Food or edible material: processes – compositions – and products – Products per se – or processes of preparing or treating... – Plant material is basic ingredient other than extract,...
Reexamination Certificate
2000-03-13
2001-07-31
Weier, Anthony J. (Department: 1761)
Food or edible material: processes, compositions, and products
Products per se, or processes of preparing or treating...
Plant material is basic ingredient other than extract,...
C426S656000, C426S658000, C514S002600, C514S909000
Reexamination Certificate
active
06268011
ABSTRACT:
The present invention relates to a composition on basis of soybean ingredients. More particularly, the invention relates to a nutritional composition which is useful as a weight-reducing diet for overweight or obese subjects. Furthermore. the invention relates to such a nutritional composition, which is useful for lowering serum lipids
Adipositas or obesity and overweight in general is a widespread problem in large parts of the world. At the same time, increased health consciousness has stimulated the interest in “keeping the slim line”. A large number of different diets have therefore been put on the market aiming at a rapid weight reduction.
Some of these diets must be considered unwarrantable seen from a nutritional point of view as they are based on a very unbalanced intake of nutrients which very quickly will result in deficiency of essential nutrients.
Other diets are based on nutritional preparations being composed in such a way that, at a low calorie content, they supply the necessary proteins, vitamins and minerals. Some of these preparations are in the form of powders containing sources of protein, carbohydrate and fat, and optionally flavouring agents, preservatives, vitamins, minerals and other conventional additives. Before intake, the powders are stirred up in water and then taken as a drink or a gruel. However, the known preparations suffer from a number of deficiencies. Many known powders can only with difficulty be stirred up in water so that the stirred up preparations will have a lumpy and gritty consistency which makes them very unpleasant to take. At the same time, sedimentation occurs very quickly, involving the risk that essential components such as sparingly soluble minerals are not taken in, but remain as a sediment at the bottom of the glass. Finally the preparations have an unpleasant tang which persists as an after-taste a long time after the preparation has been taken. These disadvantages have the effect that many persons break off the diet too soon.
EP0 425 423 B1 discloses a process for the preparation of a powdery, low-calorie nutritional preparation, especially for use as the main or sole nutrition in the treatment of adipositas. The preparation has a balanced composition of sources of protein, carbohydrate and fat, and optionally contains flavouring agents, preservatives, vitamins, minerals and other conventional additives. The protein source is a combination of a soy protein concentrate and skirmed milk powder. The soy protein concentrate is a product prepared from shelled soybeans by removing most of the oil and water soluble, non-protein constituents. Soy protein concentrate typically contains 66.0% protein, 17.0% carbohydrate, 6.0% water, 5.6% ashes, 4.0% wood substance, and 1.4% fat. The carbohydrate content is typically present as fibres which are insoluble in water. A typical soy protein concentrate does not contain all the essential amino acids in sufficient amounts. In particular, histidine and tryptophan are limitating amino acids in soy protein concentrate. In order to supply all the essential amino acids, the known nutritional preparation also contains skimmed milk powder as a protein source. However, skimmed milk is not a desirable protein source in certain parts of the world, in particular Southern Europe, Asia and Africa where lactose intolerance is not unusual due to lack of the lactose-degrading enzyme, lactase. Overweight and obesity are often accompanied by an increased fatty content in the blood, and for altering the lipid profile EP-0 425 423 B1 suggests supply of separate capsules comprising fish oil containing polyunsaturated fatty acids along with the nutritional preparation. It would be desirable if the intake of separate fish oil capsules could be avoided for improving the lipid profile. Thus, it would be highly desirable to provide a nutritional preparation which in itself had a beneficial lowering effect upon the lipid level.
As mentioned above, some of the diets presently on the market for weight reduction are based on an unbalanced intake of nutrients, which may result in deficiency of essential nutrients. In particular, a sufficient intake of protein supplying all the essential amino acids is very important in connection with any weight reducing treatment. Typically, 22-36% of the overweight is lean body mass (LBM), which is the fat-free body mass, such as musculature. The loss of proteins from e.g. muscles results in elimination of nitrogen from the body, which can be measured indirectly by determination of the concentration of uric acid in serum. If the concentration of uric acid increases substantially during a weight reduction, the reason may be too much degradation of musculature.
In New England Journal of Medicine, Vol. 333, Aug. 3, 1995, a meta-analysis of the effects of soy protein intake on serum lipids, has been described. In this study, the authors examined the relation between soy protein consumption and serum lipid concentrations in humans. It was found that ingestion of diets containing soy protein, as compared with control diets was accompanied by significant reduction in serum concentrations of total cholesterol, LDL-cholesterol and triglycerides. Soy protein intake did not significantly affect serum HDL cholesterol concentrations. The effect of soy protein intake was dependent upon initial cholesterol concentration. Subjects with normal cholesterol levels had non-significant reductions of 3.3%, and also subjects with mild hypercholesterolemia had non-significant reductions of 4.4%. Only subjects with moderate and severe hypercholesterolemia had significant decreases in cholesterol levels of 7.4% and 19.6%, respectively. The pattern of changes in serum LDL-cholesterol concentrations was similar to the pattern for total cholesterol concentrations. Also changes in serum triglyceride concentrations were significantly related to the initial serum triglyceride concentrations. Various types of soy protein were studied, such as isolated soy protein, textured soy protein, or a combination, and it was found that the type of soy protein did not have any significant effect on the net change in serum cholesterol concentrations. The study did not consider a simultaneous intake of the various types of soy proteins along with soy fibres. This meta-analysis of the effects of soy protein intake on serum lipids found its way to the international press as a sensational finding that soy protein is effective in lowering serum cholesterol, and articles appeared in International Herald Tribune on Aug. 4, 1995, Chicago Tribune on Aug. 3, 1995, and in New York Times on Aug. 3, 1995.
Potter et al., Am J Nutr Clin 1993; 58; 501-6, studied the effects of soy protein consumption with and without soy fiber-on plasma lipids in mildly hyperchoesterolemic men. Dietary treatment included 50 g protein and 20 g dietary, fiber from soy flour, isolated soy protein/soy cotyledon fiber, isolated soy protein/cellulose, and non-fat dry milk/cellulose in conjunction with a low-fat, low-cholesterol diet. The protein and dietary fibres were prepared as baked products and substituted into the diet. In the experiment using isolated soy protein and soy cotyledon fiber the subjects received per day 50 g isolated soy protein, 50 g other proteins, including 36 g animal and 14 g vegetable protein, carbohydrates corresponding to 55% energy intake, 20 g soy cotyledon fiber, fat corresponding to <30% of total energy content, and 200 mg cholesterol. As a result of the study, it was found that total and LDL-cholesterol concentrations can be lowered significantly in mildly hypercholesterolemic men, which was attributed to the replacement of 50% of dietary protein with soy protein. Similar depressions in blood lipids were noted for isolated soy protein, whether it was consumed in conjunction with soy cotyledon fiber or cellulose fiber. Plasma triclycerides concentrations were unaffected by the various dietary treatments described in the article. The study did not reveal any additive cholesterol-lowering effect of concurrent intake of cotyledon soy fib
Cooper Iver P.
Nutri Pharma ASA
Weier Anthony J.
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