U.S. patent application number 14/689806 was filed with the patent office on 2015-12-17 for compositions for improved body composition.
This patent application is currently assigned to NORTHERN INNOVATIONS HOLDING CORP. The applicant listed for this patent is Philip Apong, Debasis Bagchi, John Doherty, Vaishali Joshi, Jason Peters. Invention is credited to Philip Apong, Debasis Bagchi, John Doherty, Vaishali Joshi, Jason Peters.
Application Number | 20150359780 14/689806 |
Document ID | / |
Family ID | 53176332 |
Filed Date | 2015-12-17 |
United States Patent
Application |
20150359780 |
Kind Code |
A1 |
Bagchi; Debasis ; et
al. |
December 17, 2015 |
Compositions for Improved Body Composition
Abstract
A nutritional supplement is provided comprising alpha-lipoic
acid and curcumin. The nutritional supplement may be used for
reducing weight or reducing weight gain, for reducing fat or
reducing fat gain, for reducing loss in lean mass or maintaining
lean mass, or for reducing loss of appetite or for maintaining
appetite.
Inventors: |
Bagchi; Debasis; (Oakville,
CA) ; Doherty; John; (Oakville, CA) ; Apong;
Philip; (Oakville, CA) ; Joshi; Vaishali;
(Oakville, CA) ; Peters; Jason; (Oakville,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Bagchi; Debasis
Doherty; John
Apong; Philip
Joshi; Vaishali
Peters; Jason |
Oakville
Oakville
Oakville
Oakville
Oakville |
|
CA
CA
CA
CA
CA |
|
|
Assignee: |
NORTHERN INNOVATIONS HOLDING
CORP
Oakville
CA
|
Family ID: |
53176332 |
Appl. No.: |
14/689806 |
Filed: |
April 17, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
14178272 |
Feb 12, 2014 |
9040576 |
|
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14689806 |
|
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Current U.S.
Class: |
514/440 |
Current CPC
Class: |
A23L 33/10 20160801;
A61K 31/12 20130101; A61K 2300/00 20130101; A61K 2300/00 20130101;
A61K 31/385 20130101; A61K 31/12 20130101; A23L 33/30 20160801;
A61K 31/385 20130101; A23V 2002/00 20130101 |
International
Class: |
A61K 31/385 20060101
A61K031/385; A61K 31/12 20060101 A61K031/12 |
Claims
1. A composition comprising alpha-lipoic acid and curcumin.
2. The composition of claim 1, wherein the ratio of alpha-lipoic
acid to curcumin is from about 2:1 to about 5:1
3. The composition of claim 2, wherein the ratio of alpha-lipoic
acid to curcumin is from about 2:1 to about 4:1.
4. The composition of claim 3, wherein the ratio of alpha-lipoic
acid to curcumin is about 2.67:1.
5. The composition of claim 1, wherein the composition comprises
alpha-lipoic acid in an amount from about 100 mg to about 2000 mg
per day.
6. The composition of claim 1, wherein the composition comprises
alpha-lipoic acid in an amount from about 1.5 mg/kg/day to about 40
mg/kg/day.
7. The composition of claim 6, wherein the composition comprises
alpha-lipoic acid in an amount of about 13.33 mg/kg/day.
8. The composition of claim 1, wherein the composition comprises
alpha-lipoic acid in an amount of about 800 mg per day.
9. The composition of claim 1, wherein the composition comprises
curcumin in an amount from about 0.06 mg/kg to about 20 mg/kg.
10. The composition of claim 1, wherein the composition comprises
curcumin in an amount from about 5 mg to about 1000 mg per day.
11. The composition of claim 1, wherein the composition comprises
curcumin in an amount from about 1.5 mg/kg/day to about 40
mg/kg/day.
12. The composition of claim 11, wherein the composition comprises
curcumin in an amount of about 5 mg/kg/day.
13. The composition of claim 1, wherein the composition comprises
curcumin in an amount of about 300 mg per day.
14. A method of reducing body weight or body weight gain,
comprising administering to a subject a composition comprising
alpha-lipoic acid and curcumin, wherein the ratio of alpha-lipoic
acid to curcumin is from about 2:1 to about 5:1.
15. A method of reducing body fat or body fat gain, comprising
administering to a subject a composition comprising alpha-lipoic
acid and curcumin, wherein the ratio of alpha-lipoic acid to
curcumin is from about 2:1 to about 5:1.
16. A method of maintaining lean mass, comprising administering to
a subject a composition comprising alpha-lipoic acid and curcumin,
wherein the ratio of alpha-lipoic acid to curcumin is from about
2:1 to about 5:1.
17. A method of maintaining or increasing appetite, comprising
administering to a subject a composition comprising alpha-lipoic
acid and curcumin, wherein the ratio of alpha-lipoic acid to
curcumin is from about 2:1 to about 5:1.
18. A method of maintaining or increasing caloric intake,
comprising administering to a subject a composition comprising
alpha-lipoic acid and curcumin, wherein the ratio of alpha-lipoic
acid to curcumin is from about 2:1 to about 5:1.
19. A method of making an improved nutritional supplement, the
method comprising adding to said nutritional supplement a
composition comprising alpha-lipoic acid and curcumin prior to
ingestion of said nutritional supplement.
20. A method of reducing body weight or body weight gain according
to claim 14, wherein the ratio of alpha-lipoic acid to curcumin is
about 2.67:1.
21. A method of reducing body weight or body weight gain according
to claim 14, wherein the composition comprises alpha-lipoic acid in
an amount from about 100 mg to about 2000 mg per day.
22. A method of reducing body weight or body weight gain according
to claim 14, wherein the composition comprises curcumin in an
amount from about 5 mg to about 1000 mg per day.
23. A method of reducing body weight or body weight gain according
to claim 14, wherein the composition comprises alpha-lipoic acid in
an amount of about 800 mg per day.
24. A method of reducing body weight or body weight gain according
to claim 14, wherein the composition comprises curcumin in an
amount of about 300 mg per day.
25. A method of reducing body fat or body fat gain according to
claim 15, wherein the ratio of alpha-lipoic acid to curcumin is
about 2.67:1.
26. A method of reducing body fat or body fat gain according to
claim 15, wherein the composition comprises alpha-lipoic acid in an
amount from about 100 mg to about 2000 mg per day.
27. A method of reducing body fat or body fat gain according to
claim 15, wherein the composition comprises curcumin in an amount
from about 5 mg to about 1000 mg per day.
28. A method of reducing body fat or body fat gain according to
claim 15, wherein the composition comprises alpha-lipoic acid in an
amount of about 800 mg per day.
29. A method of reducing body fat or body fat gain according to
claim 15, wherein the composition comprises curcumin in an amount
of about 300 mg per day.
30. A method of maintaining lean mass according to claim 16,
wherein the ratio of alpha-lipoic acid to curcumin is about
2.67:1.
31. A method of maintaining lean mass according to claim 16,
wherein the composition comprises alpha-lipoic acid in an amount
from about 100 mg to about 2000 mg per day.
32. A method of maintaining lean mass according to claim 16,
wherein the composition comprises curcumin in an amount from about
5 mg to about 1000 mg per day.
33. A method of maintaining lean mass according to claim 16,
wherein the composition comprises alpha-lipoic acid in an amount of
about 800 mg per day.
34. A method of maintaining lean mass according to claim 16,
wherein the composition comprises curcumin in an amount of about
300 mg per day.
Description
FIELD OF THE INVENTION
[0001] The present application claims priority from non-provisional
patent application Ser. No. 14/178,272, filed on Feb. 12, 2014.
[0002] The present invention relates generally to dietary
supplements. Particularly, the present invention provides
compositions comprising alpha-lipoic acid and curcumin and methods
of using the compositions.
BACKGROUND OF THE INVENTION
[0003] The use of dietary supplements among individuals, including
recreational and elite athletes, as well as sedentary individuals
wishing to improve health parameters, has become increasingly
popular due to studies suggesting efficacy. While there are many
dietary supplements for diverse indications ranging from general
health improvement (e.g. vitamins and minerals) to athletic
performance improvement (e.g. creatine and beta-alanine), a large
number of dietary supplements are taken for the purpose of
improving body composition.
[0004] Depending on the goal of the individual, dietary supplements
may be taken for the purpose of reducing or maintaining body
weight; reducing or maintaining body fat; or maintaining or
increasing lean body mass. Bodybuilders, in particular, as well as
some athletes in sports with weight classes, engage in diet and
exercise programs with varying phases some of which are more
permissive to weight gain than others. In order to gain lean mass,
or muscle, it is generally acknowledged that an excess of calories
must be consumed above those expended--however, this often results
in increases in fat mass as well. Alternatively, in order to lose
weight, most of which is preferably fat, it is necessary to consume
a deficit of calories--however, this often results in an
undesirable loss of lean mass.
[0005] Most known dietary supplements benefit changes in body
composition to a limited degree and/or at the cost of an
accompanied unwanted change in body composition. Accordingly, there
is a need for dietary supplements with improved effects on body
composition.
SUMMARY OF THE INVENTION
[0006] In one embodiment of the invention, there is provided a
composition comprising alpha-lipoic acid and curcumin.
[0007] According to another embodiment, there is provided a method
of reducing weight or reducing weight gain in an individual, the
method comprising administering a composition comprising
alpha-lipoic acid and curcumin.
[0008] According to another embodiment, there is provided a method
of reducing fat or reducing fat gain in an individual, the method
comprising administering a composition comprising alpha-lipoic acid
and curcumin.
[0009] According to another embodiment, there is provided a method
of maintaining lean mass or reducing loss of lean mass in an
individual, the method comprising administering a composition
comprising alpha-lipoic acid and curcumin.
[0010] According to another embodiment, there is provided a method
of maintaining appetite, increasing appetite, or reducing loss of
appetite in an individual, the method comprising administering a
composition comprising alpha-lipoic acid and curcumin.
[0011] According to another embodiment, there is provided a method
of improving the characteristics of a nutritional supplement, the
method comprising adding to said nutritional supplement a
composition comprising alpha-lipoic acid and curcumin prior to
ingestion of said nutritional supplement.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] Embodiments will now be described, by way of example only,
with reference to the attached Figures, wherein:
[0013] FIG. 1 shows the body weight of the mice during the course
of the experiment.
[0014] FIG. 2 shows the body weight of the mice before
treatment.
[0015] FIG. 3 shows the body weight of the mice after 11 weeks of
treatment.
[0016] FIG. 4 shows the food intake (in grams) per day per gram
body weight of the mice during the course of the experiment.
[0017] FIG. 5 shows the food intake (in kcals) per day per gram
body weight of the mice during the course of the experiment.
[0018] FIG. 6 shows the DEXA results for body fat % after 10 weeks
of treatment.
[0019] FIG. 7 shows the DEXA results for fat mass after 10 weeks of
treatment.
[0020] FIG. 8 shows the DEXA results for lean mass after 10 weeks
of treatment.
DETAILED DESCRIPTION OF THE EMBODIMENTS
[0021] A used herein, the terms `composition` or `nutritional
composition` includes dietary supplements, diet supplements,
nutritional supplements, supplemental compositions and supplemental
dietary compositions or those similarly envisioned and termed
compositions not belonging to the conventional definition of
pharmaceutical interventions as is known in the art. Furthermore,
`nutritional compositions` as disclosed herein belong to category
of compositions having at least one physiological function when
administered to a mammal by conventional routes of
administration.
[0022] Alternatively, formulations and nutritional compositions
belonging to the present invention may be considered to be
nutraceuticals. As used herein, the term `nutraceutical` is
recognized and used in the art to describe a specific chemical
compound or combination of compounds found in, organic matter for
example, which may prevent, ameliorate or otherwise confer benefits
against an undesirable condition. As is known in the art, the term
`nutraceutical` is used to refer any substance that is a food, a
part of food, or an extract or derivative of food that is suitable
for consumption by an individual and providing physiological
benefit which may be medical or health-related. Furthermore, the
term has been used to refer to a product isolated, extracted or
purified from foods or naturally-derived material suitable for
consumption by an individual and usually sold in medicinal forms,
such as caplets, tablets, capsules, gel-caps and the like, not
associated with food.
[0023] The inventors have found that combinations of alpha-lipoic
acid and curcumin are effective for altering aspects of body
composition. The combinations have beneficial and synergistic
effects on a number of parameters relevant to body composition.
[0024] As used herein, the term "alpha-lipoic acid" is used
interchangeably with lipoic acid and ALA and may refer to racemic
mixtures or R-lipoic acid and to salts thereof. Lipoic acid (also
known as alpha-lipoic acid, thioctic acid, or 6,8-dithio octanoic
acid) is a nutrient essential for aerobic metabolism that the human
body makes in minute quantities. Small amounts may also be obtained
from dietary sources such as spinach, broccoli, liver, and yeast.
It is an organosulfur compound that exists as two enantiomers,
R-(+)/S-(-), with only the R-form found in nature. Oral
administration of lipoic acid has been shown to increase blood and
cellular levels of lipoic acid. Lipoic acid supplements are
available as R-lipoic acid or as a racemic mixture and are
primarily marketed as an antioxidant.
[0025] Alpha-lipoic acid, in some aspects, may be provided as a
racemic mixture or alternatively as the R-lipoic acid isomer.
Furthermore, in some aspects, alpha lipoic acid may be provided as
a salt, with sodium salts being the most common. The daily dosage
of alpha-lipoic acid in the composition is about 100 mg to about
2000 mg, or about 1.5 mg/kg to about 40 mg/kg. Preferred amounts of
alpha-lipoic acid include about 13.33 mg/kg/day for humans or about
800 mg per day for a 60 kg individual.
[0026] In other aspects, the dosage of alpha-lipoic acid in the
composition is in the range from about 100, 150, 200, 250, 300,
350, 400, 450, 500, 550 600, 650, 700 or 750 mg, to about 2000,
1900, 1800, 1700, 1600, 1500, 1400, 1300, 1200, 1150, 1100, 1050,
1000, 950, 900 or 850 mg. In other aspects, the dosage of
alpha-lipoic acid in the composition is 100, 150, 200, 250, 300,
350, 400, 450, 500, 550, 600, 650, 700, 750, 800, 850, 900, 950,
1000, 1050, 1100, 1150, 1200, 1250, 1300, 1350, 1400, 1450, 1500,
1550, 1600, 1650, 1700, 1750, 1800, 1850, 1900, 1950, or 2000
mg.
[0027] Curcumin is the one of the main curcuminoids found in the
Indian spice turmeric (Curcuma longa), which are phenols
responsible for the yellow color of turmeric and have long been
used in the food industry as food coloring. Traditionally, for
therapeutic uses, turmeric has been used to treat a variety of
conditions or disorders including pain, gastrointestinal, liver,
and pulmonary, and has been used both orally and topically.
Curcumin has been shown to have antioxidant, anti-inflammatory,
antibacterial, and antiviral activity.
[0028] Curcumin, in some aspects, may be synthetically produced. In
other aspects, curcumin may be isolated or derived from plant
material, where it may be obtained from extracts of whole plant or
from particular plant parts, preferably from rhizomes.
Alternatively, curcumin may be obtained from unprocessed plant
material. Curcumin may be obtained from different plant sources
including Curcuma longa, Curcuma aromatic, Curcuma zedoaria,
Curcuma Phaeocaulis, Curcuma xanthorrhiza, Curcuma manga, Etlingera
elatior, Costus speciosus, and Zingiber cassumunar. Preferred plant
sources include Curcuma longa. For extracts, preferred solvents
include acetone, methanol, ethanol, isopropanol, hexane, and ethyl
acetate; however, other suitable solvents may be used, which are
known to those skilled in the art. Although other suitable
extraction methods will be known to those skilled in the art, a
typical extraction procedure is as follows. Dried rhizome is ground
into powder and washed with a suitable solvent that extracts the
color fraction containing curcumin, which may be distilled to
obtain an oleoresin. The oleoresin is washed further using suitable
solvents to extract the curcumin. Commercial turmeric preparations
are available with curcumin contents ranging from about 3-98%. The
daily dosage of curcumin is about 5 mg to about 1000 mg or about
0.06 mg/kg to about 20 mg/kg. Preferred amounts of curcumin is
about 5 mg/kg/day for humans or about 300 mg per day for a 60 kg
individual.
[0029] According to one embodiment, a composition is provided
comprising alpha-lipoic acid and curcumin. The alpha-lipoic acid
may be provided as R-lipoic acid or as a racemic mixture. The
curcumin may be provided as purified curcumin, synthetic curcumin,
or as a plant or plant extract. Preferred amounts of alpha-lipoic
acid include about 13.33 mg/kg/day for humans or about 800 mg per
day for a 60 kg individual. Preferred amounts of curcumin include
about 5 mg/kg/day for humans or about 300 mg per day for a 60 kg
individual.
[0030] In other aspects, the dosage of alpha-lipoic acid in the
composition is in the range from about 400, 450, 500, 555, 600,
650, 700, 725 750 or 775 mg to about 1600, 1500, 1400, 1300, 1200,
1150, 1100, 1050, 1000, 950, 900, 875, 850 or 825 mg. In other
aspects, the dosage of alpha-lipoic acid in the composition is
about 400, 450, 500, 550, 600, 700, 725, 750, 775, 800, 825, 850,
875, 900, 950, 1000, 1050, 1100, 1150 or 1200 mg. In other aspects,
the dosage of alpha-lipoic acid in the composition is in the range
from about 5.0, 6.0, 7.0, 8.0, 9.0, 9.5, 10.0, 10.5, 11.0, 11.5,
12.0, 12.5, 13, or 13.25 mg/kg to about 50, 45, 40, 35, 30, 25, 20,
15, 14 or 13.5 mg/kg.
[0031] In other aspects, the dosage of curcumin in the composition
is in the range from about 50, 100, 150, 200, 225, 250 or 275 mg to
about 600, 550, 500 450, 425, 400, 375, 350 or 325 mg. In other
aspects, the dosage of curcumin in the composition is about 50,
100, 150, 200, 225, 250, 275, 300, 325, 350, 375, 400, 450, 500,
550 or 600 mg. In other aspects, the dosage of curcumin in the
composition is in the range from about 0.06, 0.08, 0.1, 0.2, 0.5,
1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4, or 4.5 mg/kg to about 20, 15, 10,
9, 8, 7, 6 or 5.5 mg/kg.
[0032] While the amounts of alpha-lipoic acid and curcumin in the
composition should be as described above in order to be most
effective, the ratio of the two may also be a factor in
effectiveness. The ratio of alpha-lipoic acid to curcumin in the
composition is preferably greater than 1 (i.e. more alpha-lipoic
acid than curcumin). Preferably, the ratio is from about 2:1 to
about 5:1, more preferably from about 2:1 to about 4:1. The most
preferred ratio of alpha-lipoic acid to curcumin is about
2.67:1.
[0033] According to another embodiment, a composition comprising
alpha-lipoic acid and curcumin is used in a method of reducing body
weight of an individual. In some aspects the method is for reducing
body weight gain or attenuating body weight gain in an individual,
particularly when the individual is consuming a diet permissive to
body weight gain or other circumstance permissive to body weight
gain such as during periods of inactivity. Such a diet is
frequently employed by individuals attempting to increase muscle,
or lean mass, while minimizing weight gain. In such cases,
increases in body weight are due to both increases in lean mass and
fat mass, whereas the increased fat mass is incidental to
increasing lean mass and generally undesired.
[0034] According to another embodiment, a composition comprising
alpha-lipoic acid and curcumin is used in a method of reducing body
fat of an individual. In some aspects the method is for reducing or
attenuating body fat gain in an individual, particularly when the
individual is consuming a diet permissive to body fat gain. Such a
diet is frequently employed by individuals attempting to increase
muscle, or lean mass, but wishing to minimize increases in body
fat. In some aspects the method is for reducing body fat mass or
for reducing gains in body fat mass in circumstances permissive to
increases in body fat mass. In other aspects, the method is for
reducing body fat percent (%) or for reducing gains in body fat %
as might occur in situations where body fat mass is maintained
while lean mass is increased, as is often desirable.
[0035] According to another embodiment, a composition comprising
alpha-lipoic acid and curcumin is used in a method of attenuating
loss of lean mass or of attenuating reductions in lean mass accrual
in circumstances permissive to loss of lean mass or reductions in
lean mass accrual. Circumstances permissive to loss of lean mass or
reductions in lean mass accrual include, but are not limited to,
being in a caloric deficit, periods of physical inactivity, and
periods of over-excessive intense exercise. Such a circumstance may
also include where an individual wishes to consume alpha-lipoic
acid for a specific benefit but does not wish to experience the
potential loss of lean mass or attenuated increase in lean mass
accrual. Such circumstances also arise where individuals may reduce
food intake and/or increase exercise volume/intensity in order to
reduce body weight or fat mass while maintaining existing muscle
mass. Individuals may also reduce food intake and/or increase
exercise volume/intensity in order to maintain body weight or fat
mass while attempting to increase lean mass.
[0036] According to another embodiment, a composition comprising
alpha-lipoic acid and curcumin is used in a method of attenuating
reductions in caloric intake in circumstances permissive to reduced
caloric intake. Circumstances permissive to reduced caloric intake
include, but are not limited to, loss of or reduction in appetite
such as during illness or stress. Such a circumstance may also
occur where an individual wishes to consume alpha-lipoic acid for a
specific benefit but does not wish to experience the potential
reduction in caloric intake as may arise when an individual does
not wish to lose weight as may occur with reduced caloric
intake.
[0037] According to another embodiment, a method of improving the
characteristics of a nutritional supplement is used in which a
composition comprising alpha-lipoic acid and curcumin is added to
said nutritional supplement prior to ingestion of said nutritional
supplement. By such addition, the nutritional supplement may be
improved in one or more of the following characteristics: body
weight gain reduction; body fat reduction, muscle increase; or lean
mass increase.
EXAMPLE
Method
[0038] Based on the preferred dose in humans of about 13.33
mg/kg/day or about 800 mg per day for a 60 kg individual for
alpha-lipoic acid and the preferred dose in humans of about 5
mg/kg/day or about 300 mg per day for a 60 kg individual for
curcumin, diets for the mice were designed to provide the mice with
the appropriate equivalent amounts of the required components for
each of the experimental groups. The following formula for Human
Equivalent Dose (HED) was used to calculate the dose for mouse
diets:
HED=Animal Dose.times.(Animal Weight/Human Weight).sup.0.33 [0039]
for alpha-lipoic acid,
[0039] 800 mg/kg=Animal Dose.times.(0.025 kg/60 kg).sup.0.33
13.33 mg/kg=Animal Dose.times.(0.0766) [0040] Animal Dose=174.02
mg/kg [0041] and for curcumin,
[0041] 300 mg/kg=Animal Dose.times.(0.025 kg/60 kg).sup.0.33
5 mg/kg=Animal Dose.times.(0.0766) [0042] Animal Dose=65.27
mg/kg
[0043] 5 week old C57BL6/J male mice were divided into 2 groups as
follows: normal diet (ND) (10% kcal/fat) or high fat diet (HFD)
(60% kcal/fat) each containing the same total calories. At 12 weeks
of age, the HFD group was further divided into 4 groups as follows:
HFD alone, HFD supplemented with alpha-lipoic acid (HFD+ALA), HFD
supplemented with curcumin (HFD+CUR), or HFD supplemented with
alpha-lipoic acid plus curcumin (HFD+ALA+CUR). Based on the average
food intake, the daily dose for alpha-lipoic acid in the HFD+ALA
group was about 174 mg/kg, the daily dose for curcumin in the
HFD+CUR group was about 65 mg/kg, and the daily dose for each
component in the HFD+ALA+CUR group was similar to that in the
respective groups. Each of the 5 groups contained 8-10 mice. Body
weight of the mice was recorded weekly and food intake was
monitored every two days. After 10 weeks of treatment mice from
each group were subjected to dual-energy X-ray absorptiometry
(DEXA) scan; percent (%) body fat, fat mass, and lean mass were
calculated.
Results
[0044] FIG. 1 shows the body weight of the mice during the course
of the experiment. As expected the HFD mice exhibited increase in
body weight compared to the ND mice. Each of the HFD+ALA and
HFD+CUR weight gain less than the HFD mice. However, the
HFD+ALA+CUR mice had a much greater inhibition of weight gain,
which also appeared to be more stable over time.
[0045] FIG. 2 shows the average weight prior to the start of
treatment and FIG. 3 shows the average weight at the end of 11
weeks of treatment. Before treatment, all HFD mice had gained
weight compared to ND mice. Following 11 weeks of treatment, either
alpha-lipoic acid or curcumin alone attenuated weight gain, while
alpha-lipoic acid combined with curcumin lead to a greater
inhibition of weight gain compared to each of alpha-lipoic acid or
curcumin alone. Note: for FIGS. 2 and 3 *p<0.001 compared to ND
mice, .sup.&p<0.001 compared to HFD mice,
.sup..dagger-dbl.p<0.001 compared to HFD+ALA mice.
[0046] FIGS. 4 and 5 show the food intake of the mice in grams and
the food intake of the mice in terms of kcals consumed per day per
gram body weight, respectively. Mice receiving alpha-lipoic acid
alone or combined with curcumin exhibited reduced food intake,
while reduced calorie intake was only observed in the alpha-lipoic
acid group, suggesting that curcumin may attenuate or reverse the
appetite-reducing effects of alpha-lipoic acid. Note:
.sup.&p<0.001 compared to HFD mice.
[0047] FIGS. 6-8 show the results of DEXA analysis at the end of 10
weeks treatment. FIG. 6 shows the results for body fat %, FIG. 7
shows the results for fat mass (grams), and FIG. 8 shows the
results for lean mass (grams). As expected, the HFD group showed
significantly increased body fat %. Alpha-lipoic acid alone failed
to reduce body fat %, while curcumin alone reduced the increased
body fat % from a high fat diet. Interestingly, the combination of
alpha-lipoic and curcumin exhibited near normal levels similar to
the ND group. The effects on fat mass (FIG. 7) were similar to body
fat %; however alpha-lipoic acid alone resulted in an attenuated
increase in fat mass compared to the HFD group, albeit to a lesser
degree than curcumin alone. Again, the combination of alpha-lipoic
and curcumin exhibited near normal levels of fat mass. Lean mass
was increased in the HFD group and was unaltered by treatment with
curcumin alone or with alpha-lipoic combined with curcumin, while
treatment with alpha-lipoic acid alone exhibited a significant
attenuation in lean mass accrual (FIG. 8). Note: *p<0.001
compared to ND mice, .sup.&p<0.001 compared to HFD mice,
.sup..dagger-dbl.p<0.001 compared to HFD+ALA mice.
[0048] Taking these results, the combination of alpha-lipoic acid
with curcumin exhibits beneficial effects for different parameters
of body composition, for some of which the combination exerts
synergism, enhancement, or potentiation. While each of alpha-lipoic
acid and curcumin show efficacy at attenuating weight gain in the
context of diets permissive for gaining weight, the combination
proved significantly more effective. Likewise, the combination
proved significantly more effective for attenuating body fat mass
and body fat % increases compared to either alpha-lipoic acid or
curcumin alone.
[0049] In addition to the foregoing, the compositions of the
present invention include formulations further comprising
additional active ingredients and/or inactive ingredients,
including solvents, diluents, suspension aids, thickening or
emulsifying agents, sweeteners, flavorings, preservatives, solid
binders, lubricants and the like, as suited to the particular
dosage form desired. Except insofar as any conventional carrier
medium is incompatible with the ingredients of the invention, such
as by producing any undesirable effect or otherwise interacting in
a deleterious manner with any other ingredient(s) of the
formulation, its use is contemplated to be within the scope of this
invention.
[0050] According to various embodiments of the present invention,
the nutritional supplement may be consumed in any form. For
instance, the dosage form of the nutritional supplement may be
provided as, e.g., a powder beverage mix, a liquid beverage, a
ready-to-eat bar or drink product, a capsule, a liquid capsule, a
tablet, a caplet, or as a dietary gel. The preferred dosage forms
of the present invention are as a capsule, a tablet, or a
caplet.
[0051] Furthermore, the dosage form of the nutritional supplement
may be provided in accordance with customary processing techniques
for herbal and nutritional supplements in any of the forms
mentioned above. Additionally, the nutritional supplement set forth
in the example embodiment herein may contain any appropriate number
and type of excipients, as is well known in the art.
[0052] The above-described embodiments are intended to be examples
of the present invention and alterations and modifications may be
effected thereto, by those of skill in the art. The scope of the
claims should not be limited by the preferred embodiments set forth
in the examples, but should be given the broadest interpretation
consistent with the description as a whole. It will be evident that
various modifications and changes may be made thereto without
departing from the broader spirit and scope of the invention.
[0053] All publications which are cited herein are hereby
specifically incorporated by reference into the disclosure for the
teachings for which they are cited.
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