Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
1999-06-18
2002-04-16
Criares, Theodore J. (Department: 1617)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C426S598000, C426S072000, C426S074000, C426S656000, C426S629000, C424S440000
Reexamination Certificate
active
06372782
ABSTRACT:
TECHNICAL FIELD
The present invention relates generally to a low fat, vitamin/mineral fortified soy-based oral nutritional product useful for providing soy protein in addition to the inherent isoflavones to a health conscious population.
BACKGROUND OF THE INVENTION
Substitution of vegetable protein for animal protein in an individual's diet has traditionally addressed the needs of persons with food allergies or intolerance to dairy-based formula components (usually casein, whey, or lactose) and individuals who desire to limit or avoid animal protein for life style philosophy (vegetarianism) or religious beliefs and practices. As positive outcomes from research in the area of vegetable extracts in the nutritional management of disease states are published, desire to add these “added value” vegetables to individual diets has expanded in the general population.
Many of the “active components” identified in vegetables are phytoestrogens. A number of these compounds have been identified in fruits, vegetables, and whole grains commonly consumed by humans. Phytoestrogens include isoflavones which occur in a variety of leguminous plants. Soybeans are the most significant dietary sources of isoflavones. Isoflavones have been detected and identified in biological fluids of humans consuming the plant material. Due to the phenolic structure, which is similar to those of animal estrogens, these compounds exhibit weak estrogenic properties and are termed phytoestrogens. It is the isoflavones which have received the most attention and have been reviewed in great detail in “Mammalian lignans and phyto-oestrogens- Recent studies on their formation, metabolism and biological role in health and disease” by Setchell and Adlercreutz,
Role of the Gut Flora in Toxicity and Cancer
. New York, Academic Press, 1988; pp 315-45; “Naturally Occurring Oestrogens in Foods- A Review” by Price and Fenwick,
Food Additives and Contaminants
, Vol.2, No.2, pp73-106,1985; and “Dietary Phytoestrogens” by Kurzer and Xu,
Annual Review of Nutrition
Vol 17, 1997; pp 353-81.
Studies in humans, animals and cell culture systems suggest that dietary phytoestrogens play an important role in prevention of menopausal symptoms, osteoporosis, cancer, and heart disease. Proposed mechanisms include estrogenic and antiestrogenic effects, induction of cancer cell differentiation, inhibition of tyrosine kinase and DNA topoisomerase activities, suppression of angiogenesis and antioxidant effects. The major isoflavones occurring in plants are the glycosides of genistein, daidzein and glycitein.
Isoflavones isolated from soy have become the focus of much research in the areas of heart disease, cancer, osteoporosis and kidney diseases. This expanding knowledge in the possible role of soy and its fractions in the nutritional management of disease states has presented practical challenges for the average consumer in the market place. The primary challenge is access to good tasting products with naturally high concentrations of isoflavones.
The isoflavone contents in commercial soy raw ingredients vary depending on the levels of isoflavones in the plant variety and processing procedures. For example, approximately 90% of phytoestrogens present in soy foods are beta-glucoside conjugates of daidzein and genistein. However, in fermented soy products, the aglucones (unconjugated) are the predominant forms. The nutrient and isoflavone content of the most common available soy foods, soy ingredients and nutritionals are listed in Table 1 below.
TABLE 1
Nutrient and Isoflavone Content of Different Soy Foods and Ingredients*
Protein
Fat
Estimated
Calories
g
g
Isoflavone
Soy food
Kcal
(% of Cal.)
(% of Cal.)
mg
Miso (1 oz)
35
2 (23)
1 (25)
10
Soybeans, cooked
149
14 (37)
8 (48)
35
(½ cup)
Soy flour
441
35 (32)
22 (45)
50
(3½ cup)
Soymilk (1 cup)
140
10 (28)
4 (26)
40
Soymilk, low-fat
120
8 (26)
3 (22)
40
(1 cup)
Soy nuts,
387
34 (35)
19 (44)
50
dry roasted
(½ cup)
Soy protein isolate
94
25 (100)
1 (9)
15
(1 oz)
Tempen (4 oz)
204
17 (33)
8 (35)
40
Tofu, low-fat
35
6 (68)
1 (25)
30
(3 oz)
Tofu, extra-firm
60
6 (40)
3 (45)
45
(3 oz)
Textured Vegetable
59
11 (74%)
0 (0)
35
Protein
(¼ cup, dry)
Ensure (8 fl. oz.)
250
8.8 (14)
6.1 (22)
2.6
GeniSoy
130
14 (43)
0 (0)
14-70**
(35 gm)
*Table adapted from US Department of Agriculture Handbook 8
**Based on GeniSoy literature which describes a typical isoflavone range from 1.0-5.0 mg isoflavone/gram soy protein, assuming 100% of the protein is soy protein containing isoflavone.
While there are a few soy-based foods available on the market today, they are not easily incorporated into an individual's diet. Accessibility of the products listed in Table 1 is an issue for most of the general population. A few of the products are starting to be stocked in standard grocery stores; however, many must be purchased in “Health Food Stores”. More importantly, the taste and texture of soy products are objectionable to many individuals that have not grown up with soy protein in their diets. In addition, most of the foods in Table 1 are ingredients to be incorporated into a food dish and most individuals do not know how to cook with these ingredients. While the roasted soy nuts, which would probably be an acceptable snack food for most individuals, weigh in with a high isoflavone content, the high calorie and fat content are unacceptable for daily incorporation into an individual's diet. Soy milk is a reasonable source of isoflavones and has been used by individuals with cow milk allergies for many years and there are currently more flavors and fat content options to chose from. A serving (1 cup) of “Light” soy milk contains 3 grams of fat and 8 grams of protein in 120 total calories. No inherent vitamins and a small amount of calcium and iron (2% of the RDI) are present in soy milk. A serving (1 cup) of full fat soy milk contains 4 grams of fat and 10 grams of protein in 140 total calories. The requirement for refrigerated storage and the flavor of soy milk remain a major obstacle for the average consumer.
FDA-regulated food products began using the Daily Value as the basis for declaring nutrient content May 8, 1994. Daily Values (DVs) are a set of dietary reference values to help consumers use food label information to plan a healthy overall diet. DVs actually comprise two sets of reference values for nutrients: Daily Reference Values (DRVs) and Reference Daily Intakes (RDI).
DRVs are a set of dietary references for which no set of standards previously existed. DRVs apply to fat, saturated fat, cholesterol, carbohydrate, protein, fiber, sodium and potassium. Based on 2,000 calories a day for adults and children over 4, the DRV for fat is 65 grams; saturated fat is 20 gm; cholesterol is 300 milligrams; total carbohydrate is 300 grams; fiber is 25 grams; sodium is 2,400 milligrams; potassium is 3,500 milligrams; and protein is 50 grams.
RDIs are a set of dietary references based on the Recommended Dietary Allowances (RDA) for essential vitamins and minerals. The name “RDI” replaces the term “U.S. RDA”(Recommended Daily Allowances). Recommended Dietary Allowances (RDA) are the set of estimated nutrient allowances established by the National Academy of Sciences used as the basis for setting the U.S.RDAs. It is updated periodically to reflect current scientific knowledge.
The liquid nutritional, Ensure® (Ross Products Division of Abbott Laboratories, Chicago, Ill.), a good tasting, shelf stable, ready to drink complete nutritional with a protein system that contains soy protein isolate, is an alternative to the more traditional soy foods. However, only 20% of the total protein system is soy protein isolate resulting in an isoflavone content too low to practically provide the benefit of consuming soy protein.
GeniSoy™ is a powdered protein shake manufactured by GeniSoy Products Co. (Fairfield, Calif.) with water processed isolated soy protein. A serving (8 oz.) of the Vanilla product contains 14 gm of soy protein, zero fat and 18 gm of total carbohydrate in 130 calories. The vitam
Chandler Michael Allen
Cipollo Kent Lee
Craig Lisa Diane
Lee Theresa W.
Patel Guaravkumar C.
Abbott Laboratories
Criares Theodore J.
Kim Jennifer
Parlet Nickki L.
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