Weight loss abstract
Supplement compositions designed to support weight loss and increase
energy.
Weight loss claims
I claim:
1. A composition of matter comprising, (a) glucosamine and a second
component selected from the group consisting of caffeine and ephedrine;
(b) said glucosamine and said second component present in an amount
effective to aid in weight loss.
2. The composition of matter of claim 1, wherein said second component
comprises both caffeine and ephedrine.
3. The composition of matter of claim 2, wherein said ingredients
are present the following approximate amounts:
4. A weight loss method comprising administering a stimulant in
an amount effective to increase the metabolic rate, and glucoseamine.
5. A weight loss method comprising administering glucosamine in
an amount effective to promote weight loss, the dietary fiber accompanying
said glucosamine, if any, being less than the amount of dietary
fiber required to prevent the absorption of undigested dietary fat
in the intestine.
6. The method of claim 5, said glucosamine being substantially
free of dietary fiber.
7. The method of claim 5, further comprising administering a stimulant
in an amount effective to promote weight loss.
Weight loss description
BACKGROUND
The prior art regarding this invention arises from distinct areas
not heretofore combined to create new and useful formula sets or
new and useful improvements thereof regarding a Solid-dosage Form
of a Weight Loss Product.
This invention relates to the evolving science that a new and unique
combination of ma huang extract (ephedrine alkaloids), caffeine
and glucosamine sulfate results in increased weight loss and energy.
Ma huang is a central nervous system stimulant that has the ability
to open up the adrenergic receptor sites found primarily in the
heart and lungs, thereby increasing the metabolic rate and calorie
expenditure. The net result is the release of fatty acids from stored
fat cells and a quicker conversion of the fat into energy. When
combined with a modest amount of caffeine the thermogenic effects
can be improved as much as 20%.sup.1. Ma huang also acts as an appetite
suppressant..sup.2
A double-blind, placebo-controlled study published in Metabolism
finds a thermogenic synergism between ephedrine and caffeine..sup.3
A second study published in the International Journal of Obesity
Related Metabolic Disorders concludes that the ephedrine/caffeine
combination is safe and effective in long-term treatment in improving
and maintaining weight loss..sup.4 A third study, published in the
American Journal of Clinical Nutrition, concludes that results show
that ephedrine and caffeine can promote weight loss through an increase
in energy expenditure or, in some individuals, a combination of
an increase in energy expenditure and a decrease in food intake..sup.5
In addition, the ephedrine/caffeine combination has lean body mass
saving properties.sup.6,7 and abolishes the decline in HDL-cholesterol
during active weight loss due to the beta-agonistic properties of
ephedrine..sup.8 Due to increased central nervous system stimulation,
the combination significantly prolongs exercise time to exhaustion
and improves performance in runners..sup.9, 10
Green tea leaf (camellia sinensis) extract stimulates brown adipose
tissue thermogenesis to an extent that is much greater than can
be attributed to its caffeine content per se; its thermogenic properties
reside primarily in an interaction between its high content in catechin-polyphenols
and caffeine with sympathetically released noradrenaline (NA). Green
tea extract is effective in stimulating thermogenesis by relieving
inhibition at different control points along the NA-cAMP axis. Such
synergistic interaction between catechin-polyphenols and caffeine
to augment and prolong sympathetic stimulation of thermogenesis
has value in assisting the management of obesity..sup.11
Epigallocatechin gallate from green tea polyphenols significantly
reduced food intake, body weight, blood cholesterol and triglyceride,
as well as growth of the prostate, uterus, and ovary; it may interact
specifically with a component of a leptin-independent appetite control
pathway. .sup.12 Green tea clearly has thermogenic properties, promotes
fat oxidation.sup.13 and plays a role in the control of body composition
via sympathetic activation of thermogenesis, fat oxidation or both.
Green tea polyphenols have demonstrated significant antioxidant,
anticarcinogenic, anti-inflammatory, thermogenic, probiotic, and
antimicrobial properties in numerous human, animal, and in vitro
studies. .sup.14
Glucosamine, in the form of glucosamine sulfate, another ingredient
of this compound, also contributes to weight loss. When food intake
by the body occurs at a faster rate than energy consumption, the
cellular concentration of adenosine triphosphate rises. Cells, however,
do not store extra energy in the form of extra adenosine triphosphate.
When cellular adenosine triphosphate concentrations rise because
more energy (from food) is available than can be immediately used,
high adenosine triphosphate concentrations inhibit glycolysis. Under
conditions of high cellular adenosine triphosphate concentrations,
when glycolysis is inhibited, glucose is instead converted into
glycogen and fat.
When fat stored in adipose tissue is going to be used as an energy
source, lipase enzymes hydrolyze triglycerides into glycerol and
free fatty acids in a process called lipolysis (the breakdown of
fat). These molecules (primarily the free fatty acids) serve as
blood-borne energy carriers that can be used by the liver, skeletal
muscles, and other organs for aerobic respiration..sup.15
The effect of insulin on lipogenesis, the formation of fatty acids
in the body, is blocked by glucosamine, indicating that glucosamine
plays a role as a messenger for this insulin effect. .sup.16 Insulin
is secreted when there is high sugar content; insulin secretion
allows for fat storage. High insulin levels trigger the hypothalamus
to send hunger signals, which sets off a craving for carbohydrates;
this leads one to eat more, which leads to more insulin. Excess
carbohydrates are converted into glucose, and then stored as fat.
Glucose triggers a rise in insulin. Insulin acts to lower blood
glucose levels, regulating those levels through several actions,
including lipogenesis (conversion of carbohydrate and protein into
fat). Fat cells can't be metabolized when insulin levels are normal.
When you have high insulin levels, you block lipolysis and store
fat. The body must initiate lipolysis to supply the cellular energy
source ATP, which is necessary for muscle contraction (energy).
When you reduce the level of insulin, you burn fat to provide energy.
Glucosamine blocks the effect of insulin, burning up stored fat
and resulting in weight loss..sup.17
Scientists have yet to determine at what point in the metabolic
pathway glucosamine acts to block insulin, but several studies have
demonstrated this fact. A study at the Washington University School
of Medicine concluded that direct administration of glucosamine
can rapidly lower cellular ATP levels and affect insulin action
in fat cells by independent mechanisms. .sup.18 A University of
Southern California study further explains that glucosamine induced
complete and reversible insulin resistances.sup.19. A third study
at the Albert Einstein College of Medicine adds that the etiology
of peripheral insulin resistance may be distinct from the rapid
and marked impairment in insulin signaling and that glucosamine
on insulin-stimulated glucose metabolism is a different mechanism..sup.20
Essentially, the glucosamine keeps the glucose from being stored
as fat, providing a temporary and reversible hyperglycemic effect
that allows the glucose to be used as energy instead by blunting
the insulin-induced increase in muscle glycogen content..sup.21
In addition to the hyperglycemic effect of glucosamine, Japanese
studies on dogs and ducks demonstrate that glucosamine causes glucagon
release in addition to its effect to suppress insulin release as
well as its direct inhibitory effect on glucose utilization in tissues..sup.22
By increasing the metabolic rate and calorie expenditure with ma
huang and caffeine while simultaneously encouraging the body to
use stored fat for energy, in conjunction with the carefully blended
composition of other ingredients, this new product provides a unique
and successful method for losing weight and increasing energy.
Curriculum Vitae
Albert M. Fleischner, Ph.D., has a doctorate in Pharmaceutical
Chemistry from Rutgers University and has had over thirty years
experience in the pharmaceutical industry with firms such as Schering
Corporation, Lehn & Fink Division of Sterling Drugs, Bradley
Pharmaceutical Corporation, Amerchol Division of CPC and the Goen
Group companies. He has a number of published papers and two previously
granted patents and has several patents pending.
SUMMARY
The invention discloses the formula sets that embody the invention
of the supplement composition for increasing weight loss and energy
levels. The combination of ephedrine and caffeine increases fat
loss, maintains muscle mass, prevents the fall of HDL cholesterol
during weight loss, increases insulin sensitivity, reduces lipogenesis
and is safe. With the addition of glucosamine sulfate, the new and
useful formula is further enhanced.
We now discuss in detail the most preferred version, variants or
embodiments of the invention. First, a few words on terminology.
The claim term "a" includes one and more than one. The
claim term "label" is used as defined in the Federal Food
Drug & Cosmetic Act and the regulations promulgated thereunder.
We now turn to discussing in great detail the best (or "preferred")
versions (or "embodiments") of the invention.
A representative formula for Solid-Dosage Form of Weight Loss Product
is as follows, one tablet contains:
Vitamin B.sup.6 (as pyridoxine HCI) 10.0 mg .sup. Chromium (as
chromium Chelavite .TM. 200.0 mcg dinocitinate glycinate) Vanadium
(as amino acid chelate) 200.0 mcg Glucosamine sulfate 100.0 mg.sup.
Guarana seed and green tea leaf extracts 910.0 (200 mg caffeine)
Ma huang extract 312.5 mg (25 mg ephedrine alkaloids (aerial parts)
Excipients: Dicalcium Phosphate, Microcrystalline Cellulose, a sufficient
quantity Croscarmellose Sodium, Stearic Acid, Magnesium of each
to make a Stearate, Silica, suitable tablet
The scientific rationale for the formulation is as follows:
Vitamin B6 (pyridoxine) helps the body process the protein, fat
and carbohydrates in our diet. It is required in the metabolization
of carbohydrate, fats and proteins and has a primary role in the
utilization of proteins and amino acids, converting them to carbohydrates
or fats for storage or energy. Vitamin B.sub.6 also helps the body
resist stress. Vitamin B.sub.6 activates the release of glucogen
from the muscles and liver and is thus responsible for the production
of biological energy. It works with other vitamins and minerals
to supply the energy used in our muscles, and plays a role in cell
growth..sup.23
A deficiency in chromium results in glucose intolerance. Chromium
contributes to the prevention of adult-onset diabetes. It has been
shown to decrease sugar cravings and is considered an effective
treatment against both hypoglycemia and diabetes by improving glucose
tolerance, increasing cell sensitivity to insulin, and reducing
circulating insulin levels..sup.24
Research also indicates chromium's role in lowering total cholesterol,
LDL cholesterol, and serum triglyceride levels and improves the
LDL-to-HDL cholesterol ratio, according to Dr. Jeoffry Gordon in
San Diego, Calif. Subsequent research supports this and suggests
a greater role for chromium in the treatment and prevention of high
cholesterol and cardiovascular disease. There is speculation chromium
positively affects lipid profiles by its ability to increase insulin
efficiency, thereby reducing elevated lipid levels..sup.25
Chromium polynicotinate has been shown to possess greater biological
activity and is safer than other chromium supplements. It potentiates
the effects of insulin and helps overcome insulin resistance in
overweight people. Chromium also seems to stimulate thermogenesis,
the burning of fat, without any physical exertion..sup.26
Chromium picolinate was found to cause significant chromosome damage
at a non-toxic dose. In contrast, chromium polynicotinate did not
cause chromosome damage at equivalent doses. Consumers are urged
to switch to a nontoxic form of chromium, such as niacin-bound chromium,
also known as chromium polynicotinate. .sup.27 A 1998 study demonstrated
that 9 out of 10 American diets fall short in chromium. The chromium
levels of more than 40,000 men and women were measured in this study.
After comparing various age groups, the study found that chromium
levels plummet with the passage of time..sup.28 According to Dr.
Michelle Rubin from the University of Maryland, in addition to increasing
as we age, chromium needs rise dramatically during exercise..sup.29
Vanadium is needed for cellular metabolism and for thyroid function.
Research at the Grand Forks Human Nutrition Research Center suggests
that vanadium is an essential nutrient beneficial for thyroid hormone
metabolism..sup.30 A study at the University of British Columbia
found that vanadium compounds could correct defective signaling
pathways and increase the cells' response to insulin, which would
aid normal processing of sugar in patients with diabetes..sup.31
Vanadium can mimic insulin. In other words, in research done with
cells, it has been able to replace insulin..sup.32 Vanadium has
recently been observed to have several physiological insulin-like
effects by a post-insulin receptor kinase mechanism, making it very
likely to have a favorable effect on carbohydrate metabolism..sup.33
The benefits of glucosamine have already been discussed in detail,
above.
Guarana and green tea seed extract (providing 200 mg of caffeine)
is the first of the ingredients in the Thermogenic Herbal Concentrates
group. Caffeine and the closely related alkaloids theobromine and
theophylline make up the primary active agents in guarana. Caffeine's
effects are well known and include stimulating the central nervous
system, increasing metabolic rate and having a mild diuretic effect..sup.34
The tannic acid in guarana is astringent and probably accounts for
its use as a digestive tonic. It is also a stimulant..sup.35
The benefits of ma huang extract and its ephedrine alkaloids have
been discussed above.
Without further elaboration, it is believed that one skilled in
the art can, using the preceding description, utilize the present
invention to its fullest extent. The specific formulas are included
as a preferred embodiment of the composition formula ranges, and
not to further qualify the description. Claim references to specific
components include the component itself, as well as concentrates,
metabolites, constituents, extracts or combinations of said ingredients.
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