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Weight Loss Patent Abstract
A combination of Eurycoma longifolia and citrus peel extract are
provided in a supplement to promote weight loss and help dieters
maintain high energy levels by reducing the body's normal shift
to a catabolic state during weight loss. The Eurycoma longifolia
root extract preferably includes eurypeptides and the citrus peel
extract preferably includes tangeretin, nobiletin, and sinensetin.
The supplement can be in any suitable form and is preferably administered
in conjunction with a weight loss regime that includes a caloric
deficiency diet and an exercise program.
Weight Loss Patent Claims
1. A dietary supplement, comprising:from about 1 mg to about 1000
mg of a Eurycoma longifolia root extract; andfrom about 100 mg to
about 500 mg of a citrus peel extract.
2. The dietary supplement of claim 1, wherein the Eurycoma longifolia
is obtained by a hot water extraction process yielding 18-28% eurypeptides.
3. The dietary supplement of claim 1, wherein the effective dose
comprises from about 20 mg to about 200 mg of a Eurycoma longifolia
root extract containing from about 18% to about 28% eurypeptides.
4. The dietary supplement of claim 1, wherein the citrus peel extract
comprises at least one of tangeretin, nobiletin, and sinensetin.
5. The dietary supplement of claim 1, wherein the citrus peel extract
comprises:from about 5 mg to about 20 mg tangeretin;from about 5
mg to about 20 mg nobiletin, andfrom about 2 mg to about 10 mg sinensetin.
6. The dietary supplement of matter of claim 1, wherein the citrus
peel extract comprises at least about 10 mg polymethoxylated flavones
(PMFs).
7. The dietary supplement of claim 1, wherein the citrus peel extract
comprises at least about 80 mg PMFs.
8. The dietary supplement of claim 1, further comprising:a dietary
acceptable carrier prepared in a dosage form selected from the group
consisting of a liquid, a gel, a tablet, a capsule, a powder, a
confectionary, and a supplemented food.
9. The dietary supplement of claim 8, wherein the dietary acceptable
carrier comprises an exercise beverage formulated for administration
during exercise.
10. The dietary supplement of claim 8, further comprising at least
one of whey protein, ginseng, caffeine, guarana, green tea extract,
chromium, vanadium, and CLA.
11. A method for promoting weight loss in a human subject, the
method comprising:administering to a human subject participating
in a multi-day exercise routine a dietary intake consisting of a
caloric intake that is insufficient to maintain the human subject's
weight over the course of the multi-day exercise routine; andadministering
to the human subject a dietary supplement as defined as in claim
1.
12. A topical supplement, comprising:from about 1 mg to about 1000
mg of a Eurycoma longifolia root extract;from about 100 mg to about
500 mg of a citrus peel extract; anda topical cream configured for
facilitating transdermal absorption of the citrus peel extract and
Eurycoma longifolia.
13. The supplement of claim 12, wherein the Eurycoma longifolia
is obtained by a hot water extraction process yielding 18-28% eurypeptides.
14. A method for promoting weight loss in a human subject, the
method comprising:administering to a human subject participating
in a multi-day exercise routine a dietary intake consisting of a
caloric intake that is insufficient to maintain the human subject's
weight over the course of the multi-day exercise routine; andadministering
to the human subject a topical supplement as defined as in claim
12.
15. A method for promoting weight reduction in a human subject,
the method comprising administering a supplement to a human subject
in need thereof during weight loss, the supplement comprising:an
effective dose of citrus peel extract for inhibiting weight gain
or promoting weight loss in a human subject; andan effective dose
of Eurycoma longifolia for promoting weight loss and maintaining
energy levels during weight loss in the human subject.
16. The method of claim 15, wherein:the effective dose of Eurycoma
longifolia root extract comprises from about 1 mg to about 1000
mg; andthe effective dose of citrus peel extract comprises from
about 100 mg to about 500.
17. The dietary supplement of claim 15, wherein the effective doses
are defined as sufficient to reduce salivary cortisol levels by
at least 5% relative to cortisol levels that would result in the
absence of the administration of the citrus peel extract and Eurycoma.
18. The dietary supplement of claim 15, wherein the effective doses
are defined as sufficient to decrease the cortisol:testosterone
ratio by at least 5% relative to the cortisol:testosterone ratio
that would result in the absence of the administration of the citrus
peel extract and Eurycoma.
19. The method of claim 15, further comprising administering the
supplement daily in conjunction with an exercise regime and a diet
comprising a caloric deficiency.
20. The method of claim 15, wherein the Eurycoma longifolia root
extract comprises from about from about 18% to about 28% eurypeptides.
21. The method of claim 15, wherein the Eurycoma longifolia root
extract comprises from about 20 mg to about 200 mg of a Eurycoma
longifolia root extract containing from about 18% to about 28% eurypeptides.
22. The method of claim 15, wherein the supplement is in a oral
form selected from the group consisting of a shake, beverage, a
tablet, a capsule, a powder, a confectionary, and a supplemented
food.
23. The method of claim 15, wherein the supplement is blended with
a topical cream for topical administration and the act of administering
the supplement comprises topically administering the supplement.
24. The method of claim 15, wherein the citrus peel extract comprises
at least one of tangeretin, nobiletin, and sinensetin.
25. A method for preventing or treating conditions enhanced by
the presence of excess glucocorticoids in a mammal, the method comprising:administering
to a mammal having a caloric deficiency a therapeutically effective
dose of citrus peel extract and Eurycoma longifolia root extract
for reducing excess glucocorticoids in the mammal.
26. The method of claim 25, wherein the therapeutically effective
dose of citrus peel extract comprises from about 100 mg to about
500 mg and the therapeutically effective dose of Eurycoma longifolia
root extract comprises from about 1 mg to about 1000 mg.
27. The method of claim 26, wherein the Eurycoma longifolia root
extract comprises from about from about 18% to about 28% eurypeptides.
28. The method of claim 26, further comprising placing the mammal
in said caloric deficiency by administering to the mammal a reduce
calorie diet in conjunction with an exercise regime.
29. The method of claim 25, wherein the excess glucocorticoids
are cortisol.
30. A method for promoting weight reduction in a human subject,
the method comprising administering a supplement to a human subject
in need thereof during weight loss, the supplement comprising:from
about 1 mg to about 300 mg eurypeptides; andat least about 10 mg
polymethoxylated flavones.
Weight Loss Patent Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001]This application claims the benefit of Provisional Application
No. 60/785,163, filed Mar. 23, 2006, entitled "Weight Loss
Compositions Using Citrus Peel Extract And Eurycoma Longifolia,"
which is incorporated by reference herein.
BACKGROUND OF THE INVENTION
[0002]1. The Field of the Invention
[0003]The present invention relates to the fields of food compositions
and dietary supplements. More particularly, the invention provides
compositions and methods for the use of citrus peel extract and
Eurycoma longifolia for weight loss.
[0004]2. The Relevant Technology
[0005]Obesity, diabetes, and metabolic syndrome ("Syndrome
X"--encompassing insulin resistance, type 2 diabetes, dyslipidemia,
hypertension, and abdominal obesity) are reaching epidemic proportions
in the United States and around the world. Excess glucocorticoids
such as cortisol (a primary stress hormone) have been theorized
to contribute to visceral obesity and diabetes.
[0006]One way of categorizing metabolic processes, whether at the
cellular, organ or organism level is as anabolic or catabolic. Catabolism
is the part of metabolism that breaks down molecules into smaller
units to generate energy and simultaneously takes measures to conserve
energy. Stress such as weight loss and exercise can put the body
into the catabolic state, in which the body can experience muscle
loss, reduced metabolic rate with a corresponding reduced calorie
expenditure and lower perceived energy levels, and weight gain in
the form of fat. One aspect of the catabolic state is that it can
be characterized as having high cortisol (a catabolic stress hormone)
levels and low testosterone (an anabolic hormone) levels. Conversely,
in the anabolic state the body experiences muscle maintenance or
growth, normal metabolic rates, and weight loss in the form of fat.
The anabolic state can be characterized by relatively low cortisol
levels and high testosterone levels.
[0007]As noted above, weight loss and intense exercise both place
the body in a catabolic state with reducing testosterone levels
and elevating cortisol levels. While these bodily responses serve
their intended role for survival, they inhibit the ability of humans
to lose weight or perform at a high level during lengthy strenuous
exercise. Accordingly, methods of controlling or limiting this effect
would represent an advance in the art of dietary supplements.
BRIEF SUMMARY OF THE INVENTION
[0008]The present invention uses a synergistic combination of supplements
to help mammals, e.g. people, lose weight. The inventive combinations
preferably include complementary does of Eurycoma longifolia and
citrus peel extract to promote weight loss and help dieters maintain
high energy levels by reducing the body's normal shift to a catabolic
state during weight loss. The Eurycoma longifolia root extract preferably
includes eurypeptides and the citrus peel extract preferably includes
tangeretin, nobiletin, and sinensetin. The supplement can be in
any suitable form and is preferably administered in conjunction
with a weight loss regime that includes a caloric deficiency diet
and an exercise program.
[0009]The current invention represents an important and innovative
treatment for obesity, diabetes, and related metabolic diseases
by promoting weight loss, controlling blood sugar levels, and maintaining
high energy levels. The herein disclosed supplements have been found
particularly effective at increasing weight loss during exercise
and dieting and improving the stress levels of the subjects, which
in turn increases the likelihood of a patient staying with the diet.
[0010]Accordingly, a first example embodiment of the invention
is a dietary supplement including from about 1 mg to about 1000
mg of a Eurycoma longifolia root extract and from about 100 mg to
about 500 mg of a citrus peel extract. The Eurycoma longifolia is
preferably obtained by a hot water extraction process yielding 18-28%
eurypeptides. The citrus peel extract includes polymethoxylated
flavones, preferably at least one of tangeretin, nobiletin, and
sinensetin. The supplement can be administered in a dietary acceptable
carrier prepared in a dosage form such as, by way of example only,
a shake, a beverage, liquid, a gel, a tablet, a capsule, a powder,
a confectionary, or a supplemented food. Other additives that can
be effectively added include, again by way of example only, whey
protein, ginseng, caffeine, guarana, green tea extract, chromium,
vanadium, and CLA.
[0011]Another example embodiment of the invention is a topical
supplement. One example topical supplement general includes from
about 1 mg to about 1000 mg of a Eurycoma longifolia root extract,
from about 100 mg to about 500 mg of a citrus peel extract, each
blended in a topical cream blended that is selected and configured
for facilitating transdermal absorption of the citrus peel extract
and Eurycoma longifolia.
[0012]Another example embodiment of the invention is a method for
promoting weight loss in a human subject. The method generally includes:
administering to a human subject participating in a multi-day exercise
routine a dietary intake consisting of a caloric intake that is
insufficient to maintain the human subject's weight over the course
of the multi-day exercise routine; and administering to the human
subject an oral supplement including Eurycoma longifolia and citrus
peel extract, as described elsewhere herein.
[0013]Another example embodiment of the invention is another method
for promoting weight loss in a human subject. This method generally
includes: administering to a human subject participating in a multi-day
exercise routine a dietary intake consisting of a caloric intake
that is insufficient to maintain the human subject's weight over
the course of the multi-day exercise routine, and administering
to the human subject a topical supplement including Eurycoma longifolia
and citrus peel extract, as described elsewhere herein.
[0014]Yet another example embodiment of the invention is a method
for promoting weight reduction in a human subject by administering
a supplement to a human subject in need thereof during weight loss.
The supplement generally includes an effective dose of citrus peel
extract for inhibiting weight gain or promoting weight loss in a
human subject and an effective dose of Eurycoma longifolia for promoting
weight loss and maintaining energy levels during weight loss in
the human subject. The effective dose can be defined as the amounts
sufficient to reduce salivary cortisol levels by at least about
5%, more preferably at least about 10%, still more preferably at
least about 15%, all relative to cortisol levels that would result
in the absence of the administration of the citrus peel extract
and Eurycoma. The effective dose can also be defined as the amount
sufficient to decrease the cortisol:testosterone ratio by at least
about 5%, more preferably at least about 10%, still more preferably
at least 15%, all relative to the cortisol:testosterone ratio that
would result in the absence of the administration of the citrus
peel extract and Eurycoma. This example method is preferably administered
in conjunction with an exercise regime and a diet comprising a caloric
deficiency.
[0015]Another example embodiment of the invention is a method for
preventing or treating conditions enhanced by the presence of excess
glucocorticoids, e.g. cortisol, in a mammal. This method generally
includes administering to a mammal having a caloric deficiency a
therapeutically effective dose of citrus peel extract and Eurycoma
longifolia root extract for reducing excess glucocorticoids in the
mammal. The method may optionally include placing the mammal in
the caloric deficiency by administering to the mammal a reduced
calorie diet in conjunction with an exercise regime. It has been
found according to the invention that the therapeutically effective
dose of citrus peel extract and Eurycoma longifolia root extract
reduces the levels of glucocorticoids the body accumulates in response
to such a caloric deficiency and exercise induced stress.
[0016]These and other objects and features of the present invention
will become more fully apparent from the following description and
appended claims, or may be learned by the practice of the invention
as set forth hereinafter.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0017]In the following description, numerous specific details are
set forth in order to provide a thorough understanding of the present
invention. It will be obvious, however, to one skilled in the art
that the present invention may be practiced without these specific
details. In other instances, well-known aspects of dietary supplements,
topical creams, and the various compounds discussed herein have
not been described in particular detail in order to avoid unnecessarily
obscuring the present invention.
[0018]The present invention uses a synergistic combination of supplements
to help mammals, e.g. people, lose weight. The inventive combinations
preferably include complementary does of Eurycoma longifolia and
citrus peel extract to promote weight loss and help dieters maintain
high energy levels by reducing the body's normal shift to a catabolic
state during weight loss. Each of these components is described
generally below, followed by a discussion of the inventive compositions,
with several examples.
Citrus Peel Extract
[0019]Citrus peel extract includes Polymethoxylated Flavones (PMFs),
particularly tangeretin, sinensetin, and nobilitin, which are known
to have health benefits in reducing cholesterol and promoting cardiovascular
health. According to the invention it has also been determined that
PMFs also help reduce cortisol levels. Cortisol is a stress hormone,
higher levels of which have been tied to weight gain. Accordingly,
the present invention provides compositions and methods using PMFs
for the prevention and treatment of diabetes and obesity. Individuals
at high risk of developing or having diabetes or desiring to prevent
weight gain or promote weight loss may be treated with an effective
dose of citrus polmethoxylated flavones (PMFs). More particularly,
the present invention relates to the discovery and use of PMFs to
reduce systemic and local cortisol concentrations (liver and adipose
tissue), and promoting blood sugar control and weight loss.
[0020]It has been determined that different extraction processes
in fact result in different products with different concentrations
and ratios of PMFs. The extraction process can therefore be selected
and modified as desired to shift the ratios of the component PMFs.
For example, a preferred citrus peel extract has: from about 5 mg
to about 20 mg tangeretin; from about 5 mg to about 20 mg nobiletin,
and from about 2 mg to about 10 mg sinensetin.
[0021]The weight loss promoting effect of citrus peel extract can
be enhanced with additives such as green tea extract, chromium,
vanadium, CLA, and the like.
Eurycoma longifolia
[0022]Eurycoma (Eurycoma longifolia, also known as Tongkat ali
and Malaysian ginseng) is a traditional Malaysian herbal remedy
used for increasing energy levels and libido in older men. According
to the invention, effective compositions and methods of using Eurycoma
have now been identified for the maintenance of an anabolic hormone
profile during weight loss. Individuals attempting to lose weight,
for example with the use of citrus peel extract as described below,
may be treated with an effective dose of Eurycoma to enhance weight
loss and maintain high energy levels.
[0023]Eurycoma according to the invention helps enhance weight
loss and maintain high energy levels by maintaining normal levels
of cortisol and testosterone during weight loss. More particularly,
Eurycoma is used to help maintain normal (low) cortisol and normal
(high) testosterone levels during the stress of weight loss. This
hormonal control provides energy to a person in a weight loss phase
while simultaneously helping them lose weight. As a result, effective
doses of Eurycoma help prevent the body from seeking to gain weight
by storing fat and increasing appetite. The Eurycoma as used according
to the invention can thereby help stop the "yo-yo" diet
effect where a dieter's initial weight loss of a few pounds sends
the body into a catabolic state, leading to binge eating and fat
storage. In particular, it is believed that inhibiting or reducing
the cortisol spike associated with weight loss can make it easier
or a person to control their appetite. Similarly, it is believed
that controlling the cortisol and testosterone levels helps prevent
the body from increasing fat storage and increases a person's baseline
energy.
[0024]Although not each embodiment of the invention is tied to
any particular extraction process, a presently preferred extraction
process is a hot water extraction process yielding 18-28% eurypeptides
confirmed by HPLC analysis.
[0025]The energy enhancing effect of the Eurycoma may be increased
with the aid of energy boosting supplements such as other ginseng
forms, caffeine, guarana, and the like.
Compositions
[0026]Compositions according to the invention preferably include
citrus peel extract to promote weight loss and promote blood sugar
control and Eurycoma to further promote weight loss while maintaining
high energy levels. The use of these two compositions in conjunction
with one another has been found to provide a synergistically improved
dietary supplement to promote weight loss.
[0027]In addition, the foregoing components can be preferably combined
with a variety of other supplements, vitamins, stabilizers, and
the like as are known in the art and in view of the disclosure herein
to create a desirable supplement. By way of example only, such additives
can include other forms of ginseng, caffeine, guarana, green tea
extract, chromium, vanadium, CLA, and the like.
[0028]According to one embodiment of the invention, a mammalian
subject can be administered once a day a composition of matter having
from about 10 mg to about 1,000 mg of a citrus peel extract and
from about 10 mg to about 500 mg of Eurycoma root extract, preferably
containing 18-28% eurypeptides. Of course, the amount of citrus
peel extract and Eurycoma will preferably increase or decrease depending
on the concentrations and activities of the citrus peel extract
and Eurycoma root extract. In a more preferred embodiment the composition
of matter has from about 25 mg to about 250 mg of a citrus peel
extract and from about 25 mg to about 250 mg of Eurycoma root extract,
preferably containing 18-28% eurypeptides. In a still more preferred
embodiment the composition of matter has from about 50 mg to about
100 mg of a citrus peel extract and from about 50 mg to about 100
mg of Eurycoma root extract, preferably containing 18-28% eurypeptides.
In various preferred embodiments the citrus peel extract preferably
has at least about 10 mg PMFs and at least about 10 mg of a Eurycoma
root extract containing 18-28% eurypeptides. As previously noted,
the foregoing ranges of all citrus peel extract and Eurycoma components
disclosed herein may increase or decrease depending on the extraction
techniques and other variables.
[0029]Alternatively, in addition to or in lieu of a measured dose
of citrus peel extract with the Eurycoma, the invention may include
a composition of matter having one or more of tangeretin, nobiletin,
and sinensetin with the Eurycoma. By way of example only, the dosage
may have one or more of from about 1 mg to about 50 mg of tangeretin,
from about 1 mg to about 50 mg of nobiletin, and from about 1 mg
to about 20 mg of sinensetin. Of course, the dosage will increase
or decrease depending on the concentration of the citrus peel extract.
In a more preferred embodiment the composition of matter has from
about 5 mg to about 20 mg of tangeretin, from about 5 mg to about
20 mg of nobiletin, and from about 2 mg to about 10 mg of sinensetin.
[0030]A preferred embodiment of the invention is a composition
of matter having an effective dose of citrus peel extract for promoting
weight loss in a mammal and an effective dose of Eurycoma longifolia
for promoting weight loss and maintaining energy levels during weight
loss in a mammal. As used herein, the term "an effective dose"
indicates an amount sufficient to create a desirable or required
result. For example, in one embodiment an effective dose is the
amount necessary to obtain a measurable change in cortisol levels.
One example of an effective dose may therefore an amount preferably
reduce cortisol levels by at least about 5 percent, more preferably
at least about 10%, still more preferably at least about 15%, all
relative to a cortisol level change that would occur in the absence
of taking the effective dose. In other words, an effective may be
an amount that reduces cortisol gain in a dieter from 15% to 10%.
Alternatively, an effective dose can be the amount necessary to
promote a relative weight reduction, wherein a relative weight loss
is defined by a human obtaining a lower weight than the human user
would have obtained without receiving the effective dosage. The
precise parameters of an effective dose may of course vary with
a number of factors, including by way of example only, weight, gender,
age, and desired result.
[0031]The compositions of the present invention may be formulated
for administration through various known routes of administration,
such as oral, parenteral, and transdermal routes. Examples of oral
dosage formulations include without limitation, tablets, capsules,
liquids, suspensions, gels, powders, effervescent beverages, lozenges,
chewing gum, candy, supplemented food, etc. Examples of transdermal
routes of administration include without limitation, topical formulations,
such as lotions, creams, gels, and pastes, and transdermal patches,
such as liquid reservoir patches, plasters, and adhesive matrix
patches. Suitable ingredients required to produce a particular formulation,
such as specific carriers, excipients, binders, penetration enhancers,
etc., will be readily recognized by those of ordinary skill in the
art and are not discussed in detail herein to avoid obscuring the
invention.
[0032]For example, one preferred administration route is as a diet
shake. The diet shake can be provided to a user in either liquid
form or as a powder having suitable ingredients for the user to
form a shake upon mixture with a liquid. In addition, a supplemented
food such as a nutritional bar or dessert is also preferred.
[0033]The herein disclosed supplements can be preferably combined
in the foregoing administration forms with a variety of other additives
such as known supplements, vitamins, stabilizers, and the like as
are known in the art to create a desirable administration form.
By way of example only, such additives can include other forms of
whey protein, ginseng, caffeine, guarana, green tea extract, chromium,
vanadium, CLA, and the like.
[0034]Other conventional additives such as stabilizers, pH adjusters,
excipients, carriers and diluents and the like may be added as desired
or necessary as is known in the art provided they do not interfere
with the activity of citrus peel extract.
[0035]The compositions of the invention can be formulated so as
to provide quick, sustained or delayed release of the citrus peel
extract after administration employing procedures and formulations
known in the art.
[0036]For weight reduction, a regular dosage regime is preferably,
though not necessarily, implemented. The generation of appropriate
dosage regimes and the timing of single use applications can be
determined by one of skilled in the art in view of the disclosure
herein. By way of example only, however, a person in a weight loss
regime can preferably take one daily supplement within the foregoing
ranges of citrus peel extract and Eurycoma. Alternatively, a person
can take a single supplement. The regime is preferably administered
in conjunction with an exercise regime and reduced calorie diet
where the citrus peel extract and Eurycoma increase weight loss
and reduce stress.
[0037]The following examples are shown by way of illustration only.
EXAMPLES
Example 1
[0038]A weight loss shake can be prepared by adding to water a
powder having an effective dose of citrus peel extract and Eurycoma
longifolia in a composition as follows:
TABLE-US-00001 TABLE 1 Ingredient Amount Eurycoma longifolia 50
mg (18 28% eurypeptides) Citrus peel extract 80 mg Whey protein
20 g concentrate Maltodextrin 20 g Fructose 5 g Lecithin 2 g Total
47.13 g
Example 2
[0039]A dietary supplement for human consumption incorporating
an effective dose of citrus peel extract and Eurycoma longifolia
can be prepared as listed below. The supplement is preferably administered
as a tablet, capsule, or powder or admixed into a food product or
beverage.
TABLE-US-00002 TABLE 2 Ingredient Amount Eurycoma longifolia 50
mg (18 28% eurypeptides) Citrus peel extract 80 mg Green tea 100
mg Black tea 100 mg Oolong tea 100 mg Scutellaria baicalensis 250
mg Chromium 100 mcg Vanadium 10 mcg 5-HTP 100 mg Total 780.11 mg
Example 3
[0040]A twelve week study was performed to examine the effects
of using a herein disclosed supplement in a combined diet/exercise/supplement
regimen on weight loss and metabolic parameters. Thirty-two moderately
overweight adult subjects participated in the study. They had the
following characteristics:
TABLE-US-00003 TABLE 3 Baseline Characteristics Age (y) BW (kg)
BF (%) BMI N = 29 44 .+-. 8 84.1 .+-. 39.5 35.1% .+-. 9.9% 29.5
.+-. 5.6
[0041]Subjects followed a moderate calorie-restricted diet based
on resting metabolic rate (RMR), plus a moderate exercise program
(5 days a week of aerobic and strength training), stress management
techniques (daily), and a dietary supplement of 150 mg citrus flavenoids
and 50 mg Eurycoma longifolia extract administered daily in capsule
form. The study measured body weight, RMR, body fat (by BIA and
skinfold), cortisol and testosterone (by salivary enzyme immunoassay),
total cholesterol, LDL, HDL, glucose, and triglycerides before and
after the 12-week study.
[0042]Twenty-nine subjects completed the program (9% attrition
rate), suggesting that the program was easy to follow and not overly
restrictive. Results shown in Table 4 below indicate mean values
and indicate that the overall lifestyle program led to significant
changes in body weight, body fat, testosterone, total cholesterol,
and LDL (all p<0.05 by paired t-test compared to baseline values).
Resting metabolic rate, cortisol, HDL, glucose, and triglycerides
were unchanged.
[0043]In addition, before and after participation the subjects
each completed a 65 question Profile of Mood States (POMS) questionnaire.
The Profile of Mood States (POMS) is a well known test that measures
present mood state (disturbance) by a list of adjectives. In the
test, respondents rate 65 adjectives on a 5-point intensity scale
in terms of how they have been feeling in the past week (0=not at
all and 4=extremely). Except for vigor, the higher the score, the
greater the mood disturbance/more distress. For analysis, the questions
of the POMS are divided into six categories: tension, fatigue, confusion,
vigor, depression, and anger and a score calculated for each. A
Global Mood State score is also derived from the sum of all negative
categories minus the score for vigor. For further details on the
POMS test, see McNair D M, Lorr M, and Droppleman L F., Profile
of Mood States Manual, San Diego, Calif.: Educational and Industrial
Testing Services (1971). Before and after mean results are included
in Table 3 below.
[0044]The data indicates that the use of the dietary supplement
with Eurycoma and citrus peel extract in conjunction with a weight
loss dietary regimen and aerobic and resistance exercise prevents
the expected decline in fat-free mass and resting metabolic rate
and results in favorable changes in body composition, metabolic
hormones, mood, and cardiovascular parameters. The low attrition
rate suggests that the regime was not overly stressful on users
and may be expected to result in superior long-term adherence.
TABLE-US-00004 TABLE 4 Measurement Pre Post Body Weight (lbs) 185
179 Body Fat (%) 35% 33% Fat Mass (lbs) 65 59 Fat Free Mass (lbs)
120 120 Resting Metabolic Rate (calories) 1646 1623 Cortisol-to-testosterone
ratio 0.319 0.272 Total Cholesterol (mg/dl) 238 200 LDL cholesterol
(mg/dl) 149 121 Mood (all of the following numbers are 147 114 scaled
from a psychological survey - no units) Stress 21 18 Tension 14
10 Fatigue 14 10 Confusion 14 7 Vigor 22 28 Depression 14 7 Anger
16 9
Example 4
[0045]A six week study was performed to compare the effects of
using a herein disclosed supplement in a combined diet/exercise/supplement
regimen on weight loss and metabolic parameters to the effects of
not using supplement in a combined diet/exercise/supplement regimen.
Thirty moderately overweight adult subjects completed the study,
twenty using the supplement and ten serving as controls.
[0046]The test subjects followed a moderate calorie-restricted
diet based on resting metabolic rate (RMR), plus a moderate exercise
program (5 days a week of aerobic and strength training), stress
management techniques (daily), and a dietary supplement of 150 mg
citrus flavenoids and 50 mg Eurycoma longifolia extract administered
daily in capsule form. The control subjects followed the same regime
but without the dietary supplement. The study measured body weight,
RMR, body fat (by BIA and skinfold), cortisol and testosterone (by
salivary enzyme immunoassay), total cholesterol, LDL, HDL, glucose,
triglycerides, and stress factors through Profile of Mood States
exam. The subjects were tested before and after the 6-week study.
[0047]Pre and post study results shown in Table 5 below for the
test group indicate significant changes in mean body weight, body
fat, fat mass, cortisol to testosterone ratio, total cholesterol,
LDL, and MOOD (all p<0.05 by paired t-test compared to baseline
values), and each of the individual mood scores from the POMS test.
TABLE-US-00005 TABLE 5 Measurement Pre Post Body Weight (lbs) 187
181 Body Fat (%) 37% 33% Fat Mass (lbs) 69 60 Fat Free Mass (lbs)
118 121 Resting Metabolic Rate (calories) 1655 1641 Cortisol-to-testosterone
ratio .333 .266 Total Cholesterol (mg/dl) 244 192 LDL cholesterol
(mg/dl) 155 116 MOOD (all of the following numbers are scaled 152
112 from a psychological survey - no units) Stress 22 17 Tension
16 10 Fatigue 16 7 Confusion 10 8 Vigor 20 29 Depression 15 7 Anger
15 10
[0048]In contrast, Results shown in Table 6 below for the control
group indicate negligible changes in body weight, body fat, fat
mass, total cholesterol, LDL, and MOOD (all p<0.05 by paired
t-test compared to baseline values), and each of the individual
mood scores. The only significant change was a dramatic jump in
cortisol to testosterone ratio, suggesting that the body was under
stress due to the reduced caloric intake and exercise and was increasing
cortisol levels and/or decreasing testosterone levels.
TABLE-US-00006 TABLE 6 Measurement Pre Post Body Weight (lbs) 184
182 Body Fat (%) 35% 35% Fat Mass (lbs) 64 64 Fat Free Mass (lbs)
120 118 Resting Metabolic Rate (calories) 1680 1602 Cortisol-to-testosterone
ratio .309 .392 Total Cholesterol (mg/dl) 233 229 LDL cholesterol
(mg/dl) 150 140 MOOD (all of the following numbers are scaled 144
144 from a psychological survey - no units) Stress 20 20 Tension
15 14 Fatigue 15 13 Confusion 10 9 Vigor 21 23 Depression 14 11
Anger 14 12
[0049]The data indicates that the use of the dietary supplement
with Eurycoma and citrus peel extract greatly improves a weight
loss regiment that combined aerobic and resistance exercise program
with reduced caloric intake.
[0050]The present invention may be embodied in other specific forms
without departing from its spirit or essential characteristics.
The described embodiments are to be considered in all respects only
as illustrative and not restrictive. The scope of the invention
is, therefore, indicated by the appended claims rather than by the
foregoing description. All changes which come within the meaning
and range of equivalency of the claims are to be embraced within
their scope. |