Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
2000-12-15
2002-08-06
Weber, Jon P. (Department: 1651)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
C514S773000, C514S775000
Reexamination Certificate
active
06429190
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a calorically efficient method for extending and enhancing the satiation quality of food. More particularly, the method includes addition to food of a nutritional composition containing a protein source, long chain fatty acids, and calcium to stimulate the release of cholecystokinin (CCK). Further, the nutritional composition includes soluble and insoluble fibers to bind bile salts that inhibit the release of CCK. By enhancing the satiation quality of food, the nutritional composition decreases food intake producing weight loss over time.
BACKGROUND OF THE INVENTION
It is well known in the art that specific nutritive agents can produce varying degrees of satiety following consumption. For example, it has been shown that a meal high in fat will produce a greater degree of satiety than an equal calorie meal that is high in carbohydrate. This has important implications for weight loss and weight management. The only proven way to lose weight is to either decrease caloric consumption or increase energy expenditure. For the most part, individuals on a weight loss program reduce their daily caloric consumption by decreasing the amount of fat and by increasing the amount of carbohydrate in their diet. This is logical because fat is an energy dense food (9 kcal/g) compared to carbohydrate (4 kcal/g). Although this regimen reduces total caloric intake, it may increase subjective feelings of hunger because carbohydrate is not as satiating as fat. Over time this can result in reduced compliance and diet failure. The challenge is how to make individuals on a reduced calorie, high carbohydrate diet feel less hungry between meals so they eat less and better comply with their diet regimen.
To address this problem, a number of modalities are used. This includes eating smaller meals more frequently as well as using specific pharmacologic agents that work on the brain neurotransmitters that effect appetite. Because these pharmacologic agents act non-specifically they have been shown to produce a variety of stimulant side effects involving the central nervous and cardiovascular systems.
An alternative approach would be to activate the body's own satiety pathway. Previous studies have shown that a powerful mechanism for extending satiety is through the stimulation of cholecystokinin (CCK). CCK is a peptide released following the consumption of food. Cholecystokinin is a major satiety signal in humans. Individuals, when administered CCK by injection, decreased caloric intake 16-22%. Although the full mechanism whereby CCK exerts is effect on satiety is not known, there appears to be two components, a central component involving CCK receptors in the brain and a peripheral component involving the stomach and small intestine.
When food is consumed, CCK releasing protein (CCKRP) is released in the small intestine. CCKRP stimulates CCK release from intestinal cells. The release of CCK generates the behavioral symptoms associated with satiety and at the same time activates a number of negative feedback mechanisms to turn off the CCK response. There are primarily two negative feedback mechanisms, one involving proteases secreted by the pancreas and the second bile salts released from the gallbladder. CCK stimulates the pancreas to secrete a number of proteases, specifically trypsin and chymotrypsin, which inactivate CCKRP. CCK also stimulates gallbladder contraction causing bile salts to be released into the intestinal lumen. Bile salts are powerful regulators of CCK, inhibiting its release.
The literature has also shown that CCK release can be stimulated by protein such as whey and casein, hydrolysis products of casein including glycomacropeptide, phenylalanine, calcium and long chain fatty acids.
It has been well documented that some soluble and insoluble fibers as well as plant saponins bind bile salts. Different fibers have different binding capacities to the various bile salts. For instance, cellulose has been shown to bind bile acids poorly. All of the literature to date has shown that regardless of how CCK is stimulated or what intervention is taken to prevent its breakdown, its reported effect is on the termination of the meal.
Previously, it has been shown that a nutritional intervention composition taken as a premeal beverage can reduce hunger and extend satiety following a meal. What is needed is a safe, calorically efficient method by which a nutritional composition can be added to food to increase and extend the satiation quality of that food. In this fashion, by reducing hunger one would improve compliance to a lower calorie regimen. In addition, the method should be simple, economical, easily adapted to a variety of different foods and food forms and does not require professional intervention.
DESCRIPTION OF THE PRIOR ART
U.S. Pat. No. 5,688,547 to Ritchey teaches that a dry food composition that can form a liquid composition is useful as a total meal replacement in connection with weight loss. The invention provides specific benefits derived from regular fiber intake. The critical component of the invention is the addition of up to six grams of fiber. The invention teaches that fiber elicits satiety.
U.S. Pat. No. 4,833,128 to Solomon et al discloses a dietary supplement for the oral administration of phenylalanine in conjunction with protein, carbohydrate and fat to stimulate satiety. This patent teaches that when a dietary supplement containing phenylalanine is consumed fifteen minutes prior to a meal, it generates a feeling of satiety resulting in less food consumption at the subsequent meal. The CCK release slows gastric emptying and the fiber in the invention provides an additional effect by slowing gastric emptying. The nutritional supplement in this patent contains 140 calories and it is recommended that it be taken three times a day. At a dose of three times a day, this dietary supplement would provide almost 25% of the total calories suggested in a reduced caloric program (1600 calories) to lose weight. Furthermore, the addition of phenylalanine limits its use in patients with phenylketonuria. Finally, the patent does not have any effect on extending the duration of action of CCK by inhibiting the action of trypsin and chymotrypsin on CCKRP by the addition of a proteinase inhibitor. In fact, the patent teaches that the appetite suppression of CCK may be merely temporary resulting in a limited satiety effect. This prior art patent does not teach or disclose a method for extending the satiety of food by adding a nutritional composition designed to stimulate CCK.
U.S. Pat. No. 5,290,808 to Sofia discloses a method to control the intake of food. The patent discloses methods and compositions for suppressing the desire for food consumption in animals by the administration of z-phenyl-1, 3-propanediol dicarbamate. This prior art does not teach or disclose a method for extending the satiety of food by adding a nutritional composition designed to stimulate CCK.
U.S. Pat. No. 5,688,547 to Ritchey et al discloses a dry food composition that can form a liquid composition is useful as a total meal replacement in connection with weight loss. This patent provides specific benefits derived from regular fiber intake. The critical component of this prior art patent is the addition of up to six grams of fiber, wherein this patent teaches that fiber elicits satiety. This prior art patent does not teach or disclose a method for extending the satiety of food by adding a nutritional composition to stimulate CCK.
U.S. Pat. No. 5,739,106 to Rink discloses appetite regulating compositions. The patent discloses methods and compositions for reducing food intake, suppressing appetite and controlling body weight. These compositions may include an amylin agonist (amino acid protein hormone) and a CCK agonist or a hybrid peptide. This prior art patent does not teach or disclose a method for extending the satiety of food by adding a nutritional composition designed to stimulate CCK.
U.S. Pat. No. 5,849,708 to Maratos-Flier discloses a method for promo
Gibbons Del Deo Dolan Griffinger & Vecchione
PacificHealth Laboratories, Inc.
Patten Patricia
Weber Jon P.
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