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Weight Loss Patent Abstract
A composition for promoting weight loss comprising black tea extract,
white tea extract, oolong tea extract, guarana extract, green mate
extract, thiamine, choline and N-acetylcysteine. The composition
may be administered in methods for promoting weight loss by increasing
fat oxidation and/or controlling appetite.
Weight Loss Patent Claims
1. A composition for promoting weight loss comprising: black tea
extract; white tea extract; guarana extract; oolong tea extract;
green mate extract; thiamine; choline; and N-acetylcysteine.
2. The composition of claim 1 wherein the composition further comprises
black tea extract standardized to comprise not less than about 40%
polyphenols, not less than about 20% theaflavins and not less than
about 10% caffeine.
3. The composition of claim 1 wherein the composition further comprises
white tea extract standardized to comprise not less than about 80%
polyphenols, not less than about 30% EGCG and not less than about
5% caffeine.
4. The composition of claim 1 wherein the composition further comprises
oolong tea extract standardized to comprise not less than about
40% polyphenols.
5. The composition of claim 1 wherein the composition further comprises
guarana seed extract standardized to comprise not less than 50%
caffeine.
6. The composition of claim 1 wherein the composition further comprises
green mate extract standardized to comprise not less than 30% caffeine
and not less than about 30% polyphenols.
7. The composition of claim 1 wherein the composition further comprises:
black tea extract standardized to comprise not less than about 40%
polyphenols, not less than about 20% theaflavins and not less than
about 10% caffeine; white tea extract standardized to comprise not
less than about 80% polyphenols, not less than about 30% EGCG and
not less than about 5% caffeine; oolong tea extract standardized
to comprise not less than about 40% polyphenols; guarana seed extract
standardized to comprise not less than 50% caffeine; and green mate
extract standardized to comprise not less than 30% caffeine and
not less than about 30% polyphenols.
8. The composition of claim 7 wherein a ratio of theaflavins to
polyphenols in the black tea extract is in a range from about 0.3:1
to about 1:1.
9. The composition of claim 7 wherein a ratio of theaflavins in
the black tea extract to polyphenols in the green mate extract is
in a range from about 0.5:1 to about 1.5:1.
10. The composition of claim 7 wherein the composition further
comprises: black tea extract in the amount of about 20-1,000 mg;
white tea extract in the amount of about 20-1,000 mg; guarana extract
in the amount of about 50-600 mg; oolong tea extract in the amount
of about 20-1,000 mg; green mate extract in the amount of about
10-1,000 mg; thiamine in the amount of about 0.2-12 mg; choline
in the amount of about 1-100 mg; and N-acetylcysteine in the amount
of about 1-300 mg.
11. The composition of claim 10 wherein the composition further
comprises: black tea extract in the amount of about 40-120 mg; white
tea extract in the amount of about 50-150 mg; guarana extract in
the amount of about 60-180 mg; oolong tea extract in the amount
of about 40-120 mg; green mate extract in the amount of about 30-90
mg; thiamine in the amount of about 1-3 mg; choline in the amount
of about 5-15 mg; and N-acetylcysteine in the amount of about 1-4
mg.
12. The composition of claim 10 wherein a ratio of weight of black
tea extract to weight of white tea extract is in a range from about
2.5:1 to about 1:3.75.
13. The composition of claim 10 wherein a ratio of weight of black
tea extract to green mate extract is in a range from about 4:1 to
about 1:2.25.
14. The composition of claim 10 wherein a ratio of weight of white
tea extract to green mate extract is in a range from about 5:1 to
about 1:1.8.
15. The composition of claim 10 wherein a ratio of the sum of the
weight of black tea extract and weight white tea extract to the
weight of green mate extract is in a range from about 9:1 to about
1:1.
16. The composition of claim 10 wherein the total amount of caffeine
in the composition is about 1-200 mg.
17. The composition of claim 16 wherein the total amount of caffeine
in the composition is about 1-100 mg.
18. The composition of claim 7 further comprising at least one
of rooibos tea extract, grape pomace extract, yerba mate extract,
bilberry extract, grape juice extract, apple extract, artichoke
extract, green coffee extract, cinnamon bark extract, chlorogenic
acid, vitamin C, quercitrin, isoquercitrin, calcium and inositol.
19. A method for promoting weight loss comprising: orally administering
a composition to a mammal wherein the composition comprises: black
tea extract; white tea extract; guarana extract; oolong tea extract;
green mate extract; thiamine; choline; and N-acetylcysteine; wherein
the composition controls the appetite of the mammal.
20. The method of claim 19 wherein the composition further comprises
black tea extract standardized to comprise not less than about 40%
polyphenols, not less than about 20% theaflavins and not less than
about 10% caffeine.
21. The method of claim 19 wherein the composition further comprises
white tea extract standardized to comprise not less than about 80%
polyphenols, not less than about 30% EGCG and not less than about
5% caffeine.
22. The method of claim 19 wherein the composition further comprises
oolong tea extract standardized to comprise not less than about
40% polyphenols.
23. The method of claim 19 wherein the composition further comprises
guarana seed extract standardized to comprise not less than 50%
caffeine.
24. The method of claim 19 wherein the composition further comprises
green mate extract standardized to comprise not less than 30% caffeine
and not less than about 30% polyphenols.
25. The method of claim 19 wherein the composition further comprises:
black tea extract standardized to comprise not less than about 40%
polyphenols, not less than about 20% theaflavins and not less than
about 10% caffeine; white tea extract standardized to comprise not
less than about 80% polyphenols, not less than about 30% EGCG and
not less than about 5% caffeine; oolong tea extract standardized
to comprise not less than about 40% polyphenols; guarana seed extract
standardized to comprise not less than 50% caffeine; and green mate
extract standardized to comprise not less than 30% caffeine and
not less than about 30% polyphenols.
26. The method of claim 25 wherein a ratio of theaflavins to polyphenols
in the black tea extract is in a range from about 0.3:1 to about
1:1.
27. The method of claim 25 wherein a ratio of theaflavins in the
black tea extract to polyphenols in the green mate extract is in
a range from about 0.5:1 to about 1.5:1.
28. The method of claim 25 wherein the composition further comprises:
black tea extract in the amount of about 20-1,000 mg; white tea
extract in the amount of about 20-1,000 mg; guarana extract in the
amount of about 50-600 mg; oolong tea extract in the amount of about
20-1,000 mg; green mate extract in the amount of about 10-1,000
mg; thiamine in the amount of about 0.2-12 mg; choline in the amount
of about 1-100 mg; and N-acetylcysteine in the amount of about 1-300
mg.
29. The method of claim 25 wherein the composition further comprises:
black tea extract in the amount of about 40-120 mg; white tea extract
in the amount of about 50-150 mg; guarana extract in the amount
of about 60-180 mg; oolong tea extract in the amount of about 40-120
mg; green mate extract in the amount of about 30-90 mg; thiamine
in the amount of about 1-3 mg; choline in the amount of about 5-15
mg; and N-acetylcysteine in the amount of about 1-4 mg.
30. The method of claim 29 wherein the total amount of caffeine
in the composition is about 1-200 mg.
31. The method of claim 30 wherein the total amount of caffeine
in the composition is about 1-100 mg.
32. The method of claim 29 wherein the method further comprising
controlling the appetite of the mammal by decreasing the appetite
of the mammal.
33. The method of claim 29 wherein the method further comprises
controlling the appetite of the mammal by maintaining the appetite
of the mammal at a constant level.
34. The method of claim 29 wherein the method further comprises
administering a serving of the composition at least about 30 minutes
before the mammal eats a meal.
35. The method of claim 25 wherein the composition further comprises
at least one of rooibos tea extract, grape pomace extract, yerba
mate extract, bilberry extract, grape juice extract, apple extract,
artichoke extract, green coffee extract, cinnamon bark extract,
chlorogenic acid, vitamin C, quercitrin, isoquercitrin, calcium
and inositol.
36. A method for promoting weight loss comprising: orally administering
a composition to a mammal wherein the composition comprises: black
tea extract; white tea extract; guarana extract; oolong tea extract;
green mate extract; thiamine; choline; and N-acetylcysteine; wherein
the composition increases fat oxidation by the mammal.
37. The method of claim 36 wherein the composition further comprises
black tea extract standardized to comprise not less than about 40%
polyphenols, not less than about 20% theaflavins and not less than
about 10% caffeine.
38. The method of claim 36 wherein the composition further comprises
white tea extract standardized to comprise not less than about 80%
polyphenols, not less than about 30% EGCG and not less than about
5% caffeine.
39. The method of claim 36 wherein the composition further comprises
oolong tea extract standardized to comprise not less than about
40% polyphenols.
40. The method of claim 36 wherein the composition further comprises
guarana seed extract standardized to comprise not less than 50%
caffeine.
41. The method of claim 36 wherein the composition further comprises
green mate extract standardized to comprise not less than 30% caffeine
and not less than about 30% polyphenols.
42. The method of claim 36 wherein the composition further comprises:
black tea extract standardized to comprise not less than about 40%
polyphenols, not less than about 20% theaflavins and not less than
about 10% caffeine; white tea extract standardized to comprise not
less than about 80% polyphenols, not less than about 30% EGCG and
not less than about 5% caffeine; oolong tea extract standardized
to comprise not less than about 40% polyphenols; guarana seed extract
standardized to comprise not less than 50% caffeine; and green mate
extract standardized to comprise not less than 30% caffeine and
not less than about 30% polyphenols.
43. The method of claim 42 wherein a ratio of theaflavins to polyphenols
in the black tea extract is in a range from about 0.3:1 to about
1:1.
44. The method of claim 42 wherein a ratio of theaflavins in the
black tea extract to polyphenols in the green mate extract is in
a range from about 0.5:1 to about 1.5:1.
45. The method of claim 42 wherein the composition further comprises:
black tea extract in the amount of about 20-1,000 mg; white tea
extract in the amount of about 20-1,000 mg; guarana extract in the
amount of about 50-600 mg; oolong tea extract in the amount of about
20-1,000 mg; green mate extract in the amount of about 10-1,000
mg; thiamine in the amount of about 0.2-12 mg; choline in the amount
of about 1-100 mg; and N-acetylcysteine in the amount of about 1-300
mg.
46. The method of claim 45 wherein the composition further comprises:
black tea extract in the amount of about 40-120 mg; white tea extract
in the amount of about 50-150 mg; guarana extract in the amount
of about 60-180 mg; oolong tea extract in the amount of about 40-120
mg; green mate extract in the amount of about 30-90 mg; thiamine
in the amount of about 1-3 mg; choline in the amount of about 5-15
mg; and N-acetylcysteine in the amount of about 1-4 mg.
47. The method of claim 46 wherein the total amount of caffeine
in the composition is about 1-200 mg.
48. The method of claim 47 wherein the total amount of caffeine
in the composition is about 1-100 mg.
49. The method of claim 46 wherein the method further comprises
administering a serving of the composition at least about 30 minutes
before the mammal eats a meal.
50. The method of claim 42 wherein the composition further comprises
at least one of rooibos tea extract, grape pomace extract, yerba
mate extract, bilberry extract, grape juice extract, apple extract,
artichoke extract, green coffee extract, cinnamon bark extract,
chlorogenic acid, vitamin C, quercitrin, isoquercitrin, calcium
and inositol.
Weight Loss Patent Description
BACKGROUND
[0001] Inability to properly manage weight is an increasing problem
among the adult population as indicated by increasingly rising rates
of obesity. Obesity and excessive weight lead to a litany of health
problems such as cardiovascular disease, skeletal and joint disease,
diabetes, cancer, poor body image, depression and overall decreased
energy. However, maintaining proper body weight is difficult for
individuals who lack the time to exercise or the knowledge and wherewithal
to abide by a healthy diet.
[0002] The regulation of body weight involves a complex interaction
of the central nervous system (CNS), endocrine system and digestive
system. The food consumed from all dietary sources by an individual
amounts to the total (caloric) energy intake. The extent of energy
(food stores) utilized by the body tissues to perform work (to undertake
all the functions of the body) is energy expenditure (EE). The cells
utilize energy sources to generate heat, a process known as thermogenesis.
All of the energy expended by the body is ultimately converted to
heat. The food ingested and the body's metabolic energy stores in
the forms of fat (excess calories stored as fat) and glycogen, combine
with oxygen and undergo the process of oxidation to generate bioenergy
(ATP) in the body cells, utilized for carrying out all life processes.
These metabolic processes produce energy as heat (thermogenesis).
When one consumes calories in excess of those required for immediate
energy production, conversion of a portion of these excess calories
to heat occurs, rather than its storage as fat, a process known
as diet-induced thermogenesis. The two fundamental approaches to
induce weight loss are either to decrease energy (food) intake or
to increase energy expenditure by enhanced oxidation of food sources,
or a combination of both.
[0003] The body possesses an expanded capacity to store fat. The
fat stores in the body readily accommodate increasing levels of
energy intake over and above those required for daily energy needs.
The mobilization of stored fat from the body, in the form of triglycerides,
and their hydrolysis to free fatty acids (lipolysis) provides substrates
for metabolic oxidation. Raising metabolism, particularly that of
fat, utilizes more food reserves and, therefore, results in higher
EE. The preferential deployment of fat for enhanced oxidation accelerates
the utilization of body fat, thereby depleting fat stores in the
tissues and inducing weight loss. In case there is a deficit in
the supply of energy, the body draws from fats stored from excess
energy intake (from foods) and oxidizes the same (loss of weight).
[0004] The body's physiological systems maintain homeostasis with
respect to energy (caloric) intake and energy utilization. The regulation
of energy balance involves a complex network of hormonal and neural
mechanisms. A net imbalance between energy intake and energy expenditure
over time impairs body weight maintenance, resulting in weight gain
leading to excessive body weight and eventually contributing to
obesity, depending on the severity.
[0005] When the body encounters an energy deficit in the course
of weight-reducing diets, it tends to save energy by reducing thermogenesis.
This factor contributes to a failure in sustaining body weight after
body weight loss. These circumstances require continually stimulated
thermogenesis. After losing weight for a short duration, an individual's
weight stabilizes. In order to maintain body weight there is a need
to control food intake and stimulate thermogenesis on an ongoing
basis.
[0006] Body weight control methods often yield short-term positive
results and sustained weight maintenance is a real challenge. The
difficult task is to identify substances, which are readily able
to suppress appetite and reduce food (energy) intake, and continuously
maintain increased metabolism and enhanced EE, thereby facilitating
body weight maintenance effects in regulating food intake.
[0007] Prior art attempts at increasing energy expenditure and
thermogenesis have primarily used large amounts of stimulants such
as caffeine and ephedra. Caffeine in particular has been a popular
CNS stimulant used in weight management. While caffeine at high
doses increases energy expenditure and induces fat oxidation, continued
or sustained weight loss becomes a major concern where greater amounts
of caffeine lead to a gradual habituation and eventual decrease
in efficacy. Furthermore, stimulants such as caffeine induce possible
transient side effects on the cardiovascular system. Cardiovascular
side effects are often a concern for those with unhealthy body weight
where obesity and cardiovascular health problems often overlap.
Caffeine in large amounts should also be avoided by people who suffer
from kidney disease, an overactive thyroid, a tendency to spasms,
or problems with anxiety or panic.
[0008] Accordingly, there is a need for providing a composition
for promoting weight loss, through increased fat oxidation and modulation
of appetite that contains decreased levels of caffeine. The composition
should provide weight loss effects without the drawbacks of caffeine
habituation leading to decreased efficacy over time and cardiovascular
and CNS side effects caused by high amounts of caffeine. Furthermore,
there is a need for methods for promoting weight loss by administering
a composition that increases fat oxidation and modulates appetite
with decreased levels of caffeine.
SUMMARY
[0009] In an embodiment, a composition comprises black tea extract,
white tea extract, guarana extract, oolong tea extract, green mate
extract, thiamine, choline and N-acetylcysteine. In another embodiment,
a method for promoting weight loss by increasing fat oxidation and
controlling appetite comprises administering a pharmaceutical composition
comprising black tea extract, white tea extract, guarana extract,
oolong tea extract, green mate extract, thiamine, choline and N-acetylcysteine.
The combination of the elements of the pharmaceutical composition
promotes weight loss while administering decreased amounts of caffeine
as compared to conventional formulations.
DETAILED DESCRIPTION
[0010] For simplicity and illustrative purposes, the principles
are shown by way of examples of compositions and methods described.
In the following description, numerous specific details are set
forth in order to provide a thorough understanding of the examples.
It will be apparent however, to one of ordinary skill in the art,
that the examples may be practiced without limitation to these specific
details. In other instances, well known methods and compositions
are not described in detail so as not to unnecessarily obscure understanding
of the examples.
[0011] An embodiment includes a composition for promoting weight
loss. The composition promotes weight loss by increasing fat oxidation
and controlling appetite while administering limited levels of caffeine.
In an example, the composition comprises a combination of black
tea extract, white tea extract, guarana extract, oolong tea extract,
green mate extract, thiamine, choline and N-acetylcysteine. The
combination of all of the elements provides for weight loss with
decreased amounts of caffeine.
[0012] Black tea extracts are derived from natural tea produced
from the leaves of Camellia sinensis from the genus Theaceae. In
general there are three principal types of manufactured tea, namely
green tea (unfermented), oolong (partially fermented) and black
tea (fully fermented). The term "fermentation" refers
to the oxidative transformations undergone by tea leaf phenolics,
involving natural browning reactions inducing by polyphenol oxidases
within the cells of the tea plant. During the manufacture of black
tea, a major proportion of the monomeric free catechins in the fresh
green tea leaf undergoes oxidative changes culminating in the generation
of a series of compounds, including bisflavanols, theaflavins, epitheaflavic
acids, and thearubigins, which impart the characteristic taste and
color properties of black tea.
[0013] According an embodiment, the black tea extract comprises
polyphenols, theaflavins and caffeine. One of the polyphenols specific
to the black tea extract, gallic acid, is known to have appetite
suppressing qualities. The theaflavins found in black tea suppress
NF-kappaB (nuclear factor-kappaB) and downregulate IkappaB kinase
(IKK) activity, both of which are factors involved in obesity. The
inhibition of IKK activity is related to the reversal of obesity.
Theaflavins also inhibit the activity of AP-1, a nuclear binding
protein (transcription factor) relevant to obesity. Black tea extracts
further confer a beneficial effect on the coronary circulation in
human subjects and enhance vasodilation which leads to stimulation
of metabolism and lipolysis.
[0014] Other constituents particular to black tea include rusty
red-brown thearubigins. The theaflavins, which are dimeric catechins,
the theaflavin gallates and the thearubigins, the polymers of theaflavins,
which are unique constituents of black tea may further provide a
synergistic benefit in cellular systems with increased fat oxidation
through the constituent antioxidants. They possess a higher number
of phenolic groups than those found in the catechins such as EGCg.
In particular, they are capable of providing protection for the
cellular energy producing organelles that are exposed to enhanced
oxidative stress due to increased lipid oxidation and cellular energy
production.
[0015] According an embodiment, the black tea extract may be standardized
to comprise not less than about 40% polyphenols. According to alternative
embodiments, the black tea extract may standardized to comprise
not less than about 20% theaflavins and/or the black tea extract
may be standardized to comprise not less than about 10% caffeine.
In an example, the black tea extract may be standardized to comprise
not less than about 40% polyphenols, not less than about 20% theaflavins
and not less than about 10% caffeine.
[0016] White tea, derived from young and tender tea shoots, is
the least processed of all teas. Since white tea is not fermented,
its catechins are the least modified as compared to green, oolong
and black teas. The polyphenols of white tea are even more native
than those of green tea. Therefore, white tea extracts contain higher
amounts of unmodified catechins, in particular (-)-epigallocatechin
gallate (EGCg), than those found in processed green tea. EGCg and
other catechins (including black tea polyphenols) have been implicated
in the inhibition of the enzyme, catechol-O-methyl-transferase.
This enzyme inactivates norepinephrine. According to an embodiment,
the white tea extract may be standardized to comprise not less than
about 80% polyphenols. According to an alternative embodiment, the
white tea extract may be standardized to comprise not less than
about 30% EGCg. In another example, the white tea extract may be
standardized to comprise not less than about 80% polyphenols, not
less than about 30% EGCG and not less than about 5% caffeine.
[0017] Oolong tea extracts are derived from oolong tea, which is
a partially fermented product having components common to both green
and black teas including both native and partially oxidized constituents.
In particular, several catechins characteristic of green tea, are
present in oolong tea, along with catechin oligomers, oligomeric
proanthocyanidins and polymeric polyphenolics, typically characteristic
of black tea. Specific constituents of oolong tea include dimeric
proanthocyanidins, theasinensins D-G, oolongtheanin, 8-C-ascorbyl-(-)-epigallocatechin-3-O-gallate
and novel dimeric flavan-3-ols, oolonghomobisflavans A and B. As
compared to green tea, oolong tea has been shown to increase energy
expenditure at much higher levels due to the polymerized polyphenols
that are not present in green tea.
[0018] Oolong tea constituents also appear to promote hormone sensitive
lipase activity in adipose tissues resulting in lipolysis and have
the ability to influence the sympathoadrenal system and the turn
over of catecholamines such as epinephrine and norepinephrine. The
modulation of catecholamine turn over influences circulating and
neuronal catecholamines, which increase metabolic rate and fat oxidation.
According to an embodiment, oolong tea extract may be standardized
to comprise not less than about 40% polyphenols.
[0019] Guarana extract is derived from the seed of Paullina cupana,
a tropical plant found in the Amazon basin. The seeds of Paullina
cupana are peeled, dried, roasted, ground much like coffee beans.
Guarana extracts provide concentrated amounts of caffeine in addition
to theobromine and theophylline. Caffeine related compounds derived
from guarana extract are often also known as guararine.
[0020] In addition to acting as a stimulant on the basis of caffeine
content, guarana has been shown to increase adipocyte cAMP levels
by inhibiting phosphodiesterase. Other effects include acting as
an antagonist to adenosine receptor (thereby maintaining AMP levels)
and stimulating calcium release which is relevant to adipocyte lipolysis.
According to an embodiment, the amounts of guarana extract in the
composition are limited to decrease total caffeine. In an example,
guarana extract may be standardized to comprise not less than about
50% caffeine.
[0021] Green mate is derived from the leaf of Ilex paraguariensis,
which is an evergreen plant found in South America. The mate leaves
can be dried to prepare green mate and then brewed and further processed
to prepare yerba mate. Therefore, the polyphenols in green mate
extracts are unmodified and intact as compared to yerba mate. In
addition to containing unique polyphenols, green mate is also a
natural source of caffeine which has known stimulant and thermogenic
properties. According to an embodiment, green mate extract may be
standardized to comprise not less than about 30% caffeine. According
to an alternative embodiment, the green mate extract may be standardized
to comprise not less than about 30% polyphenols. In an example of
the composition, the green mate may be standardized to comprise
not less than about 30% caffeine and not less than about 30% polyphenols.
[0022] Thiamine, also known as vitamin B.sub.1, is a water-soluble
vitamin having a structure that consists of a substituted pyrimidine
ring joined by a methylene bridge to a substituted thiazole ring.
Studies have shown that the active form of thiamine plays an essential
role as a cofactor in key reactions in carbohydrate metabolism and
thermogensis generally. It is also involved in the metabolism of
branched-chain amino acids and may have non-coenzyme (non-cofactor)
roles in excitable cells. According to an embodiment, thiamine is
in the form of thiamine hydrochloride ("thiamine HCl").
In an example, thiamine HCl may be assayed at purity of 98.5% or
above.
[0023] Choline, also known as 2-hydroxy-N,N,N-trimethylethanamine,
is an essential nutrient that is widely distributed in foods. The
three major metabolic functions of choline are as a precursor for
phosphatidylcholine biosynthesis, as a precursor for acetylcholine
biosynthesis and as a methyl donor. With regards to weight loss,
choline functions as a lipotropic agent that is necessary to remove
lipids from the liver and utilize the lipids as energy. Studies
have also shown that choline possesses anti-obesity effects. Choline
is often supplemented in the form of choline chloride or choline
bitatrate. According to an embodiment, choline is in the form of
choline bitartrate. Choline bitartrate may be assayed at not less
than about 87% purity containing not less than about 43% choline.
[0024] N-Acetylcysteine is the N-acetyl derivative of the amino
acid L-cysteine. Supplementation with N-acetylcysteine has been
shown in studies to inhibit alloxan-induced NF-kappaB activation
and reduce hyperglycemia. N-Acetylcysteine further acts as a hepatoprotectant
due to its ability to serve as a precursor of glutathione. A major
role of glutathione is the maintenance of a normal redox state of
the liver and other tissues. As a precursor of glutathione, N-acetylcysteine
also protects the cell membranes from lipid peroxidation which can
result from increased oxidative stress caused by fat oxidation.
According to an embodiment, N-acetylcysteine may be assayed at not
less than about 98% pure.
[0025] The term "standardized" as used in the field of
naturally derived nutritional products refers to the process for
delivering a product with a specific minimum level of one or more
plant constituents. Standardization represents the level of concentration
of particularly desired elements from a plant source. Methods for
standardizing plant substances, including black tea, white tea,
oolong tea, guarana and green mate, are well known in the art. Furthermore,
the measurement of particular plant constituents on which standardization
is based is also well known in the art.
[0026] The term "about" when used as a modifier of a
numerical range or amount designates an approximation of the range
or the amount whereby minor deviations from the range or amount
are within the scope of the invention. Such deviations are known
in the art of manufacturing formulations having a number of different
ingredients of varying weight and consistency.
[0027] According to an embodiment, a composition comprises black
tea extract that is standardized to comprise not less than about
40% polyphenols, not less than about 20% theaflavins and not less
than about 10% caffeine; white tea extract that is standardized
to comprise not less than about 80% polyphenols; oolong tea extract
that is standardized to comprise not less than about 40% polyphenols;
guarana seed extract that is standardized to comprise not less than
about 50% caffeine; and green mate extract that is standardized
to comprise not less than about 30% caffeine and not less than about
30% polyphenols.
[0028] An example may include a composition that comprises a weight
ratio of theaflavins to polyphenols in the black tea extract in
the range of about 0.3:1 to about 1:1. In an alternative example
the composition may contain a weight ratio of theaflavins in the
black tea extract to polyphenols in the green mate extract in the
range of about 0.5:1 to about 1.5:1.
[0029] In an embodiment, the composition may be administered to
a human on the basis of a serving size. A serving size designates
a fixed amount of the composition, whereby multiple servings or
fractions of servings may be administered to provide weight loss
through increased fat oxidation and/or appetite control.
[0030] According to an embodiment, the composition comprises thiamine
in the amount of about 0.2-12 mg per serving, black tea extract
in the amount of about 20-1,000 mg per serving, white tea extract
in the amount of about 20-1,000 mg per serving, guarana extract
in the amount of about 50-600 mg per serving, oolong tea extract
in the amount of about 20-1,000 mg per serving, green mate extract
in the amount of about 10-1,000 mg per serving, choline in the amount
of about 1-100 mg per serving and N-acetylcysteine in the amount
of about 1-300 mg per serving.
[0031] According to an alternative embodiment, the composition
comprises thiamine in the amount of about 1-3 mg per serving, black
tea extract in the amount of about 40-120 mg per serving, white
tea extract in the amount of about 50-150 mg per serving, guarana
extract in the amount of about 60-180 mg per serving, oolong tea
extract in the amount of about 40-120 mg per serving, green mate
extract in the amount of about 30-90 mg per serving, choline in
the amount of about 5-15 mg per serving; and N-acetylcysteine in
the amount of about 1-4 mg per serving.
[0032] According to an alternative embodiment of the invention,
the composition may comprise a ratio of weight of black tea extract
to weight of white tea extract in a range from about 2.5:1 to about
1:3.75. Another alternative embodiment may be composition comprising
a ratio of weight of black tea extract to green mate extract in
range from about 4:1 to about 1:2.25. Another alternative embodiment
includes a composition comprising a ratio of weight of white tea
extract to green mate extract in a range from about 5:1 to about
1:1.8. In an example the ratio of the sum of the weight of black
tea extract and weight of white tea extract to the weight of green
mate extract is in a range from about 9:1 to about 1:1.
[0033] A serving size of the composition provides the proper amounts
of constituents to provide weight loss effect while delivering a
decreased amount of caffeine as opposed to conventional formulations.
According to an embodiment, a serving size comprises less than or
equal to about 200 mg of caffeine, more preferably less than or
equal to about 100 mg of caffeine.
[0034] The composition may contain further constituents including,
but not limited to rooibos tea extract, grape pomace extract, yerba
mate extract, bilberry extract, grape juice extract, apple extract,
artichoke extract, green coffee extract, cinnamon bark extract,
chlorogenic acid, vitamin C, quercetin-3-rhamnoside (quercitrin)
and quercetrin-3-glycoside (isoquercitrin), calcium or inositol
and combinations thereof.
[0035] According to an embodiment, a composition comprises thiamine
in the amount of about 1-3 mg per serving, black tea extract in
the amount of about 40-120 mg per serving, white tea extract in
the amount of about 50-150 mg per serving, guarana extract in the
amount of about 60-180 mg per serving, oolong tea extract in the
amount of about 40-120 mg per serving, green mate extract in the
amount of about 30-90 mg per serving, choline in the amount of about
5-15 mg per serving; and N-acetylcysteine in the amount of about
1-4 mg per serving and one or more of the following ingredients:
polyphenol standardized rooibos tea extract in the amount of about
10-200 mg, polyphenol standardized yerba mate extract in the amount
of about 50-200 mg, polyphenol standardized grape pomace extract
in the amount of about 10-200 mg, anthocyanidin and polyphenol standardized
bilberry extract in the amount of about 50-200 mg, anthocyanidin
and polyphenol standardized rubired grape juice extract in the amount
of about 50-200 mg, polyphenol standardized apple extract in the
amount of about 50-200 mg, polyphenol and cynarin standardized artichoke
extract in the amount of about 50-200 mg, chlorogenic acid and polyphenol
standardized green coffee extract in the amount of about 30-200
mg, standardized cinnamon extract in the amount of about 50-250
mg, vitamin C in the amount of about 40-120 mg, quercitrin in the
amount of about 60-180 mg, inositol in the amount of about 20-50
mg and calcium in the amount of about 100-300 mg.
[0036] A composition may further include a number of non-active
compounds, such as diluents, buffers, preservatives, desiccants,
thickeners, fillers, flavorings, sweeteners, colorings, effervescents
and any other excipients or non-active ingredients known in the
art. The composition may be administered as a number of dosage forms,
including, but not limited to powders, liquids, suspensions, capsules,
tablets or chewing gums and/or may be formed as part of a food product.
The composition may be in the form of a tablet or capsule for oral
administration.
[0037] An alternative embodiment includes a method for increasing
fat oxidation by administering a composition comprising black tea
extract, white tea extract, guarana extract, oolong tea extract,
green mate extract, thiamine, choline and N-acetylcysteine. In an
example, the composition may be administered in an oral dosage form
twice a day, each oral dosage form containing one serving size of
the composition. According to an alternative embodiment, the composition
may be administered in one serving thirty minutes before breakfast
and in a second serving thirty minutes before lunch.
[0038] According an embodiment, a method for administering the
composition increases fat oxidation through affecting the sympathoadrenal
system. In particular, the combination of polyphenols (from white
tea extract, oolong tea extract, black tea extract and green mate
extract), theaflavins (from black tea extract), and caffeine (from
black tea extract, green mate extract, and guarana extract) of the
composition has the ability to influence the sympathoadrenal system
and the turn over of catecholamines such as epinephrine and norepinephrine.
[0039] Catechin compounds, such as polyphenols and theaflavins
derived from tea extracts, have been shown to elevate endogenous
levels of catecholamines. The modulation of catecholamine turn over
influences circulating and neuronal catecholamines, which increase
metabolic rate and fat oxidation. The maintenance of levels of the
intracellular signaling molecule, cyclic AMP (cAMP), in the sympathetically
innervated cells (such as cells of the adipose tissue, repository
of fat storage) is critical for increasing metabolism and enhancing
energy expenditure by the metabolism of fats. Catecholamine stimulation
of the sympathetic nervous system has been shown to increase plasma
norepinephrine levels by 27% and fat oxidation by 72%.
[0040] An embodiment also includes a method for controlling appetite
in humans. In an example, a composition comprising black tea extract,
white tea extract, guarana extract, oolong tea extract, green mate
extract, thiamine, choline and N-acetylcysteine is administered
in an oral dosage form to humans to control appetite. An oral dosage
form may contain a single serving and may be administered twice
a day. In an alternative embodiment, an oral dosage form containing
one serving of the composition may be administered once thirty minutes
before breakfast and then again thirty minutes before lunch. Controlling
appetite means both decreasing appetite and maintaining appetite
at a constant level.
[0041] According an embodiment, administration of a combination
of constituents results in decreased appetite. When taken together,
gallic acid (black tea polyphenols), EGCG (white tea polyphenols)
and oolong tea polyphenols synergistically diminish food consumption.
Additionally, the combination of tea polyphenols and methylxanthines
and green mate polyphenols and methylxanthines results in the modulation
of gamma-aminobutyric acid ("GABA") receptors and benzodiazepine
binding sites which regulate appetite and food intake. GABA (gamma-aminobutyric
acid, the major inhibitory neurotransmitter in the brain), receptors
and benzodiazepine binding sites in these receptors modulate appetite
and food intake. GABA plays an important role in controlling energy
balance within the central nervous system and food intake. The complex
interactions between several neurotransmitters such as GABA, dopamine,
serotonin, neuropeptide Y, leptin, acetylcholine, melanin-concentrating
hormone, ghrelin, nitric oxide, and cytokines and insulin and insulin
receptors in the brain ultimately determine and regulate food intake.
The composition affects appetite through modulation of GABA-benzodiazepine
receptor sites.
[0042] Additionally, catechins inhibit many aspects of the cascades
after cerebral ischemia, which involves NMDA receptor activation.
NMDA receptors contribute to some forms of natural feeding and body
weight regulation. The mixture of catechins in the composition may
impair food intake by this action.
EXAMPLE
[0043] The following table is an example of an embodiment in a
single serving size:
Example 1
[0044] TABLE-US-00001 INGREDIENTS AMOUNT PER SERVING Thiamine (as
hydrochloride) 1.5 mg Black tea extract (leaf-Camellia sinensis)
80 mg White tea extract (leaf-Camellia sinensis) 100 mg Oolong tea
extract (leaf-Camellia sinensis) 80 mg Guarana extract (seed-Paullinia
cupana) 120 mg Green mate extract (leaf-Ilex paraguariensis) 60
mg Choline (as choline bitartrate) 10 mg N-Acetylcysteine 2.5 mg
[0045] The formulation of Example 1 was used in a comparison study
to determine its effectiveness versus a conventional weight-loss
formulation characterized by high levels of caffeine versus polyphenols.
The conventional formulation is described below:
[0046] Conventional Weight-Loss Formulation TABLE-US-00002 INGREDIENTS
AMOUNT PER SERVING Vitamin A (as beta-carotene) 1,000 IU Niacin
20 mg Magnesium (as magnesium phosphate) 25 mg Potassium (as potassium
phosphate) 50 mg Bitter orange extract (pericarp-Citrus 500 mg aurantium)
Guarana extract (seed-Paullinia cupana) 200 mg Green tea extract
(leaf-Camellia sinensis) 10 mg
[0047] The conventional weight-loss formulation is generally administered
as part of a more extensive nutritional supplement and multivitamin
regimen. Therefore, Example 1 was also administered with the multivitamin
and nutritional supplement regimen to obtain an accurate comparison
with the conventional formulation. While Example 1 was used in combination
with additional nutritional supplements, an embodiment includes
administering the composition alone or in combination with other
nutritional supplements.
[0048] The additional nutritional supplements administered in combination
with Example 1 and the conventional weight-loss formulation, for
the purposes of comparison testing, are described below. The supplements
include a Multiple Vitamin and Mineral Supplement, an Omega-3 Fatty
Acid Supplement, a Multinutrient Supplement, a Probiotic Dietary
Supplement and a Citrus Dietary Supplement.
[0049] Multiple Vitamin and Mineral Supplement TABLE-US-00003 INGREDIENTS
AMOUNT PER SERVING Vitamin A (as palmitate) 2,500 IU Vitamin A (as
beta-carotene) 12,500 IU Vitamin C (as ascorbic acid) 600 mg Vitamin
D (as cholecalciferol) 400 UI Vitamin E (as d-alpha tocopheryl succinate)
150 UI Thiamine (as thiamine HCl) 4.5 mg Riboflavin 5.1 mg Niacin
(as niacinamide/niacin) 60 mg Vitamin B-6 (pyridoxine HCl) 6 mg
Folic Acid 800 mcg Vitamin B-12 (as cyanocobalamin) 36 mcg Biotin
300 mcg Pantothenic acid 30 mg Calcium (as amino acid chelate) 150
mg Phosphorus (as amino acid chelate) 25 mg Iodine (from kelp) 150
mcg Magnesium (as amino acid chelate) 175 mg Zinc (as zinc monomethionine)
15 mg Selenium (L-selenomethionine) 80 mcg Copper (as amino acid
chelate) 2 mg Manganese (as amino acid chelate) 4 mg Chromium (as
chromium citrate) 100 mcg Molybdenum (as amino acid chelate) 50
mcg Potassium (as potassium chloride and amino 100 mg acid chelate)
Inositol 6 mg Choline (as bitartrate) 60 mg Boron (as amino acid
chelate) 300 mcg Vanadium (as bis-maltolato-oxovanadium) 50 mcg
Silicon (as amino acid chelate) 500 mcg Coenzyme Q-10 150 mcg Octacosanol
2 mg Ribonucleic acid (RNA) 2 mg Garlic powder, odorless (bulb-Allium
50 mg sativum) L-Glutathione 5 mg Citrus flavonoids 100 mg Grape
extract (seed-Vitis vinifera) 5 mg Milk thistle extract (seed-Silybum
marianum) 5 mg Ginkgo extract (leaf-Ginkgo biloba) 10 mg
[0050] Omega-3 Fatty Acid Supplement TABLE-US-00004 INGREDIENTS
AMOUNT PER SERVING Vitamin E (as d-alpha tocopheryl acetate) 3 IU
Eicosapentaenoic Acid (from marine lipids) 300 mg Docosahexaenoic
Acid (from marine lipids) 200 mg
[0051] Multinutrient Supplement TABLE-US-00005 INGREDIENTS AMOUNT
PER SERVING Vitamin C (as magnesium/sodium/potassium 300 mg ascorbates)
Vitamin B-6 (as pyridoxine HCl) 2 mg Iodine (as potassium iodide)
25 mcg Magnesium (as magnesium ascorbate) 10 mg Zinc (as zinc monomethionine)
1 mg Chromium (as citrate) 50 mcg Garcinia extract (fruit-Garcinia
cambogia) 1,000 mg Oolong tea extract (leaf-Camellia sinensis) 100
mg Guarana extract (seed-Paullinia cupana) 75 mg Eleuthero extract
(root-Eleutherococcus 25 mg senticosus) Tulsi extract (leaf-Ocimum
sanctum) 25 mg Taurine 25 mg Beta-sitosterol 12.5 mg L-Carnitine
(as tartrate) 12.5 mg Gymnema extract (leaf-Gymnema sylvestre) 5
mg Vanadium (as bis-maltolato-oxovanadium) 100 mcg
[0052] Probiotic Supplement TABLE-US-00006 INGREDIENTS AMOUNT PER
SERVING Vitamin A (as beta-carotene) 1,000 IU Zinc (as zinc monomethionine)
500 mcg Lactobacillus acidophilus 0.5 Billion Bifidobacterium bifidum
0.5 Billion Fructooligosaccharides 250 mg Moomiyo 25 mg Artichoke
extract (leaf-Cynara scolymus) 250 mg
[0053] Citrus Dietary Supplement TABLE-US-00007 INGREDIENTS AMOUNT
PER SERVING D-Limonene 60 mg Grapefruit juice powder 200 mg 5-Hydroxytryptophan
(seed-Griffonia 25 mg simplicifolia)
[0054] The comparison testing was performed in two cohorts. In
the first study, a total of 38 participants who were previously
taking the conventional weight-loss formulation were administered
Example 1. Example 1 replaced the conventional formulation in the
nutritional supplement regimen. A serving of Example 1 was administered
30 minutes before breakfast and again 30 minutes before lunch. The
remaining supplement formulations were administered with a meal,
preferably breakfast, except for the probiotic supplement and multinutrient
supplement which were administered at the same time as Example 1.
[0055] Of the total number of participants in the first study,
the mean weight loss was 4.6 pounds over the course of 14 days.
The results of the study are shown as Graph 1.71% of the participants
rated Example 1 most effective for appetite control. 58% of the
participants rated Example 1 to be more effective for increasing
energy and 32% rated Example 1 to be equally effective as compared
to the conventional weight-loss formulation. 53% of the participants
rated Example 1 to be more effective in providing a longer duration
of increased energy over the conventional weight-loss formulation
with 37% rating the products equally effective. Overall, 76% of
the participants preferred Example 1 over the conventional formulation.
[0056] A second study was performed with 63 participants following
the same protocol. The conventional weight-loss formulation was
replaced with Example 1 which was administered according the same
nutritional supplement regimen.
[0057] The results of the second study are described in Graph 2.
Of the total number of participants, the mean weight loss was 2.5
pounds. Of the participants who lost weight, the mean weight loss
was 4.5 pounds. As seen in Graph 2, 65% of the participants rated
Example 1 to be more effective for appetite control. 45% of the
participants rated Example 1 to be more effective for increasing
energy and 48% rated Example 1 to be equally effective as compared
to the conventional weight-loss formulation. 53% of the participants
rated Example 1 to be more effective in providing a longer duration
of increased energy over the conventional weight-loss formulation
with 37% finding the products to be equally effective with regards
to duration of energy. Overall, 62% of the participants preferred
Example 1 over the conventional formulation.
[0058] The findings of the study show that the participants found
Example 1 to be more or equally effective in controlling appetite
and increasing energy as compared to the conventional weight-loss
formulation. The findings are surprising when considering the fact
that Example 1 contained a significantly reduced amount of caffeine
as compared to the conventional formulation, contrary to conventional
thinking in the art. Thereby, Example 1 showed superior or at least
equivalent efficacy with decreased amounts of stimulant and therefore
decreased risk of habituation and side effects. According to an
embodiment, the composition may be administered as a stand-alone
product either before meals or at any other time during the day.
[0059] Although the present invention has been described in detail
with particular reference to preferred embodiments thereof, it should
be understood that the invention is capable of other different embodiments,
and its details are capable of modifications in various obvious
respects. As is readily apparent to those skilled in the art, variations
and modifications can be affected while remaining within the spirit
and scope of the invention. Accordingly, the foregoing disclosure,
description, and figures are for illustrative purposes only, and
do not in any way limit the invention, which is defined only by
the claims. |