Production of isoflavone enriched fractions from soy protein...

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

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C426S425000, C426S431000, C426S429000, C426S443000, C426S478000, C426S490000, C426S520000

Reexamination Certificate

active

06565912

ABSTRACT:

BACKGROUND OF THE INVENTION
This invention will find use when processing any one of a number of plants or plant material, the preferred one of which is the soybean.
Those who are skilled in the art will readily perceive a variety of other plants or plant material which may be used, for example, red clover, kudzu, alfalfa, tea, cocoa, and subterranean clover are also expected to work in this invention. Accordingly, the terms plant, plant material, vegetable matter, and vegetable are to be construed herein as including these and other suitable materials.
As used herein, the term “isoflavone” is a flavonoid and includes saponins, lignans, alkaloids, catechins, and phenolic acids and also includes malonyl, acetyl, glucoside, and aglycone forms of the isoflavones.
For some background information on processing soy, reference may be made to the following articles: “
Isolated Soy Protein
” by C. W. Kolar, S. H. Richert, C. D. Decker, F. H. Steinke, and R. J. VanderZanden, found as chapter VIII of
New Protein Foods
, Vol. 5, eds. Aaron M. Altschul and Harold L. Wilcke, Academic Press, Inc. 1985
; “Traditional Soyfoods: Processing and Production
” by Peter Goldbitz; and “
Soy Protein Products: Processing and Use
” by Edmund W. Lusas and Mian N. Raz, both (0022-3166/95) published 1995 by the American Institute of Nutrition. A process for producing soy whey is disclosed on pages 386, 387 of “
Soybeans Chemistry, Technology, and Utilization
” by KeShun Liu, published by Chapman & Hall, 115 Fifth Avenue, New York, N.Y. 10003.
Isoflavones are a unique class of plant flavonoids that have a limited distribution in the plant kingdom and may be physically described as colorless, crystalline phenolic ketones. The most common and important dietary source of these isoflavones are soybeans which contain the following twelve isoflavone isomers: genistein, genistin, 6″-0-malonylgenistin, 6″-0-acetylgenistin; daidzein, daidzin, 6″-0-malonyldaidzin, 6″-0-acetylgenistin; glycitein, glycitin, 6″-0-malonylglycitin, 6″-0-acetylglycitin (Kudou, Agric. Biol. Chem. 1991, 55, 2227-2233). Ninety-seven to ninety-eight percent of the soybean isoflavones are in the glycosylated form.
Traditionally, individuals have been limited in their use of soy foods to increase their levels of dietary isoflavones because the number and variety of soy foods is limited especially in the U.S. marketplace. Also, natural flavors and color of some soy products have been described by some people as being bitter and unappetizing.
The isoflavone, genistin, was first isolated from soybean meal in 1931 by Walz (Justus Liebigs Ann. Chem 489, 118) and later confirmed in 1941 by Walter (J. Amer. Chem. Soc. 63, 3273). Patents have described the production of isoflavone enriched soy-protein products (WO 95/10512; WO95/10529; WO 95/10530), genistin malonate and daidzin malonate (U.S. Pat. No. 5,141,746), pharmaceutical-type compositions containing isoflavones (U.S. Pat. Nos. 5,424,331; 4,883,788), and isolation and modification of isoflavones from tempeh (U.S. Pat. Nos. 4,390,559; 4,366,248; 4,366,082; 4,264,509; 4,232,122; 4,157,984). The present invention relates to the manufacture of highly enriched isoflavone products containing either a wide-range of soy isoflavones or highly-purified genistin gained from an ethanol extract of defatted soybean flakes.
For example, coronary heart disease (CHD) is a leading cause of death, especially in the United States and other industrialized nations. Elevated total and low density lipoprotein (LDL) cholesterol levels are important risk factors for CHD. In humans, soy protein products appear to lower serum total cholesterol levels by an average of about 9.3% and to lower low-density lipoprotein (LDL) cholesterol by an average of about 12.9% when consumed at an average intake level of 47 g soy protein per day (Anderson et al.,
NEJM
, 333: 276-282, 1995).
Isoflavones (phytoestrogens) are implicated as a class of compounds in soy protein products which is at least partly responsible for this cholesterol-lowering effect in animals (Setchell, in McLachlan JA, ed., Estrogens in the Environment II: 69-85, 1985). In addition, studies with primates suggest that soy isoflavones may account for up to about 60-70% of the hypocholesterolemic properties of soy protein (Anthony et al., Circulation, 90: Suppl: I-235. (abstract), 1994; Anthony et al., J. Nutr., 125: Suppl 3S: 803S-804S. (abstract), 1995; Anthony et al., Circulation, 91: 925. (abstract), 1995).
It has also been suggested that isoflavones have an ability to play a role in the prevention of certain cancers. Japanese women who have consumed diets rich in isoflavones appear to have a very low incidence of breast cancer (Adlercreutz et al., J. Nutr. 125: 757S-770S, 1995). Soy products have also been shown to decrease mammary tumor formation or to inhibit mammary tumor progression in rat breast cancer models (Barnes et al., Clin. Biol. Res. 347: 239-253; Hawrylewicz et al., J. Nutr. 121: 1693-1698, 1991). Genistein has been shown to inhibit protein tyrosine kinase (Akiyama et al., J. Biol. Chem. 262: 5592-5595, 1987), to inhibit angiogenesis (Fotsis et al., Proc. Natl. Acad. Sci. USA 90: 2690-2694, 1993), and to induce differentiation in several malignant cell lines (Peterson, J. Nutr. 125: 784S-789S, 1995), all of which may be important risk factors in cancer development. Genistein and Biochanin A also appear to inhibit the growth of androgen-dependent and independent prostatic cancer cells in vitro (Peterson and Barnes, Prostate 22: 335-345, 1993). Genistein may act as an antioxidant (Wei et al., Nutr. Cancer 20: 1-12, 1993).
Beyond cancer, it is thought that at least some of the soy isoflavone fractions are especially beneficial for women in general since it is a source of plant or vegetable estrogen. It is thought that plant or vegetable estrogen provides many of the advantages and avoids some of the alleged disadvantages of animal estrogen. Hence, it is especially desirable to enable the isoflavone fractions to be used in a wide variety of ways, such as in beverages and foods including health bars. This means that the isoflavone fractions should not introduce unacceptable tastes or unappetizing colors.
Some of these medical conditions may be either preventable or treatable by a use of phytochemicals, especially isoflavones, as a source of supplemental hormones. Hence, proper diet should contain the desired phytochemicals.
It is also thought that there are superior results when a plurality of such phytochemicals are consumed in proper combinations. However, a trouble is that many people do not have or do not like the proper kind of diet which provides the desirable effects. Therefore, the problem is to furnish the necessary food values in some other form. Accordingly, it is desirable to provide a refinement process which is able to provide a selected combination of phytochemicals tailored to a specific symptom.
The process described in U.S. Pat. Nos 5,702,752; 6,017,555; and 6,033,714 produce an excellent concentration of isoflavones. However, the end product could be improved and produced at lower cost especially by reducing the energy required to dry an aqueous feed stream carrying the isoflavone fractions. Also, it is desirable to increase the concentration of the isoflavone fraction in the end product. Isoflavones are preferably formed into pills, tablets, capsules, liquids, and food ingredients which may be ingested without having to taste the original food product. Also, there are times when it is desirable to use the isoflavones as supplements in foods, beverages, medical foods, health bars, and certain other dietary supplement products.
SUMMARY OF THE INVENTION
Accordingly, an object of this invention is to provide a combination of isoflavone fractions which have a neutral color and a bland flavor, and which together provide a profile especially directed to specific health problems. In particular, an object is to provide a supplement which may be included in a great variety of foods and beverages. More particula

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