MXPA98008146A - Method of preparation and use of isoflavo - Google Patents

Abstract

A composition was prepared by introducing phytochemical compounds of vegetable matter. This composition was preferably enriched in isoflavones, lignans, saponins, catechins and phenolic acids. Soybeans are the preferred source of these chemical compounds, but other plants, such as red cloves, kudzu, flax and cocoa, can also be used. The composition is a dietary supplement for the treatment of several cancers, pre- and post-menstrual syndromes and several other conditions.

Description

METHOD OF PREPARATION AND USE OF ISOFLAVONAS FIELD OF THE INVENTION This invention relates to compositions extracted from plant material and, more particularly, to phytochemical compounds, including saponogenins and saponins, catechins, lignans, phenolic acids, catechins and isoflavones, and especially those extracted from a family of plants. which includes soy, flax, tea, and cocoa, and the methods of using those compositions as nutritional supplements or. food additives.

BACKGROUND OF THE INVENTION It is known that materials derived from plants contain numerous classes of organic compounds of low weight molecules, which exert bioactivity in several animals. Historically, these compounds have been considered as non-nutritive, however, recent scientific evidence now suggests that these compounds can play an important role in the maintenance of health, in chemoprevention, and in the mitigation of certain conditions or diseases associated with circulation of sex hormones, including sleep disturbances and vaginal dryness.

Edible plants normally contained in the diet, or materials used as herbal remedies / dietary supplements, may contain collections of structurally related compounds. These related substances are often unique in their amounts and distribution when compared between several plant sources. The most notable groups of compounds that exhibit bioactivity are those known as flavonoids, isoflavones, saponins, lignans, alkaloids, catechins and phenolic acids. Epidemiological studies that link diet and diseases suggest that the components of the diet may predispose populations to reduce the risks of certain diseases. Far Eastern populations consuming soy have reduced the rates of breast, prostate and colon cancers, and coronary heart disease, while populations in Finland have reduced rates of prostate cancer. Researchers are currently studying specific compounds in the diet, to understand the basis of epidemiological observations. Among the different plants consumed in the diet, several are rich sources of phytochemicals. Soy products contain large amounts of isoflavones and saponins. Unrefined grains of the diet include plants such as wheat, psyllium, rice, flax and oats that contain lignans. Cocoa contains catechins and phenolic acids. Certain plants that are not part of the diet are also sources of the same chemical molecules, such as lignans and isoflavones in the root of kudzu and red cloves. Isoflavones and lignans act as weak estrogenic substances. Tea plants are also a rich source of phytochemicals, including catechins and phenolic acids. Isoflavones can be used alone to treat or prevent breast cancer, prostate cancer, skin cancer and colon cancer, or as inhibitors of the mechanism. Isoflavones alone can also reduce or prevent various symptoms related to the onset and duration of menopause, including hot flashes and osteoporosis. Isoflavones alone can also be effective in certain cardiovascular applications, including cardiac diseases, reduction of cholesterol lipid levels, modulation of angiogenesis and other vascular effects. In addition, isoflavones alone have been implicated in the reduction of headaches, dementia, inflammation and alcohol abuse, as well as immunomodulation. Lignans alone have been implicated in the prevention or treatment of breast cancer, prostate cancer and colon cancer, as well as in the reduction of hot flashes, prevention of osteoporosis and have shown antiviral potential. Lignans also have antifungal and fungicidal activity. A ligand derived from plants, catecholic acid nordihidro-gualarético, was once a powerful antioxidant used by the food industry. Saponins alone have been implicated in the prevention or treatment of skin cancer, colon cancer, serum cholesterol reduction, and in immunomodulation and antiviral activity. Saponins also exhibit antioxidant effects and act as free radical scavengers. Phenolic acids have shown antioxidant activity. People who eat a diet high in soy, show reduction of many of those symptoms discussed above. This suggests that ingestion of a combination of those phytochemicals in a relationship such as that found in soy may result in an additive or synergistic effect. However, a diet high in soy has some undesirable effects, including flatulence, unpleasant taste and doubt among Western consumers to change their lifestyle, to incorporate soy into their diets, even with such benefits.

It is known that isoflavones, which are heterocyclic phenols, include soy compounds genistin, daidecin and glycitein, as well as biocanin A, ecuol, formononetin, and / or demethylalgolensin and natural derivatives thereof. It is believed that those compounds and their aglycone or de-aglylated aglycone forms, such as genistein and daidzein, have similar activities once they are ingested. They are sometimes called phytoestrogens. Lignans are defined as compounds possessing a structure of 2,3-dibenzylbutane. They include atairesinol, secolsolariciresinol, lariciresinol, isolariciresinol, nordihydroguaíarético acid, pinoresinol, olivilo, other compounds, which can be precursors of enterolactone and enterodiol and modifications thereof, including diglucosides. Phenolic acids include p-hydrobenzoic acid, protocatechuic acid, and vanillic acid. Other phenolic acids are chlorophenic acid, caffeic acid, ferulic acid, gallic acid, candipic acid, syringic acid, coumaric acid, cinnamic acid, gentisic acid, salicylic acid, hydroxybenzoic acid, and hydroxy phenyl acetic acids and their derivatives. It will be understood that this list of phenolic acids includes the different isomers and derivatives found in the natural plant source.

Catechins, or flavan-3-ols, include epigallocatechin, catechin, epicatechin, and gallocatechin. Sapogenins are C-27 sterols, in which the side chain has undergone metabolic changes to produce a spirocetal. Saponogenins are naturally found as saponins, which are 3-0-glycosides of an original steroid or triterpene. The Digitonin of Digi talis is a saponin. Saponins include sapogenin glycosides, such as triterpenoids or spheroids and saccharides, such as glucose, arabinose, galactose, or glucuronic acid. Typical examples of legume saponins are glycyrrhizin (glycyrrhetinic acid + glucuronic acid) contained in Glycyrrhi za glabra, soyasaponin contained in soy and alfalfasaponin contained in Medicago sativa. Saponins also include chemical entities identified as triterpene phenols such as tomatin, soyasapogenols A, B, C, D, E and F, fractions 3 and 4 of ginsengoside, medicagenic acid, hederagenin, glycyrrhizin digitonin, quijalla saponin, lucérnico acid and záhnico acid. Natural modifications of those compounds found in plant sources are also included in this identification. There is a need for an improved composition consisting substantially of isoflavones, lignans, saponogenins, saponins and / or phenolic acids, which will produce better results on any of them, taken alone. In addition, there is a need for a composition in which beneficial phytochemical compounds are enriched in comparison with their original source. This allows individuals to conveniently consume such phytochemicals as a nutritional supplement or as a food additive.

BRIEF DESCRIPTION OF THE INVENTION It is an objective of this invention to provide a convenient way for individuals to consume isoflavones, lignans, saponins, catechins and / or phenolic acids, either as a nutritional supplement or as an ingredient in one type of food. traditional. Another objective of this invention is to provide a composition in the form of an optimized extract of phytochemicals, which is in sufficient concentration to be released in an easy-to-consume dose, such as a dragee, tablet, capsule, liquid or ingredient in a food . Yet another objective of this invention is to prepare the phytochemical extract to be released as a topical application in a cream or lotion. In this form, the isoflavones, lignans, saponins, catechins and / or phenolic acids are dispersed and suspended in a suitable liquid or gel matrix., to obtain a cream or lotion suitable as a release vehicle. A further objective of this invention is to provide a concentrated extract, which is very similar in chemical composition to the chemical entities found in the natural source of the plant. According to this aspect of the invention, the isoflavones, lignans, saponins, catechins and / or phenolic acids are extracted from a suitable vegetable source, to make a composition, which is substantially more concentrated than the original material and with more than 5%. times in one or more of the desired bioactive components. This extract can be used alone or combined with one or more other plant extracts to produce the optimized composition. In addition, this extracted composition can be formulated with one or more other nutrients of the diet, such as vitamins, minerals, amino acids, etc., to provide a nutritional supplement even more optimized for a desired health effect. All these ingredients can be combined with the necessary binders, excipients, preservatives, colors and the like, known to those skilled in the industry to produce a tablet, capsule, dragee / liquid, cream, powder or suitable food ingredient.

These phytochemical compounds can be packaged and provided in a final form by means known in the industries of supplements and food ingredients. It is intended that the materials provide benefits to health and welfare.

DETAILED DESCRIPTION OF THE INVENTION The improved composition is obtained by fractionating a source of plants with a high content of isoflavones, lignans and other phytochemicals, such as defatted soy flakes, soy molasses, soy whey, red clove, alfalfa, flax, cocoa. , you or kudzu root. These can be fractionated together or in combination with those other plants known to have a high content of the different isoflavones, lignans, saponins, catechins and phenolic acids. The fractionation results in a substantial removal of water, carbohydrates, proteins and lipids from the original material. The fractionation method may preferably be that described in copending US Patent No. 5,702,752 or US Patent No. 4,428,876, or an extraction using ethyl acetate or n-butanol may be used. U.S. Patent No. 5,702,752 was granted to the assignee of this invention.

Other extraction processes, which can be used alone or in combination, include differential solubility, distillation, solvent extraction, adsorbent media, differential molecular filtration and precipitation. The preferred composition is an improvement over known commercial materials with respect to the amount of phytochemicals per gram of substance, and the amounts of the different phytochemicals present that affect physiological functions. These natural substances have been consumed from food sources for prolonged periods of time and are more closely related to the substances consumed that provide the basis for epidemiological evidence for health benefits. The additional benefits can be derived from the improved physical properties in relation to the chemically modified phytochemical compounds, from their original form of the food source. It is expected that the resulting composition will comprise in a preferred form: between 59, and 95% of isoflavones, between 0% and 70% of lignans, and between 2% and 70% of saponins and sapogenins. In a more preferred form, the composition will be extracted from the soybean. In another preferred form, the composition will contain a ratio of (saponins + saponogenins) to isoflavones from 1: 100 to 100: 1, with the isoflavones consisting predominantly of the natural derivatives of genistein and / or its biocanin A precursor and daidzein and / or its precursor formononetin, with a ratio of genistein derivatives to daidzein derivatives of 100: 1 to 1: 100. Preferably, the isoflavones are predominantly glycosylated derivatives. Compositional relationships can be easily varied by changing the source of the plant or by combining several plant sources for extraction. Thus, as an additional study, it is shown which combinations of phytochemical compounds are most effective for certain effects on health, the particular composition will also vary. It is known that isoflavones, lignans and saponins can be used advantageously to treat or prevent various cancers, including breast cancer, prostate cancer, skin cancer and colon cancer. It is believed that the improved composition will provide greater benefits in the form of chemoprevention. Recent experiments seem to confirm this belief.

EXAMPLE 1 An initial series of animal studies was conducted to investigate the effects of soy products in the diet on the growth of implanted male SCID mice. c. (SUBCUTANEOUSLY) with LNCaP. A soy protein isolate with a high content of isoflavones (SPI) (2.0 mg isoflavones / g SPI) is provided by Protein Technology International (St. Louis, MO), An extract of soybean phytochemicals, concentrate of soybean phytochemicals (SPC), which contains 28.5% of total soy isoflavones, and various amounts of other phytochemicals, is provided by Archer Daniels Midland Company (Decatur , IL). These materials were used to prepare six experimental diets. Table I shows the ingredients of the diets. They injected s. c. Eight-week-old male SCID mice on the right flank with 2 x 10 '' host LNCaP cells were randomly distributed into six groups (n = 10) and assigned to one of the experimental diets. , body weight and tumor volume At the end of the experiment, blood samples were collected and serum was separated for PSA analysis An aliquot of tumor tissues was fixed in formalin, embedded in paraffin and cut into 4 μm sections for the histochemical detection of apoptotic cells, and immunohistochemical analyzes of angiogenesis and proliferation Another aliquot of cellular was prepared to effect a stain to determine the expression of genetic products related to apoptosis. effects of treatment on feed intake, body weight, isoflavone consumption, and tumor volume, soy products did not significantly alter between the consumption of food or body weight. Compared to the casein-fed controls, the tumor volumes of the mice treated with SPI (20%), SPC (1.0%) and SPI and SPC (1.0%) were reduced by 12%, 28%, (P <; 0.04), or 40% (P <0.005), respectively. The factor analysis indicated that there was no significant effect of the protein source on tumor growth. Linear regression analysis indicated that the volumes of the tumors were inversely correlated with the total isoflavones in the diet (tumor volume (cm '') = -0.0008 + 2121 x Isoflavones (mg), R2 = 0.76, p < 0.03 ). Table 3 shows the effect of SPC at 1.0% of the diet on the apoptosis, proliferation and angiogenesis of the tumors of a pilot study. This indicates that supplementation of the diet with soybean phytochemicals inhibits the growth of the LNCaP tumor in vivo, increasing apoptosis and inhibiting the proliferation of tumor cells. Its inhibitory effect on tumor angiogenesis is not significant, which may be due to the small sample size (n = 2).

The results of the in vi tro study showed that genistein and the phytochemical concentrate of soy inhibited the secretion of PSA due to the LNCaP cells in the media. PSA concentrations were reduced by 68% and 74% by means of a treatment with 25 and 50 μM of genistein, respectively, and 31% and 42% with 25 and 50 μM of a treatment with soybean phytochemical concentrate, respectively .

Table I. Ingredients of the experimental diets (grams) cp Table I. Ingredients of the experimental diets (grams) (Continued) < ? l AIN formulation with minor modifications by Dr. E. A. Ulman, Research Diets, Inc.

Table . Body weight inal, total food consumption, total isoflavone consumption and tumor volume The values are the means ± SD (Standard Deviation). There are no significant differences in food intake or body weight between the treatment groups. z- Compared with the control group, the groups with SPI / LSPC, casein / HSPC, and SPI / HSPC had significantly smaller tumor volumes (* p <0.04; ** p <0.005).

Table 3. Effects of treatment on the apoptotic index (AL,% TUNNEL), proliferation index (Pl,% Staining with PCNA) and angiogenesis (density of microcapillaries) The values are the means + SD (Standard Deviation). In summary, preliminary results indicate that soy products inhibit s.c. of the LNCaP tumor in SCID mice, possibly via the induction of apoptosis, and inhibition of angiogenesis and proliferation. Isoflavones or lignans can relieve symptoms related to menopause, such as hot flashes and osteoporosis, as well as relieve symptoms associated with menstruation. It is also believed that this is due to its estrogenic activity. It is believed that the improved composition described herein will alleviate those symptoms even more efficiently. Also, isoflavones positively affect various conditions related to the cardiovascular system, including heart disease, cholesterol (saponins also positively affect cholesterol), angigogenesis and other vascular effects. It is believed that the improved composition will produce results in those cardiovascular conditions at least as beneficial as those hitherto known and at a reduced cost. As explained at the beginning, isoflavones, lignans and saponins are known for the positive individual effects they have on various neurological and immunological symptoms. It is believed that the improved composition will result in the alleviation of neurological and immunological symptoms at least as well as those compounds hitherto known and at a reduced cost. In addition, one might expect some synergism to emerge from the combination described here. The improved composition can be administered orally, parenterally, for example, subcutaneously, intravenously, intramuscularly and intraperitoneally, by intranasal instillation or by application of an aerosol spray to the mucous membranes, or to the skin by an ointment or a cream.

The administration of the improved composition can be carried out with any suitable carrier, in solid or liquid dosage forms such as tablets, capsules, powders, soft gels, solutions, suspensions, emulsions, ointments or creams. The improved composition can also be administered as a food supplement or as a food ingredient. The amount of the improved composition administered will vary depending on the person, the mode of administration and the desired results. An effective amount is expected to be 10 mg to 2000 g / per dose.

Example 2. Manufacture of Tablets The composition provided by this patent can be used to prepare tablets or other dosage form. In Example 2 an example preparation of a capsule is provided. The higher the concentration of the active component, the easier it is to form a tablet or emulsion. This leads to a greater capacity 'to incorporate other nutrients from the diet. An example would be to prepare a tablet of phytochemical compound that incorporates calcium and vitamin E as a supplement, to maintain bone health and / or reduce postmenopausal symptoms such as hot flashes. In one example of this embodiment, tablets were prepared by dry compression of 600 mg with a total content of 125 mg of isoflavone concentrate (50 mg of isoflavone compound). Included in the tablet formulation was a source of calcium and magnesium. Dry compression tablets were first produced by mixing the following ingredients: 4 kg of the improved composition (39.83% isoflavones), 1.91 kg of sorbitol, 0.095 kg of magnesium stearate, and 13.11 kg of calcium phosphate, a 120-capacity Hobart mixer. This mixture of ingredients was then dry compressed at a pressure of 1 ton with a simple Stokes BB2 press, in tablets having a total weight of 600 mg with a content of 125.53 mg of the improved composition and therefore 50 mg of total isoflavones. Alternatively, a phytochemical concentrate may be provided in a single dosage form, a skin cream or as a food ingredient added to a conventional food in amounts of 10 mg to 2000 mg / per dose, in order to exercise a positive effect on health and well-being. - These benefits include: prevention of cancer, diseases related to estrogen and sex hormones, inhibition of the pituitary-thyroid-gonadotropic axis, reduction of alcohol dependence, modulation of the cardiovascular, immune systems and nervous, antiviral effects and analgesic effects.

EXAMPLE 3 Two two-piece gelatin capsules were produced by filling the receiving end of the empty "0" number capsules with 0.106 g of improved composition (44.45% isoflavones) and closing with the shell end, providing a capsule with a content of 47.2 mg of total isoflavones.

Example 4 A comparison between several sources of phytochemical compound preparations is given in Table 4. It can readily be seen that the phytochemical components of the composition of the "Isoflavone Concentrates" of this invention are substantially superior to the corresponding amounts in the natural plant materials. Notably, the amounts of glycon, isoflavones and saponins are 100 times more concentrated compared to the food source and 20 times more concentrated compared to the plant's germ, which naturally concentrates these phytochemicals. The comparison of the "Isoflavone Concentrate" of this invention with the other concentrates shows that the isoflavone fraction predominates in these latter products, reducing the amount of other healthy phytochemicals. Additionally, the methods of extracting these other products employ techniques which modify the components, particularly the isoflavones, so that they are not identical to the substances found in the natural plant material (U.S. Patent No. 5,637,562). A version of the improved composition was compared with other compositions described above. The results are shown in the Table.

Table 4. Comparative Products with the Invention Table 4. Comparative Products with the Invention (continued) a Table 4. Comparative Products with the Invention (continued) ro Wag H. and Murphy P. A. J. Agrie. Food Chem 1994, 42, 1666-1673.

Anberson R. L. and Wolf J. J. Nutr. 125: 5818-5888, 1995 Se A and Morr C. V., J. Agrie. Food Chem 1984, 32, 530-533. SorLife promotional literature "WO95 / 10530 PCT / US9710697 WO95 / 10512 PCT / US9710699 WO95 / 10529 PCT / US9710696 article NC Novogen promotional literature Example 5 The improved composition, which contains glycosidic forms of isoflavones, has as an aspect an improved solubility at body temperature, superior to those of the compositions described above containing the aglycosidic forms. Separate solutions (0.02% in distilled water) were made for genistein, genistin, daidzein, daidzin, and isoflavone concentrate in volumetric flasks. The samples were then placed in a water bath at 37 ° C for 17 hours, followed by rapid filtration through a syringe-type 0.2-meter filter to remove particles. The filtered samples were then analyzed to determine the concentration of isoflavone by CLAP (High Pressure Liquid Chromatography). The results were tabulated as shown in table 5.

Table 5. Differential Solubility of the Isoflavone vs. Glycosides, Aglycones Table 5. Differential Solubility of Isoflavone Glycosides vs. Agliconas (continuation) The glycosidic forms, genistin and daidzin, are at a concentration at least 4.57 and 13.32 times higher than 37 ° C than their corresponding aglycone forms, respectively. The modifications made to the isoflavones are to remove the carbohydrate attached to the portion corresponding to the isoflavone. This modification makes the isoflavone less soluble in water. The maintenance of the natural modification, glycosylation, increases the solubility. This fact is shown in the comparative solubility chart of Table 5. This chart shows that the isoflavone of genistin is 4.6 times higher and that the isoflavone of daidzin is 13.3 times higher than the corresponding non-glycosylated form. A higher solubility can lead to a better bioavailability in the intestinal organs. Glycosylation does not inhibit absorption in the intestine because the intestinal microflora converts the glycine form to the aglycone form before absorption occurs.

Example 6. Extraction of Flax Lignans Lignans can be easily extracted from flax using the following method. 978 g of degreased flax meal were extracted (Fl) with 2000 g of 85% ethanol at 40 ° C for 10 minutes, forming a suspension. The resulting suspension was filtered and the extraction repeated twice with a total of 6000 g of ethanol. The ethanolic fraction was then evaporated under vacuum at 70 ° C, resulting in an aqueous fraction of 1186 g. The aqueous fraction was combined with 1000 g of water and mixed. The mixed sample was then ultrafiltered through a membrane with a molecular weight cutoff of 5000, resulting in a permeate fraction of 767 g and a retained fraction of 1283 g.

The concentrated fraction was lyophilized, resulting in a sample of 27.84 g (F2). The 767 g of the permeated fraction at 50 ° C were fed to a column of XAD-4 resin with a bed volume of 35 ml, at a rate of 10 ml / min. The effluent from the column was collected and dried, resulting in 14.8 g of sample (F3). XAD-4 is a registered trademark for an absorbent resin, available from Rohm & Haas. The column was then eluted with 4 bed volumes (140 ml) of 70% ethanol at 50 ° C. The eluent sample was evaporated under vacuum at 70 ° C and dried, resulting in a sample of 1.79 g (F4). The four fractions were analyzed to determine their lignan content, measured as the concentration in weight of secoisolariciresinol. As shown in Table 6, this extraction method enriches the concentration of lignan.

Table 6 CONCENTRATIONS OF LIGNANO AS SECOISOLARICIRESINOL Although the present invention has been described in terms of the preferred embodiment to facilitate a better understanding of the invention, it should be appreciated that the invention can be practiced in various ways without departing from the principles of the invention. Therefore, it should be understood that the invention includes all modalities, modifications and possible equivalents to the described embodiment that do not depart from the principles of the invention as set forth in the appended claims.

Claims (74)

CHAPTER CLAIMEDICATORÍO Having described the invention, it is considered as a novelty and, therefore, the content is claimed in the following CLAIMS:

1. A composition of matter of a plant, characterized in that the composition is enriched in at least two phytochemical compounds selected from the group consisting of isoflavones, lignans, saponins, catechins and phenolic acids,

2. The composition according to claim 1, characterized in that consists essentially of at least 70% by weight of phytochemicals selected from the group comprising isoflavones, lignans, saponins, catechins and phenolic acids.

3. The composition according to claim 1, characterized at least one of the selected phytochemical compounds comprises at least 10% by weight of the composition.

4. The composition according to claim 1, characterized in that it consists essentially of at least 80% by weight of phytochemicals selected from the group comprising isoflavones, lignans, saponins, catechins and phenolic acids.

The composition according to claim 1, characterized in that it consists essentially of at least 90% by weight of phytochemicals selected from the group comprising isoflavones, lignans, saponins, catechins and phenolic acids.

6. The composition according to claim 1, characterized in that the ratio of isoflavones to lignans is selected from the range of about 1000: 1 to about 1:50.

The composition according to claim 1, characterized in that the ratio of isoflavones to saponins is selected from the range of about 1:10 to about 10: 1.

The composition according to claim 1, characterized in that the ratio of isoflavones to phenolic acids is selected from the range of about 100 to 1 to about 1 to 100.

9. The composition according to claim 1, characterized in that the ratio of lignans to saponins is selected from the range of about 100 to 1 to about 1 to 100.

The composition according to claim 1, characterized in that the ratio of lignans to phenolic acids is selected from the range of about 100 to 1 to about 1 to 100.

The composition according to claim 1, characterized in that the ratio of saponins to phenolic acids is selected from the range of about 100 to 1 to about 1 to 100, 12.

The composition according to claim 1, characterized because the ratio of catechins to phenolic acids is selected from The range of from about 100 to 1 to about 1 to 100.

The composition according to claim 1, characterized in that the isoflavones are present in an amount of about 5% to about 90% by weight.

The composition according to claim 1, characterized in that the lignans are present in an amount of about 1% to about 70% by weight.

15. The composition according to claim 1, characterized in that the saponins are present in an amount of about 5% to about 70% by weight.

16. The composition according to claim 1, characterized in that the phenolic acids are present in an amount from about 1% to about 70% by weight.

17. The composition according to claim 1, characterized in that the isoflavones are selected from the group consisting essentially of genistein, daidzein, glycitein, biocanin A, formonomethin, and natural modifications thereof.

18. The composition according to claim 1, characterized in that the lignans are selected from the group consisting essentially of matairesinol, secoieolariciresinol, lariciresinol, isolariciresinol, nordihydroguaiarético acid, pinoresiniol, olivilo, and enterolactone and enterodiol precursors and natural modifications thereof.

19. The composition according to claim 1, characterized in that the saponins are selected from the group consisting essentially of tomatin, soyasapogenols A, B, C, D, E, E and F, soyasaponin, alfalfasaponin, fractions 3 and 4 of ginsengósido, medicagénico acid, hederagenina, glicirrizin digitonina, quillaja saponina, lucérnico acid, acid záhnico, and natural modifications of those compounds.

The composition according to claim 1, characterized in that the phenolic acids are selected from the group consisting essentially of chlorogenic acid, caffeic acid, ferulic acid, gallic acid, sinapic acid, syringic acid, vanillic acid, cummeric acid, cinnamic acid , gentisic acid, salicylic acid, hydroxybenzoic acid and hydroxy phenyl acetic acids and derivatives thereof.

The composition according to claim 1, characterized in that the catechins are selected from the group consisting essentially of catechin, epicatechin, gallocatechin, and epigallocatechin.

22. The composition according to claim 1, characterized in that the plant material is selected from one or more of the group consisting essentially of soy, red clove, kudzu, flax, alfalfa, tea and cocoa.

23. The composition according to claim 1, characterized in that the soybean plant material.

24. The composition according to claim 23, characterized in that the soy is selected from the group consisting of soy, soy foods, soy molasses, soy whey, soy protein and soybean meal.

25. A product for oral administration, characterized in that it comprises a composition extracted from the plant material, which is enriched in two or more of the phytochemical compounds selected from the group consisting of isoflavones, lignans, saponins, catechins and phenolic acids.

26. The product according to claim 25, characterized in that the product is selected from the group consisting of tablets, capsules, dragees, concentrates, powders, liquids and ingredients added to foods.

27. The product according to claim 26, characterized in that it comprises tablets comprising: a. the composition of plant matter; and b. a filler selected from the group consisting of sorbitol, lactose, cellulose and dicalcium phosphate.

The product according to claim 27, characterized in that it additionally comprises a supplementary nutrient of the diet, selected from the group consisting of dicalcium phosphate, magnesium stearate, calcium citrate, calcium malate, other sources of calcium, vitamins and minerals

29. The product for oral administration according to claim 27, characterized in that the product comprises between about 15% and about 25% in weight of the composition, and between about 65%. and about 85% by weight of the filler.

30. The product according to claim 28, characterized in that the product comprises: a. between about 15% and about 25% by weight of the composition; b. between about 60% and about 84% by weight of the filler; and c. between about 1% and about 25% by weight of the supplemental nutrient in the diet.

31, The product for oral administration according to claim 26, characterized in that it comprises capsules which include: a. a predetermined dose of the composition of plant material; and b. a gelatin capsule.

32. The product for oral administration according to claim 26, characterized in that the composition of plant material is extracted from the plants selected from the group consisting of soy, red clove, kudzu, flax, alfalfa, tea and cocoa.

33. The product for oral administration according to claim 23, characterized in that the product comprises between about 10 milligrams and between about 2000 milligrams of the composition of plant material.

34. A method for treating a disease selected from the group consisting of breast cancer, skin cancer and colon cancer, the method is characterized in that it comprises the step of administering to the subject a therapeutically effective amount of a composition extracted from plant material, the which is enriched in at least one of the phytochemical compounds selected from the group of isoflavones, lignans, saponins, catechins and phenolic acids.

35. The method of compliance with the claim 34, characterized in that it is for the treatment of breast cancer.

36. The method according to claim 34, characterized in that it is for the treatment of skin cancer.

37. The method according to claim 34, characterized in that it is for the treatment of colon cancer.

38. A method for treating at least one disease selected from the group consisting of urinary cancer, bladder cancer and prostate cancer in a subject, the method is characterized in that it comprises the step of administering to the subject a therapeutically effective amount of an extracted composition of plant material, which is enriched in at least one of the phytochemical compounds selected from the group consisting of isoflavones, lignans, saponins, catechins and phenolic acids.

39. The method according to claim 38, characterized in that the treatment is for urinary cancer.

40. The method according to claim 38, characterized in that the treatment is for bladder cancer.

41. The method according to claim 38, characterized in that the treatment is for prostate cancer.

42. A method for treating a condition selected from the group consisting of migraine, headache and dementia in a subject, the method is characterized in that it comprises the step of administering to the subject a therapeutically effective amount of a composition extracted from plant material, which is enriched in at least one of the phytochemical compounds selected from the group consisting of isoflavones, lignans, saponins, catechins and phenolic acids.

43. The method according to claim 42, characterized in that the treatment is for migraine and headache.

44. The method according to claim 42, characterized in that the treatment is for dementia.

45. A method for reducing alcohol dependence in a subject, the method is characterized in that it comprises the step of administering to the subject a therapeutically effective amount of a composition extracted from plant material, which is enriched in at least one of the selected phytochemical compounds of the invention. group consisting of isoflavones, lignans, saponins, catechins and phenolic acids.

46. A method to reduce cholesterol in the blood flow, reducing the risk of coronary heart disease, or by modulating the blood lipid profiles in a subject, the method is characterized in that it comprises the step of administering to the subject a therapeutically effective amount of a composition extracted from plant material, which is enriched in at least one of the selected phytochemicals of the group consisting of isoflavones, lignans, saponins, catechins and phenolic acids.

47. The method according to claim 46, characterized in that it reduces cholesterol in the blood flow.

48. The method according to claim 46, characterized in that it reduces the risk of coronary heart disease i: las.

49. The method according to claim 46, characterized in that it modulates the lipid profiles in blood.

50. A method for reducing or preventing hot flashes, osteoporosis, sleep disturbances, vaginal dryness or premenstrual syndrome in a subject, the method is characterized in that it comprises the step of administering to the subject a therapeutically effective amount of a composition extracted from plant material, which is enriched in at least one of the phytochemical compounds selected from the group consisting of isoflavones, lignans, saponins, catechins and phenolic acids.

51. The method of compliance with the claim 50, characterized in that it serves to treat or prevent hot flashes.

52. The method of compliance with the claim 51, characterized in that it serves to treat or prevent osteoporosis.

53. The method according to claim 51, characterized in that it serves to treat or prevent premenstrual syndrome.

54. The method according to claim 51, characterized in that it serves to treat or prevent disturbances of sleep.

55. The method according to claim 51, characterized in that it serves to treat or prevent vaginal dryness.

56. The composition according to claim 1, characterized in that the plant material is flax.

57. The composition according to claim 56, characterized in that it consists of at least about 1% by weight of lignans.

58, The composition according to claim 56, characterized in that it consists of at least about 50% by weight of lignans.

59. The composition according to claim 1, characterized in that the selected phytochemical compounds are in a substantially native form.

60. The composition according to claim 1, characterized in that the isoflavones are in substantially glycosylated form.

61. The composition according to claim 1, characterized in that it is added as a supplement to a food.

62. The composition according to claim 1, characterized in that it is consumed as a dietary supplement.

63. The composition according to claim 1, characterized in that the plant material is tea.

64. The composition according to claim 1, characterized in that the vegetable material is cocoa.

65. A composition made by the process characterized in that it comprises the steps of: a. extract a defatted material from a group of plant material consisting of protein, flour, whey, molasses, soluble substances and germs in a solution that includes an alcohol solvent to produce a suspension; b. filtering the solution from step (a) to produce an alcohol fraction; c. evaporating the alcoholic fraction of step (b) to produce an aqueous fraction; d. ultrafiltrate the aqueous fraction from step (c); and. feed a permeate from step- (d) through a resin column; and f. Collect an effluent from the column after washing.

66. The composition according to claim 65, characterized in that it also comprises the step of preparing the effluent from passage (f) in a form which i f 46 is suitable for oral administration, such form is taken from a group consisting of a concentrate, dry powder, capsule, granule and dragee,

67. The composition according to claim 66, characterized in that the dry powder is a volume of granulate of the material for further manufacture to provide individual dose sizes for oral administration.

68. The composition according to claim 65, characterized in that the plant material is selected from a group consisting of soybeans, red cloves, kudzu, flax, alfalfa, tea and cocoa.

69. The composition according to claim 65, characterized in that the plant material is soybean.

70. The composition according to claim 65, characterized in that step (c) includes a step of diluting the aqueous fraction.

71. The composition according to claim 65, characterized by the additional step of fractionating the effluent to select at least one of the group consisting essentially of isoflavones, lignans, saponins, catechins and phenolic acid.

72. The composition according to claim 65, characterized by the additional step of fractionating the effluent to select the isoflavones.

73. The composition according to claim 65, characterized in that the solution of step (a) is about 70% ethanol and the extraction is carried out at about 40 ° C.

74. The composition according to claim 65, characterized in that the evaporation of step (c) is carried out under vacuum at about 70 ° C.