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Weight Loss Patent Abstract
A composition for promoting weight loss comprising sage extract,
oolong tea extract and guarana extract in concert with thiamine
and niacin. The composition is administered to promote weight loss
by increasing fat oxidation and/or controlling appetite, thereby
promoting weight loss.
Weight Loss Patent Claims
1. A composition for promoting weight loss comprising: Sage extract
Oolong tea extract; Guarana extract; Thiamine; and Niacin.
2. The composition of claim 1 wherein the sage extract is standardized
to comprise not less than about 10% sage polyphenols.
3. The composition of claim 1 wherein the oolong tea extract is
standardized to comprise not less than about 40% oolong tea polyphenols.
4. The composition of claim 1 wherein the guarana extract is standardized
to comprise not less than about 50% caffeine.
5. The composition of claim 1 wherein the composition further comprises:
sage extract standardized to comprise not less than about 10% sage
polyphenols; oolong tea extract standardized to comprise not less
than about 40% oolong tea polyphenols; and guarana extract standardized
to comprise not less than about 50% caffeine.
6. The composition of claim 5 wherein a ratio of total amount of
polyphenols in the composition to total amount of caffeine in the
composition is in a range from about 4:1 to about 1.2:1.
7. The composition of claim 5 wherein a ratio of weight of sage
extract to weight of oolong tea extract is in a range from about
5:1 to about 3:4.
8. The composition of claim 5 wherein a ratio of weight of sage
extract to weight of guarana extract is in a range from about 6:1
to about 1.5:1.
9. The composition of claim 5 wherein a ratio of weight of oolong
tea extract to weight of guarana extract is in a range from about
5:1 to about 1:2.
10. The composition of claim 5 wherein a weight ratio of the sum
of the weight of sage extract and the weight of oolong tea extract
to the weight of guarana extract is in a range from about 10:1 to
about 2:1.
11. The composition of claim 5 wherein the composition further
comprises: Sage extract in the amount of 300-500 mg; Oolong tea
extract in the amount of 100-400 mg; Guarana extract in the amount
of 90-200 mg; Thiamine in the amount of 3-5 mg; Niacin in the amount
of 20-40 mg.
12. The composition of claim 11 wherein the composition comprises
about 1-200 mg of caffeine.
13. The composition of claim 12 wherein the composition comprises
about 1-60 mg of caffeine.
14. The composition of claim 1 further comprising at least one
of L-glutamine, chlorogenic acid, green coffee extract, lysine,
inositol, choline, vitamin A, calcium, magnesium, potassium, vitamin
C and quercitrin.
15. A method for promoting weight loss comprising: orally administering
an effective amount of a composition to a mammal wherein the composition
comprises: Sage extract; Oolong tea extract; Guarana extract; Thiamine;
and Niacin; wherein the composition controls the appetite of the
mammal.
16. The method of claim 15 wherein the sage extract is standardized
to comprise not less than about 10% sage polyphenols.
17. The method of claim 15, wherein the oolong tea extract is standardized
to comprise not less than about 40% oolong tea polyphenols.
18. The method of claim 15 wherein the guarana extract is standardized
to comprise not less than about 50% caffeine.
19. The method of claim 15 wherein the composition further comprises:
sage extract standardized to comprise not less than about 10% sage
polyphenols; oolong tea extract standardized to comprise not less
than about 40% oolong tea polyphenols; and guarana extract standardized
to comprise not less than about 50% caffeine.
20. The method of claim 19 wherein a ratio of total amount of polyphenols
in the composition to total amount of caffeine in the composition
is in a range from about 4:1 to about 1.2:1.
21. The method of claim 19 wherein a ratio of weight of sage extract
to weight of oolong tea extract is in a range from about 5:1 to
about 3:4.
22. The method of claim 19 wherein a ratio of weight of sage extract
to weight of guarana extract is in a range from about 6:1 to about
1.5:1.
23. The method of claim 19 wherein a ratio of weight of oolong
tea extract to weight of guarana extract is in a range from about
5:1 to about 1:2.
24. The method of claim 19 wherein a weight ratio of the sum of
the weight of sage extract and the weight of oolong tea extract
to the weight of guarana extract is in a range from about 10:1 to
about 2:1.
25. The method of claim 19 wherein the composition further comprises:
Sage extract in the amount of 300-500 mg; Oolong tea extract in
the amount of 100-400 mg; Guarana extract in the amount of 90-200
mg; Thiamine in the amount of 3-5 mg; Niacin in the amount of 20-40
mg.
26. The method of claim 25 wherein the composition comprises about
1-200 mg of caffeine.
27. The method of claim 26 wherein the composition comprises about
1-60 mg of caffeine.
28. The method of claim 19 further comprising administering the
composition to the mammal at least about 30 minutes before the mammal
eats a meal.
29. The method of claim 19 further comprising controlling appetite
by decreasing the appetite of the mammal.
30. The method of claim 19 further comprising controlling appetite
by maintaining the appetite of the mammal at a constant level.
31. The method of claim 15 wherein the composition further comprises
at least one of L-glutamine, chlorogenic acid, green coffee extract,
lysine, inositol, choline, vitamin A, calcium, magnesium, potassium,
vitamin C and quercitrin.
32. A method for promoting weight loss comprising: orally administering
an effective amount of a composition to a mammal wherein the composition
comprises: Sage extract; Oolong tea extract; Guarana extract; Thiamine;
and Niacin; wherein the composition increases fat oxidation by the
mammal.
33. The method of claim 32 wherein the sage extract is standardized
to comprise not less than about 10% sage polyphenols.
34. The method of claim 32, wherein the oolong tea extract is standardized
to comprise not less than about 40% oolong tea polyphenols.
35. The method of claim 32 wherein the guarana extract is standardized
to comprise not less than about 50% caffeine.
36. The method of claim 32 wherein the composition further comprises:
sage extract standardized to comprise not less than about 10% sage
polyphenols; oolong tea extract standardized to comprise not less
than about 40% oolong tea polyphenols; and guarana extract standardized
to comprise not less than about 50% caffeine.
37. The method of claim 36 wherein a ratio of total amount of polyphenols
in the composition to total amount of caffeine in the composition
is in a range from about 4:1 to about 1.2:1.
38. The method of claim 36 wherein a ratio of weight of sage extract
to weight of oolong tea extract is in a range from about 5:1 to
about 3:4.
39. The method of claim 36 wherein a ratio of weight of sage extract
to weight of guarana extract is in a range from about 6:1 to about
1.5:1.
40. The method of claim 36 wherein a ratio of weight of oolong
tea extract to weight of guarana extract is in a range from about
5:1 to about 1:2.
41. The method of claim 36 wherein a weight ratio of the sum of
the weight of sage extract and the weight of oolong tea extract
to the weight of guarana extract is in a range from about 10:1 to
about 2:1.
42. The method of claim 36 wherein the composition further comprises:
Sage extract in the amount of 300-500 mg; Oolong tea extract in
the amount of 100-400 mg; Guarana extract in the amount of 90-200
mg; Thiamine in the amount of 3-5 mg; Niacin in the amount of 20-40
mg.
43. The method of claim 42 wherein the composition comprises about
1-200 mg of caffeine.
44. The method of claim 43 wherein the composition comprises about
1-60 mg of caffeine.
45. The method of claim 36 further comprising administering the
composition to the mammal at least about 30 minutes before the mammal
eats a meal.
46. The method of claim 32 wherein the composition further comprises
at least one of L-glutamine, chlorogenic acid, green coffee extract,
lysine, inositol, choline, vitamin A, calcium, magnesium, potassium,
vitamin C and quercitrin.
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 time and knowledge
to prepare 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
is 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.
[0007] Prior art attempts at increasing energy expenditure have
primarily used large amounts of stimulants such as caffeine and
ephedra. Caffeine in particular has been a favored 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 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] According to an embodiment, a composition comprises sage
extract, oolong tea extract, guarana extract, thiamine and niacin.
In another embodiment a method comprises promoting weight loss by
increasing fat oxidation and/or decreasing appetite by administering
a pharmaceutical composition comprising standardized sage extract,
standardized oolong tea extract, standardized guarana extract, thiamine
and niacin. The combination of the elements of the 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] In an example of a composition for promoting weight loss,
the composition promotes fat oxidation and controls appetite while
applying limited levels of caffeine. In an embodiment, a composition
comprises a combination of oolong tea extract, sage extract, guarana
extract, thiamine and niacin. The combination of all of the elements
provides for weight loss with decreased amounts of caffeine.
[0012] Oolong tea extracts are derived from natural tea produced
from the leaves of Camellia sinensis of the genus Theaceae. Tea
products are manufactured first by rolling and steaming of tender
tea leaves to prepare green tea. The green tea is then fermented
through the oxidative transformation of tea leaf phenolics, involving
natural browning reactions induced by oxidizing enzymes (polyphenol
oxidases) within the plant cell. The green tea is fully fermented
into black tea. Oolong tea is partially fermented tea that contains
both native polyphenols and oxidized polyphenols as a result of
the partially completed fermentation process. Therefore, oolong
teas have a unique blend of natural and oxidized tea polyphenols.
[0013] The components of oolong tea display intestinal lipase inhibitory
and thermogenic properties. 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.
[0014] The oolong tea extract may be standardized to contain particular
concentrations of chemical components such as native polyphenols,
oxidized polyphenols and caffeine. While the polyphenols and caffeine
of the oolong tea extract are part of the total amount of polyphenols
and total amount of caffeine of the composition, the standardized
extract provides qualitatively and quantitatively different constituents
than those provided by additional elements of the composition, such
as sage extract and guarana extract. According to an embodiment,
oolong tea extract may be standardized to comprise not less than
about 40% polyphenols. In another embodiment, the oolong tea extract
polyphenols are part of the total amount of polyphenols in the composition
and the oolong tea extract caffeine is part of the total amount
of caffeine in the composition.
[0015] Sage extract is derived from the leaf of Salvia officinalis.
The active ingredients in sage have a number of effects on the CNS.
The polyphenols and related aromatic ingredients in the sage extract
modulate the gamma-aminobutyric acid (GABA) system and the benzodiazepine
receptor binding sites, which influence satiety, appetite, food
intake, energy expenditure and energy balance. GABA plays an important
role in controlling energy balance within the central nervous system
and food intake. Sage extracts also influence the function of NMDA
(N-methyl-D-aspartic acid) receptors. NMDA receptors contribute
to systems controlling natural feeding and body weight regulation.
[0016] Additionally, sage extracts reduce body weight gain and
accumulation of epididymal fat weight by suppressing pancreatic
lipase activity and fat accretion. Other components reduce nuclear
factor-kappaB, a transcription factor involved in obesity.
[0017] The sage extract may be standardized to contain particular
concentrations of chemical components such as sage polyphenols.
While the polyphenols of the sage tea extract are part of the total
amount of polyphenols, the standardized extract provides qualitatively
and quantitatively different constituents than those provided by
additional elements of the composition, such as the oolong tea extract.
According to an embodiment, sage extract may be standardized to
contain not less than about 10% polyphenols. In another embodiment,
the sage extract polyphenols are part of the total amount of polyphenols
in the composition.
[0018] 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. The amounts
of guarana extract in the composition are limited to decrease total
caffeine.
[0019] The guarana extract may be standardized to contain particular
concentrations of chemical components such as polyphenols and caffeine.
While the polyphenols and caffeine of the guarana extract are part
of the total amount of polyphenols and total amount of caffeine
of the composition, the standardized extract provides qualitatively
and quantitatively different constituents than those provided by
additional elements of the composition, such as sage extract and
oolong tea extract. According to an embodiment, guarana extract
may be standardized to comprise not less than about 50% caffeine.
In another embodiment, the guarana extract caffeine is part of the
total amount of caffeine in the composition and the guarana extract
polyphenols are part of the total amount of polyphenols in the composition.
[0020] According an embodiment, a composition comprises oolong
tea extract standardized to comprise not less than 40% polyphenols,
sage extract standardized to comprise not less than 10% polyphenols
and guarana extract standardized to comprise not less than about
50% caffeine. According to another embodiment, the ratio of total
amount of polyphenols to total amount of caffeine in the composition
is in the range of about 4:1 to about 1.2:1.
[0021] In another embodiment, the composition may comprise a weight
ratio of sage extract to oolong tea extract in the range from about
5:1 to about 3:4. The composition may comprise a weight ratio of
sage extract to guarana extract in the range from about 6:1 to about
1.5:1. The composition may alternatively comprise a weight ratio
of oolong tea extract to guarana extract in the range from about
5:1 to about 1:2. According to another embodiment, the weight ratio
of the sum of sage extract and oolong tea extract to guarana extract
is in the range from about 10:1 to about 2:1.
[0022] 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 concentration 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 oolong tea,
sage and guarana extracts, 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. In an example, oolong tea
extract standardization may be performed by UV spectrophotometry
using appropriate standards and sage extract may be measured by
any number of spectrophotometric assays. Other methods of measurement
include chromatography, such as thin layer chromatography, high
pressure liquid chromatography, gas chromatography and liquid chromatography-mass
spectrometry.
[0023] 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.
[0024] According to an embodiment, a composition contains standardized
sage extract in the amount of about 30-1000 mg; standardized oolong
tea extract in the amount of about 40-1000 mg; and standardized
guarana extract in the amount of about 20-600 mg.
[0025] A composition may be administered 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 fat oxidation and/or appetite control.
[0026] According to an embodiment, a composition comprises; standardized
sage extract in the amount of about 300-500 mg per serving; standardized
oolong tea extract in the amount of about 100-400 mg per serving;
and standardized guarana extract in the amount of about 90-150 mg
per serving.
[0027] The compositions may contain limited amounts of caffeine
per serving size. In an example, the composition may include less
than 100 mg of caffeine per serving size. In an alternative embodiment,
the amount of caffeine per serving size may be less than 60 mg per
serving.
[0028] 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 coenzyme/cofactor in key reactions in carbohydrate metabolism
and thermogenesis 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 may
be in the form of thiamine hydrochloride ("thiamine HCl").
In an example, thiamine HCl may be assayed at purity of 98.5% or
above.
[0029] Niacin, also known as nicotinic acid or vitamin B.sub.3,
has the chemical name pyridine-3-carboxylic acid. The vitamin, via
its active forms, is involved in a wide range of biological processes,
including the production of energy, the synthesis of fatty acids,
cholesterol and steroids, signal transduction, the regulation of
gene expression and the maintenance of genomic integrity. Pharmaceutical
doses are used as an anti-hyperlipidemic agent. According to an
embodiment, niacin may be in the form of niacinamide. In an example,
niacin may be assayed at purity of 98% or above.
[0030] According to an embodiment, a composition contains thiamine
in the amount of about 0.2-12 mg; niacin in the amount of about
1-60 mg; sage extract in the amount of about 30-1000 mg; oolong
tea extract in the amount of about 40-1000 mg; and guarana extract
in the amount of about 20-600 mg.
[0031] According to an embodiment, a composition comprises thiamine
in the amount of about 3-5 mg per serving; niacin in the amount
of about 20-40 mg per serving; sage extract in the amount of about
300-500 mg per serving; oolong tea extract in the amount of about
100-400 mg per serving; and guarana extract in the amount of about
90-150 mg per serving. The compositions may contain limited amounts
of caffeine per serving size. In an example, the composition may
include less than 100 mg of caffeine per serving size. In an alternative
embodiment, the amount of caffeine per serving size may be less
than 60 mg per serving.
[0032] In an embodiment, the composition may contain further ingredients
including, but not limited, to L-glutamine, chlorogenic acid, green
coffee extract, lysine, inositol, choline, vitamin A, calcium, magnesium,
potassium vitamin C, quercetin-3-rhamnoside (quercitrin) or quercetin-3-glucoside
(isoquercitrin) and combinations thereof.
[0033] According to an embodiment, a serving size of the composition
contains thiamine in the amount of 3-5 mg; niacin in the amount
of about 20-40 mg; sage extract in the amount of about 300-500 mg;
oolong tea extract in the amount of about 100-400 mg; guarana extract
in the amount of about 90-150 mg; and one or more of the following
ingredients: L-glutamine in the amount of about 300-500 mg; chlorogenic
acid in the amount of about 100-300 mg; green coffee extract in
the amount of about 100-300 mg; lysine in the amount of about 200-400
mg; inositol in the amount of about 20-50 mg; choline in the amount
of about 20-40 mg; vitamin A in the amount of about 1,000-3,000
IU; magnesium in the amount of about 50-150 mg; calcium in the amount
of about 100-300 mg; potassium in the amount of about 50-150 mg;
vitamin C in the amount of about 40-120 mg; and quercitrin in the
amount of about 60-180 mg.
[0034] 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, caplets or chewing gums and/or may be formed as part of
a food product. In an example, the composition is in the form of
a tablet, capsule or caplet for oral administration.
[0035] An alternative embodiment comprises a method for increasing
fat oxidation by administering a composition comprising standardized
sage extract, standardized oolong tea extract and standardized guarana
extract. According to the method, 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 about
thirty minutes before breakfast and in a second serving about thirty
minutes before lunch. The composition may also be administered in
combination with a number of other nutritional supplement products.
[0036] According to an embodiment, the method for administering
the composition increases fat oxidation through affecting the sympathoadrenal
system. In particular, the combination of polyphenols, from oolong
tea extract, sage extract and guarana extract, and caffeine, from
guarana extract and oolong tea extract, has the ability to influence
the sympathoadrenal system and the turn over of catecholamines such
as epinephrine and norepinephrine.
[0037] Polyphenols, related to the compounds found in tea extracts
and sage 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%. An alternative embodiment
comprises a method for controlling appetite. According to the method,
a composition comprising standardized sage extract, standardized
oolong tea extract and standardized guarana extract may be administered
in an oral dosage form to control appetite. Additional elements
may include thiamine and niacin. The oral dosage form preferably
contains 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 about thirty minutes
before breakfast and then again about thirty minutes before lunch.
[0038] According to an embodiment, administration of the combination
of constituents results in controlling appetite. Appetite may be
controlled by either being decreased or maintained at a constant
level without increase. When taken together, sage polyphenols and
oolong tea polyphenols, in concert with other oolong tea constituents,
synergistically diminish food consumption. Additionally, the combination
of tea polyphenols, non-polyphenol oolong tea constituents and sage
polyphenols 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. Sage polyphenols in particular show affinity to
human benzodiazepine receptors. The complex interactions between
several neurotransmitters such as GABA, dopamine, serotonin, neuropeptide
Y, leptin, acetylcholine, melanin-concentrating hormone, nitric
oxide, cytokines, insulin and insulin receptors in the brain ultimately
determine and regulate food intake. The composition affects appetite
through modulation of GABA-benzodiazepine receptor sites.
[0039] Sage extracts also influence the function of NMDA (N-methyl-D-aspartic
acid) receptors. NMDA receptors contribute to some forms of natural
feeding and body weight regulation. The mixture of polyphenols in
the composition may impair food intake by this action.
Example: The following table is an example of an embodiment of
a composition in a serving size:
EXAMPLE 1
[0040] TABLE-US-00001 INGREDIENTS AMOUNT PER SERVING Thiamine (as
HCl) 3 mg Niacin (as niacinamide) 20 mg Sage extract (leaf-Salvia
officinalis) 300 mg Oolong tea extract (leaf-Camellia sinensis)
200 mg Guarana extract (seed-Paullinia cupana) 90 mg
[0041] The formulation of the Example 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:
[0042] Conventional Weight-Loss Formulation TABLE-US-00002 AMOUNT
PER INGREDIENTS SERVNG 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 aurantium)
500 mg Guarana extract (seed-Paullinia cupana) 200 mg Green tea
extract (leaf-Camellia sinensis) 10 mg
[0043] 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 above was used
in combination with additional nutritional supplements, an alternative
embodiment may be administering alone or in combination with other
nutritional supplements.
[0044] 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.
[0045] 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 IU Vitamin E (as d-alpha tocopheryl succinate)
150 IU 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
[0046] 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
[0047] 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
[0048] 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
[0049] Citrus Dietary Supplement TABLE-US-00007 INGREDENTS AMOUNT
PER SERVING D-Limonene 60 mg Grapefruit juice powder 200 mg 5-Hydroxytryptophan
(seed-Griffonia 25 mg simplicifolia)
[0050] The comparison testing was performed in two cohorts. In
the first study, a total of 42 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 the
multinutrient supplement which were administered at the same time
as Example 1.
[0051] Of the total number of participants in the first study,
the mean weight loss was 1.6 pounds over the course of 14 days.
The results of the study are shown as Graph 1 below. According to
the first bar of Graph 1, 62% of the participants rated Example
1 to be most effective for appetite control as compared to the conventional
weight-loss formulation. 45% of the participants rated Example 1
to be most effective for increasing energy as compared to the conventional
weight-loss formulation with 31% of the participants rating the
two products to be equally effective. Overall, 54% of the participants
rated Example 1 to be superior to the conventional weight-loss formulation
and 23% rated the two to be equivalent.
[0052] A second study was performed on 36 participants following
the same protocol. The conventional weight-loss formulation was
replaced with Example 1 which was administered according the same
nutritional supplement regimen.
[0053] The results of the second study are described in Graph 2.
Of the total number of participants, the mean weight loss was 0.9
pounds. Of the participants who lost weight, the mean weight loss
was 2.5 pounds. As seen in Graph 2, 74% of the participants rated
Example 1 to be more effective for appetite control. While 49% of
the participants rated Example 1 to be more effective for increasing
energy, 40% rated Example 1 to be equally effective as compared
to the conventional weight-loss formulation. 64% of the participants
rated Example 1 to be more effective in providing a longer duration
of increased energy over the conventional weight-loss formulation.
Overall, 61% of the participants preferred Example 1 over the conventional
formulation and 33% of the participants found the products to be
equally effective.
[0054] 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 results are surprising when considering the fact
that the example formulation contained a significantly reduced amount
of caffeine, contrary to conventional thinking in the art. Thereby
an embodiment showed superior or at least equal 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.
[0055] 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 may 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. |