Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from leguminosae
Reexamination Certificate
1999-07-16
2002-11-19
Cook, Rebecca (Department: 1614)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from leguminosae
C514S028000, C514S027000, C426S629000
Reexamination Certificate
active
06482448
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to soy formulations, dietary supplements comprising the soy formulations and food products which include the soy formulations and/or the dietary supplements. The present invention also relates to pharmacological compositions comprising the soy formulation that may additionally comprise a medicinal composition. The present invention further relates to processes for producing soy formulations. In addition, the present invention relates to methods for promoting the health of an individual utilizing the soy formulations, dietary supplements, food products and/or pharmacological compositions of the present invention.
BACKGROUND
Soybeans include natural plant estrogens, known as phytoestrogens or isoflavones. These isoflavones are thought to bind to estrogen receptors and thus exert an estrogenic response. Medical studies have shown that isoflavones in soy protein have many beneficial interactions with a variety of human tissues, are safe, cause no significant side-effects, and are the primary reason for many health benefits. Research has discovered in Asian countries like Japan, where the traditional diet is high in soy protein, very few women complain about menopausal symptoms, for example only 9% of Japanese women complain about hot flashes. In addition, younger women have fewer menstrual periods per year, and occurrences of some cancers (breast and endometrial), heart disease, and other chronic diseases are very low. It has been reported that Japanese women consume up to 200 mg of isoflavones in their daily diet and have a lower incidence of perimenstrual and menopausal symptoms than women in other cultures consuming less daily dietary isoflavones. Previous studies using isoflavone dosages of 76 mg per day report a 45% reduction in hot flashes in women after 12 weeks.
In addition to providing isoflavones, soybeans provide a source of protein. It is believed that the benefits from soy come from the phytoestrogens (isoflavones) other compounds such as lignans and saponins, the soy protein itself and undoubtedly undiscovered compounds.
Several soy protein formulations are commercially available. Formulations produced exclusively from the whole soy bean generally include 1-5 milligrams isoflavone per gram of the formulation and may be up to 90% protein. Formulations produced exclusively from the heart (center) of the soy bean generally include 24-36 milligram isoflavone per gram of the formulation. Although tablets with concentrations of 100-750 milligram isoflavones per gram are available, formulations having concentrations greater than 36 mg isoflavones per gram of the formulation are chemically extracted and modified and therefore are not considered natural.
Dietary levels of 60 milligrams, in particular 120-200 milligrams of isoflavones are difficult to achieve utilizing currently available natural soy protein formulations. To achieve a dietary level of greater than 60 milligrams, and in particular 120-200 milligrams of isoflavones from soy formulations produced utilizing the whole soy bean could require ingesting greater than 60 grams, in particular up to 120-200 grams of soy protein. Intake of soy protein at this volume level tends to cause digestive side effects such as bloating and constipation. To achieve a dietary level of greater than 60 milligrams, preferably 120-200 milligrams, of isoflavones from soy formulations produced utilizing the heart of the soy bean may require ingesting only 3 to 8 grams of soy protein. However, with soy protein levels this low, the person ingesting the formulation would be receiving minimal benefits and nutritional value from soy protein itself.
Accordingly, it would be advantageous to have a natural soy formulation having a milligram isoflavone to gram of the formulation ratio falling between the ratios of natural soy formulations produced from the whole soybean and natural soy formulations produced from the heart of the soy bean.
It would also be advantageous to have dietary supplements that include the natural soy formulations. In particular, it would be advantageous to have dietary supplements which when ingested in reasonable amounts provide dietary isoflavone levels of greater than 60 milligrams, preferably greater than 120 milligrams, for example 120-200 milligrams or higher, e.g. greater than 200 milligrams. For certain applications it may be advantageous to have dietary supplements or soy formulations that provide dietary isoflavone levels as high as 1500-2200 milligrams, or greater.
Further, it would be advantageous to have food products that include the natural soy formulations and/or the natural dietary supplements. In particular, it would also be advantageous to have food products which when ingested in reasonable amounts provide dietary isoflavone levels of greater than 60 milligrams, preferably greater than 120 milligrams, for example 120-200 milligrams, or higher, e.g. greater than 200 milligrams, up to 400-900 milligrams or greater. For certain applications it may be advantageous to have food products, dietary supplements or soy formulations that provide dietary isoflavone levels as high as 1500-2200 milligrams, or greater.
These and other advantages are achieved by the present invention.
SUMMARY OF THE INVENTION
The present invention provides soy protein formulations (soy formulations), dietary supplements and food products (including medical foods) comprising the soy formulations and/or dietary supplements. The present invention also provides pharmaceutical compositions.
A soy formulation of the present invention includes a higher concentration of natural plant estrogens, referred to as isoflavones or phytoestrogens, per gram of the formulation, than currently available in a natural product. The soy formulation may further include protein, therefore providing a higher concentration of isoflavones per gram of the formulation, and per gram of protein in the formulation, than currently available in a natural product.
The isoflavone component of the soy formulation of the present invention may comprise naturally occurring isoflavones, including, but not limited to: diadzin, genistin, and glycitin. In another aspect, the present invention provides soy formulations having diadzin as a major isoflavone component.
A dietary supplement of the present invention comprises a soy formulation of the present invention. The dietary supplement may further comprise ingredients such as enzymes, a fiber source, vitamins and the like.
A food product of the present invention comprises a soy formulation of the present invention and/or a dietary supplement of the present invention. The food product may further comprise additional ingredients.
A pharmaceutical composition of the present invention comprises a soy formulation of the present invention in a pharmacologically effective amount. The compositions may additionally comprise prescription medicines. The combination may advantageously produce one or more of the following effects:
1) additive and/or synergistic benefits;
2) reduction of the side effects and/or adverse effects associated with use of the prescription medicine in the absence of the soy formulation; and/or
3) the ability to lower the dosage of the prescription medicine in comparison to the amount of prescription medicine needed in the absence of the soy formulation.
Further advantages and possible embodiments of a drug formulation of the present invention are discussed in detail below.
The soy formulations, dietary supplements, food products and/or pharmaceutical compositions of the present invention may advantageously be utilized in methods for promoting the health of an individual. The soy formulations, dietary supplements, food products and pharmaceutical compositions of the present invention may provide higher concentrations of isoflavones than currently available soy products in a readily digestible and absorbable form.
The soy formulations, dietary supplements, food products and pharmaceutical compositions of the present invention may also provide protein. The isoflavones a
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