Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
2001-08-13
2002-07-16
Killos, Paul J. (Department: 1623)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C514S909000, C424S725000, C424S729000
Reexamination Certificate
active
06420350
ABSTRACT:
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%
1
. Ma huang also acts as an appetite suppressant.
2
A double-blind, placebo-controlled study published in Metabolism finds a thermogenic synergism between ephedrine and caffeine.
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.
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.
5
In addition, the ephedrine/caffeine combination has lean body mass saving properties
6,7
and abolishes the decline in HDL-cholesterol during active weight loss due to the beta-agonistic properties of ephedrine.
8
Due to increased central nervous system stimulation, the combination significantly prolongs exercise time to exhaustion and improves performance in runners.
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.
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.
12
Green tea clearly has thermogenic properties, promotes fat oxidation
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.
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.
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.
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.
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.
18
A University of Southern California study further explains that glucosamine induced complete and reversible insulin resistances
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.
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.
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.
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
Goen Group, Inc.
Killos Paul J.
Pharmaceutical Patent Atty's LLC
Pohl, Esq. Mark
Tucker Zachary
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