CA2348067A1 - Composition for extending post meal satiety - Google Patents

Abstract

A nutritional composition in a dry powder form including an extract of potatoes that provides a source of proteinase inhibitor that is mixed with water and ingested before a meal which extends satiety and thereby reduces appetite. The nutritional composition includes between about 10 % and about 80 % by weight of a protein, between about 10 % and about 40 % by weight of a medium to long chain fatty acid, between about 2 % and about 5 % by weight o f a calcium salt, and between about 1 % and about 5 % by weight of a proteinas e inhibitor provided by the extract of potatoes.

Description

COMPOSITION FOR EXTENDING POST MEAL SATIETY
BACKGROUND OF THE INVENTION
Field of Invention The present invention relates to a nutritional composition for extending satiety following a meal. More particularly the nutritional composition includes protein, medium and/or long chain fatty acids and calcium to stimulate the secretion of cholecystokinin a gastric peptide, and a source ofproteinase inhibitor extracted from potatoes that prevents the breakdown of cholecystokinin. By increasing and sustaining the levels of cholecystokinin, the present invention extends satiety.
Back.~round of the Prior Art Over the last forty years there has been extensive research conducted on mechanisms that would extend satiety following the ingestion of a meal. The benefits of such an invention have obvious utility in producing weight loss. Weight loss research has focused on three areas.
1 ~ Because the brain plays an essential role in the control of appetite, researchers have looked at various neurotransmitters, specifically, serotonin, dopamine and nor-epinephrine. A number of prescription and over-the-counter products have been developed which influence these neurotransmitters, thereby reducing appetite. Reducing appetite pharmacologically has a number of drawbacks, including a loss of effectiveness over a period of time. Drugs that affect neurotransmitters also affect the central nervous systems and can cause jitteriness and anxiety. In addition, these agents can produce cardiovascular effects that may even be fatal.
A second approach has focused on slowing gastric emptying thereby creating a feeling of fullness. This approach utilizes insoluble fibers, which slow the movement of food through the gastrointestinal tract. The disadvantage with the use of fiber is that the quantities needed to 2s produce an effect create an unpalatable diet as well as numerous gastrointestinal effects including bloating, gas and diarrhea.

A third approach investigates stimulating the body's satiety mechanism. When food is consumed a peptide is released called Cholecystokinin Releasing Protein (CCK-RP).
Cholecystokinin Releasing Protein then stimulates the release of cholecystokinin in the gut.
Cholecystokinin has been shown to increase satiety. When cholecystokinin is released it also stimulates the release of enzymes which inactivate CCK-RP. When CCK-RP is inactivated, CCK levels drop and the feeling of satiation is diminished. Studies have shown that cholecystokinin is extremely effective in extending satiety following ingestion of a meal.
Although CCK has been shown to extend satiety and reduce food intake, a major disadvantage is that it must be given intravenously. When administered orally, CCK is inactivated by gastric enzymes. This has severely limited its use as a potential weight loss agent.
A number of nutritive agents can stimulate the release of cholecystokinin.
Researchers have shown that protein, fat (particularly medium chain fatty acids), and calcium stimulate the release of CCK.
United States Patent No. 4,491,78 discloses the oral administration of a trypsin inhibitor 1 ~ to stimulate satiety by stimulating the release of cholecystokinin. The trypsin inhibitor was postulated to act by inhibiting the negative feedback signal for cholecystokinin secretion. In this fashion, the trypsin inhibitor sustained levels of cholecystokinin thereby extending satiety.
A number of studies have shown that proteinase inhibitor extracted from potatoes stimulates the release of cholecystokinin.
There is a definite need in the art for a nutritional intervention composition that can be taken orally, stimulate cholecystokinin levels prior to the initiation of a meal and sustain cholecystokinin levels and satiety for an extended period following consumption of a meal. An important element of this invention is the design of a product taken in a specified interval prior to the commencement of a meal. Thus, satiety levels are already enhanced before the meal, 2~ decreasing the quantity of food consumed during that meal.
SUMMARY OF THE INVENTION

The present invention provides for nutritional composition in a dry powder form for extending satiety following ingestion of a meal.
The dry nutritional composition includes proteins in the range of 10% to 80%.
The protein can be in the form of soy, whey, casein or a specific amino acid mixture containing essential amino acids or of the amino acid phenylalanine.
The dry nutritional composition also includes the mineral calcium in the range of 2% to 6%. The calcium can be in the form of a salt including calcium chloride, calcium carbonate, calcium lactate etc.
The dry nutritional composition also includes medium and/or long chain fatty acids (Cz2-C») in the range of 10°~0-40%.
The dry nutritional composition also includes a source of proteinase inhibitor extracted from potatoes wherein the protease inhibitor is present in the range of 0.02%-5%.
BRIEF DESCRIPTION OF THE DRAWINGS
Fig. 1 is a graphical representation of the responses of test subjects as to their feeling of satiety taken in fifteen minute intervals over a three and one-half hour period following a meal, showing both subjects who were administered a placebo and subjects who were administered a nutritional supplement according to the present invention.
Fig. 2 is a graphical representation of the responses of test subjects as to their feeling of hunger taken in fifteen minute intervals over a three and one-half hour period following a meal, showing both subjects who were administered a placebo and subjects who were administered a nutritional supplement according to the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
The nutritional composition for nutritional intervention for extending satiety includes nutritional agents being protein, medium and/or chain fatty acids, calcium, an extract ofpotatoes 2~ containing proteinase inhibitor, and, in a preferred form, flavoring agents and coloring agents.
The proteinase inhibitor is a heat stable protein present in potatoes and in extracts from potatoes and has a molecular weight of approximately 21,000. It is both a trypsin and chymotrypsin inhibitor, with its critical functionality being that it stimulates the release of cholecystokinin.
The protease inhibitor with the desired activity is present in potatoes and in more concentrated form in commercially available extracts or fractions of potatoes, such as coarse potato flour and potato fiber. Specifically, coarse potato flour available from Nonpariel Company contains approximately 0.49 mg of potato protease inhibitor two per gram, and Paselli PPC potato flour available from Avebe Company, The Netherlands, contains about 1.35 mg potato protease inhibitor rivo per gram. A method of extraction of a relatively pure proteinase inhibitor with the desired activity of the present invention is described in Bryant, J., Green, T. R., Gurusaddalah, T., and Ryan, C. A. {1976), Biochem. I5, 3418.
Experiment 1 This study was conducted with 21 subjects having a mean BMI =31.2 kglm2 (range 27.0 - 35.8) and mean age = 30.9 years (range 22 - 45). The study was a cross over design consisting of two parts. In the first phase the subjects were either given a placebo whose isocaloric I ~ composition was equal to the nutritional drink composition or the nutritional drink composition.
Both treatments were administered in 8 oz. of water 15 minutes prior to the meal. The meal consisted of 460 calories. Subjects were required to consume the meal within 15 minutes.
Following the consumption of the meal subjects were asked to rate their feelings of hunger and satiety on 6 visual analog scales every 15 minutes for 3 '/2 hours.
The nutritional drink composition is set out below:

wo ovmsa~ Pcr~usoonois~
Nutritional Drink Composition Constituent Grams %

Whey Protein 13.00 71.5 Non-Dairy Creamer4.00 22.0 containing 50% oleic acid Calcium Lactate0.635 3.5 Flavor 0.19 1.0 Color 0.05 0.3 POT 2' 0.30 1.7 ~ POT ? includes10% by weight einase approx. of the prot inhibitor Hunger ratings following ingestion of the nutritional drink composition were significantly decreased throughout the post-meal measurement period, reaching a 30% decrease by 3 hours post meal (p=0.033). Consistent with this finding, fullness ratings were significantly greater starting 3 hours post meal (37% increase, p=0.043). No differences in subjective ratings of other hunger-related items, or in thirst, were observed between the conditions.
Accordingly, an advantage of the present invention is that it provides for a nutritional intervention composition for extending satiety and reducing hunger following the termination of a meal.
Experiment 2:
This study was conducted with 21 subjects having a mean BMI =31.2 kg/mZ (range 27.0 I ~ - 35.8) and mean age = 30.9 years (range 22 - 45). During the diet, subjects drank 8 oz. (80 kcal) of the nutritional drink composition of Experiment 1 twice daily fifteen minutes before lunch and dinner. The effect of the nutritional drink composition on satiety was measured in a laboratory before and in the fourth week of the diet. On separate days subjects ingested the nutritional drink composition beverage or a placebo beverage (matched for volume and energy) fifteen minutes before a 350 calorie meal. Subjects rated hunger and fullness on visual analog scales every 1 S minutes for 3 '/2 hours.

The results of the study show that after four weeks on the diet, fullness ratings after lunch were higher after the consumption of the nutritional drink composition than the placebo beverage (mean ~ SD for alI time intervals = 71.0 t 17.3 vs. 65.5 ~ 16.7, p < 0.05).
Hunger ratings were 32% lower after the protease inhibitor than the placebo beverage (10.5 t 12.0 vs. 15.4 t 13.3, p < 0.01 ). There were no adverse reactions to the nutritional drink composition, and subjects reported that it helped them to reduce their food intake. Weight loss was significant (2.0 t 1.1 kg in 4 weeks, p < 0.001 ).
Accordingly an advantage of the present invention is that it provides continual effectiveness over a 30-day period and by extending satiety results in significant weight loss.
I 0 The source of the protease inhibitor may vary depending on the particular application for the satiety extending product of the present invention. For example, while coarse potato flour contains a significant amount of the protease inhibitor, it is difficult to disperse in water. Those having ordinary skill in the art, following the teachings of the invention set out above can readily accomplish determining an appropriate source of protease inhibitor as well as other components 15 that may be added to the composition to improve characteristics such as mouth feel, taste, and the like. Although the description above contains many specificities, these should not be construed as limiting the scope of the invention, but as merely providing illustrations of some of the presently preferred embodiments of this invention.

Claims (5)

What is claimed is:

1. A nutritional composition in a dry powder form that is mixed with water and ingested before a meal which extends satiety and thereby reduces appetite, comprising:
(a) a protein comprising between about 10% and about 80% by weight of said dry composition;
(b) one or more fatty acids comprising between about 10% and about 40% by weight of said dry composition;
(c) a calcium salt comprising between about 2% and about 5% by weight of said dry composition; and (d) an extract of potatoes providing a source of proteinase inhibitor that comprises between about 0.02% and about 5% by weight of said dry composition.

2. A nutritional composition as defined in claim 1, wherein said fatty acid comprises oleic acid.

3. A nutritional composition as defined in claim 1, further comprising a water soluble flavoring selected from the group including natural extracts and artificially produced extract components of apple, banana, cherry, cinnamon, cranberry, grape, honeydew, honey, kiwi, lemon, lime, orange, peach, peppermint, pineapple, raspberry, tangerine, watermelon, and wild cherry.

4. A nutritional composition as defined in claim 1, further comprising a colorant selected from the group including water soluble natural or artificial dyes of blue, green, orange, red, violet, and yellow.

5. A nutritional composition as defined in claim 1, further comprising a colorant selected from the group including iron oxide dyes, ultramarine pigments of blue, pink, red, and violet.