharmacological
composition comprises a soy formulation comprising 3 to 23
milligrams, preferably 5 to 15 milligrams, more preferably 6-9
milligrams of at least one isoflavone per gram of the formulation
wherein the amount of the soy formulation is sufficient to provide
greater than 60 milligrams, preferably greater than 200 milligrams,
more preferably greater than 1800 milligrams, of at least one
isoflavone per dose; and a medicinal composition wherein the amount
of the medicinal composition is sufficient to achieve a desired
therapeutic effect.
[0099] A preferred medicinal composition for this embodiment is a
medicinal composition for estrogen replacement therapy or hormone
replacement therapy (estrogen+progestins). Premarin is an example
of a medicinal composition for this embodiment of the method of the
present invention The combination of a soy formulation of the
present invention and a medicinal composition for hormone
replacement therapy and/or estrogen replacement therapy may provide
one or more of the following advantages:
[0100] 1) an additive benefit to heart and bone tissues while
reducing menopausal symptoms;
[0101] 2) reduced breast and endometrial proliferation; or
[0102] 3) a reduction in the amount of medicinal composition needed
to achieve a therapeutic effect, for example less Premarin,
resulting in lower cost to a patient and less risk.
HEART/CARDIOVASCULAR RELATED CONDITIONS
[0103] Lowering total cholesterol, LDL cholesterol, triglycerides
and increasing HDL cholesterol or other favorable improvement in
lipid profiles.
[0104] Lowering of blood pressure.
[0105] Prevention of myocardial infarction.
[0106] Prevention of second myocardial infarction.
[0107] Prevention or delaying restenosis of coronary bypass grafts
or any other vascular grafts.
[0108] Prevention of stroke.
[0109] Improvement of cardiac stroke volume.
[0110] In a particular embodiment of a method of the present
invention for benefiting heart/cardiovascular related conditions
the method comprises having an individual ingest a pharmacological
composition of the present invention wherein the pharmacological
composition comprises a soy formulation comprising 3 to 23
milligrams, preferably 5 to 15 milligrams, more preferably 6-9
milligrams of at least one isoflavone per gram of the formulation
wherein the amount of the soy formulation is sufficient to provide
greater than 60 milligrams, preferably greater than 200 milligrams,
more preferably greater than 1800 milligrams, of at least one
isoflavone per dose; and a medicinal composition wherein the amount
of the medicinal composition is sufficient to achieve a desired
therapeutic effect.
[0111] A preferred medicinal composition for this embodiment is
Lipitor or another cholesterol lowering medication. The combination
of a soy formulation of the present invention and a medicinal
composition for cholesterol lowering may provide one or more of the
following advantages:
[0112] 1) an additive benefit to heart and bone tissues while
generating a better lipid profile;
[0113] 2) a reduction in the amount of medicinal composition needed
to achieve a therapeutic effect, for example less Lipitor,
resulting in lower cost to a patient and less risk of liver
abnormalities caused by Lipitor.
BONE/SKELETAL SYSTEM CONDITIONS
[0114] Osteoporosis.
[0115] Hip fracture.
[0116] Quicker recovery after hip fracture surgery.
[0117] Disorders of the joints or cartilage.
[0118] Stimulation of growth and reduction of inflammation of
connective tissue/joints.
[0119] In a particular embodiment of a method of the present
invention for minimizing or alleviating symptoms of menopause/pms,
the method comprises having an individual ingest a pharmacological
composition of the present invention wherein the pharmacological
composition comprises a soy formulation comprising 3 to 23
milligrams, preferably 5 to 15 milligrams, more preferably 6-9
milligrams of at least one isoflavone per gram of the formulation
wherein the amount of the soy formulation is sufficient to provide
greater than 60 milligrams, preferably greater than 200 milligrams,
more preferably greater than 1800 milligrams, of at least one
isoflavone per dose; and a medicinal composition wherein the amount
of the medicinal composition is sufficient to achieve a desired
therapeutic effect.
[0120] A preferred medicinal composition for this embodiment is a
medicinal composition for strengthening bones, estrogen replacement
therapy or hormone replacement therapy (estrogen+progestins).
Fosamax, Raloxifene and Premarin is an example of a medicinal
composition for this embodiment of the method of the present
invention The combination of a soy formulation of the present
invention and a medicinal composition may provide one or more of
the following advantages:
[0121] 1) an additive benefit to heart and bone tissues while
reducing menopausal symptoms;
[0122] 2) reduced breast and endometrial proliferation; or
[0123] 3) a reduction in the amount of medicinal composition needed
to achieve a therapeutic effect, for example less Premarin,
resulting in lower cost to a patient and less risk.
BREAST/PROSTRATE RELATED CONDITIONS
[0124] Prevention and treatment of any abnormal breast tissue
including, but not limited to, fibrocystic disease, ductal
hyperplasia, ductal carcinoma in situ (DCIS), locally confined
breast cancer or metastatic breast cancer.
[0125] Hot flushes and other menopause-like symptoms caused by
breast cancer treatment or preventative treatment (eg. hot flashes
caused by use of tamoxifen).
[0126] Improved quality/extension of life after diagnosis of breast
tumor.
[0127] Early childhood treatment with isoflavones for prevention of
breast cancer/prostate cancer later in life.
[0128] Reduces growth rate of cancerous tissue/cells.
[0129] Extension of life span after breast/prostate cancer.
[0130] In a particular embodiment of a method of the present
invention for minimizing or alleviating symptoms of
breast/prostrate related conditions, the method comprises having an
individual ingest a pharmacological composition of the present
invention wherein the pharmacological composition comprises a soy
formulation comprising 3 to 23 milligrams, preferably 5 to 15
milligrams, more preferably 6-9 milligrams of at least one
isoflavone per gram of the formulation wherein the amount of the
soy formulation is sufficient to provide greater than 60
milligrams, preferably greater than 200 milligrams, more preferably
greater than 1800 milligrams, of at least one isoflavone per dose;
and a medicinal composition wherein the amount of the medicinal
composition is sufficient to achieve a desired therapeutic
effect.
[0131] A preferred medicinal composition for this embodiment is a
medicinal composition for estrogen replacement therapy or hormone
replacement therapy (estrogen+progestins). Premarin is an example
of a medicinal composition for this embodiment of the method of the
present invention Other medicinal compositions include tamoxifen,
raloxifene or SERM's. The combination of a soy formulation of the
present invention and a medicinal composition may provide one or
more of the following advantages:
[0132] 1) an additive benefit to heart and bone tissues while
having a preventive effect for breast cancer;
[0133] 2) reduced breast and endometrial proliferation; or
[0134] 3) a reduction in the amount of medicinal composition needed
to achieve a therapeutic effect, for example less Premarin,
resulting in lower cost to a patient and less risk.
ENDOMETRIUM
[0135] Prevention and treatment of endometrial abnormalities or
disease.
[0136] Prevent endometrial hyperplasia/cancer caused by medications
that stimulate the endometrium (e.g. tamoxifen).
[0137] In a particular embodiment of a method of the present
invention for preventing and/or minimizing endometrial conditions,
the method comprises having an individual ingest a pharmacological
composition of the present invention wherein the pharmacological
composition comprises a soy formulation comprising 3 to 23
milligrams, preferably 5 to 15 milligrams, more preferably 6-9
milligrams of at least one isoflavone per gram of the formulation
wherein the amount of the soy formulation is sufficient to provide
greater than 60 milligrams, preferably greater than 200 milligrams,
more preferably greater than 1800 milligrams, of at least one
isoflavone per dose; and a medicinal composition wherein the amount
of the medicinal composition is sufficient to achieve a desired
therapeutic effect.
[0138] A preferred medicinal composition for this embodiment is a
medicinal composition comprising tamoxifen, raloxifene or SERM's.
The combination of a soy formulation of the present invention and a
medicinal composition may provide one or more of the following
advantages:
[0139] 1) an additive benefit to heart and bone tissues while
treating endometrial conditions;
[0140] 2) reduced breast and endometrial proliferation, and
prevention of endometrial hyperplasia/cancer (tamoxifen has been
shown to promote formation of endometrial cancers, the soy
formulation of the present invention may reduce this risk); or
[0141] 3) a reduction in the amount of medicinal composition needed
to achieve a therapeutic effect, for example less Premarin,
resulting in lower cost to a patient and less risk.
HEAD/BRAIN SYMPTOMS
[0142] Prevention and treatment of Alzheimer's or other diseases of
cognition.
[0143] Macular degeneration.
[0144] Migraine/vascular-related headaches.
[0145] Anxiety, nervousness, depression or other similar affective
disorders
[0146] Hereditary hemorrhagic talengiectasia (HHT).
[0147] Male pattern baldness and female baldness.
[0148] Improvement in cognitive function.
[0149] In a particular embodiment of a method of the present
invention for minimizing or alleviating head/brain symptoms, the
method comprises having an individual ingest a pharmacological
composition of the present invention wherein the pharmacological
composition comprises a soy formulation comprising 3 to 23
milligrams, preferably 5 to 15 milligrams, more preferably 6-9
milligrams of at least one isoflavone per gram of the formulation
wherein the amount of the soy formulation is sufficient to provide
greater than 60 milligrams, preferably greater than 200 milligrams,
more preferably greater than 1800 milligrams, of at least one
isoflavone per dose; and a medicinal composition wherein the amount
of the medicinal composition is sufficient to achieve a desired
therapeutic effect.
[0150] A preferred medicinal composition for this embodiment is a
medicinal composition for Alzheimer's disease. The combination of a
soy formulation of the present invention and a medicinal
composition may provide one or more of the following
advantages:
[0151] 1) an additive benefit to heart and bone tissues while
treating Alzheimer's symptoms;
[0152] 2) a reduction in the amount of medicinal composition needed
to achieve a therapeutic effect, resulting in lower cost to a
patient and less risk.
GASTROINTESTINAL (GI) TRACT CONDITIONS
[0153] Any disorders of the gastrointestinal tract such as:
[0154] Constipation.
[0155] Peptic ulcers or other ulcers.
[0156] Gastroesophageal reflux (GERD).
[0157] Any inflammatory bowel diseases such as ulcerative colitis
or Crohn's disease.
[0158] Cancers of the GI tract such as colon cancer.
SKIN/FACE CONDITIONS
[0159] Prevention of acne.
[0160] Treatment/reduction/prevention of facial wrinkling and
sagging.
[0161] Prevention/treatment of skin cancers.
[0162] Growth stimulation of hair and nails.
[0163] Prevention/restoration of hair loss (men/women)
[0164] Promotion of strong nails and hair.
[0165] As understood by those of ordinary skill in the art, these
skin/face conditions are often undesired side effects of a
treatment protocol utilizing prescription drugs. Use of a
pharmcological composition of the present invention comprising a
soy formulation of the present invention and the prescription drug
may advantageously reduce these conditions while also acheiving the
desired therapeutic effect.
KIDNEY RELATED CONDITIONS
[0166] Prevention of disease, particularly diabetic nephropathies,
polycystic kidney disease.
[0167] Improvement in kidney function such as increasing glomerular
filtration rate (GFR).
[0168] Management of lipid abnormalities secondary to renal
disease.
LUNG AND BREATHING RELATED CONDITIONS
[0169] Improvement in elasticity.
[0170] Treatment of cancers.
ADDITIONAL PROSTATE/URINARY TRACT CONDITIONS
[0171] Any prostate disorders.
[0172] Prevention/treatment of bladder or other reproductive tract
cancers in men and women.
[0173] Prevention of death from prostate cancer (Japanese men have
equal incidence of prostate cancer, but death rate is very
low).
[0174] Treatment/prevention of symptoms of benign prostatic
hyperplasia (BPH) (urgency, frequency, painful ejaculation,
nocturia, etc.) and prostate cancer.
[0175] Prevention of prostrate cancer progression.
[0176] Treatment for impotence.
[0177] Lowering prostate specific antigen (PSA).
[0178] Lowering circulating dihydrotestosterone (DHT) levels.
[0179] Inhibition of 5-alpha reductase.
[0180] In a particular embodiment of a method of the present
invention for acheiving these health benefits, the method comprises
having an individual ingest a pharmacological composition of the
present invention wherein the pharmacological composition comprises
a soy formulation comprising 3 to 23 milligrams, preferably 5 to 15
milligrams, more preferably 6-9 milligrams of at least one
isoflavone per gram of the formulation wherein the amount of the
soy formulation is sufficient to provide greater than 60
milligrams, preferably greater than 200 milligrams, more preferably
greater than 1800 milligrams, of at least one isoflavone per dose;
and a medicinal composition wherein the amount of the medicinal
composition is sufficient to achieve a desired therapeutic
effect.
[0181] A preferred medicinal composition for this embodiment is a
medicinal composition for estrogen replacement therapy or hormone
replacement therapy (estrogen+progestins). Premarin is an example
of a medicinal composition for this embodiment of the method of the
present invention The combination of a soy formulation of the
present invention and a medicinal composition for hormone
replacement therapy and/or estrogen replacement therapy may provide
one or more of the following advantages:
[0182] 1) an additive benefit to heart and bone tissues while
reducing menopausal symptoms;
[0183] 2) reduction of estrogenic side effects (enlarged breasts,
decreased libido, feminization)
[0184] 3) reduced breast and endometrial proliferation; or
[0185] 4) a reduction in the amount of medicinal composition needed
to achieve a therapeutic effect, for example less Premarin,
resulting in lower cost to a patient and less risk.
IMMUNE SYSTEM CONDITIONS
[0186] Autoimmune/rheumatological disorders such as sarcoidosis,
rheumatoid arthritis, lupus.
[0187] Boosting immune system of immunocompromised individuals.
REPRODUCTIVE SYSTEM CONDITIONS
[0188] Increasing length of time between menstrual cycles.
[0189] Birth control at higher doses.
[0190] Increased fertility by causing regular menstrual cycles.
NERVOUS SYSTEM CONDITIONS
[0191] Treatment of pain, minimizing pain associated with
trauma/surgery.
[0192] Treatment/minization of nerve damage associated with
trauma/surgery.
[0193] It has been found that having mice ingest a soy formulation
shortens time of neuropathies induced by nerve damage. Thus, for
example, a breast cancer patient could take soy before surgery to
minimize nerve damage/potential pain from surgery.
[0194] As understood by those of ordinary skill in the art, nervous
system conditions/pain are often treated utilizing prescription
drugs. Use of a pharmcological composition of the present invention
comprising a soy formulation of the present invention and the
prescription drug may advantageously provide the foregoing
advantages thus reducing the amount of prescription drug necessary
to acheive the desired therapeutic effect.
DIABETES ASSOCIATED DISEASES
[0195] Prevention of diabetic retinopathies.
[0196] Prevention/treatment of heart disease (see e.g. above).
[0197] Prevention/treatment of nerve damage (see e.g. above).
[0198] Prevention/treatment of kidney disease (see e.g. above).
EYE CONDITIONS
[0199] Prevention of cataracts and macular degeneration.
GENERAL CONDITIONS
[0200] Improvement in sexual function--men and women.
[0201] Obesity.
[0202] Treatment for chronic fatigue syndrome and fibromyalgia.
[0203] Treatment of hypo/hyperglycemia.
[0204] The following example illustrates the production of a soy
formulation of the present invention which may be utilized in a
dietary supplement and/or food product of the present invention
and/or in a method of the present invention.
EXAMPLE
[0205] The following is one example of a blend of a first portion
of higher isoflavone concentration soy product from the heart of
the bean and a second portion of lower isoflavone concentration soy
product to achieve a natural soy formulation of the present
invention having an milligram isoflavone to gram soy protein ratio
and a diadzin to genistin to glycitin ratio falling in the
preferred ranges of the formulation of the present invention.
[0206] Soy product derived from the heart of the soybean produces
relatively higher concentrations of isoflavones (24-36 mg of
isoflavones per gram of protein). The higher isoflavone
concentration soy product produced from the heart of the soy bean
used in the present invention contains
Diadzin/Diadzein:Genistin/Genistein:Glycitin/Glycitein in the
average ratios of 3.33:1.00:2.33, respectively (Table 1). Soy
derived from the whole soybean, such as found in soy product
produced from the whole soy beans, yields relatively lower
concentrations of isoflavones (<1.0-5 mg isoflavones per gram of
protein). The lower isoflavone concentration soy product used in
the present invention contains
Diadzin/Diadzein:Genistin/Genistein:Glycitin/Glycitein in the
average ratios of 5.00:10.00:1.00, respectively (Table 1). One
example of the invention is a blend of approximately 4 grams of the
higher isoflavone concentration soy product and approximately 18.4
grams of the lower isoflavone concentration soy product resulting
in Diadzin/Diadzein:Genist- in/Genistein:Glycitin/Glycitein in the
approximate ratios of 2.00:1.00:1.00, respectively (Table 1).
1TABLE 1 AVERAGE RATIOS OF ISOFLAVONES Higher isoflavone Lower
isoflavone concentration concentration Blend ratios soy product soy
product (approximate) Isoflavone (4 gm) (18.4 gm) (22.4 gm)
Diadzin/Diadzein 3.33 5.00 2.00 Genistin/Genistein 1.00 10.00 1.00
Glycitin/Glycitein 2.33 1.00 1.00
[0207] Long soybean crop histories and multiple testings of
isoflavone concentrations in soy product derived therefrom
consistently demonstrate these average ratios of constituent
isoflavone concentrations in naturally grown soybeans. Naturally
grown soybeans are defined as those without genetic modifications
for isoflavone content. Actual ratios of constituent isoflavones in
the final blended formulation depend on the relative amounts of
higher isoflavone concentration soy product and lower isoflavone
concentration soy product combined. The final soy formulation of
the present invention preferably has an isoflavone concentration
falling within the ranges discussed above. An example of a final
soy composition of the present invention is illustrated in Table
2.
2TABLE 2 grams mg Isoflavones Protein per per Isoflavone gram gram
Total mg Concentration formulation formulation Isoflavones Higher 4
24-36 96-144 Lower 18.4 <1.0-3.4 <18.4-62.56 Total 22.4 6-9
<114.4-206.56
[0208] Although the invention has been described with reference to
particular embodiments and features, other similar embodiments and
features may be utilized to obtain similar results. Variations and
modifications of the soy formulations, dietary supplements, food
products and methods of the present invention will be apparent to
one skilled in the art and the present disclosure is intended to
cover all such modifications and equivalents within the scope of
the following claims.
* * * * *