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Weight Loss Patent Abstract
Disclosed are combinations of soy protein, chromium and free leucine
in amounts effective to inhibit the loss of lean body mass of a
subject under conditions of caloric restriction. The soy protein,
chromium and free leucine can be administered in several products,
including a powder that is mixable into a liquid beverage (such
as a shake), a snack bar, and a nutritional supplement (such as
one or more tablets). Some embodiments also include corosolic acid
and/or a tea drink that provides an effective dose of taurine. The
products may be contained in kits containing the disclosed combinations
as well as methods of using the products for weight loss and the
inhibition of the loss of lean body mass in a subject during weight
loss. The products and methods are also useful in the improvement
of lipid profiles (for example reducing total cholesterol and LDL
cholesterol levels).
Weight Loss Patent Claims
1. A dosage form comprising: an effective amount of soy protein,
chromium and free leucine that substantially preserves lean body
mass under conditions of caloric restriction, the dosage form providing
a daily dosage of at least 30 g of soy protein, at least 400 .mu.g
of chromium, and a sufficient amount of free leucine that the weight
ratio of soy protein to free leucine is more than 10:1.
2. The dosage form of claim 1, wherein the soy protein, chromium
and free leucine are present in the dosage form in an amount providing
a daily dosage of 32-40 g of soy protein, 400-800 .mu.g of chromium,
and 2.25-4.0 g of free leucine.
3. The dosage form of claim 2, wherein the soy protein, chromium
and free leucine are present in the dosage form in an amount providing
a daily dosage of about 35-39 g of soy protein, 600 .mu.g of chromium,
and 2.9 g of free leucine.
4. The dosage form of claim 3, further comprising an amount of
corosolic acid effective to inhibit the loss of lean body mass in
the subject under conditions of caloric restriction.
5. The dosage form of claim 4, wherein the effective amount of
corosolic acid is 0.25-1 mg of corosolic acid.
6. The dosage form of claim 5, wherein the corosolic acid is provided
by banaba leaf extract.
7. The dosage form of claim 2, wherein the dosage form further
provides a daily dosage of 25-35 mg banaba leaf extract, 300-500
mg magnesium, 15-25 mg zinc, 50-150 .mu.g vanadium, and 600-1000
mg taurine.
8. The dosage form of claim 1, wherein the dosage form comprises
multiple dosage forms, wherein the soy protein, chromium and free
leucine are each distributed into more than one dosage form.
9. The dosage form of claim 8, wherein the multiple dosage forms
comprise a powdered shake mix, a consumable snack, and a supplement.
10. The dosage form of claim 9, wherein: the shake mix provides
a daily dosage of 26-30 g soy protein, 100-300 .mu.g chromium, and
2-3 g free leucine; the consumable snack provides a daily dosage
of 6-10 g soy protein and 0.25-1.0 g free leucine; and the supplement
provides a daily dosage of 300-500 .mu.g chromium.
11. The dosage form of claim 9, wherein the multiple dosage forms
further comprise a tea preparation.
12. The dosage multiple dosage forms of claim 11, wherein the tea
preparation provides a daily dosage of 700-900 mg taurine.
13. The dosage form of claim 10, wherein the shake mix is divided
into two dosage units that divide the daily dosage of the shake
mix between the two dosage units.
14. The dosage form of claim 13, wherein the dosage form comprises
the following dosage forms delivering substantially the following
daily dosages: TABLE-US-00030 Per serving Supple- Daily Shake Snack
ment Total Soy protein (g) 13-15 6-10 32-40 Chromium (.mu.g) 50-150
300-500 400-800 Banaba leaf extract (mg) 25-35 25-35 Magnesium (mg)
100-175 100-150 300-500 Zinc (mg) 3-7 9-11 15-25 Vanadium (.mu.g)
50-150 50-150 Free Leucine (g) 1-1.5 0.25-1 2.25-4
15. The dosage form of claim 14, wherein the dosage form comprises
the following dosage forms delivering substantially the following
daily dosages: TABLE-US-00031 Per serving Supple- Daily Shake Snack
ment Total Soy protein (g) 14.2 8.4 36.8 Chromium (.mu.g) 100 400
600 Banaba leaf extract (mg) 32 32 Magnesium (mg) 140 120 400 Zinc
(mg) 5.25 9.75 20.25 Vanadium (.mu.g) 100 100 Free Leucine (g) 1.2
0.5 2.9
16. The dosage form of claim 14, wherein the dosage form further
comprises a tea preparation that delivers a single daily dose of
about 700-900 mg of taurine.
17. The dosage form of claim 16, wherein the tea preparation delivers
a single daily dosage of about 800 mg taurine, so that the dosage
form delivers substantially the following daily dosages in the following
forms: TABLE-US-00032 Per serving Supple- Daily Shake Snack ment
Tea Total Soy protein (g) 14.2 8.4 36.8 Chromium (.mu.g) 100 400
600 Banaba leaf extract (mg) 32 32 Magnesium (mg) 140 120 400 Zinc
(mg) 5.25 9.75 20.25 Vanadium (.mu.g) 100 100 Taurine (mg) 800 800
Free Leucine (g) 1.2 0.5 2.9
18. A method of promoting weight loss in a subject while substantially
preserving lean body mass, the method comprising: administering
the dosage form of claim 1 to deliver a daily dosage of at least
30 g of soy protein, at least 400 .mu.g of chromium, and a sufficient
amount of free leucine that the weight ratio of soy protein to free
leucine is more than 10:1; and sufficiently restricting caloric
intake of the subject to induce weight loss.
19. The method of claim 18, comprising administering a daily dosage
of 32-40 g of soy protein, 400-800 .mu.g of chromium, and 2.25-4.0
g of free leucine.
20. The method of claim 19, comprising administering a daily dosage
of about 35-39 g of soy protein, about 600 .mu.g of chromium, and
about 2.9 g of free leucine.
21. The method of claim 20, further comprising administering an
amount of corosolic acid effective to inhibit the loss of lean body
mass in the subject while sufficiently restricting caloric intake
of the subject to induce weight loss.
22. The method of claim 21, wherein administering the amount of
corosolic acid comprises administering 0.25-1 mg of corosolic acid.
23. The method of claim 22, wherein the corosolic acid is provided
by administering banaba leaf extract.
24. The method of claim 21, further comprising administering a
daily dosage of 25-35 mg banaba leaf extract, 300-500 mg magnesium,
15-25 mg zinc, 50-150 .mu.g vanadium, and 600-1000 mg taurine.
25. The method of claim 18, wherein administering the daily dosage
comprises administering different dosage forms, wherein the soy
protein, chromium and leucine are each distributed into more than
one dosage form.
26. The method of claim 25, wherein administering the different
dosage forms comprises administering a powdered shake mix, a consumable
snack, and a supplement.
27. The method of claim 26, wherein administering the different
dosage forms further comprises administering a tea preparation.
28. The method of claim 27, wherein administering the tea preparation
comprises administering a tea beverage made from the preparation
once a day, wherein the tea beverage provides a dosage of 700-900
mg taurine.
29. The method of claim 25, wherein administering the different
dosage forms comprises: administering divided dosages of the shake
mix in a beverage, wherein the shake mix provides a daily dosage
of 26-30 g soy protein, 100-300 .mu.g chromium, and 2-3 g free leucine;
administering the consumable snack that provides a daily dosage
of 6-10 g soy protein and 0.25-1.0 g free leucine; and administering
the supplement that provides a daily dosage of 300-500 .mu.g chromium.
30. The method of claim 29, wherein administering the divided dosages
of the shake comprises administering two substantially equal dosages
of the shake mix per day in two different beverages, as a substitute
for two different meals on the same day, administering the consumable
snack comprises administering a single consumable snack per day
between meals, and administering the supplement comprises administering
a single serving of supplement per day.
31. The method of claim 30, further comprising providing no more
than one meal a day and supplemental food items of a selected caloric
intake to maintain the subject in a condition of a caloric deficit
with respect to calories consumed and energy expended.
32. The method of claim 31, wherein the dosage form comprises:
TABLE-US-00033 Per serving Supple- Daily Shake Snack ment Total
Soy protein (g) 13-15 6-10 32-40 Chromium (.mu.g) 50-150 300-500
400-800 Banaba leaf extract (mg) 25-35 25-35 Magnesium (mg) 100-175
100-150 300-500 Zinc (mg) 3-7 9-11 15-25 Vanadium (.mu.g) 50-150
50-150 Free Leucine (g) 1-1.5 0.25-1 2.25-4
33. The method of claim 32, wherein the dosage form comprises:
TABLE-US-00034 Per serving Supple- Daily Shake Snack ment Total
Soy protein (g) 14.2 8.4 36.8 Chromium (.mu.g) 100 400 600 Banaba
leaf extract (mg) 32 32 Magnesium (mg) 140 120 400 Zinc (mg) 5.25
9.75 20.25 Vanadium (.mu.g) 100 100 Free Leucine (g) 1.2 0.5 2.9
and the method comprises administering the daily dosage of the
shake mix in two shake servings per day, and administering a single
consumable snack and supplement per day.
34. The method of claim 32, further comprising administering a
tea preparation each day, wherein the tea preparation comprises
700-900 mg of taurine.
35. The method of claim 34, wherein the dosage forms contain daily
dosages distributed as follows: TABLE-US-00035 Per serving Supple-
Daily Shake Snack ment Tea Total Soy protein (g) 14.2 8.4 36.8 Chromium
(.mu.g) 100 400 600 Banaba leaf extract (mg) 32 32 Magnesium (mg)
140 120 400 Zinc (mg) 5.25 9.75 20.25 Vanadium (.mu.g) 100 100 Taurine
(mg) 800 800 Free Leucine (g) 1.2 0.5 2.9
36. A weight loss kit comprising the dosage form of claim 1 and
instructions for its use to lose weight while preserving lean body
mass.
37. A weight loss kit comprising the dosage form of claim 17 and
instructions for its use to lose weight while preserving lean body
mass.
Weight Loss Patent Description
PRIORITY
[0001] This is a continuation-in-part (CIP) of U.S. patent application
Ser. No. 10/722,368 filed Nov. 24, 2003, which claims the benefit
of U.S. Provisional Application 60/428,993, filed Nov. 22, 2002.
FIELD
[0002] The disclosed products and methods concern dietary and nutritional
supplements for use in weight loss programs.
BACKGROUND
[0003] Obesity has been recognized as a public health problem in
the United States and throughout the world. Overweight or obese
individuals are at a higher risk for developing diseases such as
hypertension, dyslipidemia, type-2 diabetes (non-insulin dependent
diabetes mellitus or NIDDM), coronary heart disease, stroke, gallbladder
diseases, osteoarthritis, sleep apnea, and respiratory problems.
Obesity is also associated with a higher prevalence of endometrial,
breast, prostate and colon cancers. It is therefore not surprising
that obesity is also associated with increased mortality and premature
death.
[0004] The pharmaceutical industry has developed drugs to help
people lose weight. However, no drug has been discovered that allows
individuals to eat all they desire and retain a sedentary lifestyle
while simultaneously losing weight. Furthermore, the drug products
available to the general public, whether by prescription or as over-the-counter
preparations, are not free of risk. Known risks include valvular
heart disease arising out of the use of the combination of fenfluramine
and phentermine (Fen-Phen), and irregular heart beat (arrhythmia)
that is associated with the use of phenylpropanolamine (PPA). These
risks have resulted in bans on the use of these drugs in weight
loss products and programs in some countries.
[0005] Health risks of anti-obesity preparations are not limited
to prescription and/or over-the-counter medications. The use of
ephedra in nutritional products employed for weight loss has been
associated with arrhythmia and even sudden death in susceptible
individuals.
[0006] Weight gain is caused by consuming more calories than the
body requires for its basal metabolic functions and additional activities
in which an individual is involved. The human body stores these
excess calories as fatty deposits (lipids in adipose tissue) throughout
the body, but is not able to readily access these fatty deposits
to satisfy energy needs. To use these stored lipids as an energy
source, the number of calories ingested must be less than the total
energy expenditure of the body (basal metabolic rate plus activity
level). Under hypocaloric conditions the body consumes fat as a
source of fuel, but the switch to energy utilization of stored fat
is not instantaneous. The body has feedback mechanisms that attempt
to preserve existing lipid stores. Therefore, in the interim between
the initial reduction in caloric intake and the conversion of lipids
to energy, the body consumes lean body mass as a source of energy.
Hepatic gluconeogenesis utilizes amino acids from muscle to generate
glucose which the body uses as its preferred energy source. Hence,
the body will consume some muscle tissue as its energy source during
this period of conversion.
[0007] The use of lean body mass as an energy source is vitally
important to normal physiology and maintenance of energy homeostasis.
Under conditions of caloric restriction muscle tissue represents
the primary energy source used to maintain the body's basal metabolic
rate. However the reduction in lean body mass retards the loss of
fat during periods of intentional caloric restriction intended to
induce weight loss. Any weight lost as lean body mass represents
weight that would otherwise have been lost as fat. The loss of lean
body mass can also reduce muscle mass, which is often considered
aesthetically and functionally undesirable.
[0008] Reduced caloric intake usually induces cravings for food
that reduce adherence to weight loss regimens. These cravings are
caused by both psychological and physiological mechanisms. For example,
ingested carbohydrates are absorbed from the digestive tract into
the bloodstream to increase blood glucose levels. In response to
the increase in blood glucose, the pancreas releases insulin to
aid in the transport of glucose into the cells of the body where
glucose is employed as an energy source. However, if the amount
of insulin released is greater than the amount of glucose present
(which is often the case in overweight individuals), then the body
reacts by signaling the brain to ingest more carbohydrates in order
to balance the amount of insulin in the bloodstream. This insulin-induced
craving for carbohydrates is very common during periods of caloric
restriction.
[0009] Food cravings can also be attributed to a lack of specific
food types. For instance, individuals who attempt to lose weight
by eating a high protein, low fat diet often find themselves craving
foods that contain fats. Although there are many "fat-free"
foods available in commercially available products, they often lack
the palatability provided by the presence of fat.
[0010] The use of soy protein in combination with soybean fibers,
and optionally also in combination with other vitamins and minerals
(such as iron, zinc, iodine, manganese, chromium, and selenium),
has been described in U.S. Pat. No. 6,268,011.
[0011] The use of a chromium salt in nutritional products has been
the subject of many patents, for instance, U.S. Pat. Nos. 4,954,492;
5,087,623; 5,175,156; 5,194,615; 6,251,888; 6,251,889; 6,323,192;
6,432,942; and 6,471,998. Some of these patents describe the use
of a chromium salt, either alone or in combination with other ingredients,
in lowering blood levels of lipids and/or controlling blood glucose
levels. U.S. Pat. Nos. 5,087,624; 6,251,889; 6,323,192; 6,432,942;
and 6,471,998 describe the use of chromium salts either alone or
in combination with other materials for increasing lean body mass.
In this latter context, the chromium salt is employed as an anabolic
agent to increase muscle mass when taken while following a strength
building exercise program. The use of chromium salts in dietary
preparations is also described in U.S. Pat. Nos. 6,277,842; 6,399,089;
and 6,413,545.
[0012] Layman et al. have recently noted that a higher protein
diet improves utilization of body fat as an energy source, while
reducing (but not eliminating) the loss of lean body mass. J. Nutr.
133:411-417, 2003. Layman has also noted that branched chain amino
acids (BCAAs) such as leucine are linked to glucose homeostasis
by enhancing recycling of glucose via the glucose-alanine cycle.
The BCCAs also enhance translational regulation of muscle protein
synthesis through the insulin signaling cascade. Increased leucine
concentration is sensed by an element of the insulin-signaling pathway
that triggers a phosphorylation cascade that stimulates the translational
initiation factors eIF4 and p70.sup.s6K. J. Nutr. 133:261S-267S,
2003. Although Layman found that reduced-calorie diets that included
protein sources with high endogenous BCAA and leucine content (such
as red meat, milk and cheese) did reduce loss of lean body mass,
about 12-18% of total weight lost was lean body mass loss.
[0013] In spite of extensive prior research, there is still a need
for a weight-loss product that helps promote a sensation of satiety
to assist with a reduction in caloric intake, while substantially
preserving lean body mass as weight loss occurs. Although many researchers
have contributed to the complex body of knowledge about physiologic
energy utilization under conditions of caloric restriction, existing
nutritional supplements and regimens still result in an undesired
loss of lean body mass.
SUMMARY
[0014] It has now been found possible to lose weight under conditions
of caloric restriction (hypocaloric conditions) with a surprising
preservation of lean body mass. This surprising result is achieved
by providing an effective combination of soy protein, chromium and
free leucine (which is referred to herein as "SCL"). The
soy protein provides a balanced blend of amino acids for protein
synthesis. The chromium enhances insulin sensitivity so that tissue
uptake of glucose is promoted to spare utilization of muscle protein
for this purpose. In addition, the free leucine is processed in
skeletal muscle to provide gluconeogenic precursors to the liver
for additional energy production. The free leucine also stimulates
protein synthesis by enhancing translation initiation events and
insulin-induced protein synthesis. Administering an adequately balanced
combination of soy protein, chromium and free leucine has been found
to be surprisingly effective in preserving lean body mass under
conditions of caloric restriction and weight loss. This combination
is also able to improve the subject's lipid profile.
[0015] The soy protein, chromium and free leucine may be administered
in a dosage form (for example a drink or shake mix, or a combination
of a shake mix, snack bar and supplement) that provides a daily
dosage of at least 30 g of soy protein, at least 400 .mu.g of chromium,
and a sufficient amount of free leucine that the weight ratio of
soy protein to free leucine is more than 10:1 for example more than
11:1, such as about 11.8:1 or 12.2:1 or 13:1. In other embodiments,
the weight ratio of soy protein to free leucine is between 10:1
to 20:1, for example 10-15:1. In some examples, there is at least
2 g of free leucine. In particular examples, the soy protein, chromium
and free leucine are present in the dosage form in an amount providing
a daily dosage of 32-40 g of soy protein, 400-800 .mu.g of chromium,
and 2.25-4.0 g of free leucine, for example a daily dosage of about
35-39 g of soy protein, 600 .mu.g of chromium, and 2.9 g of free
leucine.
[0016] In certain examples, other forms of protein (such as whey
protein) are substituted for the soy protein.
[0017] In some embodiments the dosage form further includes an
amount of corosolic acid effective to inhibit the loss of lean body
mass in the subject under conditions of caloric restriction. In
particular examples the effective amount of corosolic acid is 0.25-1
mg of corosolic acid (for example about 0.3 mg), and the corosolic
acid may be provided by banaba leaf extract. In even more particular
embodiments the dosage form provides a daily dosage of 25-35 mg
banaba leaf extract containing about 1% corosolic acid, 300-500
mg magnesium, 15-25 mg zinc, 50-150 .mu.g vanadium, and 600-1000
mg taurine.
[0018] A particularly advantageous embodiment breaks the dosage
form into multiple dosage forms, wherein the soy protein, chromium
and free leucine are each distributed into more than one dosage
form such as a drink mix, a consumable snack, and a supplement.
For example, the dosage forms can include a drink mix that provides
a daily dosage of 26-30 g soy protein, 100-300 .mu.g chromium, and
2-3 g free leucine; a consumable snack (such as a snack bar) that
provides a daily dosage of 6-10 g soy protein and 0.25-1.0 g free
leucine; and a supplement (such as an ingestible capsule or tablet)
that provides a daily dosage of 300-500 .mu.g chromium (for example
distributed into three separate tablets that can be ingested at
different times throughout the day to deliver equal separate doses
of the chromium that aggregate to the daily dose). In some embodiments
the dosage form also includes a tea preparation, such as a tea bag
or tea leaves in a prepackaged unit, which can be made into a drink
that provides a daily dosage of 700-900 mg taurine (for example
in a single or multiple servings).
[0019] In particular examples, the dosage forms are administered
in a pattern consistent with social norms for daily nutritional
intake. For example, the drink mix is divided into two dosage units
that substantially equally divide the daily dosage between the two
units, for example two drink (such as shake) servings per day that
substitute for two different meals (such as breakfast and lunch,
or breakfast and dinner, or any other combination of two meals).
In certain specific examples, the dosage form is made up of three
component dosage forms, such as a drink mix administered in a liquid
base twice a day (abbreviated "bid"), a snack consumed
once a day, and a supplement consumed once, twice or three times
a day, wherein the dosages provided by the dosage form are distributed
as follows and provide the indicated daily totals: TABLE-US-00001
Per serving Drink Supple- Daily Mix Snack ment Total Soy protein
(g) 13-15 6-10 32-40 Chromium (.mu.g) 50-150 300-500 400-800 Banaba
leaf extract (mg) 25-35 25-35 Magnesium (mg) 100-175 100-150 300-500
Zinc (mg) 3-7 9-11 15-25 Vanadium (.mu.g) 50-150 50-150 Free Leucine
(g) 1-1.5 0.25-1 2.25-4
[0020] for example approximately TABLE-US-00002 Per serving Drink
Daily Mix (bid) Snack Supplement Total Soy protein (g) 14.2 8.4
36.8 Chromium (.mu.g) 100 400 600 Banaba leaf extract (mg) 32 32
Magnesium (mg) 140 120 400 Zinc (mg) 5.25 9.75 20.25 Vanadium (.mu.g)
100 100 Free Leucine (g) 1.2 0.5 2.9
Since the drink mix is consumed twice a day in this example, the
drink mix provides twice the daily dosage listed under the "Drink
Mix" heading in the table (about 28.4 g of soy protein, about
200 .mu.g of chromium, about 280 mg of magnesium, about 10.5 mg
of zinc, and about 2.4 g of free leucine). The Supplement dosages
are set forth above as a unit dose, but they are preferably split
into multiple dosage forms (such as three tablets that can be taken
substantially simultaneously or at different times throughout the
day, such as at morning, noon and night). When the Supplement is
administered in three tablets, each of the tablets provides about
one-third of the amounts listed in the Supplement column (about
133 .mu.g chromium, 10.6 mg banaba leaf extract, 40 mg magnesium,
3.25 mg zinc, and 33 .mu.g vanadium).
[0021] In yet other embodiments, the dosage form further includes
a tea preparation component that delivers a single daily dosage
of about 700-900 mg taurine, for example 800 mg taurine, so that
the dosage form delivers substantially the following daily total
dosages in the following forms, the drink mix dosage is administered
twice a day (for example at breakfast and lunch or breakfast and
dinner), the supplement dosage is delivered in either a single dosage
(for example in the morning), or divided into three dosages (for
example morning, noon and evening), and the snack and tea daily
dosages are provided in a single serving of each (for example in
mid-afternoon): TABLE-US-00003 Per serving Drink Mix Supple- Daily
(bid) Snack ment Tea Total Soy protein (g) 13-15 6-10 32-40 Chromium
(.mu.g) 50-150 300-500 400-800 Banaba leaf 25-35 25-35 extract (mg)
Magnesium (mg) 100-175 100-150 300-500 Zinc (mg) 3-7 9-11 15-25
Vanadium (.mu.g) 50-150 50-150 Taurine (mg) 700- 700-900 900 Free
Leucine 1-1.5 0.25-1 2.25-4 (g)
[0022] such as TABLE-US-00004 Per serving Drink Mix Supple- Daily
(bid) Snack ment Tea Total Soy protein (g) 14.2 8.4 36.8 Chromium
(.mu.g) 100 400 600 Banaba leaf extract (mg) 32 32 Magnesium (mg)
140 120 400 Zinc (mg) 5.25 9.75 20.25 Vanadium (.mu.g) 100 100 Taurine
(mg) 800 800 Free Leucine (g) 1.2 0.5 2.9
[0023] Of course the daily dosages can be delivered in any combination
of servings, such as divided between multiple servings of the drink
mix, snack, supplement and tea component dosage forms.
[0024] Also disclosed herein is a method of promoting weight loss
in a subject while substantially or even completely preserving lean
body mass. The method includes administering a daily dosage of at
least 30 g of soy protein, at least 400 .mu.g of chromium, and a
sufficient amount of free leucine that the weight ratio of soy protein
to free leucine is more than 10:1, for example 10-20:1, such as
10-15:1. In particular embodiments the ratio is more than 11:1,
such as about 11.8:1, 12.2:1 or 13:1, while sufficiently restricting
caloric intake of the subject to induce weight loss. In some examples,
there is at least 2 g of free leucine. An advantage of this method
is that weight loss can surprisingly occur with substantially no
loss of lean body mass, and lean body mass can in some examples
even be completely preserved (including instances in which lean
body mass does not change or even increases).
[0025] In certain examples, a daily dosage is delivered of 32-40
g soy protein, 400-800 .mu.g chromium, and 2.25-4.0 g free leucine,
for example a daily dosage of about 35-39 g soy protein (such as
about 36.8 g), about 600 .mu.g chromium, and about 2.9 g free leucine.
Any or all of the dosages can be divided into multiple dosage components,
however it has been found particularly advantageous for the dosage
of soy protein and free leucine to be divided into one snack and
two servings of the drink mix wherein the drink mix is dispensed
as a beverage after the powdered mix is dissolved or otherwise suspended
in a liquid base (such as water or reduced fat/low fat/skim milk).
In particular embodiments the drink mix is delivered as a "shake"
that provides a thickened consistency to a liquid in which it is
dispensed (for example thickening the consistency of a milk base
in which it is delivered).
[0026] In other examples the method also includes administering
an amount of corosolic acid effective to inhibit the loss of lean
body mass in the subject while sufficiently restricting caloric
intake of the subject to induce weight loss. In disclosed embodiments
the amount of administered corosolic acid is 0.25-1 mg corosolic
acid, for example about 0.3 mg corosolic acid, which can be administered
in banaba leaf extract (a source of corosolic acid). In other examples
the method further comprises administering a daily dosage of 10-35
mg banaba leaf extract (as the source of corosolic acid, about 1-3%
by weight of the extract), 300-500 mg magnesium, 15-25 mg zinc,
50-150 .mu.g vanadium, and 600-1000 mg taurine.
[0027] In certain embodiments of the method, the soy protein, chromium
and free leucine are each distributed into more than one dosage
form. Administering these different dosage forms at different times
throughout the day helps maintain their physiological availability
in a more sustained fashion. In addition the distribution of dosages
throughout the day can better mimic food intake according to social
norms in which subjects traditionally consume food in three meals
throughout the day (such as breakfast, lunch and dinner). For example,
the soy protein is delivered in two different delivery vehicles
(such as a powdered beverage mix and a snack bar), the chromium
is delivered in two different vehicles (such as the powdered beverage
mix and a supplement), and the free leucine dosage is divided between
the powdered drink mix and the snack bar. The method can also include
separately administering a tea preparation, for example to provide
a dosage of 700-900 mg taurine.
[0028] A particular example of the method includes administering
a daily dosage in a beverage (as from a powdered beverage mix) of
26-30 g soy protein, 100-300 .mu.g chromium, and 2-3 g free leucine;
administering the consumable snack that provides a daily dosage
of 6-10 g soy protein and 0.25-1 g free leucine; and administering
the supplement that provides a daily dosage of 300-500 .mu.g chromium.
In particularly disclosed embodiments the soy protein is delivered
in divided dosages by administering two substantially equal dosages
of the beverage mix per day (where the mix is delivered in a liquid
base) as a substitute for two different meals on the same day, the
consumable snack is eaten once per day in between meals (for example
in mid-afternoon between lunch and dinner), and the supplement is
ingested in three separate dosages at different times of the day
(for example morning, noon and evening). In some embodiments a brewed
drink (such as tea) is also administered, for example as a source
of taurine.
[0029] The method may also include providing no more than one full
meal a day, although supplemental food may also be consumed. The
additional food can be selected to maintain a particular daily consumption
of calories, with the goal of maintaining the subject in a condition
of a caloric deficit with respect to calories consumed and energy
expended. Providing a meal and/or supplemental food includes (without
limitation) either advising consumption of it or actually dispensing
it (as in a prepackaged form). A meal or the supplemental food could
be, for example, a dinner that does not include any of the beverage,
snack, supplement or tea. In some embodiments supplemental food
may be administered by itself or together with the snack depending
on the caloric requirements of the individual.
[0030] Meals and supplemental foods are designed to be well-balanced
and include nutritious food choices from a variety of food groups
such as meat, fruit, vegetables, breads and cereals and fats. When
the meals and/or supplemental foods are consumed with certain embodiments
of the method (such as the powdered beverage mix and snack) as part
of a total weight loss program, they may provide a macronutrient
balanced diet with approximately 40%-45% of calories coming from
carbohydrate, 25-30% of calories coming from protein and 25-30%
of calories from fat. The source of carbohydrates provided in the
meals and snacks is primarily from complex carbohydrates (whole
grain breads and starches, fresh fruits and vegetables) which are
good sources of dietary fiber and tend to have a low glycemic index.
Protein food choices are from leaner cuts of meats, chicken, turkey
and fish and the fat content in the meals tends to come from monounsaturated
fats (ie. olive and canola oils) so as to limit intakes of saturated
and trans fats whenever possible. Meals and supplemental food are
incorporated into a range of calorie levels (1200, 1500, 1800 and
2100) and several variations including no dairy, no red meat and
lacto-ovo vegetarian meal plans.
[0031] The method can also include reducing hyperlipidemia, for
example by reducing one or more of total cholesterol, LDL cholesterol,
and the total cholesterol:HDL ratio, by administering any of the
soy protein, chromium and free leucine combinations, or by following
the methods described above for promoting weight loss.
[0032] The soy protein, chromium and free leucine compositions
can be included in a weight loss kit that includes the dosage forms
described above, in combination with instructions for its use to
lose weight while preserving lean body mass. Particular embodiments
of the kit provide instructions for consuming the components of
the kit (such as the powder, snack, tea and supplement) in a manner
that provides the desired dosages of the various components in a
manner that enhances their effect of losing weight while preserving
lean body mass.
DETAILED DESCRIPTION
Abbreviations
[0033] BID: Twice a day.
[0034] SCL: Soy/Chromium/Leucine (a composition that contains soy
protein, chromium and free leucine).
Explanation of Terms
[0035] "Administering" a dosage or dosage form includes
self-administration by the subject, administration by another to
the subject, and providing advice for administration to the subject
(as in instructions provided in a tangible medium, such as printed
instructions or advice on a computer readable medium). Administration
by another to the subject can include, for example, administration
by a physician, nurse or other health care provider or dietary consultant.
Administration also includes providing an end product (such as a
mixed beverage) that is consumed, or precursors that contain the
end product (such as a powdered mix to be dispensed in a beverage)
that another (such as the subject) may prepare for consumption.
[0036] Amounts expressed herein as percentages are percentages
by weight unless indicated otherwise.
[0037] As used herein, a "condition of caloric restriction"
refers to a condition in which a subject is following a calorically
restricted diet and on average consumes fewer calories than are
expended in a relevant period, such as a day, a week, a month, or
longer. In certain examples, depending on the activity of the subject,
the subject consumes less than or equal to about 2,100 total calories
per day (on average), for example, a diet of from about 1,800 to
about 2,100 calories per day, or in other cases a diet of from about
1,500 to about 1,800 calories per day, or in other cases a diet
of from about 1,200 to about 1,500 calories per day. In still other
cases an individual follows a diet of less than 1,200 calories per
day. In some examples, an individual remains under conditions of
caloric restriction for from about a day to about a year or longer,
for example, for about one week, for about one month, for about
8 weeks, for about 12 weeks, or for about one year.
[0038] Ingredients can be "distributed into more than one
dosage form," meaning that one ingredient (such as soy protein)
may be administered in different dosage forms (for example in both
a shake mix and snack).
[0039] A "dosage form" comprises any preparation, or
combination of preparations, that provides a desired dosage. Hence
a dosage form can include a single composition (such as a powdered
beverage mix or other ingestible preparation) or a combination of
several different compositions (such as a powdered beverage mix,
a snack and a supplement). A dosage form can "provide a daily
dosage" in either a single unit dosage form (such as a tablet
or a liquid beverage in which the powder mix is dispensed) or in
multiple dosages taken at different times throughout a day. Hence
a dosage form that includes multiple sub-dosage forms can provide
the total daily dosage administered at different times during a
day (for example at breakfast and lunch), and in different forms
(for example as a liquid beverage and a chewable snack bar). A particular
example of a dosage form is an artificial preparation that includes
a pharmaceutical carrier. A further distinction can be drawn between
an exogenous preparation and a food preparation, wherein an exogenous
preparation is in addition to consumed conventional food.
[0040] "Free leucine" refers to leucine in its amino
acid form, and not contained in proteins, as it would be found in
foods. The free leucine can, for example, be a single amino acid
of leucine in the form of the free base or as a salt of leucine
(such as but not limited to leucine hydrochloride), or an ester
of leucine (such as but not limited to a methyl- or ethyl ester),
or a chelate of leucine such as but not limited to a metal (such
as copper chelate). The preferred form of the amino acid is L-leucine,
which is the preferred biologically active form of the amino acid.
The free leucine can also include analogs, variants, derivatives
and precursors of leucine that provide an equivalent effect. The
amounts of free leucine in the product formulations contained herein
are expressed as the free base, without any accompanying counterion.
[0041] "Hyperlipidemia" refers to an elevation of lipids
(fats) in the bloodstream that predispose a subject to the development
of atherosclerosis. These lipids include cholesterol, cholesterol
esters, phospholipids and triglycerides. They are transported in
the blood as part of large molecules called lipoproteins. Examples
of hyperlipidemic levels of certain lipid components in the blood
include an LDL (low density lipoprotein) of more than 130 mg/dl,
a total cholesterol of greater than 200 mg/dl, or triglyceride levels
of more than 150 mg/dl. "Dyslipidemia" refers to hyperlipidemia
or any other dysregulation of the lipid profile, for example undesired
levels of HDL or total cholesterol/HDL ratios.
[0042] It is generally preferred that HDL cholesterol, which is
believed to provide a protective function, not be less than 40 mg/dl
in men or 50 mg/dl in women. An additional factor to consider is
the total cholesterol/HDL ratio. A typically accepted goal is to
keep this ratio below 5:1; the optimum ratio is below 3.5:1.
[0043] A method of treating hyperlipidemia or other abnormal lipid
levels can improve levels of one or more of these blood levels,
to return them towards or to within the desired ranges. For example
with the methods disclosed herein, the lipid levels can be moved
from a higher risk range to a lower risk range (for example from
high to borderline, or borderline to desirable). [0044] Desirable:
TC<150 mg/dL, HDL>50 mg/dL, LDL<130 mg/dL [0045] Borderline:
TC 200-239, HDL>40-50 mg/dL, LDL 131-159 mg/dL [0046] High: LDL>160
or TC>240 mg/dL or HDL<40 mg/dL.
[0047] As used herein, the terms "individual" or "subject"
refer to an animal, such as a mammal, for example a human.
[0048] A subject's "lean body mass" is the mass of the
individual that is muscle, vital organ, bone and connective tissue.
Under conditions of caloric restriction an individual loses body
weight in the form of both lean body mass and fat. Loss of lean
body mass is "inhibited" when, under conditions of caloric
restriction, the relative loss of lean body mass is less than would
be expected based on the difference between the number of calories
ingested and expended. One measure of the inhibition of loss of
lean body mass is a reduction in the percent of lean body mass lost
as a percentage of total body mass lost. Lean body mass is "substantially
preserved" when lean body mass loss is partially or completely
inhibited. In particular examples disclosed herein, lean body mass
loss is completely inhibited, so that there is no loss of lean body
mass as measured herein. Loss of lean body mass is estimated by
determining body fat percentage using calipers.
[0049] "Metabolic Syndrome" is a condition indicated
by a concurrence of disturbed glucose and insulin metabolism, overweight
and abdominal fat distribution, mild dyslipidemia, and hypertension,
and is associated with subsequent development of type 2 diabetes
mellitus and cardiovascular disease (CVD). As used herein, a subject
having Metabolic Syndrome has at least three of the following clinical
features: a waist circumference greater than about 102 cm in men
and about 88 cm in women; serum triglycerides level of at least
about 150 mg/dL (1.69 mmol/L); high-density lipoprotein cholesterol
level of less than about 40 mg/dL (1.04 mmol/L) in men and about
50 mg/dL (1.29 mmol/L) in women; blood pressure of at least about
130/85 mm Hg; or serum glucose level of at least about 110 mg/dL
(6.1 mmol/L). This definition corresponds to the recent definition
noted in the Journal of the American Medical Association. Ford et
al, JAMA, 287:356-359, 2002.
[0050] A "shake mix" or "drink mix" or "beverage
mix" refers to a mixture, such as a powdered mixture, that
is suitable for mixing in a liquid base (such as water or milk)
to provide a beverage in which the mixture is dispensed to a subject.
The shake mixture increases the thickness of the liquid base.
[0051] A "snack" refers to an edible solid having at
least some organoleptic properties consistent with food. Examples
of a snack include a snack bar (similar in appearance and mouth
feel to a chewable candy bar), and a solid snack (more similar in
appearance and mouth feel to a hard candy).
[0052] A "supplement" refers to a non-food form of dosage
administration other than the liquid beverage or a solid snack.
An example of a supplement is a pharmaceutical preparation (such
as a tablet, enteral liquid, parenteral liquid, capsule, intranasal
liquid or other form). In a particular disclosed example the supplement
is a pharmaceutical preparation, in particular a tablet or capsule.
[0053] "Supplemental food" refers to food that is provided
in addition to the drink mixture, snack, supplement and tea.
[0054] In certain embodiments, the shake mix, snack and supplement
are an exogenous preparation that is administered or consumed in
addition to food preparations such as the prescribed diet and supplemental
food.
[0055] The other above noted criteria are evaluated by any reliable
means, such as those conventionally used in medical examinations.
Serum triglycerides, glucose levels and high-density lipoprotein
cholesterol levels are measured, for example by standard blood chemistry
panels. Blood pressure is measured for example by a sphygmomanometer.
EXAMPLE 1
Starting Materials
[0056] Soy protein/chromium/free leucine (SCL) compositions for
inhibiting loss of the lean body mass under conditions of caloric
restriction are disclosed herein. Such compositions include soy
protein and chromium and free leucine in amounts that are effective
to inhibit or even avoid the loss of lean body mass in an individual
under conditions of caloric restriction.
[0057] Soy protein, as used herein, refers to the protein component
obtained from the soybean plant and/or from concentrated sources
such as soy protein isolates. In some cases the soy protein is isolated
from the soybean by methods well known in the art. For example,
a concentrated soy protein fraction is prepared from cleaned, dehulled
soybeans by removing a majority of the non-protein components so
that the isolated product contains at least about 80% protein by
total weight (including moisture content). The soy protein isolate
is prepared through a series of steps in which the soybean protein
portion is separated from most of the remainder of the soybean.
In particular examples, bland tasting soy protein isolate materials
are used. Further, although genetically modified soy (GM soy) protein
is used in some cases, non-genetically modified soy (Non-GM soy)
protein may also be used. Such soy protein isolates are available
from a variety of companies such as Protein Technologies, Inc. Soy
protein isolate refers to the material isolated from the soybean
plant, a portion of which is soy protein. In certain examples disclosed
herein, a soy protein isolate contains about 85% soy protein. In
such an example, a dose of 14.2 g of soy protein is contained in
16.7 g of soy protein isolate (0.85.times.16.7=14.2).
[0058] As used herein, chromium refers to chromium in a biologically
acceptable salt or chelate of chromium. It is provided in any bioactive
and physiologically acceptable form. Though the chromium is provided
in many forms, when referring to an amount of chromium herein it
is meant the amount of actual chromium in the biologically acceptable
salt or chelate (for example, 100 .mu.g of chromium is provided
by about 1.0 mg of the biologically acceptable chelate chromium
nicotinate). In some cases the chromium is in the form of a chromium
salt, such as chromium chloride, while in other cases it is in the
form of a chromium chelate, such as chromium nicotinate (including
mononicotinate, dinicotinate, trinicotinate, and polynicotinate),
chromium picolinate (including monopicolinate, dipicolinate, and
tripicolinate), protein chelates, and chelates of any bioavailable
organic acid (such as amino acids), or compositions or combinations
thereof, such as a composition of chromium mononicotinate, dinicotinate,
trinicotinate, and polynicotinate or monopicolinate, dipicolinate,
and tripicolinate. In particular examples chromium is provided in
the form of chromium nicotinate or picolinate. An effective amount
of chromium for use in inhibiting the loss of lean body mass is
from at least about 50 or 100 .mu.g per serving or dose and ranges
to about 1 milligram (mg) per serving or dose or daily total dose.
In particular examples an effective amount of chromium is from about
100 .mu.g, to about 200, 400 or 600 .mu.g.
[0059] Amino acids are the constituent building blocks of proteins
that are covalently bound together by peptide bonds. The amino acids
are grouped into different structural and functional categories.
One such category is the "branched chain amino acids"
(BCAAs) which are leucine, valine and isoleucine. Individual or
isolated amino acids are readily commercially available from a variety
of sources. The L-amino acids are the biologically active forms,
and are the type typically administered in supplement preparations.
[0060] Corosolic acid (2-alpha-3-beta-dihydroxy-12-ursen-28-oic
acid; 3-alpha, 3-beta-di-hydroxyursolic acid) refers to a triterpene
compound that can be extracted from the leaves of the plant Lagerstroemia
speciosa (banaba leaf) and Punica granatum and also is known as
colosolic acid and botanical insulin. As used herein corosolic acid
also refers to equivalent effective amounts of pharmaceutically
acceptable salts, analogs, derivatives, isomers, and metabolites
of corosolic acid such as, methyl and glucopranosyl esters (at the
carbonyl group), and methyl, acetyl, or cinnamoyl substitutions
(at one or more hydroxyl group) that retain the desired biological
effect of corosolic acid.
[0061] In some cases the disclosed compositions include other ingredients
for added nutrition, preservation, or flavor, such as fructose,
high oleic sunflower oil powder, acacia gum, canola oil, inulin,
short chain fructooligosaccharides, dicalcium phosphate, silicon
dioxide, sodium citrate, potassium chloride, magnesium oxide, lecithin,
whey protein isolate, rice protein concentrate, cocoa powder, guar
gum, flavoring, sweeteners (for example honey), and vitamin and
mineral premixes. Vitamin premixes include, for example, premixes
of ascorbic acid, mixed tocopherol concentrate, d-alpha tocopheryl
acetate, vitamin A palmitate, vitamin B 12, vitamin D3, pyridoxine
hydrochloride, riboflavin, thiamine mononitrate, niacinamide, calcium
pantothenate, folic acid, and biotin. Mineral premixes include,
for example, ferrous fumarate, potassium iodide, molybdenum yeast,
selenium yeast, zinc oxide, copper gluconate, manganese sulfate,
and potassium iodide.
[0062] In specific examples where vitamin and mineral premixes
are included in a combined soy protein/chromium/free leucine composition
(such as a shake mix), the weight of the soy protein is from about
10% to about 50% of the total weight of the composition, for example,
the soy protein is from about 20-40% or about 25-35% of the total
weight of the composition; the weight of the chromium in the bioactive
form provided (such as chromium nicotinate) is from about 0.0005%
to about 0.10% of the total weight of the composition, for example
the weight of the chromium is from 0.002% to about 0.01% of the
total weight of the composition or, in an even more specific example,
from about 0.002% to about 0.003% of the total weight of the composition;
and the weight of the free leucine is from about 1% to about 10%
of the total weight of the composition, for example, the weight
of the free leucine is from about 1-5% or about 1-3% of the weight
of the total composition. In certain instances the other ingredients
are also used in certain relative amounts. In certain cases the
weight of fructose is about 20% to about 35% of the total weight
of the composition, for example the weight of fructose is about
30% to about 33% of the total weight of the composition; the weight
of high oleic sunflower oil powder is about 5% to about 7% of the
total weight of the composition, for example about 6% to about 7%
of the total weight of the composition; the weight of acacia gum
is about 8% to about 16% of the total weight of the composition,
for example about 10-15% of the total weight of the composition;
the weight of canola oil is about 0.4% to about 4% of the total
weight of the composition, for example, about 0.6% of the total
weight of the composition; the weight of short chain fructooligosaccharides
is about 3% to about 5% of the total weight of the composition,
for example about 4% of the total weight of the composition; the
weight of guar gum is about 0.3% to about 0.5% of the total weight
of the composition; dicalcium phosphate is about 1-3%, for example
about 2%; the weight of silicon dioxide is about 0.5-2%, for example
about 1%; the amount of sodium citrate is 1-2%, for example about
1.2%; the amount of potassium chloride is about 0.5-2%, for example
about 1%; the amount of flavoring (such as vanilla flavor) is about
1-3%, for example about 2%; the amount of lecithin (such as soy
lecithin) is about 0.5-2%, for example about 1%; the amount of whey
protein isolate is 0.5-2%, for example about 0.9%; the amount of
the rice protein concentrate is about 0.1-1%, for example about
0.4%, and the amount of magnesium oxide is about 0.25-2%, for example
about 0.6% by weight of the composition. The composition may also
contain, for example about 0.05-0.15% of inulin, such as about 0.1%
of inulin.
[0063] In some examples the powdered beverage mix includes a separate
or included vitamin mix component, which is about 0.05% to about
2% of the total weight of the composition, for example, the weight
of vitamin mix is about 0.15% to about 0.2% of the total weight
of the powdered premix. The vitamin mix component may include, for
example, the following in amounts of greater than zero but less
than 0.1% of each of ascorbic acid, mixed tocopherol concentrate,
d-alpha tocopheryl acetate, vitamin A (as in vitamin A palmitate),
niacinamide, pantothenic acid (for example in the form of calcium
pantothenate), vitamin B12, vitamin D3, pyridoxine (as in the hydrochloride
salt), riboflavin, thiamine (as in the mononitrate form), folic
acid, and biotin. In disclosed embodiments the vitamin mix component
comprises less than 0.2% of the total weight of the powdered beverage
mix.
[0064] The powdered beverage mix may also include a mineral mix
component that is separate from or included in the powdered mix,
and which comprises less then 1% by weight of the total beverage
mix, for example less than 0.5% by weight, such as about 0.1% by
weight. In particular examples, the mineral mix component includes
selenium (for example as selenium yeast), molybdenum (for example
as molybdenum yeast), zinc (for example as the oxide), copper (for
example as the gluconate), manganese (for example as the sulfate),
chromium (for example as the nicotinate), potassium (for example
as the iodide), and iron (for example as ferrous fumarate). Additional
nutritional supplements, preservatives, and flavorings are included
in some instances. One of ordinary skill in the art would be able
to determine appropriate combinations of these ingredients and others
for adding nutrition to the composition, preserving the composition
from spoilage, and/or adding flavor to it.
[0065] As already noted, the soy protein/chromium/free leucine
composition is in some examples a dry drink powder. For example,
each component of the composition is mixed together into a powder.
In one specific case such a powder is made by combining the liquid
ingredients (lecithin, canola oil and mixed tocopherol concentrate)
in a vessel and mixing these ingredients to form a homogenous mixture.
In a separate vessel all the dry ingredients including the soy protein,
chromium and free leucine are combined (except silicon dioxide and
a portion of high oleic sunflower oil powder). The vessel may be
a blending device, or the dry ingredients can be transferred to
an appropriate blending device, preferably one equipped with a chopping
device. The dry ingredients are then mixed thoroughly.
[0066] While mixing the dry ingredients, the liquid ingredients
are introduced onto the well-blended dry ingredients in an even
and consistent fashion, preferably with a spraying device. After
the addition of the liquid ingredients, the mixture is mixed (such
as by tumbling) and chopped until it is well blended. The remainder
of the high oleic sunflower oil powder and silicon dioxide is then
added to the mixture and the entire mixture is blended until these
ingredients are also well blended into the mixture, which forms
a dry powder.
[0067] The powdered mix may be administered as a beverage in a
liquid base. For example, in some instances a dry drink powder is
mixed with a liquid such as water (for example purified water),
milk (for example non-fat milk), or juice and agitated to mix the
liquid and the powder to create a shake drink having a thicker consistency
than the original liquid base. This mixing is sometimes performed
before the composition is packaged, and sometimes is performed by
the consumer of the composition.
[0068] In an example in which 1 cup of non-fat milk (245 g) is
mixed with the shake powder (48-50 g), certain specific examples
of the relative amounts of the components of the shake drink, as
expressed in weight of the ingredient to the total weight of the
shake drink are from about 60% to about 95% liquid, such as non-fat
milk, for example from about 75% to 85% liquid, from about 2% to
about 30% soy protein, for example from about 2% to about 15% soy
protein (preferably 5-6%) from about 0.2 to about 1% of free leucine
(not present in proteins), from about 0% to about 5% other proteins,
such as whey protein or rice protein or combinations thereof, for
example, from about 0.05% to about 0.2% other protein, from about
2% to about 12% carbohydrates, for example, from about 6% to about
10% carbohydrates, from about 0.5% to about 5% fats (lipids), for
example, from about 1% to about 3% fats, from about 1% to about
10% fiber, for example, from about 1% to about 5% fiber, and a trace
percentage of chromium, for example, from about 80 .mu.g to about
200 .mu.g, and vitamin premix, mineral premix, and other ingredients
as desired.
[0069] A dietary program that includes the shake mix and supplements
is designed to maintain protein intake at about 30% of total calories
consumed, total carbohydrate content of the program not greater
than 50% (and preferably closer to 40-45%) of total calories consumed,
while fat intake does not exceed 30% of total calories or go below
20% of calories consumed. In disclosed embodiments, the shake composition
itself provides about 35% calories from protein, 50% calories from
carbohydrate and 15% calories from fat. The disclosed snack bars
provide roughly 32% calories from protein, 48% calories from carbohydrate
and 20% calories from fat.
[0070] The administered compositions can be made to have any desired
amount of calories. In some examples, the soy protein/chromium/free
leucine compositions contain from about 100 to about 200 calories
as the powder and from about 250 to about 300 calories when mixed
with non-fat milk. In particular instances the compositions contain
no more than about 200 calories as the powder, or no more than 350
calories when mixed with non-fat milk or another vehicle such as
soy milk. The caloric content of the composition that is administered
is deducted from the total number of calories consumed per day to
arrive at a total caloric intake that will achieve the desired caloric
restriction. The caloric content of the snack bars may be, for example,
100-150 calories, such as 130 calories.
EXAMPLE 2
Methods of Promoting Weight Loss
[0071] This Example discloses general methods of promoting body
weight loss and/or improvements in lipid profile that include consuming
a combination of soy protein, chromium and free leucine under conditions
of caloric restriction in amounts sufficient to inhibit the loss
of lean body mass. As used herein, a method of losing weight refers
to a conscious effort to reduce body weight, whether measured in
body weight or another measure of weight loss (for example, body
mass index or BMI). In some cases a soy protein/chromium/free leucine
combination is consumed as a combined soy protein/chromium/free
leucine combination composition, as discussed above. In other cases
the soy protein, free leucine and the chromium are consumed separately.
In some instances, the method further includes instruction regarding
a calorically restricted diet. In certain embodiments the method
promotes weight loss in a subject having the Metabolic Syndrome.
[0072] Methods are also disclosed for treating an overweight subject
by selecting an overweight subject and administering to the subject
(for example, instructing or otherwise causing the subject to consume)
the combination of soy protein, free leucine and chromium in amounts
effective to inhibit or even avoid the subject's loss of lean muscle
mass under conditions of caloric restriction. In some cases the
combination is administered as the disclosed soy protein/chromium/free
leucine powdered composition. In other cases the soy protein, chromium
and free leucine are administered separately. In other embodiments
the combination is distributed between the powdered composition
and other preparations, such as a snack preparation and/or supplements.
[0073] Selecting an overweight subject includes selecting an individual
having an excess of body weight that puts the subject at risk for
complications associated with being overweight. For example, weight-related
complications include hypertension, dyslipidemia, type-2 diabetes
(non-insulin dependent diabetes mellitus or NIDDM), coronary heart
disease, stroke, gallbladder diseases, osteoarthritis, sleep apnea,
and respiratory problems. Typically, being overweight refers to
having an excess of body weight compared to set standards. A generally
accepted standard for determining whether a human is overweight
is BMI, which is calculated as weight in kilograms (kg) divided
by height in meters squared (m.sup.2). Generally an individual having
a body mass index (BMI) of at least 25 is considered overweight.
However, BMI is not always an accurate measurement of whether an
individual is overweight for the purposes of determining whether
the individual's weight constitutes a health risk. For example,
a muscular athlete may have a high BMI because of the large amount
of weight the individual carries as muscle, in the absence of health
risks generally associated with being overweight. Other indicators
such as percentage body fat are also used in making this determination.
Additionally, the location of an individual's body fat is also relevant.
Body fat concentrated in the abdominal region and/or around the
hips is associated with a higher risk for most overweight associated
complications than body fat concentrated in other areas, such as
the legs. One of ordinary skill in the art would be able to determine
whether a person is overweight in this medically relevant sense.
[0074] An obese individual is a particular example of an overweight
person who may be treated with the methods disclosed herein. As
used herein the term obese refers to an individual having an abnormally
high proportion of body fat. Typically an individual with a BMI
of 30 or higher would be considered obese.
[0075] In certain cases selecting an overweight subject further
includes selecting a subject having Metabolic Syndrome, for example
by testing the subject for the clinical features of Metabolic Syndrome.
[0076] In some cases the soy protein/chromium/free leucine combination
is consumed orally in any ingestible form. In some instances the
soy protein/chromium/free leucine combination is consumed in a composition
described elsewhere herein. In some instances the soy protein/chromium/free
leucine composition is consumed as a dry powder, in others as a
shake drink, and in still others in bar form. In some examples the
soy protein/chromium/free leucine combination is consumed using
enteral delivery methods, for example through a nasogastric tube
or percutaneous endoscopic gastrostomy (PEG) tube.
[0077] In some examples at least some of the components of the
combination are consumed separately. For example at least some of
the chromium may be separately consumed orally or enterally in any
ingestible form, such as capsules (hard or soft), tablets, elixirs,
powders, granules, suspensions in water or non-aqueous media, or
as an additive to food or beverages. In some cases the chromium
is mixed with a pharmaceutical carrier (conventional tableting ingredients
such as corn starch, lactose, maltodextrin, sucrose, sorbitol, talc,
stearic acid, magnesium stearate, dicalcium phosphate or gums) and/or
other pharmaceutical diluents, such as water, to form a solid preformulation
composition containing a substantially homogenous mixture of the
composition, or a non-toxic pharmaceutically acceptable salt thereof.
When referring to the preformulation compositions as substantially
homogenous, it is meant that the active ingredients are dispersed
evenly throughout the composition so that the composition may readily
be subdivided into equally effective unit dosage forms such as capsules,
pills, and tablets. In other cases the chromium is consumed in liquid
preparations for oral administration, such as solutions, syrups,
or suspensions.
[0078] The disclosed methods include administering to a subject
the disclosed soy protein/chromium/free leucine combinations or
compositions for a length of time sufficient to have the desired
effect. In certain cases the soy protein/chromium/free leucine combinations
are consumed daily for a week or more, for example for up to a year
or more. In particular examples, the combinations are consumed for
a period of from about 8 weeks to about 12 weeks, for example, either
8 weeks or 12 weeks. In other cases the combinations are consumed
for a period of about five days or more.
[0079] In some situations an individual or subject is instructed
regarding a calorically restricted diet. For example the subject
may be orally instructed concerning the need to consume fewer calories
than the subject expends to achieve a condition of caloric restriction.
In other instances instructions are provided in written form. In
certain cases the subject is also advised regarding how to determine
the caloric content of foods by reading the information labeling
on food products or by accessing other data regarding the caloric
content of various foods. In some instances, the subject is instructed
concerning the effects of portion or serving sizes of various foods
on weight loss. In some instances the subject is also instructed
concerning obtaining adequate nutrition during periods of caloric
restriction as well as warning signs of improper or dangerous caloric
restriction and nutritional deficiencies.
[0080] In some examples the individual or subject is instructed
regarding participation in exercise with either oral or written
instructions to participate in an exercise such as walking at least
one mile or for at least 30 minutes each of at least five days a
week, or exercise with a similar or higher level of exertion. Still
other embodiments include performance of such exercise by the subject,
or an absence of exercise by the subject.
[0081] Some embodiments of the methods further include consuming
corosolic acid, and optionally one or more of magnesium, zinc, taurine,
and vanadium. These agents may, for example, be components of the
soy protein/chromium/free leucine powdered composition, or they
may be consumed separately from the composition, for example in
a separate nutritional supplement or supplements (such as tablets).
[0082] If the nutritional supplement is consumed separately from
the soy protein/chromium/free leucine powdered composition, the
nutritional supplement is consumed at any time or times of the day.
In certain embodiments the nutritional supplement is consumed at
or near the time of one or more meals in a day, such as the largest
meal of the day, for example within half an hour of the meal or
during the meal. In some embodiments, the nutritional supplement
is consumed in two or more doses, for example at or near the time
of the two largest meals of the day, or at or near the time of each
of three meals of the day (breakfast, lunch and dinner).
[0083] In certain embodiments where the soy protein/chromium/free
leucine combination and the corosolic acid are administered, subjects
are not instructed regarding a calorically restricted diet and are
not required to follow any particular diet, and/or do not consciously
follow a calorically restricted diet.
EXAMPLE 3
Kits
[0084] Components of the dietary regimen may be provided in kits,
such as packages that may or may not include instructions regarding
a calorically restricted diet; instructions to follow or not follow
any particular diet; and/or instructions to consciously follow or
not consciously follow a calorically restricted diet. In other embodiments,
subjects are instructed to follow or are not instructed to follow
a prescribed exercise regimen.
[0085] These kits can include the compositions described elsewhere
in this specification. For example, the kit can contain the powdered
drink mix, a snack bar, the tea mix, and the supplement.
[0086] The instructions provided with the kit are in a fixed form,
such as written or recorded onto an audiocassette, videocassette,
compact disc, or digital videodisc. The instructions instruct an
individual about amounts of the kit components to consume in order
to inhibit the loss of lean body mass while dieting, or to achieve
an improvement in blood lipid levels.
[0087] In some cases the kits contain a composition of soy protein/chromium/free
leucine, such as a shake drink comprising soy protein, chromium,
and free leucine. In other cases the composition is provided in
the form of a dry drink powder, with instructions to mix it in a
liquid delivery vehicle. In some instances the composition is provided
in bulk form, with more than one serving per container. In such
cases the instructions inform an individual to consume a certain
amount of the composition per day, such as the amounts described
herein. In other instances, the composition is provided in containers
having single servings, and the instructions instruct consumption
of a certain number of single servings per day. In both cases an
individual following the instructions consumes an amount of soy
protein, chromium and free leucine that is effective to inhibit
the loss of lean body mass under conditions of caloric restriction.
The composition may be sold without the instructions for using the
product in the methods of promoting weight loss and/or improving
lipid profiles. Instructions can also be provided separately from
the sold product, for example posted on a web site.
[0088] Some embodiments of the kits further include corosolic acid
in any form and in amounts effective to cause subjects to lose weight,
such as part of the disclosed soy protein/chromium/free leucine
composition or separately. In particular examples the corosolic
acid is delivered in a banaba leaf extract that contains 1% corosolic
acid, for example as 32 mg of banaba leaf extract that is contained
in the supplement.
EXAMPLE 4
Additional Methods of Promoting Weight Loss
[0089] This example discloses the use of compositions in methods
of promoting weight loss and/or improvements in the lipid profile
of a subject while substantially preserving lean body mass (such
as muscle mass). Dosage forms of the composition are administered
to deliver desired daily dosages of soy protein, chromium and free
leucine, optionally in combination with other agents, while sufficiently
restricting caloric intake of the subject to induce weight loss.
The composition may be used as a partial meal replacement for the
treatment of obesity or hyperlipidemia or other dyslipidemias, for
example to reduce blood levels of triglycerides and/or LDL cholesterol
and/or the ratio of total cholesterol to HDL.
[0090] In particular examples of the methods, the program provides
a 500-600 calorie deficit per day leading to losses in body weight
of approximately 1-1.5 lb per week. It is particularly suitable
for use by overweight, but otherwise healthy, adults. The program
components, which may be provided in a kit, include a drink mix,
a snack bar, a vitamin/mineral supplement, a tea drink mix, and
a 30-day menu/recipe plan (the menu plan serves as a guide for preparing
daily meals). In this example, participants follow one of three
plans depending on initial body weight: TABLE-US-00005 Initial Body
Weight (lb) Daily Energy Intake (kcal) <150 1200 150-175 1500
>175 1800
[0091] Energy intake throughout the day occurs as follows: TABLE-US-00006
Breakfast Drink mix plus fruit Lunch Drink mix Afternoon Snack bar
+/- food Dinner Meal
[0092] In this example, the program (products and meals) provides
a daily macronutrient distribution range of no more than 30% protein,
no more than 50% carbohydrate, and no more than 30% fat. A particular
desired range is as follows: TABLE-US-00007 Macronutrient % of Energy
Protein 25-30 Carbohydrate 40-50 Fat 20-30
[0093] The dosage forms included in the kit and administered in
the method (vitamin/mineral supplement, drink mix, and bar) provide
at least 100% of the Daily Value for all essential micronutrients
except Vitamins A and K and iron. The meal plan foods contain relatively
abundant amounts of these latter nutrients, hence the products plus
the menu plan foods are expected to deliver these nutrients in quantities
that meet or exceed their required daily amounts.
[0094] The daily intake of products containing energy (calorie)
content (two drink mixes plus one snack bar) remains the same for
all three calorie plans. Additional other calories for the plans
are provided by different levels of supplemental food intake. Although
free leucine is administered as part of the program, additional
protein-bound leucine intake occurs. The method described in this
example assumes intake of a 1200 kcal plan.
[0095] Free L-leucine that meets food grade and USP specifications
is used in both products as an integral component of each mixture
and therefore is not separated from the other ingredients (although
it can also be administered in a separate product). The drink mix
and snack bar contain 1.2 and 0.5 g of added free leucine per serving,
respectively. These products also contain a mixture of soy and rice
or whey protein isolates (the protein contents of the drink mix
and snack bar are 16 and 10 g, respectively). The label instructions
advise that the drink mix powder is mixed with one cup of nonfat
milk for consumption. Thus, to calculate the total leucine exposure
per eating occasion, the amount of free leucine is added to the
amount of leucine contained within the protein isolates and nonfat
milk as follows: TABLE-US-00008 Drink mix Snack bar Leucine source
g/serving g/serving Free base 1.2 0.5 Protein isolate 1.2 0.8 Nonfat
milk 0.8 N/A Total/eating occasion 3.2 1.3
In disclosed embodiments the total leucine per eating occasion
is about 2.8-3.2 g leucine in the drink (powder dispensed in milk),
and about 1.0-1.5 g leucine in the snack bar (inclusive of free
leucine and leucine in intact protein).
[0096] To calculate the estimated leucine exposure (per eating
occasion and daily total), the amount of leucine provided by the
meals can also be considered. In this example, the total leucine
and protein exposure per day from both products and food is as follows:
TABLE-US-00009 Protein (g) Leucine (g) Drink mix (w/nonfat milk)
24 3.2 Snack bar 10 1.3 Food.sup.a 38 2.8 Daily total.sup.b 96 10.5
(2.9 g free base) .sup.aaverage value determined from 8 menu plan
days (1200 kcal plan) .sup.bbased on recommended plan (sum of two
drinks mixed with nonfat milk, one bar and one meal)
Hence, for the 1200 calorie plan, daily totals of protein intake
are about 90-100 g protein, and about 8-12 g leucine (of which about
2-4 g are free leucine).
[0097] Serving sizes of the drink mix powder and snack bar are
approximately 50 and 35 g, respectively.
[0098] The total amount of ingested protein-bound leucine can vary
depending on the particular plan followed, and this example is not
intended to require amounts of leucine that are presented in this
example.
EXAMPLE 5
Promoting Weight Loss with Different Meal Plan
[0099] This example discloses an additional use of compositions
in methods of promoting weight loss and/or improvements in the lipid
profile of a subject while substantially preserving lean body mass
(such as muscle mass). Dosage forms of the composition are administered
to deliver desired daily dosages of soy protein, chromium and free
leucine, optionally in combination with other agents, while sufficiently
restricting caloric intake of the subject to induce weight loss.
The composition may be used as a partial meal replacement for the
treatment of obesity or hyperlipidemia or other dyslipidemias, for
example to reduce blood levels of triglycerides and/or LDL cholesterol
and/or the ratio of total cholesterol to HDL. The methods of use
are the same as in Example 4, except as otherwise specified in the
present Example.
[0100] In the present Example, the program provides a 600-1000
calorie deficit per day leading to losses in body weight of approximately
1.5-2.0 lb per week. In this example, participants follow one of
three plans depending on initial body weight: TABLE-US-00010 Initial
Body Weight (lb) Daily Energy Intake (kcal) <150 1200 151-200
1500 201-250 1800 >250 2100
[0101] Energy intake throughout the day occurs as follows: TABLE-US-00011
Breakfast Drink mix plus fruit Mid-morning Food (2100 calorie plan
only) Lunch Drink mix Afternoon Snack bar +/- food (depending on
calorie plan) Dinner Meal
[0102] In this example, the program (products and meals) provides
a daily macronutrient distribution range of no more than 30% protein,
no more than 45% carbohydrate, and no more than 30% fat. A particular
desired range is as follows: TABLE-US-00012 Macronutrient % of Energy
Protein 25-35 Carbohydrate 40-45 Fat 20-30
EXAMPLE 6
Particular Example of Soy/Chromium/Free Leucine Composition
[0103] Although many different embodiments of the disclosed products
are possible, this example sets forth a particular example of a
product that contains useful amounts of soy protein, free leucine
and chromium to achieve desired weight reduction with preservation
of lean body mass. The following Table 1 shows the distribution
of nutrients and active ingredients among the Supplement, Beverage,
Tea, and Snack, with active ingredients shown in bold type at the
bottom of the table: TABLE-US-00013 TABLE 1 Micronutrient and Other
Actives Content of Preparations Per serving Shake Supple- Daily
Daily Mix Snack ment Tea Total.sup.a Value Vitamin A (IU) 500 0
2500.sup.b 3500 70% Vitamin C (mg) 20 0 39 79 135% Vitamin D (IU)
140 0 260 540 135% Vitamin E (IU) 10 0 20 40 135% Vitamin K (.mu.g)
0 0 52 52 65% Thiamin (mg) 0.5 0.4 1.0 2.4 160% Riboflavin (mg)
0.6 0.4 1.1 2.7 160% Niacin (mg) 7 5 13 32 160% Vitamin B.sub.6
(mg) 0.7 0.5 1.3 3.2 160% Folate (.mu.g) 140 100 260 640 160% Vitamin
B.sub.12 (.mu.g) 2 1.5 4 9.5 160% Biotin (.mu.g) 105 75 195 480
160% Pantothenic 3.5 2.5 6.5 16 160% acid (mg) Calcium (mg) 350
0 300 1000 100% Iron (mg) 4.5 0 0 9 50% Phosphorous (mg) 350 0 300
1000 100% Iodine (.mu.g) 52.5 0 97.5 203 135% Molybdenum (.mu.g)
26 0 49 101 135% Selenium (.mu.g) 24.5 0 45.5 94.5 135% Copper (mg)
0.7 0 1.3 2.7 135% Manganese (mg) 0.7 0 1.3 2.7 135% Magnesium (mg)
140 0 120 400 100% Zinc (mg) 5.25 0 9.75 20.25 135% Chromium (.mu.g)
100 0 400 600 500% Banaba Leaf 32/0.32 32/0.32 N/A Extract/corosolic
acid(mg) Vanadium (.mu.g) 100 100 N/A Taurine (mg) 800 800 N/A Soy
Protein (g) 14.2-14.4 6.9-9.7 35-39 N/A Free leucine (g) 1.2 0.5
2.9 N/A .sup.abased on recommended product plan (sum of 1 serving
of vitamin/mineral supplement, 2 servings of drink mix, 1 serving
of tea, and 1 snack bar) .sup.bas .beta.-carotene
[0104] The weight management program, including the normal food
suggested in the menu plan, is intended to deliver 10-12 grams of
total leucine per day at the 1200 calorie diet plan. The bulk of
this leucine (about 8 g) is leucine found in the proteins consumed
(from soy protein in the shake and snack bar, milk with which the
shake is mixed, and foods/recipes provided in the menu plan). Free
leucine added to the shake and bar totals about 2.9 g of this total,
but this amount of dietary supplementation with free leucine has
been found to provide the unexpectedly superior results of the present
invention.
[0105] The following Table 2 shows the sources of leucine and protein
in a diet that aims for 30% of calories to be derived from protein.
In this Table, "other leucine" refers to the leucine that
is found within the intact protein (soy and other foods) in each
product and food. The food column describes the 1200 kcal plan,
and total protein and leucine (protein-bound) amounts will change
with higher calorie plans (food menus are provided for 1200, 1500,
1800 and even 2100 cal plans). All these plans include the same
number of free leucine-containing products (2 shakes and 1 snack
bar) and thus identical amounts of free leucine.
[0106] Amounts have been approximated as allowed by food regulations
and thus some of the totals appear larger than the sum of the individual
components. The Daily Totals also are based on two daily servings
of the beverage powder, one serving of tea, one serving of the snack,
and one serving of the supplement. Table 2 includes a column for
milk because the beverage powder is typically mixed with non-fat
milk for each serving. The milk contributes protein and "other
leucine (protein-bound)," thus each serving of shake when used
as directed delivers 24 g of total protein (including free leucine)
and 3.2 g of total leucine of which soy protein comprises 14.3 g
and free leucine comprises 1.2 g. TABLE-US-00014 TABLE 2 Sources
of leucine and protein in a diet that aims for 30% of calories to
be derived from protein Per serving Beverage Snack Daily powder
Milk Bar Food Total.sup.a Soy 14.2-14.4 -- 7-10 variable 35-39 90-100
g protein (g) total protein/ Other <0.5 8 0-3 38 57-59 day protein
(g) Free 1.2 -- 0.5 -- 2.9 10-12 g leucine (g) total leucine/ Other
1.2 0.8 0.8 3 8 day leucine (g) .sup.abased on recommended product
plan (sum of 1 serving of vitamin/mineral supplement, 2 servings
of shake, 1 serving of tea, one meal, and 1 snack bar)
EXAMPLE 7
Example of Drink Mix
[0107] In one particular embodiment, a vanilla flavored soy protein/chromium/free
leucine beverage powder to be used in the method includes the following
specific ingredients shown in Table 3: TABLE-US-00015 TABLE 3 Vanilla
flavored soy protein/chromium/free leucine beverage powder Percent
by Weight Ingredients Weight/Serving (g) of Powder (% w/w) Soy protein
isolate 16.73 (provides 34.60 (29.27 14.15 g soy protein) soy protein)
Fructose 15.05 31.13 High oleic sunflower oil 3.16 6.54 powder Acacia
gum 4.85 10.04 Canola oil 0.31 0.64 Short chain 2.00 4.14 fructooligosaccharides
Leucine 1.20 2.48 Guar gum 0.20 0.41 Dicalcium phosphate 0.99 2.05
Silicon dioxide 0.52 1.08 Sodium citrate 0.58 1.20 Potassium chloride
0.57 1.17 Flavoring 0.75 1.55 Lecithin 0.55 1.14 Whey protein isolate
0.45 0.93 Magnesium oxide 0.28 0.58 Chromium nicotinate 0.001 (provides
0.002 100 .mu.g chromium) Vitamin premix 0.085 0.176 Mineral premix
0.063 0.131 TOTAL 48.34 100.00
EXAMPLE 8
Example of Snack
[0108] Although the snack component of the weight management products
can take many different forms, a particular example of it is set
forth in Table 4. This particular example of the snack is in the
form of a snack bar that can be flavored, for example with a chocolate
flavor. TABLE-US-00016 TABLE 4 CHOCOLATE FLAVORED SNACK BAR Percent
by Weight Ingredients Weight/Serving (g) of Snack Bar (% w/w) Soy
protein isolates 10.42 (provides 33.61 (27.03 8.38 g soy protein)
soy protein) Leucine 0.51 1.65 Whey protein isolate 0.90 2.90 Fructose
4.17 13.46 Canola oil 0.47 1.50 Acacia gum 0.34 1.10 Guar gum 0.34
1.10 Inulin 0.95 3.05 Vitamin premix 0.03 0.09 Flavorings 4.69 15.13
Sweeteners 4.94 15.92 Medium chain triglycerides 0.16 0.50 Glycerine
3.10 10.00 Total 31.00 100.00
EXAMPLE 9
Supplement Composition
[0109] The nutritional supplement is a major source of supplemental
chromium in the weight management products and in this example is
the sole source of the corosolic acid. A particular example of supplement
that serves this purpose is the supplement shown in Table 5, which
is administered in a tablet form. The amounts shown in the Table
are daily dosages, which in this example are split among three tablets
that can be taken at the same time or at different times of the
day. TABLE-US-00017 TABLE 5 Supplement Composition Percent by Weight
of Supplement Tablets Ingredients Weight/Serving (mg) (% w/w) Magnesium
oxide 219.39 (provides 6.80 120 mg magnesium) Zinc gluconate 80.87
(provides 2.51 9.75 mg zinc) Chromium nicotinate 3.38 (provides
0.10 338 .mu.g chromium) Trace mineral protein 7.53 (provides 0.23
hydrolysate 62 .mu.g chromium) Banaba leaf extract 32.00 (provides
1.00 0.32 mg corosolic acid) Vanadium amino acid 4.57 (provides
0.14 chelate 100 .mu.g vanadium) Other vitamins and 1,522.13 47.21
minerals Herbal blend 630.20 19.55 Other ingredients 24.07 0.75
Excipients 699.92 21.71 Total 3,224.06 100.00
[0110] The other vitamins and minerals are as described in Table
1.
EXAMPLE 10
Example of Tea
[0111] Some examples of the disclosed product and method provide
a tea mix as a source of taurine. The tea mix may be provided in
powdered form which is dissolved in water (such as hot water) to
produce a tea beverage for consumption. The source of taurine in
this example provides 0.98 of the active ingredient, hence the 0.82
g of the taurine source supplies about 0.8 g of taurine. TABLE-US-00018
TABLE 6 Tea mix powder Percent by Weight of Ingredients Weight/Serving
(g) Tea Powder (% w/w) Maltodextrin 0.48 28.3 Taurine 0.82 (provides
48.2 0.8 g taurine) Tea extract 0.29 17.2 Green tea powder 0.02
1.2 Flavors 0.09 5.0 Total 1.70 100
EXAMPLE 11
Other Examples of Drink Mix
[0112] Two additional embodiments of the soy protein/chromium/free
leucine beverage powder to be used in the method include the following
specific ingredients shown in Tables 7 and 8. These Examples differ
from earlier embodiments in that they remove the whey and short
chain fructoologisaccharides and add rice protein concentrate, inulin
and more acacia gum. TABLE-US-00019 TABLE 7 Vanilla flavored soy
protein/chromium/free leucine beverage powder Percent by Weight
Ingredients Weight/Serving (g) of Powder (% w/w) Soy protein isolate
17.00 (provides 35.10 (29.69 14.38 g soy protein) soy protein) Fructose
15.05 31.08 High oleic sunflower oil 3.22 6.64 powder Acacia gum
6.81 14.06 Canola oil 0.31 0.64 Inulin 0.05 0.10 Leucine 1.20 2.48
Guar gum 0.20 0.41 Dicalcium phosphate 0.99 2.05 Silicon dioxide
0.52 1.08 Sodium citrate 0.58 1.20 Potassium chloride 0.57 1.17
Flavoring 0.75 1.55 Lecithin 0.55 1.14 Rice protein concentrate
0.20 0.41 Magnesium oxide 0.28 0.58 Chromium nicotinate 0.001 (provides
0.002 100 .mu.g chromium) Vitamin premix 0.085 0.176 Mineral premix
0.063 0.131 TOTAL 48.42 100.00
[0113] TABLE-US-00020 TABLE 8 Chocolate flavored soy protein/chromium/free
leucine beverage powder Percent by Weight Ingredients Weight/Serving
(g) of Powder (% w/w) Soy protein isolate 16.96 (provides 33.42
(28.28 14.35 g soy protein) soy protein) Fructose 16.20 31.92 High
oleic sunflower oil 2.98 5.88 powder Acacia gum 6.81 13.41 Canola
oil 0.31 0.61 Inulin 0.05 0.10 Leucine 1.20 2.36 Cocoa powder 1.00
1.97 Guar gum 0.20 0.39 Dicalcium phosphate 0.99 1.95 Silicon dioxide
0.52 1.03 Sodium citrate 0.58 1.14 Potassium chloride 0.57 1.12
Flavoring 1.20 2.36 Lecithin 0.55 1.08 Rice protein concentrate
0.20 0.39 Magnesium oxide 0.28 0.55 Chromium nicotinate 0.001 (provides
0.002 100 .mu.g chromium) Vitamin premix 0.085 0.168 Mineral premix
0.063 0.125 TOTAL 50.76 100.00
EXAMPLE 12
Other Examples of the Snack
[0114] Two additional embodiments of the snack component of the
weight management products are set forth in Tables 9 and 10. These
particular examples of the snack are in the form of bars that can
be flavored, for example with a peanut butter or lemon flavor. TABLE-US-00021
TABLE 9 PEANUT BUTTER FLAVORED SNACK BAR Percent by Weight Ingredients
Weight/Serving (g) of Snack Bar (% w/w) Soy protein isolate 8.68
(provides 28.00 (22.39 6.94 g soy protein) soy protein) Leucine
0.51 1.65 Fructose 3.34 10.77 Acacia gum 0.47 1.50 Guar gum 0.47
1.50 Inulin 1.09 3.50 Vitamin premix 0.03 0.09 Flavoring 7.60 24.50
Sweeteners 7.13 23.00 Medium chain triglycerides 0.16 0.50 Glycerine
1.55 5.00 Total 31.00 100.00
[0115] TABLE-US-00022 TABLE 10 LEMON FLAVORED SNACK BAR Percent
by Weight Ingredients Weight/Serving (g) of Snack Bar (% w/w) Soy
protein isolate 11.78 (provides 38.00 (31.23 9.68 g soy protein)
soy protein) Leucine 0.51 1.65 Fructose 2.87 9.27 Soy Fiber 0.47
1.50 Canola oil 1.78 5.75 Acacia gum 0.54 1.75 Guar gum 0.54 1.75
Inulin 1.16 3.75 Vitamin premix 0.03 0.09 Flavoring 0.87 2.80 Sweeteners
7.44 24.00 Color 0.06 0.20 Dried cranberries 1.24 4.00 Medium chain
triglycerides 0.16 0.50 Glycerine 1.55 5.00 Total 31.00 100.00
EXAMPLE 13
Use of the Composition
[0116] This study example illustrates the use of the disclosed
products to help promote weight loss while preserving lean body
mass, and/or reduce harmful blood lipid levels. Twenty-seven overweight
but otherwise healthy subjects initially participated, of which
13 women and one man completed the 12 week program. Subjects in
this study were determined to be clinically overweight as measured
by their body mass index. Subjects in the study comprised one group
that adhered to a calorically restricted diet as described in Example
4 for 12 weeks. All subjects consumed:
[0117] the drink mix composition of Example 7 containing about
14.2 g of soy protein, 100 .mu.g of chromium, 1.2 g of free leucine,
140 mg of magnesium, and 5.25 mg of zinc for two meals per day,
dispensed in non-fat milk;
[0118] a snack bar of Example 8 once per day providing about 8.4
g of soy protein and 0.5 g of free leucine;
[0119] one tablet of the Supplement of Example 9 containing a total
dose of about 400 .mu.g of chromium, 32 mg of banaba leaf extract
(providing 0.32 mg of corsolic acid), 120 mg of magnesium, 9.75
mg of zinc, and 100 .mu.g of vanadium, taken three times per day
(morning, noon and evening) and;
[0120] one serving of the tea mix of Example 10 containing 800
mg of taurine
[0121] Subjects were instructed to consume one additional meal
and any supplemental food per day that provided 540-1140 kcal/day
depending on caloric needs. Additionally, subjects were encouraged
to engage in exercise and were provided instructions on how to participate
in a walking program.
[0122] The loss of fat mass and fat-free mass for these subjects
was determined from body skinfold measurements, which is a commonly
accepted predictor of body fat. Skinfold measurements were made
by a single trained observer following standard procedures using
Accu-Measure.RTM. skinfold calipers (see ACSM's Guidelines for Exercise
Testing and Prescription, 6th ed. 2000, Philadelphia: Lippincott
Williams & Wilkins). Body density was calculated using triceps
and subscapular skinfold measurements using the equations of Durnin
and Womersley (Br J Nutr, 32(1): p. 77-97, 1974), while percent
body fat content was calculated from body density by the Siri's
equation (Adv Biol Med Phys, 4: p. 239-80, 1956).
[0123] Fat-free mass was determined as the difference between body
weight and fat mass. Measurement of body fat from skinfold and dual
energy x-ray absorptiometry are well correlated with published correlations
of 0.75-0.94.
[0124] Waist circumference was measured around the subject's waist
along a substantially horizontal line at a point just below the
subject's naval with a measuring tape.
[0125] A baseline weight, fat mass and fat-free mass was established
for each subject, and the subjects were again tested periodically
throughout the 12 week program. The amounts of weight, fat mass
and fat-free mass at baseline, week 6 and week 12 are presented
in the following table as mean.+-.SEM. Analysis of variance (ANOVA)
for repeated measures followed by Tukey's post-hoc analysis was
used to determine statistical significance and .alpha. was set to
0.05. TABLE-US-00023 TABLE 11 Weight Loss Results Using SCL Method
and Products Parameter Measured Baseline Week 6 Week 12 Weight (kg)
84.9 .+-. 2.9 81.1 .+-. 2.6* 77.9 .+-. 2.5* Fat Mass (kg) 39.7 .+-.
1.7 35.6 .+-. 1.5* 32.3 .+-. 1.5* Fat-Free Mass (kg) 45.2 .+-. 1.6
45.6 .+-. 1.6 45.7 .+-. 1.6 Weight Lost (kg) 3.8 .+-. 1.2 7.0 .+-.
2.0 Fat Mass Lost (kg) 4.1 .+-. 0.6 7.4 .+-. 1.0 Fat-Free Mass Gained
(kg) 0.4 .+-. 0.3 0.5 .+-. 0.6 Fat-Free Mass Lost 0.sup. 0.sup.
Fat-Free Mass Lost as 0% 0% % of Total Weight Lost Ratio of Fat-Free
Mass 0% 0% Lost to Fat Mass Lost Waist Circumference 7.4 .+-. 1.5
10.5 .+-. 1.8 Lost (cm) Hip Circumference Lost (cm) 5.0 .+-. 1.2
6.5 .+-. 1.7 Decrease in Waist to 0.03 .+-. 0.02 0.04 .+-. 0.02
Hip Ratio Data are presented as .+-.SEM. *Indicates P < 0.05.
[0126] As can be seen from the results in Table 11, on average
subjects lost 7.0 kg over the 12 week period. Subjects lost 7.4
kg of fat mass, and although not statistically significant, gained
0.5 kg of fat-free mass. These data indicate that the weight loss
came entirely from body fat and that fat-free mass was preserved
throughout the hypocaloric intervention. Waist circumference and
hip circumference decreased 10.5 and 6.5 cm, respectively and waist
to hip ratio was reduced by 0.04.
[0127] At baseline and week 12, plasma triglycerides, total cholesterol,
low density lipoprotein and high density lipoprotein were measured
for each subject. The decrease in cholesterol, triglycerides and
low density lipoprotein (LDL) as well as the increase in high density
lipoprotein (HDL) are presented in the table below. A paired student's
t-test was used to determine statistical significance and a was
set to 0.05. TABLE-US-00024 TABLE 12 Lipid Profile Improvements
using SCL Method and Products Parameter Measured Baseline Week 12
Triglycerides, mg/dL 128 .+-. 18 84 .+-. 7* Percent Decrease in
Triglycerides 34.4% Total Cholesterol, mg/dL 209 .+-. 9 187 .+-.
7* Percent Decrease in Cholesterol 10.5% Low Density Lipoprotein,
mg/dL 124 .+-. 6 109 .+-. 6 High Density Lipoprotein, mg/dL 60 .+-.
2 62 .+-. 2 Ratio of total cholesterol to 3.5 .+-. 0.2 3.1 .+-.
0.1* high density lipoprotein Data are presented as .+-.SEM. *Indicates
P < 0.05.
[0128] These results illustrate there were favorable changes in
the blood lipid profiles. There were significant reductions in triglycerides,
total cholesterol and the ratio of total cholesterol to HDL. Although
total cholesterol decreased and LDL tended to decrease (p=0.05),
there was a slight but non-significant increase in HDL (which is
generally considered a "protective" cholesterol).
[0129] The data in the present Example is further broken down to
show body mass changes in two week intervals: TABLE-US-00025 TABLE
13 Weight Lost with SCL Products and Method Week Week Week Week
Week Week Parameter Measured 2 4 6 8 10 12 Weight Lost (kg) 1.7
2.7 3.8 4.9 6.0 7.0 Fat Lost (kg) 1.7 NM 4.1 NM 6.3 7.4 Fat-Free
Mass (kg) 45.2 NM 45.6 NM 45.5 45.7 Waist Circumference 3.7 6.3
7.4 8.9 8.7 10.5 Lost (cm) Hip Circumference 2.5 4.0 5.0 6.1 6.8
6.5 Lost (cm) Decrease in Waist 0.01 0.02 0.03 0.03 0.02 0.04 to
Hip Ratio NM = Not Measured
[0130] As an added benefit, when asked about the sensation of satiety
(feeling of fullness), test subjects responded that they felt satiated.
These same subjects also responded positively when questioned about
the ability of the program to reduce cravings for food. Subjects
particularly noted a reduced craving for carbohydrates. Additionally,
these subjects reported feelings of increased energy and vitality
while using this product and method.
EXAMPLE 14
Comparative Data with Prior SS and SSS Trials
[0131] The composition and method of Example 13 offers unexpectedly
superior preservation of lean body mass in comparison to prior dietary
regimens that have included soy protein, chromium or protein-bound
leucine.
[0132] To demonstrate this superiority, the results of the soy
protein/chromium/free leucine (SCL) trial were compared to the compositions
and methods disclosed in the assignee's prior U.S. patent application
Ser. No. 10/722,368 filed Nov. 24, 2003 and published as US20040166181
on Aug. 26, 2004, as well as in corresponding PCT Publication 04047765
published Jun. 10, 2004. The comparisons were performed between
the SCL group and the Supplement plus Spray (SS) or the Supplement
plus Spray plus Shake (SSS) groups described in the prior application.
[0133] In particular the SS group received the nutritional supplement
of Example 6 plus the dietary composition of Example 7 of that prior
application. The nutritional supplement of Example 6 of that prior
application was two capsules that delivered a total daily dosage
of about 32 mg of banaba leaf extract standardized to contain about
1% corosolic acid and about 400 .mu.g chromium in the form of chromium
polynicotinate, as well as about 200 mg magnesium, about 5 mg zinc,
about 500 mg taurine, about 100 .mu.g vanadium, and about 10 mg
alpha lipoic acid. The dietary composition of Example 7 of that
prior application was a spray that contained equal amounts of dilutions
of about 3.times.Fucus vesiculosus, about 3.times.Gambogia garcinia,
about 30 C Apis mellifica, about 4.times.Badiaga, about 30.times.Calcarea
carbonica, about 3.times.Passiflora incamata, about 12.times.Baryta
carbonica, about 12.times.Calcarea fluorica, about 6.times.Lycopodium
clavatum, about 6.times.Berberis vulgaris, about 3.times.Leptandra
virginica, about 6.times.Thuja occidentalis, about 3.times.Galium
aparine, about 30 C Urtica urens, about 200 C Histaminum muriaticum,
and about 30 C Sabadilla, which were mixed with about 20% by volume
of alcohol and provided in a spray bottle adapted to spray about
0.1-0.5 mL of the dietary composition per spray.
[0134] The SSS group in addition received the soy protein/chromium
shake drink composition of Example 4 of the prior application. The
soy protein/chromium drink of the prior application contained the
following ingredients: TABLE-US-00026 Prior Shake Drink Percent
by Weight Ingredients of Powder (% w/w) Weight/Serving Soy Protein
Isolate 29.40 13.91 g (24.88 soy (provides 11.77 protein) g soy
protein) Fructose 23.43 11.08 g High Oleic Sunflower Oil 12.68 6.00
g Powder Acacia Gum 15.85 7.50 g Canola Oil 2.56 1.07 g Inulin 2.11
1.00 g Milk Protein Isolate 1.90 0.90 g Dicalcium Phosphate 2.10
0.99 g Silicon Dioxide 1.69 0.80 g Sodium Citrate 1.23 0.58 g Potassium
Chloride 1.20 0.57 g Soy Lecithin 1.06 0.50 g Whey Protein Isolate
0.95 0.45 g Guar Gum 1.90 0.90 g Flavoring 0.79 0.37 g Vitamin Premix
0.45 0.21 g Mineral Premix 0.37 0.18 g (provides 40 .mu.g chromium)
Chromium Nicotinate 0.003 1.4 mg (provides 140 .mu.g chromium) Ferrous
Fumarate 0.025 11.9 mg Sucralose 0.0085 4.0 mg Mixed Tocopherol
Concentrate 0.002 0.9 mg TOTAL 100.00 47.31 g
[0135] The data set forth in Table 14 illustrates the superior
preservation of lean body mass with the SCL method of the present
invention, as compared to the prior SS Group and SSS Group. In Table
14, the Diet and Exercise group underwent caloric restriction and
an exercise regimen without using any weight loss products. TABLE-US-00027
TABLE 14 Comparison of SCL Method to Prior Methods at 12 Weeks of
Use SCL Diet and SS SSS Current Parameter Measured Exercise Group
Group Trial Weight Lost (kg) 6.7 6.6 5.7 7.0 Fat Lost (kg)* 4.5
4.4 3.8 7.4 Lean Body Mass Lost (kg)* 2.1 2.0 1.6 0 (-0.5) Lean
Body Mass Lost as % 31% 30% 28% 0 of Total Body Weight Lost* Ratio
of Lean Body Mass 0.47 0.46 0.28 0 Lost* To Fat Lost Waist Circumference
Lost 5.7 5.0 4.6 10.5 (cm) Hip Circumference Lost (cm) 3.8 4.5 3.7
6.5 Decrease in Waist to Hip 0.02 0.01 0.01 0.04 Ratio *Data from
the current trial (SCL) are estimates of fat-free mass and fat mass.
In the prior study (SS and SSS), lean body mass was measured via
DEXA, whereas in the SCL trial skinfold calipers were used to estimate
body fat percentage.
EXAMPLE 15
Prior Protein-Bound Leucine-Containing Diet of Layman et al.
[0136] Some prior publications have disclosed the results of studies
of the effect of protein-bound leucine on the preservation of lean
body mass. Such a study is found, for example, in Layman, et al.,
J. Nutr. 133:411-417, 2003, in which 24 overweight women (45-56
y old) were divided into two groups of 12 subjects. Both groups
consumed isocaloric diets of 1700 cauday (a 500 cauday deficit)
for 10 weeks. The control diet was fashioned according to the USDA
Food Guide Pyramid guide and provided 16% of daily calories from
protein (containing 5.4 g of protein-bound leucine per day), 58%
from carbohydrate, and 26% from fat. The protein-bound leucine test
diet provided 30% of daily calories from proteins containing ample
endogenous leucine content such as meats, cheeses and eggs (daily
total of roughly 9.9 g protein-bound leucine), 41% carbohydrate,
and 29% fat. The table below shows the results obtained with respect
to preservation of lean body mass. It is notable that even though
the Layman et al. study provided 9.9 g of protein-bound leucine
each day, almost 12% of lean body mass was still lost by subjects
in that trial. Layman et al. did not administer free leucine; the
different amounts of leucine consumed by each group reflected different
amounts of dietary protein. TABLE-US-00028 TABLE 15 Weight Loss
after 10 Weeks of Higher Protein Diet of Layman et al. Control Diet
(16% Protein Diet (30% protein, 5.4 g protein, 9.9 g protein-bound
protein-bound Parameter Measured leucine/day) leucine/day) Weight
Lost (kg) 6.96 7.53 Fat Lost (kg) 4.74 5.60 Lean Body Mass Lost
(kg) 1.21 0.88 Lean Body Mass Lost (% 17.4%.sup. 11.7%.sup. of Total
Weight Lost) Ratio of Lean Body Mass 0.26 0.16 Lost to Fat Mass
Lost
EXAMPLE 16
Comparative Data with Protein-Bound Leucine Containing Diet of
Layman et al.
[0137] The ratio of lean body mass lost to fat mass lost in the
Layman et al. study was 0.16, as compared to substantially zero
with the SCL weight management products of the present invention.
Similarly, the loss of lean body mass as a percentage of total weight
lost was 12% in the Layman et al. diet versus essentially zero in
the SCL method. These unexpected and superior results are illustrated
in Table 16. TABLE-US-00029 TABLE 16 Weight Loss after 10 Weeks
of SCL Method versus Higher Protein Diet of Layman et al. Protein
Diet (30% SCL protein, 9.9 g protein- Parameter Measured Method
bound leucine/day) Weight Lost (kg) 6.0 7.53 Fat Lost (kg) 6.3 5.60
Lean Body Mass Lost (kg) 0 (-0.3) 0.88 Lean Body Mass Lost (% 0%
11.7% of Total Weight Lost) Ratio of Lean Body Mass 0 0.16 Lost
to Fat Mass Lost
[0138] The above-described examples merely disclose particular,
specific embodiments of the disclosed compositions, methods, and
kits. They are not intended to be limiting in any way. Moreover,
although these embodiments have been described in detail, those
of ordinary skill in the art will understand that variations may
be made thereto without departing from the spirit of the invention
or scope of the appended claims. |