MXPA00004783A - Soy formulations and their use for promoting health - Google Patents

Abstract

The present invention provides novel soy formulations comprising 3-23 milligrams of at least one isoflavone per gram of the formulation. The soy formulations may additionally comprise 0.4 to 1.2 grams of protein per gram of the formulation. In another aspect, the present invention provides novel soy formulations comprising diadzin, genistin and glycitin in a ratio of 3:1:2 to 3:4.5:1, preferably approximately 2:1:1 such that diadzin is a major isoflavone component. The present invention further provides dietary supplements and food products comprising a soy formulation of the present invention. In another aspect the present invention provides pharmacological compositions comprising a soy formulation of the present invention. The pharmacological compositions may additionally comprise a medicinal composition. Also disclosed are methods for promoting the health of an individual, preferably utilizing the soy formulations, dietary supplements, food products and/or pharmacological compositions of the present invention.

Description

SOY FORMULATIONS AND ITS USE TO PROMOTE HEALTH DECLARATION ON RELATED APPLICATIONS: This application claims the priority of the United States provisional patent application serial number 60 / 092,985 filed on July 16, 1998 and of the United States provisional patent application serial number 60 / 105,797 filed on October 27, 1999. The exhibit of this provisional application is incorporated herein by reference.

FIELD OF THE INVENTION The present invention relates to soy formulations, dietary supplements comprising soy formulations and food products that include soy formulations and / or dietary supplements. The present invention also relates to pharmacological compositions comprising soy formulations which may further comprise a medicinal composition. The present invention also relates to processes for producing soy formulations. In addition, the invention relates to processes for promoting the health of an individual using the soy formulations, dietary supplements, food products and / or pharmacological compositions of this invention.

BACKGROUND Soybean includes natural plant estrogens known as phytoestrogens or isoflavones. It is thought that these isoflavones bind to the e-estrogen receptors and thus exert an estrogenic response. Medical studies have shown that soy protein isoflavones have many beneficial interactions with a variety of human tissues, are safe, do not cause significant side effects and are the main reason for their many health benefits. Research has found that in Asian countries such as Japan, where the traditional diet is high in soy protein, very few women complain of menopausal symptoms, for example only 9% of Japanese women complain of hot flashes. In addition, young women have fewer menstrual periods a year and the appearance of some types of cancer (breast and endometrial), heart disease and other chronic diseases is very low. It has also 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 from other cultures who consume less isoflavones in their daily diet. Previous studies using isoflavone doses of 76 mg per day report a 45% reduction in hot flushes in women after 12 weeks. In addition to providing isoflavones, soybeans provide a source of protein. It is believed that the benefit of soy comes from phytoestrogens (isoflavones), other compounds such as lignans and saponins, the soy protein itself and undoubtedly undiscovered compounds. Various formulations of soy protein are commercially available. Formulations produced exclusively from whole soybean generally include 1 to 5 milligrams of isoflavone per gram of the formulation and can have up to 90% protein. Formulations produced exclusively from the heart (center) of soybeans in general include 24-36 milligrams of isoflavone per gram of the formulation. Although tablets with concentrations of 100 to 750 milligrams of isoflavones per gram are available, formulations having concentrations greater than 36 mg isoflavones per gram of the formulation are chemically extracted and chemically modified and therefore not considered to be natural. Dietary levels of 60 milligrams, in particular 120 to 200 milligrams of isoflavones are difficult to achieve using the currently available natural soy protein formulations. To achieve a dietary level of more than 60 milligrams and, in particular, 120 to 200 milligrams of isoflavones from the soy formulations produced using the whole soybean would require ingesting more than 60 grams, in particular up to 120-200 grams of soy protein. The intake of soy protein in these volume levels tends to cause digestive side effects such as bloating and constipation. To achieve a dietary level greater than 60 milligrams, and preferably 120 to 200 milligrams of the isoflavones from soy formulations produced using the heart of soybeans, only 3 to 8 grams of the soy protein may be required. However, when the levels of soy protein are low, the person who ingests the formulation would be receiving minimal benefits and a minimum nutritional value of the soy protein itself. Consequently, it is beneficial to have a natural soy formulation that has a ratio of milligrams of isoflavone per gram of the formulation within proportions found in natural soybean formulations produced from whole soybeans and natural soybean formulations produced at from the heart of soybeans. It would also be helpful to have dietary supplements that include natural soy formulations. In particular, it would be advantageous to have dietary supplements that, when ingested in reasonable amounts, provide dietary levels of isoflavone greater than 60 milligrams, preferably greater than 120 milligrams, for example between 120 and 200 milligrams or higher, for example greater than 200 milligrams . For certain applications it may be helpful to have dietary supplements or soy formulations that provide dietary isoflavone levels of up to 1500-2200 milligrams or greater. In addition, it would be helpful to have food products that include natural soy formulations and / or natural dietary supplements. In particular, it would be advantageous to have food products that when ingested in reasonable amounts would provide dietary levels of isoflavone greater than 60 milligrams, preferably greater than 120 milligrams, for example between 120 and 200 milligrams or higher, for example greater than 200 milligrams up to 400 milligrams. -900 milligrams or greater. For some applications it may be advantageous to have food products, dietary supplements or soy formulations that provide dietary levels of isoflavone up to 1500-2200 milligrams, or greater. These and other advantages are achieved with the present invention.

SUMMARY OF THE INVENTION This invention provides formulations of soy protein (soy formulations), dietary supplements and food products (including medical foods) that comprise soy formulations and / or dietary supplements. The present invention also provides pharmaceutical compositions. A soy formulation of this invention includes a higher concentration of natural plant estrogens, referred to as isoflavones or phytoestrogens, per gram of the formulation, with respect to the concentration currently available in natural products. The soy formulation may further include protein, thus providing a higher concentration of isoflavones per gram of the formulation and per gram of protein in the formulation, relative to the concentrations currently available in natural products. The isoflavone component of the soy formulation of this invention may comprise isoflavones that occur naturally, including diadzin, genistin and glycitin. In another aspect, the present invention provides soy formulations having diadzin as a major component of isoflavone. A dietary supplement of the present invention comprises a soy formulation of the present invention.

The dietary supplement can also comprise ingredients such as enzymes, a source of fiber, vitamins and the like. A food product of this invention comprises a soy formulation of the present invention and / or a dietary supplement of the present invention. The food product may also comprise additional ingredients. A pharmaceutical composition of the invention comprises a soy formulation in a pharmacologically effective amount. The compositions may additionally comprise prescription drugs. The combination may advantageously produce one or more of the following effects: 1) additive and / or synergistic benefits; 2) reduction of side effects and / or adverse effects associated with the use of prescription medicine in the absence of the soy formulation; and / or 3) the ability to decrease the dose of the prescription medicine compared to the amount of prescription medicine that is needed in the absence of the soy formulation.

Other advantages and possible embodiments of a medicament formulation of the present invention will be discussed below. The soy formulation, the dietary supplements, the food products and / or the pharmaceutical compositions of this invention can be advantageously used in methods to promote the health of an individual. The soy formulations, the dietary supplements, the food products and the pharmaceutical compositions of this invention can provide higher concentrations of isoflavones with respect to the concentrations currently available in soy products, and in a more easily digestible and absorbable form. The soy formulations, dietary supplements, food products and pharmaceutical compositions of this invention can also provide protein. The isoflavones and / or proteins provided by the soy formulations, dietary supplements, food products and pharmaceutical compositions of the invention may also provide various health benefits to an individual. In particular, the soy formulations, dietary supplements, food products and pharmaceutical compositions of this invention can be ingested in amounts that provide more than 60 milligrams and, in certain embodiments more than 200 milligrams, or more than 1800 milligrams, and which additionally can provide more than 20 milligrams of protein, without the unpleasant side effects that occur in individuals who have experienced other products. The additional details and advantages of this invention are provided in the following detailed description.

DETAILED DESCRIPTION OF THE INVENTION In one aspect, this invention provides a soy formulation that includes a higher concentration of natural plant estrogens (referred to as isoflavones or phytoestrogens) for each gram of protein, relative to what was previously available. A soy formulation of this invention comprises 3 to 23 milligrams of at least one isoflavone per gram of the formulation. Preferably a soy formulation of this invention comprises from 5 to 15 milligrams of at least one isoflavone per gram of the formulation, more preferably from 6 to 9 milligrams of at least one isoflavone per gram of the formulation. In this aspect, the invention provides a natural soy formulation comprising 3 to 23 milligrams of at least one isoflavone per gram of the formulation.

In embodiments of the present invention the natural soy formulation may comprise 5 to 15 milligrams of at least one isoflavone for each gram of the formulation or 6 to 9 milligrams of at least one isoflavone for each gram of the formulation. The isoflavone component of the soy formulation of this invention preferably comprises isoflavones that occur naturally, including diadzin, genistin and / or glycitin. In another aspect, the invention provides a soy formulation comprising diadzin, genistin and glycitin and having a ratio between diadzin, genistin and glycitin of between 3: 1: 2 and 3: 4.5: 1. In other words, in this aspect the soy formulation comprises 3 parts of diadzin; 1 to 4.5 parts of genistin; and 1 to 2 parts of glicitin. Preferably a soy formulation of this invention has a ratio of diadzin to genistin to glycitin close to or approximately 2: 1: 1, respectively, so that diadzin is the main isoflavone component. Although the isoflavones discussed herein are discussed with respect to their glucone forms, the present invention can utilize aglucone forms of the isoflavones that can be digested and / or absorbed more easily by an individual. The aglucone form refers to glucone after the breakdown of the glucose subgroup. In a further aspect, the soy formulations of this invention comprise 0.4 to 1.2 grams, preferably 0.4 to 0.9 grams, more preferably 0.6 to 0.8 grams of protein per gram of the formulation. Therefore, one embodiment of a soy formulation of this invention comprises: 3 to 23 milligrams, preferably 5 to 15 milligrams, more preferably 6 to 9 milligrams of at least one isoflavone; and 0.4 to 1.2 grams, preferably 0.4 to 0.9 grams, more preferably 0.6 to 0.8 grams of protein per gram of the formulation. The soy formulation may also include a plurality of isoflavones, including diadzin, genistin and glycitin. In one embodiment of the soy formulation, it has a ratio of diadzin to genistin to glycitin between 3: 1: 2 and 3: 4.5: 1. More preferably, the soy formulation can have a ratio of diadzin to genistin to glycitin of about 2: 1: 1, respectively, so that diadzin is the main component of isoflavone. In yet another aspect, the invention provides a soy formulation produced by combining a first portion of a soy product of higher concentration of isoflavone produced from the heart of soybeans and a second portion of a soy product of lower concentration of soybeans. isoflavone produced from whole soybean, to achieve a soy formulation comprising 3 to 23 milligrams of at least one isoflavone per gram of the formulation, preferably 5 to 15 milligrams of at least one isoflavone per gram of the formulation, more preferably from 6 to 9 milligrams of at least one isoflavone per gram of the formulation. The isoflavone (s) may comprise diadzin, genistin and glycitin. The soy formulation obtained in this way can also comprise 0.4 to 1.2 grams, preferably 0.4 to 0.9 grams, more preferably 0.6 to 0.8 grams of protein per gram of the formulation. It is further preferred that the soy formulation include the diadzin-genistin-glicitin ratios already mentioned in the foregoing. A soy formulation of this invention can take many forms. For example, the soy formulations of the invention may be in powder form. Alternatively, the soy formulations may be in tablet or liquid form. In addition, the soy formulations of the invention may be included within a dietary supplement or within food products such as nutritional bars, liquid beverages, cereals, etc., in a food product developed by the present invention. In the soy formulations of the present invention they can be used in dietary supplements. In one aspect, a dietary supplement of this invention comprises a soy formulation of the present invention. The dietary supplement may comprise a soy formulation having one or more of the characteristics described above. The amount of soy formulation that is used in a dietary supplement of this invention will depend on the level of isoflavone desired for each portion or dose of the dietary supplement. As will be explained below, it is generally desired that the dietary supplement provide more than 60 milligrams of at least one isoflavone per serving or dose. Thus, for example, a portion of a dietary supplement of this invention could comprise 10 grams of a soy formulation of the invention comprising 7 milligrams of at least one isoflavone per gram of the formulation, to provide 70 milligrams of isoflavones To achieve higher levels of isoflavones, the dietary supplement could include additional amounts of a soy formulation and / or a soy formulation that has a higher level of isoflavones per gram. Therefore, one embodiment of a dietary supplement comprises: a soy formulation comprising 3 to 23 milligrams, preferably 5 to 15 milligrams, more preferably 6 to 9 milligrams of at least one isoflavone per gram of the formulation, in wherein the amount of the soy formulation is sufficient to provide more than 60 milligrams of at least one isoflavone per serving. In another embodiment, a dietary supplement of this invention comprises a soy formulation comprising 3 to 23 milligrams, preferably 5 to 15 milligrams, more preferably 6 to 9 milligrams of at least one isoflavone per gram of the formulation, and 0.4 to 1.2 grams, preferably 0.4 to 0.9 grams, more preferably 0.6 to 0.8 grams of protein per gram of the formulation, wherein the amount of the soy formulation is sufficient to provide more than 60 milligrams of at least one isoflavone per serving. In a further embodiment, a dietary supplement of this invention comprises: a soy formulation produced by combining a first portion of a soy product of high concentration of isoflavone produced from the heart of the soybeans and a second portion of a soy product. soybean of lower concentration of isoflavone produced from whole soybean, to achieve a soy formulation comprising 3 to 23 milligrams of at least one isoflavone for each gram of the formulation, preferably 5 to 15 milligrams of at least one isoflavone for each gram of the formulation, more preferably 6 to 9 milligrams of at least one isoflavone for each gram of the formulation, wherein the amount of soy formulation in the dietary supplement is sufficient to provide more than 60 milligrams of at least one isoflavone per portion. The isoflavone components and / or their proportions include those discussed above in relation to the soy formulations of this invention. In particular embodiments of a dietary supplement of the present invention, the amount of soy formulation used may be a sufficient amount to provide well above 60 milligrams of at least one isoflavone per serving. In particular embodiments of a dietary supplement, the amount of soy formulation used may be an amount sufficient to provide 120 to 200 milligrams of at least one isoflavone per serving, more than 200 milligrams of at least one isoflavone per serving.; 400 to 900 milligrams of at least one isoflavone per serving; more than 1800 milligrams of at least one isoflavone per serving, or 1800 to 2200 milligrams of at least one isoflavone per serving.

In yet another embodiment, a dietary supplement of the present invention comprises: a soy formulation comprising diadzin, genistin and glycitin and having a ratio of diadzin to genistin to glycitin of between 3: 1: 2 and 3: 4.5: 1. Preferably the soy formulation has a ratio of diadzin to genistin to glycitin close to 2: 1: 1, respectively, so that diadzin is the main component of isoflavone. In this embodiment, the dietary supplement can provide any milligram level of at least one isoflavone for each serving, therefore different amounts of the soy formulation can be used in the dietary supplement. In specific embodiments according to this aspect of the dietary supplement of the invention, the amount of soy formulation used is sufficient to provide more than 60 milligrams of at least one isoflavone per serving. In particular embodiments of this dietary supplement, the amount of soy formulation used may be an amount sufficient to provide 120 to 200 milligrams of at least one isoflavone per serving; more than 200 milligrams of at least one isoflavone per serving; 400 to 900 milligrams of at least one isoflavone per serving; more than 1800 milligrams of at least one isoflavone per serving; or 1800 to 2200 milligrams of at least one isoflavone per serving. In a further aspect, a dietary supplement of this invention comprises a soy formulation of the present invention and further characterized by comprising: 40 to 90%, preferably 70 to 90% by weight of protein; 1 to 10%, preferably 1 to 5% by weight of fat; and 1 to 59%, preferably 1 to 25% by weight of carbohydrates. The analysis of proteins, carbohydrates and fats can be achieved using conventional techniques. In another aspect, a dietary supplement of this invention further comprises one or more of the following ingredients: digestive enzymes, fibers, sweeteners, preservatives, vitamins, minerals and the like, including but not limited to calcium phosphate, soy lecithin, salt, potassium chloride, artificial and / or natural flavorings, carrageenan, carboxymethylcellulose, xanthan gum or milk solids. Suitable digestive enzymes include, but are not limited to: alpha galactosidase. Suitable fiber sources include, but are not limited to: psyllium. Suitable sweeteners include, but are not limited to: natural sweeteners including sucrose, dextrose, fructose and the like, artificial sweeteners including sucralose (Splenda ™), aspartame, saccharin and SinetK ™ (acesulfame K) and similar; and sweeteners derived from vegetables that include stevia. The amounts of one or more of the additional ingredients are those necessary for the dietary supplement to retain the aforementioned protein, carbohydrate and fat ratios. A dietary supplement of the present invention can be in any digestible form including a powder, a tablet or a liquid. A dietary supplement of the present invention may also be agglomerated and / or treated to improve the solubility, digestibility or other aspects of the dietary supplement. As will be understood by those of ordinary skill in the art, a dietary supplement of the invention may also include ingredients similar to those set forth below with respect to a food product of the present invention. In a further aspect of the present invention there is provided a digestible food product that includes more than 60 milligrams of at least one isoflavone per serving. In particular embodiments of the dietary supplement the amount of the soy formulation used may be an amount sufficient to provide 120 to 200 milligrams of at least one isoflavone per serving, more than 200 milligrams of at least one isoflavone for each serving, 400 to 900 milligrams of at least one isoflavone for each serving, more than 1800 milligrams of at least one isoflavone per serving, or 1800 to 2200 milligrams of at least one isoflavone per serving. In one aspect, a food product of the present invention comprises a soy formulation of the present invention. The dietary supplement may comprise a soy formulation having one or more of the characteristics described above. The amount of soy formulation used in a food product of this invention will depend on the level of isoflavones desired for each portion of the food product. As already explained above, it is generally desired that the food product provides more than 60 milligrams of at least one isoflavone per serving. For example, a portion of a product of the present invention could comprise 8 grams of a soy formulation of the present invention containing 9 milligrams of at least one isoflavone per gram of the formulation, to provide 72 milligrams of isoflavones. To achieve higher levels of isoflavones, the food product may include additional amounts of a soy formulation and / or a soy formulation having a higher level of isoflavones per gram. Thus, one embodiment of a food product comprises: a soy formulation containing 3 to 23 milligrams, preferably 5 to 15 milligrams, more preferably 6 to 9 milligrams of at least one isoflavone per gram of the formulation, wherein the amount of the soy formulation is sufficient to provide more than 60 milligrams of at least one isoflavone per serving. In one embodiment, a food product of the present invention comprises: a soy formulation containing 3 to 23 milligrams, preferably 5 to 15 milligrams, more preferably 6 to 9 milligrams of at least one isoflavone per gram of the formulation; and 0.4 to 1.2 grams, preferably 0.4 to 0.9 grams, more preferably 0.6 to 0.8 grams of protein per gram of the formulation; wherein the amount of the soy formulation is sufficient to provide more than 60 milligrams of at least one isoflavone per serving. In a further embodiment, a food product of this invention comprises: a soy formulation produced by combining a first portion of the soy product of higher concentration of isoflavone produced from the heart of the soy bean and a second portion of the soy product from lower isoflavone concentration produced from the whole soybean, to achieve a soy formulation comprising 3 to 23 milligrams of at least one isoflavone per gram of the formulation, preferably 5 to 15 milligrams of at least one isoflavone per gram of the formulation, more preferably 6 to 9 milligrams of at least one isoflavone per gram of the formulation, wherein the amount of the soy formulation in the food product is sufficient to provide more than 60 milligrams of at least one isoflavone per serving. The isoflavone components and / or their proportions include those discussed above in relation to the soy formulations of this invention. Particular embodiments of the food product of the present invention include amounts of soy formulation in an amount sufficient to provide much greater than 60 milligrams of at least one isoflavone per serving. In particular embodiments of a food product, the amount of soy formulation used may be an amount sufficient to provide 120 to 200 milligrams of at least one isoflavone per serving, more than 200 milligrams of at least one isoflavone per serving, 400 to 900 milligrams of at least one isoflavone per serving, more than 1800 milligrams of at least one isoflavone per serving, or 1800 to 2200 milligrams of at least one isoflavone per serving. In still another embodiment, a food product of the present invention comprises a soy formulation containing diadzin, genistin and glycitin and having a ratio of diadzin to genistin to glycitin of between 3: 1: 2 and 3: 4.5: 1. Preferably the soy formulation has a ratio of diadzin to genistin to glycitin close to 2: 1: 1, respectively, so that diadzin is the main component of isoflavone. In this embodiment, the food product can provide any milligram concentration of at least one isoflavone per portion, so that different amounts of the soy formulation can be used in the food product. In specific embodiments according to one aspect of a food product of this invention, the amount of soy formulation used is sufficient to provide more than 60 milligrams of at least one isoflavone per serving. In particular embodiments of the food product, the amount of soy formulation used may be an amount sufficient to provide 120 to 200 milligrams of at least one isoflavone per serving; more than 200 milligrams of at least one isoflavone per serving; 400 to 900 milligrams of at least one isoflavone per serving, more than 1800 milligrams of at least one isoflavone per serving, or 1800 to 2200 milligrams of at least one isoflavone per serving.

In another aspect of a food product of the present invention it may preferably comprise: 20 to 40% by weight of protein, preferably provided by a soy formulation of the present invention; 10 to 80% by weight of carbohydrates; and 1 to 10% by weight of fat. The food product may further comprise other components including preservatives, flavors, vitamins, minerals and the like, including but not limited to calcium phosphate, soy lecithin, salt, potassium, chloride, artificial and natural flavors, carrageenan, carboxymethylcellulose, xanthan gum , water or milk. Suitable carbohydrates for use in this invention include fructose, glucose, dextrose, maltodextrin and corn syrup solids. A food product of this invention can also be produced in a low calorie form by replacing all sugars or a portion thereof with an artificial sweetener. Suitable artificial sweeteners include sucralose (Splenda ™), aspartame, saccharin and SinetK ™ (acesulfame K). Sweeteners derived from vegetables such as stevia are also suitable. A food product of this invention can also be in different forms, including a powder to be dispersed in a liquid, a tablet, a bar, liquid beverages, a cereal, etc. As an example, a powdered food product of this invention may comprise: 30 to 32% by weight of a soy formulation of the present invention; 55 to 57% by weight of carbohydrates; 3 to 5% by weight of fat; 0.2 to 1% by weight of calcium; 0.2 to 1% by weight of phosphorus; 0.1 to 0.7% by weight of sodium; 0.2 to 1% by weight of potassium; and includes ingredients such as fructose, sugar, cocoa, calcium phosphate, maltodextrin, soy lecithin, salt, potassium chloride, artificial flavoring, carrageenan, carboxymethylcellulose and xanthan gum, wherein the food product provides more than 60 milligrams, preferably from 120 to 200 milligrams of at least one isoflavone per portion, preferably a plurality of isoflavones in the aforementioned proportions. A food product of this invention may also include vitamins and minerals in amounts up to 100% or more of the daily recommendations for each vitamin. In a preferred embodiment, a food product of this invention can include 20 to 40% of the recommended daily proportions of most minerals. In another aspect, the present invention provides a pharmacological composition comprising a soy formulation of this invention. The amount of the soy formulation used in a pharmacological composition of this invention will depend on the level of isoflavones desired for each dose of the pharmacological composition. As will be explained below, it is generally desired that the pharmacological composition provide more than 60 milligrams, preferably more than 200 milligrams, more preferably more than 1800 milligrams of at least one isoflavone per dose. Thus, an example of a portion of a pharmacological composition of this invention could comprise 9 grams of a soy formulation of the present invention consisting of 7 milligrams of at least one isoflavone per gram of the formulation, to provide milligrams of isoflavones. To achieve higher levels of isoflavones, the pharmacological composition may include additional amounts of a formulation and / or a soy formulation having a higher level of isoflavones per gram. Therefore, one embodiment of a pharmacological composition comprises: a soy formulation consisting of 3 to 23 milligrams, preferably 5 to 15 milligrams, more preferably 6 to 9 milligrams of at least one isoflavone per gram of the formulation, in wherein the amount of the soy formulation is sufficient to provide more than 60 milligrams, preferably more than 200 milligrams, more preferably more than 1800 milligrams of at least one isoflavone per dose. In another embodiment, a pharmacological composition of this invention comprises: a soy formulation consisting of 3 to 23 milligrams, preferably 5 to 15 milligrams, more preferably 6 to 9 milligrams of at least one isoflavone per gram of the formulation; and 0.4 to 1.2 grams, preferably 0.4 to 0.9 grams, more preferably 0.6 to 0.8 grams of protein per gram of the formulation; wherein the amount of the soy formulation is sufficient to provide more than 60 milligrams, preferably more than 200 milligrams, more preferably more than 1800 milligrams of at least one isoflavone per dose. In a further embodiment, a pharmaceutical composition of the present invention comprises: a soy formulation produced by combining a first portion of a soy product of higher concentration of isoflavone from the heart of the soybeans and a second portion of a soy product of lower concentration of isoflavone produced from whole soybean, to achieve a soy formulation comprising 3 to 23 milligrams of at least one isoflavone per gram of formulation, preferably 5 to 15 milligrams of at least one isoflavone per gram of the formulation, more preferably 6 to 9 milligrams of at least one isoflavone per gram of the formulation, wherein the amount of the soy formulation in the pharmaceutical composition is sufficient to provide more than 60 milligrams, preferably more than 200 milligrams, more preferably more than 1800 milligrams of at least one isoflavone for each dose. The isoflavone components and / or their ratios include those discussed above in relation to the soy formulations of this invention. In particular embodiments of a pharmaceutical composition of the present invention, the amount of soy formulation used may be an amount sufficient to provide well above 60 milligrams of at least one isoflavone per dose. In particular embodiments of a pharmacological composition, the amount of the soy formulation used may be an amount sufficient to provide 120 to 200 milligrams of at least one isoflavone per dose, more than 200 milligrams of at least one isoflavone per dose , 400 to 900 milligrams of at least one isoflavone for each dose; more than 1800 milligrams of at least one isoflavone for each dose; or 1800 to 2200 milligrams of at least one isoflavone for each dose. In still another embodiment, a pharmacological composition of the present invention comprises a soy formulation containing diadzin, genistin and glycitin and having a ratio of diadzin to genistin to glycitin of between 3: 1: 2 and 3: 4.5: 1. Preferably the soy formulation has a ratio of diadzin to genistin to glycitin of about 2: 1: 1, respectively, so that diadzin is the main component of isoflavone. In this embodiment, the pharmacological composition can provide any milligram concentration of at least one isoflavone for each dose, so that different amounts of the soy formulation can be used in the pharmacological composition. In specific embodiments according to this aspect of a pharmacological composition of the present invention, the amount of the soy formulation used is sufficient to provide more than 60 milligrams, preferably more than 200 milligrams, more preferably more than 1800 milligrams of at least one isoflavone per dose. In particular embodiments of this pharmacological composition, the amount of the soy formulation used may be an amount sufficient to provide 120 to 200 milligrams of at least one isoflavone per dose, more than 200 milligrams of at least one isoflavone per dose; 400 to 900 milligrams of at least one isoflavone per dose; more than 1800 milligrams of at least one isoflavone per dose; or 1800 to 2200 milligrams of at least one isoflavone per dose. As already mentioned and detailed below, a principal advantageous feature of this invention is that, in another aspect thereof, a pharmacological composition comprising a soy formulation of the present invention and further comprising a medicinal composition is provided. Suitable medicinal compositions include, but are not limited to, medicinal compositions, medications and / or prescription medications that are used in estrogen replacement therapy.; hormone replacement therapy; cholesterol lowering therapy; bone strengthening therapy; endometrial therapy; cancer therapy, including chemotherapy; therapy for ulcer; prostate therapy; skin therapy; kidney therapy; blood therapy; lymphatic therapy; pulmonary therapy; nervous system therapy; therapy for diabetes; therapy for the eyes and the like. These medicinal compositions include, but are not limited to: Premarin; Fosamax; Raloxifene; Tamoxifen; SERM (selective estrogen receptor modulators) and other medications known to those with ordinary skill in this field. The amount of the medicinal composition used in this embodiment of a pharmaceutical composition of the present invention is an amount sufficient to achieve the desired therapeutic effect while decreasing adverse or collateral effects. In general, the amount of the medicinal composition used in a pharmaceutical composition of the present invention will be the same or less than the amount used in conventional therapy in the absence of the soy formulation of the present invention. One embodiment of the pharmaceutical composition of the present invention comprises a soy formulation of this invention and a medicinal composition and is that the combination can have synergistic effects. Therefore, a smaller amount of the medicinal composition can be used in a pharmacological composition of this invention with respect to the amount traditionally used in the absence of the soy formulation of this invention, while essentially achieving the same desired therapeutic effects. . This feature may also provide an additional advantage of reducing the side effects or adverse effects caused by the medicinal composition, due to the lower amounts of it being used. Other details of specific examples of possible uses of the pharmacological compositions of this invention comprising the soy formulation of the invention and a medicinal composition are set forth below with respect to the methods of the present invention. Therefore, one embodiment of a pharmaceutical composition comprises: a soy formulation containing 3 to 23 milligrams, preferably 5 to 15 milligrams, more preferably 6 to 9 milligrams of at least one isoflavone per gram of the formulation, in wherein the amount of the soy formulation is sufficient to provide more than 60 milligrams, preferably more than 200 milligrams, more preferably more than 1800 milligrams of at least one isoflavone per dose, and a medicinal composition wherein the amount of the The medicinal composition is sufficient to achieve a desired therapeutic effect. In a further embodiment, a pharmacological composition of this invention comprises: a soy formulation consisting of 3 to 23 milligrams, preferably 5 to 15 milligrams, more preferably 6 to 9 milligrams of at least one isoflavone per gram of the formulation; 0.4 to 1.2 grams, preferably 0.4 to 0.9 grams, more preferably 0.6 to 0.8 grams of protein per gram of the formulation and a medicinal composition wherein the amount of the soy formulation is sufficient to provide more than 60 milligrams, of preference more than 200 milligrams, more preferably more than 1800 milligrams of at least one isoflavone per dose and wherein the amount of the medicinal composition is sufficient to achieve a desired therapeutic effect. In yet another embodiment, a pharmacological composition of the present invention comprises: a soy formulation produced by combining a first portion of a soy product of higher concentration of isoflavone produced from the heart of soybeans and a second portion of a soy product. Soy of lower concentration of isoflavone produced from whole soybean, to achieve a soy formulation consisting of 3 to 23 milligrams of at least one isoflavone per gram of the formulation, preferably 5 to 15 milligrams of at least one isoflavone per gram of the formulation, more preferably 6 to 9 milligrams of at least one isoflavone per gram of the formulation, wherein the amount of the formulation is soy in the composition pharmacological is sufficient to provide more than 60 milligrams, preferably more than 200 milligrams, more preferably more than 1800 milligrams of at least one isoflavone per dose, and a medicinal composition wherein the amount of the medicinal composition is sufficient to achieve a desired therapeutic effect. The isoflavone components and / or their proportions include those mentioned above in relation to the soy formulations of the present invention. In particular embodiments of a pharmacological composition of the present invention, the amount of soy formulation used may be an amount sufficient to provide well above 60 milligrams of at least one isoflavone per dose. In particular embodiments of a pharmacological composition the amount of soy formulation used may be an amount sufficient to provide 120 to 200 milligrams of at least one isoflavone per dose, more than 200 milligrams of at least one isoflavone per dose, 400 to 900 milligrams of at least one isoflavone per dose; more than 1800 milligrams of at least one isoflavone per dose; or 1800 to 2200 milligrams of at least one isoflavone per dose. In still another embodiment, a pharmaceutical composition of this invention comprises: a soy formulation consisting of diadzin, genistin and glycitin and having a ratio of diadzin to genistin to glycitin of between 3: 1: 2 and 3: 4.5: 1; and a medicinal composition wherein the amount of the medicinal composition is sufficient to achieve a desired therapeutic effect. Preferably the soy formulation has a ratio of diadzin to genistin to glycitin of about 2: 1: 1, respectively, so that diadzin is the main component of isoflavone. In this embodiment, the pharmaceutical composition can provide any level of concentration of at least one isoflavone per dose, so that different amounts of the soy formulation can be used in the pharmacological composition. In the specific embodiments according to this aspect of a pharmacological composition of the invention, the amount of soy formulation used is sufficient to provide more than 60 milligrams, preferably more than 200 milligrams, more preferably more than 1800 milligrams of minus one isoflavone for each dose. In particular embodiments of this pharmacological composition, the amount of soy formulation used may be an amount sufficient to provide 120 to 200 milligrams of at least one isoflavone per dose, more than 200 milligrams of at least one isoflavone per dose; 400 to 900 milligrams of at least one isoflavone per dose; more than 1800 milligrams of at least one isoflavone per dose; or 1800 to 2200 milligrams of at least one isoflavone per dose. The embodiments of a pharmacological composition of the present invention may additionally comprise a biologically compatible inert carrier composition comprising one or more of the following ingredients: a gel composition; a cellulose composition; a starch; a glycol composition; hydroxypropyl methylcellulose; microcrystalline cellulose; polyethylene glycol; and / or sodium lauryl sulfate. Other ingredients known in the art may be used in the carrier composition. Among the advantages of the soy formulations, the dietary supplements, the food products and the pharmacological compositions of the present invention are that the soy formulations, dietary supplements, the food products and the pharmacological compositions can be used in the methods of the present invention. invention to promote the health of an individual. In addition, these products provide a dietetic means to provide beneficial amounts of an isoflavone or a plurality of isoflavones as well as protein to an individual, without requiring the individual to ingest unpleasant or difficult-to-digest amounts of protein. In addition to the aforementioned soy formulations, dietary supplements, food products and pharmacological compositions, the invention provides methods for promoting the health of an individual. One method of the present invention for promoting the health of an individual comprises having the individual ingest more than 60 milligrams, preferably more than 120 milligrams, more preferably 120 to 200 milligrams of at least one isoflavone per day. The embodiments of a method of this invention may further comprise having the individual ingest more than 200 milligrams of at least one isoflavone per day. Preferably the individual will ingest the isoflavones by ingesting a soy formulation of the present invention, a dietary supplement of the present invention, a food product of the present invention or a pharmacological composition of the present invention. It is therefore preferred that in a method of the present invention, an individual ingests a soy formulation, a dietary supplement, a food product and / or a pharmacological composition that includes a soy formulation consisting of 3 to 23 milligrams of at least one isoflavone per gram of the formulation, more preferably 5 to 15 milligrams of at least one isoflavone per gram of the formulation, still more preferably 6 to 9 milligrams of at least one isoflavone per gram of the formulation. The soy formulation used in a method of the present invention may further comprise 0.4 to 1.2 grams, preferably 0.4 to 0.9 grams, more preferably 0.6 to 0.8 grams of protein per gram of the formulation. The isoflavone (s) may comprise diadzin, genistin and / or glycitin. It is also preferred that in a method of the present invention an individual ingests the isoflavones in a ratio of diadzin to genistin to glycitin of between 3: 1: 2 and 3: 4.5: 1, preferably a ratio of diadzin to genistin to glycitin of approximately 2: 1: 1, respectively, so that diadzin is the main component of isoflavone. The present invention also provides methods for strengthening health, including digesting a soy formulation of the present invention and / or dietary supplements and / or food products and / or pharmaceutical compositions that include a soy formulation of the present invention. A method of this invention can be used to promote the health of an individual by reducing menopausal-like symptoms, including hot flashes, pains and the like that are experienced by women, for example as a result of hysterectomy, breast cancer or recent pregnancy. A method of the present invention can be used to promote the health of an individual by providing a dietary medium that achieves the effects of estrogen therapies. The methods of the present invention can also be used to promote the health of an individual by reducing hot flashes, vaginal dryness / itching, irritability, mood swings, insomnia, night sweats, nervousness, headaches and painful sexual intercourse, decreasing menstrual problems as colics, bloating, irritability and weight gain and increasing the time between menstrual periods (ie fewer periods per year); decreasing fatigue by raising energy levels and improving mood, maintaining healthy tissue of the breasts, endometrial tissue and other tissues, maintaining a strong and healthy skeletal system (bones and joints) and helping to support a healthy heart, to the cardiovascular system and to cholesterol levels. The methods of this invention can also be used to promote the health of an individual by decreasing the effects of Alzheimer-type dementia, the loss of cognitive function related to age and alcoholism. Other potential uses of the methods of this invention include: birth control (at higher doses); hormone replacement therapy in combination with mammalian estrogens; preventive of breast cancer, preventive of prostate cancer, prevention and / or treatment of headaches and migraines, prevention and / or treatment of acne and other skin conditions, improvement of sexual function, decrease in the effects of chronic fatigue and weight loss. As noted above and in more detail below, the methods of this invention can be used to produce health benefits in an individual by alleviating or decreasing symptoms of the following conditions and / or providing health benefits in the following areas: MENOPAUSE / PREMENSTRUAL SYNDROME The symptoms of menopause such as hot flashes, vaginal itching / dryness, irritability, mood swings, insomnia, night sweats. Symptoms similar to menopause. Post-partum hot flashes. Surgically induced menopause symptoms (ie, ophrectomy). Symptoms of premenstrual syndrome. Normal menstrual discomfort such as cramps, bloating, irritability and weight gain. Abnormal vaginal bleeding from any cause Endometriosis, fibroids or other diseases where it can be beneficial to block estrogen. In a particular embodiment of a method of the present invention for reducing or alleviating the symptoms of the menopause / premenstrual syndrome, the method comprises having an individual ingest a pharmacological composition of the present invention wherein it comprises a soy formulation consisting of 3 to 23 milligrams, preferably 5 to 15 milligrams, more preferably 6 to 9 milligrams of at least one isoflavone per gram of the formulation, wherein the amount of the soy formulation is sufficient to provide more than 60 milligrams, of preference more than 200 milligrams, more preferably more than 1800 milligrams of at least one isoflavone per dose; and a medicinal composition wherein the amount of the medicinal composition is sufficient to achieve a desired therapeutic effect. A preferred medicinal composition for this embodiment is a medicinal composition for estrogen replacement therapy or hormone replacement therapy (estrogen + progestins). Premarin is an example of a medicinal composition for this embodiment of the method of the present invention. The combination of a soy formulation of the present invention and a medicinal composition for hormone replacement therapy and / or estrogen replacement therapy can provide one or more of the following advantages: 1) an additive benefit to bone tissues and to the heart by reducing menopausal symptoms; 2) endometrial and reduced breast proliferation; or 3) a reduction in the amount of the medicinal composition that is needed to achieve a therapeutic effect, for example less Premarin, resulting in lower cost to patients and lower risk.

CONDITIONS RELATED TO CARDIAC SITUATIONS / CARDIOVASCULAR Decrease total cholesterol levels, LDL cholesterol, triglycerides and increase HDL cholesterol or other favorable improvements in lipid profiles. Decrease blood pressure Prevention of myocardial infarction. Prevention of second myocardial infarction. Prevention or reduction of restenosis of coronary bypass grafts or any other vascular graft. Prevention of cerebral vascular accident. Improvement of cardiac pumping volume. In a particular embodiment of a method of the present invention for the benefit of conditions related to the cardiovascular / heart system, the method comprises having an individual ingest a pharmacological composition of the present invention comprising a soy formulation consisting of 3 to 23 milligrams. , preferably 5 to 15 milligrams, more preferably 6 to 9 milligrams of at least one isoflavone per gram of the formulation, wherein the amount of the soy formulation is sufficient to provide more than 60 milligrams, preferably more than 200 milligrams, more preferably more than 1800 milligrams of at least one isoflavone per dose; and a medicinal composition wherein the amount thereof is sufficient to achieve a desired therapeutic effect. A preferred medicinal composition for this modality is Lipitor or another medication that lowers cholesterol. The combination of a soy formulation of this invention and a medicinal composition for lowering cholesterol can provide one or more of the following advantages: 1) an additive benefit to the heart and bone tissues while generating a better lipid profile; 2) a reduction in the amount of the medicinal composition that is needed to achieve a therapeutic effect, for example less Lipitor, resulting in lower cost to the patient and lower risk of liver abnormalities caused by the Lipitor.

CONDITIONS OF THE BONE / SKELETAL SYSTEM Osteoporosis. Hip fracture. Faster recovery after hip fracture surgery. Joint or cartilage disorders. Stimulation of growth and reduction of inflammation of connective tissue / joints. In a particular embodiment of a method of this invention, the symptoms of menopause / premenstrual syndrome are diminished or alleviated, the method comprises making an individual ingest a pharmacological composition of the present invention, wherein the pharmacological composition comprises a soy formulation consisting of in 3 to 23 milligrams, preferably 5 to 15 milligrams, more preferably 6 to 9 milligrams of at least one isoflavone per gram of the formulation, wherein the amount of the soy formulation is sufficient to provide more than 60 milligrams, preferably more than 200 milligrams, more preferably more than 1800 milligrams of at least one isoflavone per dose, and a medicinal composition wherein the amount of the medicinal composition is sufficient to achieve a desired therapeutic effect. A preferred medicinal composition for this embodiment is a medicinal composition for bone strengthening, for estrogen replacement therapy or hormone replacement therapy (estrogen + progestins). Fosamax, Raloxifene and Premarin are an example of a medicinal composition for this embodiment of the method of the invention.

The combination of a soy formulation of the present invention and a medicinal composition can provide one or more of the following advantages: 1) an additive benefit to the heart and bone tissues while reducing menopausal symptoms; 2) reduced endometrial and breast proliferation; or 3) a reduction in the amount of the medicinal composition that is needed to achieve a therapeutic effect, for example less Premarin, resulting in lower costs for the patient and lower risks.

CONDITIONS RELATED TO BREAST / PROSTATE Prevention and treatment of any abnormal breast tissue including, but not limited to, fibrocystic disease, ductal hyperplasia, ductal carcinoma in yes tu (DCIS), locally confined breast cancer or metastatic breast cancer. Hot flushes and other symptoms similar to menopause caused by the treatment of breast cancer or preventive treatment (for example, hot flashes caused by the use of tamoxifen). Improve the quality / extension of life after diagnosis of breast cancer. Treatment in early youth with isoflavones to prevent breast / prostate cancer in later life. Reduce the growth rate of tissues / cancerous cells. Extend the period of life after breast / prostate cancer. In a particular embodiment of a method of the present invention for reducing or alleviating symptoms of breast / prostate related conditions, the method comprises causing an individual to ingest a pharmacological composition of the present invention comprising a soy formulation consisting of 3 to 23 milligrams, preferably 5 to 15 milligrams, more preferably 6 to 9 milligrams of at least one isoflavone per gram of the formulation, wherein the amount of the soy formulation is sufficient to provide more than 60 milligrams, preferably more of 200 milligrams, more preferably more than 1800 milligrams of at least one isoflavone per dose, and a medicinal composition wherein the amount of the medicinal composition is sufficient to achieve a desired therapeutic effect. A preferred medicinal composition for this embodiment is a medicinal composition for estrogen replacement therapy or hormone replacement therapy (estrogen + progestins). Premarin is an example of a medicinal composition for this embodiment of the method of the present invention. Other medicinal compositions include tamoxifen, raloxifen or SERMs. The combination of a soy formulation of this invention and a medicinal composition can provide one or more of the following advantages: 1) an additive benefit to the heart and bone tissues' while having a preventive effect of breast cancer; 2) endometrial and reduced breast proliferation; or 3) a reduction in the amount of the medicinal composition that is needed to achieve a therapeutic effect, for example less Premarin, resulting in lower costs to the patient and lower risks.

ENDOMETRY Prevention and treatment of diseases or endometrial anomalies. Hyperplasia / endometrial cancer caused by medications that stimulate the endometrium (for example tamoxifen) is prevented. In a particular embodiment of the method of this invention for preventing and / or decreasing endometrial conditions, the method comprises causing an individual to ingest a pharmacological composition of the invention comprising soy formulation consisting of 3 to 23 milligrams, preferably 5 to 15 milligrams. , more preferably 6 to 9 milligrams of at least one isoflavone per gram of the formulation, wherein the amount of the soy formulation is sufficient to provide more than 60 milligrams, preferably more than 200 milligrams, more preferably more than 1800 milligrams of at least one isoflavone per dose, and a medicinal composition wherein the amount of the medicinal composition is sufficient to achieve a desired therapeutic effect. A preferred medicinal composition of this embodiment is a medicinal composition comprising tamoxifen, raloxifen or SERMs. The combination of a soy formulation of this invention and a medicinal composition can provide one or more of the following advantages: 1) an additive benefit to the heart and bone tissues in treating the endometrial condition; 2) endometrial and reduced breast proliferation and prevention of hyperplasia / endometrial cancer (tamoxifen has been shown to promote the formation of endometrial cancer, the soy formulation of this invention can reduce this risk); or 3) a reduction in the amount of the medicinal composition that is needed to achieve a therapeutic effect, for example less Premarin, resulting in lower cost to the patient and lower risk.

CRANIAL / CEREBRAL SYMPTOMS Prevention and treatment of Alzheimer's disease or other cognitive diseases. Macular degeneration Headaches related to migraine / vascular type. Anxiety, nervousness, depression, other affective disorders similar. Hereditary hemorrhagic talengiectasia (HHT). Baldness in men and women. Improvement of cognitive function. In a particular embodiment of a method of the present invention for decreasing or alleviating cranial / cerebral symptoms, the method comprises causing an individual to ingest a pharmaceutical composition of this invention comprising a soy formulation consisting of 3 to 23 milligrams, preferably 5 to 23 mg. to 15 milligrams, more preferably 6 to 9 milligrams of at least one isoflavone per gram of the formulation, where the amount of the soy formulation is sufficient to provide more than 60 milligrams, preferably more than 200 milligrams, more preferably more than 1800 milligrams of at least one isoflavone per dose, and a medicinal composition in which the amount thereof is sufficient to achieve a desired therapeutic effect. A preferred medicinal composition for this embodiment is a medicinal composition for Alzheimer's disease. The combination of a soy formulation of the present invention and a medicinal composition can provide one or more of the following advantages: 1) an additive benefit to the heart and bone tissues in treating Alzheimer's symptoms; 2) a reduction in the amount of the medicinal composition that is needed to achieve a therapeutic effect, resulting in lower costs to a patient and less risk.

CONDITIONS OF GASTROINTESTINAL TRACT (Gl) Any disorder of the gastrointestinal tract such as: Constipation. Peptic ulcer or other ulcers. Gastroesophageal reflux (GERD). Any inflammatory bowel disease such as ulcerative colitis or Crohn's disease. Cancer of the Gl tract as colon cancer.

SKIN / FACE CONDITION Acne prevention. Treatment / reduction / prevention of facial wrinkles and deformation. Prevention / treatment of skin cancer. Stimulation of hair and nail growth. Prevention / restoration of hair loss (men / women). Promotion of resistant nails and hair. As will be understood by experts in this technique, these skin / face conditions are usually undesirable side effects of a treatment protocol that uses prescription drugs. The use of a pharmacological composition of this invention comprises a soy formulation thereof and the prescription drug can advantageously reduce these conditions while also achieving the desired therapeutic effect.

CONDITIONS RELATED TO THE LIVER Prevention of disease, particularly diabetic nephropathies, polycystic liver disorders. Improvement of liver function, for example, an increase in the glomerular filtration rate (GFR). Management of abnormalities in lipids, secondary to kidney disorders.

CONDITIONS RELATED TO LUNGS AND BREATHING Improved elasticity. Cancer treatment ADDITIONAL CONDITIONS OF PROSTATE / URINARY TRACT Any prostate disorder. Prevention / treatment of bladder cancer and other types of cancer in the reproductive tract in men and women. Prevention of death from prostate cancer (Japanese men have the same incidence of prostate cancer but the mortality rate is very low). Treatment / prevention of symptoms of benign prostatic hyperplasia (BPH) (urgency, frequency, painful ejaculation, nocturia, etc.) and prostate cancer. Prevention of progression of prostate cancer. Impotence treatment Decrease in prostate-specific antigen (PSA). Decrease in levels of circulating dihydrotestosterone (DHT). Inhibition of 5-alpha reductase. In a particular embodiment of a method of the present invention for achieving these health benefits, the method comprises causing an individual to ingest a pharmacological composition of the invention comprising a soy formulation consisting of 3 to 23 milligrams, preferably 5 to 15 milligrams. milligrams, more preferably 6 to 9 milligrams of at least one isoflavone per gram of the formulation, wherein the amount of the soy formulation is sufficient to provide more than 60 milligrams, preferably more than 200 milligrams, more preferably more than 1800 milligrams of at least one isoflavone per dose, and a medicinal composition wherein the amount of the medicinal composition is sufficient to achieve a desired therapeutic effect. A preferred medicinal composition for this embodiment is a medicinal composition for estrogen replacement therapy or hormone replacement therapy (estrogen + progestins). Premarin is an example of a medicinal composition for this embodiment of the method of the invention. The combination of a soy formulation of the invention and a medicinal composition for hormone replacement therapy and / or estrogen replacement therapy can provide one or more of the following advantages: 1) additive benefit to the heart and bone tissue while reducing menopausal symptoms; 2) reduction of estrogenic side effects (breast swelling, decreased libido, feminization); 3) endometrial and reduced breast proliferation; or 4) reduction in the amount of medicinal composition that is needed to achieve a therapeutic effect, for example less Premarin, resulting in lower costs for a patient and lower risks.

CONDITIONS OF THE IMMUNE SYSTEM Autoimmune / rheumatological disorders such as sarcoidosis, rheumatoid arthritis, lupus. Strengthen the immune system of immunocompromised individuals.

CONDITIONS OF THE REPRODUCTIVE SYSTEM Increase the time between menstrual cycles. Birth control at high doses. Greater fertility causing regular menstrual cycles.

CONDITIONS OF THE NERVOUS SYSTEM Treatment of pain, reduction of pain associated with trauma / surgery. Treatment / reduction of nerve damage associated with trauma / surgery. It has been found that by making mice ingest a soy formulation the time of neuropathies induced by nerve damage is shortened. Therefore, for example, a patient with breast cancer could take soy before surgery to reduce nerve damage / potential pain from surgery. As those skilled in the art will understand, nervous system / pain conditions are usually treated using prescription medications. The use of a pharmacological composition of this invention comprising a soy formulation of this invention and a prescription medicine can advantageously provide the aforementioned advantages by reducing the amount of the prescription medicine that is needed to achieve the desired therapeutic effect.

DISEASES ASSOCIATED WITH DIABETES Prevention of diabetic retinopathies. Prevention / treatment of heart disease (refer to the above). Prevention / treatment of nerve damage (refer to the above). Prevention / treatment of kidney diseases (refer to the above).

EYE CONDITIONS Prevention of cataracts and macular degeneration.

GENERAL CONDITIONS Improvement of sexual function - men and women. Obesity. Treatment of chronic fatigue syndrome and fibromyalgia. Treatment of hypo / hyperglycemia. The following examples illustrate the production of a soy formulation of the present invention that can be used in a dietary supplement and / or food product of the present invention and / or a method of the present invention.

Example: The following is an example of a mixture of a first portion of a product of higher concentration of isoflavone from the heart of soybean and a second portion of a soy product of lower concentration of isoflavone to achieve a soy formulation natural of the present invention having a ratio of milligrams of isoflavone to grams of soy protein and a ratio of diadzin to genistin to glycitin falling within the preferred ranges of the formulation of the present invention. The soy product derived from the heart of soybeans produces relatively higher concentrations of isoflavones (24 to 36 milligrams of isoflavones per gram of protein). The soy product of higher concentration of isoflavone produced from the heart of the soybeans used in the present invention contains Diadzin / Diadzein: Genistin / Genistein: Glicitin / Glicitein in average ratios of 3.33: 1.00: 2.33, respectively (Table 1) : Soy that is derived from whole soybeans, as found in soybean product produced from whole soybeans, produces relatively low concentrations of isoflavones (< 1.0-5 milligrams isoflavones per gram of protein). The soy product of lower isoflavone concentration used in the present invention contains Diadzin / Diadzein: Genistin / Genistein: Glicitin / Glicitein in average ratios of 5.00: 10.00: 1.00, respectively (Table 1). An example of the invention is a mixture of about 4 grams of soy product of higher concentration of isoflavone and about 18.4 grams of soy product of lower concentration of isoflavone results in an approximate ratio of Diadzin / Diadzein: Genistin / Genistein: Glicitin / Glicitein of 2.00: 1.00: 1.00, respectively (Table 1).

Table 1 - AVERAGE RELATIONS OF ISOFLAVONAS The history of soybean harvests and the multiple isoflavone concentration tests in the soybean product derived from them consistently demonstrate that these average proportions of constituent isoflavone concentrations in naturally grown soybeans. Naturally grown soybeans are defined as those without genetic modifications in terms of isoflavone content. The actual proportions of constituent isoflavones in the final mixed formulation depend on the relative amounts of the soy product of higher concentration of isoflavone and of the soy product of lower concentration of isoflavone, combined. The final soy formulation of the present invention preferably has an isoflavone concentration that falls within the ranges discussed above. An example of a final soy composition of the present invention is illustrated in Table 2.

Table 2 Although the invention has been described in relation to the particular modalities and characteristics, other modalities and characteristics may be used to obtain similar results. Variations and modifications of the soy formulations, dietary supplements, food products and methods of the present invention will be apparent to those skilled in the art and the present disclosure is intended to cover all such modifications and equivalents within the scope of the following claims .

Claims (53)

1. CLAIMS: 1. A natural soy formulation comprising 3 to 23 milligrams of at least one isoflavone per gram of the formulation. The natural soy formulation according to claim 1, wherein the soy formulation comprises from 5 to 15 milligrams of at least one isoflavone per gram of the formulation. 3. The natural soy formulation according to claim 2, wherein the soy formulation comprises from 6 to 9 milligrams of at least one isoflavone per gram of the formulation. 4. The natural soy formulation according to claim 1, wherein the isoflavone comprises diadzin. The natural soy formulation according to claim 4, wherein the soy formulation comprises a plurality of isoflavones comprising diadzin, genistin and glycitin. 6. The natural soy formulation according to claim 5, wherein the ratio of diadzin to genistin to glycitin is between 3: 1: 2 and 3: 4.5: 1. 7. A natural soy formulation comprising diadzin, genistin and glycitin isoflavones, wherein the ratio of diadzin to genistin to glycitin is between 3: 1: 2 and 3: 4.5: 1. 8. The natural soy formulation according to claim 7, wherein the ratio of diadzin to genistin to glycitin is about 2: 1: 1. 9. The natural soy formulation according to claim 7, wherein the isoflavones comprise their glucone forms. The natural soy formulation according to claim 7, wherein the isoflavones comprise their aglucone forms. 11. A natural soy formulation comprising: 3 to 23 milligrams of at least one isoflavone; and from 0.4 to 1.2 grams of protein; for each gram of the formulation. The natural soy formulation according to claim 11, wherein the soy formulation comprises from 5 to 15 milligrams of at least one isoflavone per gram of the formulation. The natural soy formulation according to claim 12, wherein the soy formulation comprises from 6 to 9 milligrams of at least one isoflavone per gram of the formulation. The natural soy formulation according to claim 11, wherein the soy formulation comprises 0.4 to 0.9 grams of protein per gram of the formulation. 15. The natural soy formulation according to claim 13, wherein the soy formulation comprises 0.4 to 0.9 grams of protein per gram of the formulation. 16. The natural soy formulation according to claim 11, wherein the isoflavone comprises diadzin. 17. The natural soy formulation according to claim 15, wherein the isoflavone comprises diadzin. 18. The natural soy formulation according to claim 15, wherein the soy formulation comprises a plurality of isoflavones comprising diadzin, genistin and glycitin. 19. The natural soy formulation according to claim 18, wherein the ratio of diadzin to genistin to glycitin is between 3: 1: 2 and 3: 4.5: 1. 20. A natural soy formulation produced by the combination of a first portion of a soy product of higher concentration of isoflavone produced from the heart of soybean and a second portion of a soy product of lower concentration of isoflavone produced at from the whole soybean to achieve a formulation comprising 3 to 23 milligrams of at least one isoflavone per gram of the formulation. 21. The natural soy formulation according to claim 20, wherein the soy formulation further comprises 0.4 to 1.2 grams of protein per gram of the formulation. 22. The natural soy formulation according to claim 20, wherein the soy formulation comprises from 6 to 9 milligrams of at least one isoflavone per gram of the formulation. 23. The natural soy formulation according to claim 21, wherein the soy formulation comprises from 6 to 9 milligrams of at least one isoflavone per gram of the formulation. 24. The natural soy formulation according to claim 23, wherein the soy formulation comprises 0.4 to 0.9 grams of protein per gram of the formulation. 25. A dietary supplement comprising the soy formulation according to claim 1, wherein the amount of the soy formulation in the dietary supplement is sufficient to provide more than 60 milligrams of at least one isoflavone per serving. 26. A dietary supplement comprising the soy formulation according to claim 7, wherein the amount of the soy formulation in the dietary supplement is sufficient to provide more than 60 milligrams of at least one isoflavone per serving. 27. A dietary supplement comprising the soy formulation according to claim 11, wherein the amount of the soy formulation in the dietary supplement is sufficient to provide more than 60 milligrams of at least one isoflavone per serving. 28. A food product comprising the soy formulation according to claim 1, wherein the amount of the soy formulation in the food product is sufficient to provide more than 60 milligrams of at least one isoflavone per serving. 29. A food product comprising the soy formulation according to claim 7, wherein the amount of the soy formulation in the food product is sufficient to provide more than 60 milligrams of at least one isoflavone per serving. 30. A food product comprising the soy formulation according to claim 11, wherein the amount of the soy formulation in the food product is sufficient to provide more than 60 milligrams of at least one isoflavone per serving. 31. A pharmacological composition comprising the soy formulation according to claim 1, wherein the amount of the soy formulation in the pharmacological composition is sufficient to provide more than 60 milligrams of at least one isoflavone per dose. 32. The pharmaceutical composition according to claim 31, further comprising a medicinal composition in an amount per dose sufficient to produce a desired therapeutic effect. The pharmacological composition according to claim 32, wherein the medicinal composition comprises: Premarin, Fosamax, Raloxifene, Tamoxifen or a SERM. 34. The pharmacological composition comprising the formulation according to claim 7, wherein the amount of the soy formulation in the pharmacological composition is sufficient to provide more than 60 milligrams of at least one isoflavone per dose. 35. The pharmacological composition according to claim 34, further comprising a medicinal composition in an amount per dose sufficient to produce a desired therapeutic effect. 36. The pharmacological composition according to claim 35, wherein the medicinal composition comprises: Premarin, Fosamax, Raloxifene, Tamoxifen or a SERM. 37. The pharmacological composition comprising the soy formulation according to claim 11, wherein the amount of the soy formulation in the pharmacological composition is sufficient to provide more than 60 milligrams of at least one isoflavone per dose. 38. The pharmacological composition according to claim 37, further comprising a medicinal composition in an amount per dose sufficient to produce a desired therapeutic effect. 39. The pharmacological composition according to claim 38, wherein the medicine composition comprises: Premarin, Fosamax, Raloxifene, Tamoxifen or a SERM. 40. A method for promoting the health of an individual, which comprises having the individual ingest more than 60 milligrams of at least one isoflavone per day. 41. The method according to claim 40, wherein the method comprises having the individual ingest 120 to 200 milligrams of at least one isoflavone per day. 42. The method according to claim 40, wherein the step of causing the individual to ingest more than 60 milligrams of at least one isoflavone per day comprises having the individual ingest a soy formulation according to claim 1. 43. The method according to claim 40, wherein the step of having the individual ingest more than 60 milligrams of at least one isoflavone per day comprises having the individual ingest a soy formulation according to claim 7. 44. The method according to claim 40 , wherein the step of having the individual ingest more than 60 milligrams of at least one isoflavone per day comprises having the individual ingest a soy formulation according to claim 11. 45. The method according to claim 40, wherein the The step of causing the individual to ingest more than 60 milligrams of at least one isoflavone per day comprises having the individual ingest a pharmacological composition according to the Claim 32. 46. The method according to claim 40, wherein the step of having the individual ingest more than 60 milligrams of at least one isoflavone per day comprises having the individual ingest a pharmacological composition according to claim 35. 47. The method according to claim 40, wherein the step of causing the individual to ingest more than 60 milligrams of at least one isoflavone per day comprises having the individual ingest a pharmacological composition according to claim 38. 48. The method according to the claim 40, where the promotion of the health of the individual includes reducing symptoms similar to those of menopause. 49. The method according to claim 48, wherein the symptoms similar to menopause include: hot flushes, vaginal itching, vaginal dryness, irritability, insomnia, night sweats, headaches and / or mood swings. 50. The method according to claim 40, wherein the promotion of the health of the individual comprises mitigating the menstrual problems. 51. The method according to claim 40, wherein the promotion of the health of the individual comprises reducing fatigue. 52. The method according to claim 40, wherein the promotion of the health of the individual comprises reducing the effects of dementia of the Alzheimer type., 53. The method according to claim 40, wherein the promotion of the health of the individual comprises reducing the risk of breast cancer.