MXPA99001127A

MXPA99001127A - Dietary supplements

Info

Publication number: MXPA99001127A
Application number: MXPA/A/1999/001127A
Authority: MX
Inventors: D Jackson Sherry; B Blumberg Jeffrey
Original assignee: Energetics Inc
Priority date: 1996-07-30
Filing date: 1999-01-29
Publication date: 2000-05-01

Abstract

The present invention relates to dietary supplements for supplementing the dietary needs of women and preventing or reducing life stage associated health risks during each of their principal adult life stages (pre-perimenopause, perimenopause and menopause, or post-menopause). It also relates to a method of supplementing the dietary needs of women whereby an effective amount of a life stage appropriate dietary supplement is administered to a woman at each of her life stages throughout her life. The present also relates to dietary supplements for supplementing the specific phytochemical dietary needs of perimenopausal and menopausal women which contain low doses of phytoestrogens, and a method for such dietary supplementation.

Description

FOOD COMPLEMENTS This application is a continuation request in part of serial application number 08 / 688,448, filed July 30, 1996.

FIELD OF THE INVENTION The present invention relates to food supplements. More particularly, it refers to food supplements formulated to complement the specific phytochemical and micronutrient needs of a woman during each of her adult life stages, thus promoting her well-being and avoiding or reducing the health risks to which she is exposed.

BACKGROUND OF THE INVENTION The health and nutritional needs of women differ in many respects from those of men. Moreover, they can vary with each stage of life or development. For women, in particular, each stage of adult life has wide variant nutritional requirements that significantly affect the health risks to which they are exposed. In general, women go through three main stages of life or adult development - the fertility or pre-perimenopausal stage; the perimenopausal and menopausal stage; and the post-menopausal stage. Numerous risks and health conditions can develop during each of these stages of life. They include coronary heart disease (CHD), some cancers, cervical dysplasia, menopause, osteoporosis, pre-menstrual syndrome (PMS), iron deficiency anemia, and fetal neural tube defects. The incidence of these conditions and risks varies with each stage of life and has been shown to be influenced by diet and food supplements. CHD is a major cause of death in women. It claims the lives of almost 250,000 women a year, the majority being post-menopausal. Although it usually does not manifest until the post-menopausal stage, CHD develops for decades. Well-established risk factors for CHD include elevated plasma cholesterol levels and abnormal glucose metabolism. High homocysteine levels and the effects of free radicals are also implicated in the development of CHD. It has been shown that phytoestrogens, antioxidants, chromium and folic acid mitigate these risk factors. In general, the risk of cancer increases with age. Breast cancer, which afflicts one in nine women, is the main concern among women. Both antioxidants and phytoestrogens seem to have a role in the prevention of some cancers, particularly breast cancer. In addition, it has been shown that folic acid reduces the risk of cervical dysplasia, which is a precursor of cervical cancer. Menopause can result in several unpleasant symptoms, including hot flashes, night sweats, changes in humor, insomnia and fatigue. It has been shown that phytoestrogens reduce these symptoms. Osteoporosis is associated with the aging process and predominantly affects women. It is characterized by decreased bone density, which results in increased bone fractures and collapse of the spine. Bone loss starts around 35 years of age. This loss accelerates during menopause, which usually occurs around 45 to 55 years of age. Osteoporosis develops over decades and is related to peak bone mass, as well as the degree of bone loss. Proper calcium intake prevents osteoporosis. Moreover, certain vitamins and minerals intensify the absorption and utilization of calcium. PMS is a common recurrent multi-symptomatic condition experienced by many menstruating women. Symptoms include water retention, breast tenderness, headaches, mood swings, etc. It has been shown that vitamin B6 reduces some of these symptoms. Iron deficiency anemia is also common in women, particularly in menstruating women, but it can also be found among older women. The treatment of iron deficiency anemia usually consists of supplementing with iron. However, iron is not easily absorbed and can cause constipation, particularly in older women. The presence of vitamin C in adequate amounts increases the bioavailability of iron.

Fetal neural tube defects can occur during the first month of pregnancy, often before a woman is aware of her pregnancy. Folic acid prevents fetal neural tube defects and, therefore, should be consumed in sufficient quantities by women of childbearing age. Preventive measures are probably the most effective method of dealing with these conditions and such measurements should include diet and food supplements. Althothe etiology of the disease is multi-factorial, it has been shown that certain food supplements provide a statistically significant benefit in reducing the risk or reducing the incidence of various diseases and conditions. However, to date, the approach to micronutrient supplementation has not considered the changing needs of adult women. A more individualized, sophisticated and focused approach is clearly necessary. Because the incidence of these conditions varies with the different stages of a woman's life, there is a need for food supplements focused on these changing health risks in each of the stages of life.

BRIEF DESCRIPTION OF THE INVENTION In one aspect of the present invention, food supplements are provided to supplement the nutritional needs of women and to prevent or reduce the health risks associated with the life stage during each of their life stages. major adults (pre-perimenopause, perimenopause and menopause, or post-menopause). In one embodiment of this aspect of the invention, a food supplement is provided to supplement the phytochemical and micronutrient needs of pre-perimenopausal women to prevent or reduce the risk of fetal neural tube defects, iron deficiency anemia, PMS, osteoporosis. , coronary heart disease, cervical dysplasia and some cancers throut this stage and the rest of a woman's life, comprising approximately 200 to approximately 500 mg of calcium, approximately 100 to approximately 200 mg of magnesium, approximately 0.5 to about 1.5 mg of boron, about 0.5 to about 1.5 mg of copper, about 2 to about 2.6 mg of manganese, about 10 to about 13 mg of zinc, about 200 to about 300 IU of vitamin D, about 12 to about approximately 18 mg of iron, approximately 400 to approximately 440 μ g of folic acid, about 2 to about 10 μg of vitamin B12, about 50 to about 100 mg of vitamin B6, about 50 to about 100 μg of chromium, about 100 to about 200 IU of vitamin E, about 100 to about 1000 mg of vitamin C and about 8 to less than 50 mg of phytoestrogen in admixture with a pharmaceutically acceptable carrier.

In another embodiment of this aspect of the invention, the food supplement is formulated to supplement the changing nutritional needs of perimenopausal and menopausal women for the prevention or reduction of risk of PMS, menopausal symptoms, fetal neural tube defects, osteoporosis, CHD. , cervical dysplasia and some forms of cancer throut that stage and the rest of a woman's life. This food supplement comprises from about 200 to about 1000 mg of calcium; from about 100 to about 200 mg of magnesium; from about 1.5 to about 2.5 mg of boron; from about 1.5 to about 2.5 mg of copper; from about 2.4 to about 3.6 mg of manganese; from about 12 to about 15 mg of zinc; from about 300 to about 400 IU of vitamin D; from about 10 to about 15 mg of iron; from about 400 to about 440 μg of folic acid; from about 2 to about 15 μg of vitamin B12; from about 50 to about 100 mg of vitamin B6; from about 75 to about 200 μg of chromium; from about 200 to about 400 IU of vitamin E; from about 200 to about 1000 mg of vitamin C; and from about 10 to less than 50 mg of phytoestrogen in admixture with a biologically acceptable carrier. In yet another embodiment of this aspect of the invention, the food supplement is formulated to complement the needs increased nutritional levels of post-menopausal women for the prevention or reduction of the risk of coronary heart disease, some forms of cancer and osteoporosis throughout the final stage of their life. This food supplement comprises from about 200 to about 1500 mg of calcium, about 150 to about 250 mg of magnesium, about 2.5 to about 3.5 mg of boron, about 2.5 to about 3.5 mg of copper, about 4.4 to about 5.6 mg of manganese, about 15 to about 18 mg of zinc, about 300 to about 800 IU of vitamin D, about 5 to about 10 mg of iron, about 400 to about 440 μg of folic acid, about 2 to about 18 μg of vitamin B12, about 1 .6 to about 10 mg of vitamin B6, about 100 to about 200 μg of chromium, about 350 to about 800 IU of vitamin E, about 300 to about 1000 mg of vitamin C and about 10 to less than 50 mg of phytoestrogen in mixture with a biological carrier Only acceptable. The food supplements of this invention can be formulated as a tablet, capsule, powder, gel or liquid or food bar and are preferably formulated for once-a-day administration. It can be provided as a series or as individual compositions.

In another aspect of the invention, a method is provided for supplementing dietary needs and avoiding or reducing the health risks associated with the life stage in pre-perimenopausal women, perimenopausal and menopausal women, and / or post-menopausal women. This method comprises administering to the woman an effective amount of the appropriate food supplement of the life stage of the invention throughout that life stage. Preferably, an appropriate life-stage food supplement of the invention is administered throughout each of the three major adult life stages of the woman. Unexpectedly, the compositions of the present invention provide phytoestrogen physiologically effective women even when phytoestrogens are administered at levels of less than 25 mg per day, preferably at levels of less than 20 mg per day. As such, another advantage of this invention is to provide compositions and methods to supplement the micronutrient needs of women by providing phytoestrogens at these levels. In another aspect of the invention, a once-daily dietary supplement formulated specifically for the nutritional needs of peri-menopausal and menopausal women is provided. This food supplement comprises at least about 20 mg of phytoestrogen, preferably less than about 15 mg, and most preferably about 14.5 mg to about 1 mg of phytoestrogen once a day in admixture with a biologically acceptable carrier.

A method is also provided to supplement the dietary needs of peri-menopausal and menopausal women. This method comprises administering a composition comprising less than 20 mg of phytoestrogen, preferably less than about 15 mg and most preferably less than about 14.5 mg to about 1 mg of phytoestrogen once a day to a woman in need thereof in admixture with a biologically acceptable carrier.

DETAILED DESCRIPTION OF THE INVENTION The present invention provides food supplements for women that are designed to meet the health needs of women at each particular stage of their life, such as pre-perimenopause, perimenopause and menopause, or post-menopause, or during the transition from one such cycle of life to the next. This is achieved by supplying, in the food supplements of the invention, a variety of nutrients that address common health risks associated with each of these stages of life. Thus, each of the food supplements of the present invention provides a variety of nutrients, including antioxidants to increase the resistance of LDL cholesterol to oxidation, elements to enhance the utilization and absorption of calcium, nutrients to direct deficiency anemia. of iron, folic acid to prevent fetal neural tube defects, compounds to reduce serum homocysteine and improve the lipid and phytoestrogen profile to reduce menopausal symptoms, as well as help in the prevention of osteoporosis, breast cancer and CHD. Additionally, the amount of each nutrient present varies according to the stage of life for which the composition is focused. The specific life-stage food supplements of this invention are not intended to replace a well-balanced diet, but instead seek to supplement a prudent diet. In contrast to known broad-spectrum food supplements, this invention does not simply provide the Recommended Daily Allowance (RDA) (prescribed daily dose) of micronutrients, but instead is prepared to emphasize the properties of prevention of micronutrient complement diseases. . In this way, the cumulative preventive and beneficial effects should be achieved by food supplementation with the appropriate food supplement of the invention, especially when it is used assiduously for more than one life stage. As discussed earlier, a woman goes through three major stages of adult life. The beginning of each of the different stages of life can occur at different stages for different individuals and the ages suggested below for the various stages of life are only approximations. The life stage of pre-perimenopause (Stage I), approximately ages 18 to 46, includes the fertile age or reproductive stage, which is a period of maximum ovarian function. The main health concerns that arise during this stage of life include iron deficiency anemia, PMS, and prevention of neural tube defects during pregnancy.

The stage of perimenopause and menopause (Stage II), approximately ages 45 to 55, is characterized by decreasing ovarian function. At first, menstrual cycles may be erratic and PMS may be intensified. For 80% of all women, this stage will eventually include symptoms of menopause, such as hot flashes, night sweats, insomnia, fatigue and mood swings. The speed of bone loss is accelerated and the lipid profile becomes more atherogenic, thus establishing the stage for the future attack of CHD and osteoporosis. The final stage, post-menopause (Stage III), age 55 and older, is characterized by complete cessation of ovarian function and an increase in the incidence of cancer, osteoporotic fracture and CHD. Anemia related to menstruation, PMS and pregnancy are no longer health concerns during this stage of life. The food supplements of this invention contain vitamins, minerals and other compounds that are specifically included to address common health concerns that arise during each of these life stages. Moreover, they are formulated to prevent or reduce the risk of conditions known to develop in later life stages. For example, the food supplement intended to be used during pre-perimenopause (food supplement of Stage I) contains compounds to combat the risk of fetal neural tube defects, decrease or prevent PMS and iron deficiency anemia and prevent or decrease the risk of osteoporosis, coronary heart disease and cancer, which usually manifest in the post-menopausal stage of life. Phytoestrogens are included in each of the food supplements of this invention. Clinical trials have shown that these compounds modulate the menstrual cycle, reduce menopausal symptoms, and lower LDL cholesterol levels. J. Nutr. , 1996, 126 (1): 161 -7; N. Engl. J. Med., 1995, 333: 276-82. Epidemiological observations indicate that women in countries where diets are rich in phytoestrogen (averaging approximately 40-50 mg / day) have a decreasing incidence of breast cancer, menopausal symptoms and osteoporosis. Nutr. Cancer, 1994, 21: 113-131; J. Nutr. , 1995, 125; 757s-770S; Am. J. Clin. Nutr. 1995, 62: 645. Animal studies have provided a biological basis for these observations. J. Ster. Biochem & Mol. Bio., 1992, 41 (3-8): 331 -7; First International Symposium on the Role of Soy and Preventing and Treating Chronic Disease (1994), Speaker Abstracts. In particular, with respect to alleviating menopausal symptoms, it is known in the art to use moderate to high levels, i.e., generally from at least 20 to 90 mg per day of phytoestrogens, to reduce the symptoms of menopause. Some researchers believe that a diet having such moderate to high levels of phytoestrogens may play a role in reducing the incidence of painful symptoms of menopause; others believe that phytoestrogens alone are inadequate without adjunctive therapy. Adiercruetz, et al. , INPHARMA (1996), Examining the Benefits of Dietary Phytoestrogens; Adiercruetz, et al., The Lancet (1992), 339: 1233. U.S. Patent No. 5,498,631 discloses that moderate to high levels of isoflavonoids effectively reduce the symptoms of conditions caused by altered levels of estrogen, such as menopause and premenstrual syndrome. Solgar, a New Jersey company, provides a pill called "Genistein" formulated from soy isoflavone extract containing 15 to 20 mg of a mixture of genestein and daidzein for twice daily consumption, which would provide at least 30 to 40 mg of phytoestrogen per day. Phytoestrogens are a class of soflavones or isoflavonoids derived from plants, commonly soy. However, the source of the plant is not critical. Algos phytoestrogens, such as genistin, glycitin and diadzin contain a glycosidic portion, while other phytoestrogens are non-glycosylated, for example, genistein, glycitein and daidzein. Phytoestrogens obtained from a single plant are generally a mixture of both glycosylated and non-glycosylated forms. Current food supplements generally contain a mixture of phytoestrogens; however, purified phytoestrogens can be used. Mixtures of phytoestrogens can be obtained commercially. Phytoestrogen levels of less than 25 mg per day, preferably greater than 5 to about 25 mg per day, and most preferably around 10 to about 20 mg per day, provide women with phytoestrogen levels that are physiologically effective and they can be used to supplement the micronutrient needs of women.

Vitamin B 2, vitamin B 6 and folic acid are included in each of the specific food supplements of the life stage of this invention. These elements act synergistically to reduce serum homocysteine, high levels of which are associated with coronary heart disease. Am. J. Clin. Nutr. , 1992, 55: 131-138; New Eng. J. Med., 1992, 32: 1832-1835; Am J. Clin. Nutr., 1989, 50: 353-358. The amount of folic acid in the three food supplements of this invention is maintained at approximately the same level in the three compositions, since folic acid not only reduces the risk of fetal neural tube defects, but, as noted above, It has also been shown to have beneficial cardiac effects and decrease the risk of cervical dysplasia. Scand. J. Clin. Lab Invest. , 1988, 48: 215-221. On the other hand, higher doses of vitamin Bs are included in the formulations of Stage I and Stage II, compared to Stage II I, to assist in alleviating the symptoms of PMS. J. Royal Coli. Gen. Prac, 1989, 39: 364-368; Obstretrics and Gyn. , 1987, 70: 147-149. Other components of the food supplements of this invention include vitamin D, calcium, magnesium, manganese, copper, zinc, boron and chromium. The combination of vitamin D, and magnesium, manganese, copper, zinc and boron (the "enhancement compounds") acts synergistically with calcium to improve the absorption and / or utilization of calcium, and thereby enhances bone density. Am. J. Clin. Nutr. , 1982, 36: 1046-1059; J. Am Col. Nutr. , 1993, 12: 383-389; Magnesium Trace Elem. , 1990, 9:61 -69; Am. J. Clin. Nutr. , 1991, 54: 177S-226S; Clin. Obstretics and Gyn. , 1987, 30: 789-81 1. Chromium is included to optimize the metabolism of glucose and lipids. Diabetes Care, 1994, 17: 1449-1452; Metabolism, 1992, 41: 768-771; Biol. Trace Element Res., 1992, 32: 19-24. Aging is associated with an increased production of oxygen free radicals (highly toxic molecules), which contribute to the pathogenesis of many chronic diseases. This invention is formulated to address this point. In this way, antioxidants, such as vitamin E, are included, particularly to reduce the atherogenicity of LDL cholesterol particles, which reduces damage to arterial walls. Am. J. Clin. Nutr. , 1991, 53: 305S-313S; Lancet, 1996, 347: 781-786. Another antioxidant, vitamin C, is included to decrease the risk of breast cancer and other cancers. Vitamin E and vitamin C can work together in a synergistic way. Am. J. Clin. Nutr. 1991, 54: 1310S-1314S. Each of the life stage food supplements of this invention are formulated specifically to contain a sufficient amount of each of the components discussed above, to prevent or reduce the health risks associated with Stage I, Stage II or Stage II I of the life of the woman. The iron dose is higher in the food supplement of the Stage I of this invention and lower in the complement of Stage II I, because iron deficiency anemia is a major health concern of women with menstruation (Stage 1 and part of Stage II). Deficiency of vitamin B 2 results in pernicious anemia. Because this condition can be clinically masked if folate is given In the diet without vitamin B 2, all formulations of this invention contain both folic acid and Vitamin B 12. The compositions of Step I also contain an amount of vitamin B6 sufficient to reduce the symptoms of PMS and to compensate for the reduced levels of this vitamin caused by the use of oral contraceptives. The amount of folic acid contained in the nutritional supplement of Stage I is sufficient to prevent fetal neural tube defects during pregnancy, as well as to reduce the risk of cardiovascular disease by maintaining low homocysteine levels. It also reduces the risk of cervical dysplasia. In this way, the dietary supplement of Stage I contains enough vitamin B6 to reduce the effects of PMS, an amount of folic acid sufficient to prevent fetal neural tube defects and provides cardiac benefit, a sufficient amount of vitamin B12 to act in agreement with vitamin B6 and folic acid present in the composition to reduce serum homocysteine levels, a sufficient amount of chromium to intensify the metabolism of glucose and lipids, antioxidants to help prevent CHD and some cancers, and calcium, along with a combination of other nutrients known to intensify their absorption and / or use to prevent osteoporosis, and an amount of phytoestrogens to beneficially modulate menstruation and provide protection against osteoporosis, some cancers and CHD. Therefore, the dietary supplement of Stage I is particularly suited to meet the needs and address the health risks of a young adult woman, while decreases the risk of osteoporosis, cancer and coronary heart disease that occur in later life. Food supplements formulated for the life stage of perimenopause and menopause (composition of Stage II) include a higher dosage of phytoestrogens than that used in the food supplement for the pre-perimenopausal life stage, since phytoestrogens reduce symptoms menopausal, and provide even more protection against osteoporosis, cancer and CHD, whose incidence increases with age. Similarly, the components that affect the intake and utilization of calcium also increase in the dietary supplement of Stage II, since the amount of bone loss increases with menopause. Concomitant with the onset of menopause is a worsening of the lipid profile. LDL cholesterol and total cholesterol increase significantly, while HDL cholesterol decreases. To address this problem, the levels of both phytoestrogens and chromium have been increased in the composition of Stage II relative to the composition of Stage I. Also antioxidant levels have been increased to help prevent the attack related to the CHD age and breast cancer. The food supplement of Step III of this invention is formulated to address the health concerns and health risks that occur most frequently in the post-menopausal years, eg, osteoporosis, cancer and coronary heart disease. The compositions of Step II I contain phytoestrogen therein concentration than Stage II. However, calcium, vitamin D and intensification compounds are increased, such as antioxidants and chromium. Chromium has a positive effect on blood sugar levels and lipid profile. On the other hand, vitamin B6 and iron levels are decreased, because health concerns addressed by larger amounts of these components are less relevant. Optionally, the food supplements of this invention may also contain an amount of vitamin A or mixed carotenoids sufficient to supplement the nutritional needs of a woman in a particular life stage. Vitamin A can be provided as preformed vitamin A or as mixed carotenoids, or both. There are more than 500 carotenoids that occur naturally, about 50 of which can serve as retinol precursors, and therefore have provitamin A activity. These include alpha- and beta-carotene and cryptoxanthin. However, it has also been shown that non-provitamin A carotenoids, such as lutein and lycopene, have beneficial effects and can also be provided. Lycopene uptake, for example, has been inversely associated with the risk of cervical cancer. Nutr & Cancer 1994, 21: 193-201; Intemat J. Cancer 1991; 48: 34-8. The amount of preformed vitamin A and mixed carotenoids included in the food supplement of Step I is in the range of about 400 to about 1200 RE, preferably about 600 to about 1000 RE, and most preferably about 800 RE. The amount of vitamin a preformed and mixed carotenoids included in the Stage II food supplement is in the range of about 800 to about 1600 RE, preferably about 1000 to about 1400 RE, and most preferably about 1200 RE. The amount of preformed vitamin A and mixed carotenoids included in the Stage III food supplement is in the range of about 1200 to about 2000 RE, preferably about 1400 to about 1800 RE, and most preferably about 1600 RE. Preferably, the amount of preformed vitamin A is about 200 to about 400 RE, and most preferably about 400 RE. Each of the food supplements of this invention is formulated to prevent and reduce the risk of disease during one of three specific life stages, during the transition from one life stage to the next, and during the later stages of life. The administration of the food supplements of this invention during the appropriate life stage reduces the risk factors for the disease, such as iron deficiency anemia during the pre-perimenopausal life stage, high cholesterol during the perimenopausal and menopausal stage of life , and CHD, osteoporosis, and some cancers during the post-menopausal stage of life. The maximum benefit is obtained by complementing the diet with the appropriate food supplement of life stage throughout the entire life cycle; however, you also get benefit when the complementation starts at any time during a particular life cycle. For example, supplementing the diet with the dietary supplement of Stage I at 30 to 40 years of age, which is well in the pre-perimenopausal life stage, decreases the risk of, or anticipates, future osteoporosis, cancer and coronary heart disease, and provides health benefits for those conditions that occur during this life cycle, for example, PMS, fetal neural tube defects, and iron deficiency anemia. It is understood that the phrase "administration throughout the life cycle", as used herein, means a continuous administration at any time during a life cycle that complementation begins. The food supplements of the present invention can be formulated using any pharmaceutically acceptable form of the vitamins, minerals and other nutrients discussed above, including their salts. Preferred forms are calcium carbonate, magnesium hydroxide or magnesium sulfate, sodium tetraborate, cupric oxide, manganese sulfate, zinc sulfate, cholecalciferol, ferrous fumarate, pyridoxine hydrochloride, chromium picolinate, d-alpha-acetate, tocopherol, and ascorbic acid. They can be formulated in capsules, tablets, powders, gels or liquids. The food supplements can be formulated as powders, for example, to be mixed with consumable liquids such as milk, juice, water or gels or consumable syrups to be mixed in other food liquids or foods. The food supplements of this invention can be formulated with other foods or liquids for provide pre-measured complementary foods, such as one-serving bars, for example. Flavors, binders, proteins, complex carbohydrates and the like may be added as necessary. The food supplements of the invention are intended for daily administration. Preferably, they are formulated for once-a-day administration, but can be formulated in multiple portions or as time-release compositions for more or less frequent administration; for example, the food supplement can be formulated as two tablets for administration twice a day, or as a sustained release capsule for administration every three days. In the latter case, the capsule is formulated to release the daily amount of nutrients prescribed by the food supplements of the invention during each of the three days. For reasons of size (ease of swallowing) or bioabsorption or improved use (for example, before or after a meal or before sleeping), a given dosage can be divided into two, three or more tablets (or capsules, etc.). A daily dosage can be administered as a tablet, as two tablets taken together, or as two tablets taken separately (for example, one in the morning and one in the afternoon). The specific formulation for each of the three specific food supplements of life stage is provided below.

FOOD SUPPLEMENT OF STAGE I The food supplement for pre-perimenopausal women includes from about 200 to about 500 mg of calcium, preferably from about 200 to about 300 mg of calcium, and most preferably about 200 mg of calcium; from about 100 to about 200 mg of magnesium, preferably about 100 to about 150 mg of magnesium, and most preferably about 100 mg of magnesium; from about 0.5 to about 1.5 mg of boron, preferably about 0.7 to about 1.3 mg of boron, and most preferably about 1 mg of boron; from about 0.5 to 1.5 mg of copper, preferably about 0.7 to about 1.3 mg of copper and most preferably about 1 mg of copper; from about 2 to about 2.6 mg of manganese, preferably about 2 to about 2.4 mg of manganese, and most preferably about 2 mg of manganese; from about 10 to about 13 mg of zinc, preferably about 10 to about 12 mg of zinc, and most preferably about 10 mg of zinc; from about 200 to about 300 IU of vitamin D, preferably about 200 to about 250 IU of vitamin D, and most preferably about 200 IU of vitamin D; from about 12 to about 18 mg of iron, preferably about 16 to about 18 mg of iron and most preferably about 18 mg of iron; from about 400 to about 440 μg of folic acid, preferably about 400 to about 420 μg of folic acid and most preferably about 400 μg of folic acid; from about 2 to about 10 μg of vitamin B12, from preferably about 2 to about 4 μg of vitamin B12, and most preferably about 2 μg of vitamin B12; from about 50 to about 100 mg of vitamin Bs, preferably about 50 to about 65 mg of vitamin B6, and most preferably about 50 mg of vitamin Bs; from about 50 to about 100 μg of chromium, preferably about 50 to about 75 μg of chromium, and most preferably about 50 μg of chromium; from about 100 to about 200 IU of vitamin E, preferably about 100 to about 150 IU of vitamin E, and most preferably about 100 IU of vitamin E; from about 100 to about 1000 mg of vitamin C, preferably about 100 to about 150 mg of vitamin C, and most preferably about 100 mg of vitamin C; and from about 8 to less than 50 mg of phytoestrogen, preferably about 8 to about 12 mg of phytoestrogen, and most preferably about 10 mg of phytoestrogen.

It has been shown that this range of folic acid is effective in preventing fetal neural tube defects and reducing the risk of cervical dysplasia; the amount of vitamin B6 is enough to reduce at least some symptoms of PMS; it has been shown that the amounts of vitamin B12, vitamin B6 and folic acid reduce serum homocysteine; the amount of iron present in the composition is sufficient to reduce or prevent iron deficiency anemia; and phytoestrogen, antioxidants and chromium help reduce the risk of disease cardiovascular. Antioxidants and phytoestrogens also provide some protection against osteoporosis and some cancers. A preferred dietary supplement of Stage 1 is shown in Table I.

FOOD COMPLEMENT OF STAGE II The food supplement for perimenopausal and menopausal women includes from about 200 to about 1000 mg of calcium, preferably from about 300 to about 400 mg of calcium, and most preferably about 300 mg of calcium; from about 100 to about 200 mg of manganese, preferably from about 100 to about 150 mg of magnesium, and most preferably about 150 mg of magnesium; from about 1.5 to about 2.5 mg of boron, preferably about 1.7 to about 2.3 mg of boron, and most preferably about 2 mg of boron; from about 1.5 to about 2.5 mg of copper, preferably about 1.7 to about 2.3 mg of copper, and most preferably about 2 mg of copper; from about 2.4 to about 3.6 mg of manganese, preferably about 2.6 to about 3.4 mg of manganese, and most preferably about 3 mg of manganese; from about 12 to about 15 mg of zinc, preferably about 12 to about 14 mg of zinc, and most preferably about 12 mg of zinc; from about 300 to about 400 IU of vitamin D, preferably about 300 to about 350 IU of vitamin D, and most preferably about 300 IU of vitamin D; from about 10 to about 15 mg of iron, preferably about 13 to 15 mg of iron, and most preferably about 15 mg of iron; from about 400 to about 440 μg of folic acid, preferably about 400 to about 420 μg of folic acid, and most preferably about 400 μg of folic acid; from about 2 to about 15 μg of vitamin B 2, preferably about 2 to about 6 μg of vitamin B 12, and most preferably about 2 μg of B 12; from about 50 to about 100 mg of vitamin B6, preferably about 50 to about 65 mg of vitamin Bs, and most preferably about 50 mg of vitamin B6; from about 75 to about 200 μg of chromium, preferably about 75 to about 100 μg of chromium, and most preferably about 75 μg of chromium; from about 200 to about 400 IU of vitamin E, preferably about 200 to about 300 IU of vitamin E, and most preferably about 200 IU of vitamin E; from about 200 to about 1000 mg of vitamin C, preferably about 200 to about 300 mg of vitamin C, and most preferably about 200 mg of vitamin C; Y from about 10 to less than 50 mg of phytoestrogen, preferably about 12 to about 17 mg of phytoestrogen and most preferably 15 mg of phytoestrogen. The amount of calcium, magnesium, boron, copper, manganese, zinc and vitamin D in the composition of Stage II has been increased compared to the composition of Stage I, since it has been shown that these nutrients enhance absorption and / or use of calcium; the amount of vitamin B6 is the same as in the composition of Stage I and is sufficient to prevent or reduce the symptoms of PMS; the amounts of folic acid will prevent fetal neural tube defects and reduce the risk of cervical dysplasia, and in combination with vitamin B12 and vitamin B6 are associated with a reduced risk of CHD; Chromium has also been increased to help regulate the lipid profile and therefore reduce the risk of CHD; the amount of phytoestrogen contributes to the reduction of menopausal symptoms, osteoporosis, CHD and some forms of cancer, and therefore, increases in the composition for the second stage of life. Similarly, the amount of antioxidants is increased in the composition of Step II because they also provide protection against CHD and some cancers. A preferred daily food supplement of Step 11 is shown in Table I.

FOOD SUPPLEMENT OF STAGE II I The food supplement for post-menopausal women includes from approximately 200 to approximately 1500 mg of calcium, preferably from about 300 to about 300 to about 500 mg of calcium, and most preferably about 400 mg of calcium; from about 150 to about 250 mg of magnesium, preferably from about 150 to about 200 mg of magnesium, and most preferably about 200 mg of magnesium; from about 2.5 to about 3.5 mg of boron, preferably about 2.7 to about 3.3 mg of boron, and most preferably about 3 mg of boron; from about 2.5 to about 3.5 mg of copper, preferably about 2.7 to about 3.3 mg of copper, and most preferably about 3 mg of copper; from about 4.4 to about 5.6 mg of manganese, preferably about 4.6 to about 5.4 mg of manganese, and most preferably about 5.0 mg of manganese; from about 15 to about 18 mg of zinc, preferably about 15 to about 17 mg of zinc, and most preferably about 15 mg of zinc; from about 300 to about 800 IU of vitamin D, preferably about 350 to about 400 IU of vitamin D, and most preferably about 400 IU of vitamin D; from about 5 to about 10 mg of iron, preferably about 8 to 10 mg of iron, and most preferably about 10 mg of iron; from about 400 to about 440 μg of folic acid, preferably about 400 to about 420 μg of folic acid, and most preferably about 400 μg of folic acid; from about 2 to about 18 μg of vitamin B12, preferably about 2 to about 8 μg of vitamin B12, and most preferably about 2 μg of vitamin B 2; from about 1.6 to about 10 mg of vitamin B6, preferably about 1.6 to 3.2 mg of vitamin B6, most preferably about 1.6 mg of vitamin B6; from about 100 to about 200 μg of chromium, preferably about 100 to about 150 μg of chromium, and most preferably 100 μg of chromium; from about 350 to about 800 IU of vitamin E, preferably about 350 to about 450 IU of vitamin E, and most preferably about 400 IU of vitamin E; from about 300 to about 1000 mg of vitamin C, preferably about 350 to about 450 mg of vitamin C, and most preferably about 400 mg of vitamin C; and from about 10 to less than 50 mg of phytoestrogen, preferably about 12 to about 17 mg of phytoestrogen, and most preferably about 15 mg of phytoestrogen. The amounts of calcium, manganese, boron, copper, magnesium, zinc and vitamin D are optimized to intensify the intake and / or utilization of calcium for the prevention of osteoporotic fractures; the amounts of antioxidant, vitamin B12, vitamin B6, folic acid, and chromium are maximized to prevent or reduce the risk of CHD; the phytoestrogens and Antioxidants help reduce the risk of cardiovascular disease or some cancers. A preferred daily food supplement of Stage III is shown in Table I.

TABLE I FOOD SUPPLEMENTS In a second aspect of the invention a method is provided for preventing or decreasing the risk of diseases associated with the life stage and health conditions in women, by orally administering a food supplement of this invention during the appropriate life stage of the invention. woman. For example, the dietary supplement of Step I of this invention is orally administered to a pre-perimenopausal woman, the dietary supplement of Stage II is orally administered to the woman when she reaches the perimenopausal or menopausal stage and the dietary supplement of the Stage. III of this invention is administered to women when they reach the post-menopausal stage. In a preferred embodiment, the appropriate food supplement is administered throughout at least one life stage of the woman, most preferably throughout the three adult life stages defined herein. Although the approximate age varies for these stages were noted before, any woman can have an accelerated course through these phases. Delayed transitions can also occur but are less likely. In this way, a woman taking the Phase I formulation that begins to experience hot flashes, insomnia, or other menopausal symptoms would benefit more from the formulation of Stage II and should switch to that formulation at any age that occurs. symptom. It is suggested that you remain in the Phase II formulation until it is clearly post-menopausal, as determined by medical convention (generally an increased FSH - follicle-stimulating hormone ~ and without menstrual cycle for twelve months). Then the formulation of Stage III is recommended. Similarly, when a woman has had cessation of menstruation in relation to decreased ovarian function as determined by medical convention, she should change from the formulation of Stage 1 to the formulation of Stage II for at least six months to one year , even when you do not have any painful menopausal symptoms. When clearly through this transition phase, the formulation of Stage I II is recommended due to its additional preventive properties for post-menopausal diseases. Y, a woman who undergoes surgical menopause at an early age, for example, at age 35, no longer requires the formulation of Stage I. Although the composition of Stage II would not be inappropriate for a year or two, the preferred formulation for this woman would be the formulation of Stage III because it has gone from a phase of fertile age to a post-menopausal phase without a significant transition period. The present method to prevent or reduce the risk of health conditions associated with the life stage is effective in the prevention of fetal neural tube defects, prevention or reduction of symptoms of PMS and menopause, prevention or reduction of the risk of developing osteoporosis , iron deficiency anemia, coronary heart disease, some cancers and cervical dysplasia. In another aspect of the invention, a food supplement formulated specifically for peri-menopausal women and menopausal women is provided. menopausal The supplement may also be used by pre-perimenopausal women to, for example, intensify the effects of complementation once the peri-menopausal and menopausal stage of life has been reached, or by post-menopausal women who exhibit residual symptoms of the disease. menopause. Use during the pre-perimenopausal life stages also helps regulate or otherwise impact the menstrual cycle in a positive way. The food supplement of this aspect of the invention is a once-a-day coinplement comprising physiologically effective phytoestrogen in an amount of less than about 20 mg, preferably less than about 15 mg and more preferably, less than about 14.5 mg to about 1 mg. The phytoestrogen to be used can be selected from naturally occurring, concentrated phytoestrogen (such as whole soy extract), synthesized phytoestrogen, or mixtures thereof. One or more different phytoestrogens may be included. Preferably, the phytoestrogen is selected from the group consisting of genistin, glycitin, daidzin, malonyl diadzin, malonyl genistin, malonyl glycitin, acetyl glycitin, acetyl daidzin, acetyl genistin, genistein, glycitein, daidzein and mixtures thereof. Phytoestrogen can be derived from any suitable source, for example, from a plant extract rich in phytoestrogens. Preferably, the phytoestrogen is derived from whole soybean (as opposed to soybean germ). However, other sources of phytoestrogen can be used.

The phytoestrogens can be glycosylated, such as genistin, glycitin or daidzin, malonyl daidzin, malonyl genistin, malonyl glycitin, acetyl glycitin, acetyl daidzin, acetyl genistin, or non-glycosylated, such as genistein, glycitein or daidzein. Preferably, the phytoestrogen has the following phytoestrogen profile (percent by weight): about 31 to 35% daidzin, about 8 to 10% of glycitin, about 36 to 40% of genistin, about 3 to 5% of malonyl daidzin, approximately 0.5 to 2.5% of malonyl glycitin, approximately 2.6 to 4.6% of malonyl genistin, approximately 3.7 to 5.7% of acetyl daidzin, approximately 0.1 to 1.1% of acetyl glycitin, approximately 3.2 to 5.2% of acetyl genistin, approximately 0.1 to 1% daidzein, approximately 0.1 to 1% glycitein, and approximately 0.1 to 0.9% genistein. Most preferably, the phytoestrogen has a phytoestrogen profile similar to that described in Table II, which sets forth the phytoestrogen profile for total phytoestrogens in a concentrate of phytoestrogens derived from whole soy. The food supplement may be provided in the form of tablets, patches, gels, creams or capsules, for example or formulated in an appetizing confection, such as a candy bar, beverage, cereal, powder, chewing gum and the like. In a preferred embodiment, a food supplement is provided once a day containing a mixture of daidzin, glycitin, gensitin, malonyl daidzin, malonyl genistin, malonyl glycitin, acetyl glycitin, acetyl daidzin, acetyl genistin, genistein, glycitein and daidzein in a total weight amount of approximately 10 up to about 15 mg, more preferably 13 to 15 mg. Preferably, each of the phytoestrogens is provided in the following percentages (by weight) of the total phytoestrogens: about 33% daidzin, about 9% glycitin, about 38% genistin, about 4% malonyl daidzin, about 1%. .5% malonyl glycitin, approximately 3.6% malonyl genistin, approximately 4.7% acetyl daidzin, approximately 0.6% acetyl glycitin, approximately 4.2% acetyl genistin, approximately 0.5% daidzein, approximately 0.5% glycitein, and approximately 0.4 % of genistein. In a highly preferred embodiment, a supplement is provided using approximately 50 mg of soybean phytoestrogen concentrate having the phytoestrogen profile set forth in Table II, to give a phytoestrogen content of 14.15. This tablet provides phytoestrogens in the following forms and amounts: approximately 4,726 mg of daidzin, approximately 1,257 mg of glycitin, approximately 5,312 mg of genistin, approximately 0.586 mg of malonyl daidzin, approximately 0.217 mg of malonyl glycitin, approximately 0.510 mg of malonil genistin, approximately 0.670 mg of acetyl diadzine, approximately 0.082 mg of acetyl glycitin, approximately 0.595 mg of acetyl genistin, approximately 0.076 mg of daidzein, approximately 0.062 mg of glycitein, and approximately 0.060 mg of genistein (See Table II).

TABLE II COMPLEMENT OF FITOESTROGENS EXAMPLE 1 The diet of a pre-perimenopausal woman is supplemented daily with the dietary supplement of Stage I of this invention. The food supplement is administered as a tablet, formulated for administration once a day. The Complementation of the diet is done throughout the entire pre-perimenopausal life stage. When the woman reaches the stage of perimenopausal life, the food supplementation is changed from the food supplement from Stage I to Stage II of the invention. The dietary supplement of Stage II is administered in the same manner as the supplement to Stage I. Food supplementation continues throughout perimenopause and menopause, after which the dietary supplement of Stage III is administered instead. of the complement of Stage II.

EXAMPLE 2 The diet of two menopausal women who are unable or unwilling to take hormone replacement therapy (HRT) and who have menopausal symptoms including hot flashes, insomnia and night sweats, which were marked as severe in number and / or quality were supplemented with a diet of approximately 15 mg / day of phytoestrogens. Both women had been on HRT in the past (one woman for two and a half months and the other for two years). However, no woman would consider its continued use. Both women had also treated alternative treatment regimens, such as acupuncture and Chinese herbs with little or no lasting relief. Both women reported immediate relief (within several days) when taking the tablets containing approximately 15 mg / day of phytoestrogen The effect progressively improved for four to six weeks at which time a plateau was reached. Each woman reported a significant reduction in hot flashes, that is, from more than twenty per day to less than five per day, as well as a reduction in intensity (from "sudden hot" to "warm" access). Night sweats were also significantly reduced and sleep duration and quality were improved. A SMAC-18 laboratory analysis was obtained for each woman before the start of phytoestrogen therapy and again at four to six weeks and eight to thirteen weeks after the start of phytoestrogen therapy. There were no adverse changes in the SMAC-18 data. Specifically, kidney function and liver enzyme levels remained unchanged. As a comparison, at least one of the women was provided with a phytoestrogen supplement already commercially available to replace the phytoestrogen supplement of the invention. She reported that it was completely unsatisfactory.

Claims

CLAIMS 1 . A food supplement to supplement the nutritional needs of pre-perimenopausal women comprising approximately 200 to approximately 500 mg of calcium, approximately 100 to approximately 200 mg of magnesium, approximately 0.5 to approximately 1.5 mg of boron, approximately 0.5 to approximately 1.5 mg. of copper, about 2 to about 2.6 mg of manganese, about 10 to about 13 mg of zinc, about 200 to about 300 IU of vitamin D, about 12 to about 18 mg of iron, about 400 to about 440 μg of folic acid, about 2 to about 10 μg of vitamin B12, about 50 to about 100 mg of vitamin B6, about 50 to about 100 μg of chromium, about 100 to about 200 IU of vitamin E, about 100 to about 1000 mg of vitamin C and about 8 to less than 50 mg of phytoestrogen in admixture with a biologically acceptable carrier.
2. The food supplement of claim 1, which further comprises from about 400 to about 1200 RE of preformed vitamin A and mixed carotenoids.
3. The food supplement of claim 1, wherein said food supplement is formulated in the form of tablets, powder, liquid, capsule or gel, or food bar.
The food supplement of claim 1 comprising about 200 to about 300 mg of calcium, about 100 to about 150 mg of magnesium, about 0.7 to about 1.3 mg of boron, about 0.7 to about 1.3 mg of copper, about 2 to about about 2.4 mg of manganese, about 10 to about 12 mg of zinc, about 200 to about 250 IU of vitamin D, about 16 to about 18 mg of iron, about 400 to about 420 μg of folic acid, about 2 to about 4 μg of vitamin B12, about 50 to about 65 mg of vitamin B6, about 50 to about 75 μg of chromium, about 100 to about 150 IU of vitamin E, about 100 to about 150 mg of vitamin C and about 8 to about 12 mg of vitamin C phytoestrogen in mixture a with a biologically acceptable carrier.
The food supplement of claim 1, comprising about 200 mg of calcium, about 100 mg of magnesium, about 1 mg of boron, about 1 mg of copper, about 2 mg of manganese, about 10 mg of zinc, about 200 IU of vitamin D, approximately 18 mg of iron, approximately 400 μg of folic acid, approximately 2 μg of vitamin B12, approximately 50 mg of vitamin B6, approximately 50 μg of chromium, approximately 100 IU of vitamin E, approximately 100 mg of vitamin C and approximately 10 mg of phytoestrogen in mixture with a biologically acceptable carrier.
6. A food supplement to supplement the nutritional needs of perimenopausal or menopausal women, comprising from about 200 to about 1000 mg of calcium; from about 100 to about 200 mg of magnesium; from about 1.5 to about 2.5 mg of boron; from about 1.5 to about 2.5 mg of copper; from about 2.4 to about 3.6 mg of manganese; from about 12 to about 15 mg of zinc, from about 300 to about 400 IU of vitamin D; from about 10 to about 15 mg of iron; from about 400 to about 440 μg of folic acid; from about 2 to about 15 μg of vitamin B12; from about 50 to about 100 mg of vitamin B6; from about 75 to about 200 μg of chromium; from about 200 to about 400 IU of vitamin E; from about 200 to about 1000 mg of vitamin C; and from about 10 to less than 50 mg of phytoestrogen in admixture with a biologically acceptable carrier.
7. The food supplement of claim 6, which further comprises from about 800 to about 1600 RE of preformed vitamin A and mixed carotenoids.
The food supplement of claim 6, wherein said supplement is formulated in the form of a tablet, powder, liquid, capsule or gel, or food bar.
The food supplement of claim 6, comprising from about 300 to about 400 mg of calcium; from about 100 to about 150 mg of magnesium; from about 1.7 to about 2.3 mg of boron; from about 1.7 to about 2.3 mg of copper; from about 2.6 to about 3.4 mg of manganese; from about 12 to about 14 mg of zinc; from about 300 to about 350 IU of vitamin D; from about 13 to about 15 mg of iron; from about 400 to about 420 μg of folic acid; from about 2 to about 6 μg of vitamin B1; from about 50 to about 65 mg of vitamin B6; from about 75 to about 100 μg of chromium; from about 200 to about 300 IU of vitamin E; from about 200 to about 300 mg of vitamin C; and from about 12 to about 17 mg of phytoestrogen in admixture with a biologically acceptable carrier.
10. The food supplement of claim 6, wherein said supplement comprises approximately 300 mg of calcium, about 150 mg of magnesium, about 2 mg of boron, about 2 mg of copper, about 3 mg of manganese, about 12 mg of zinc, about 300 IU of vitamin D, about 15 mg of iron, about 400 μg of folic acid, about 2 μg of vitamin B12, about 50 mg of vitamin B6, about 75 μg of chromium, about 200 IU of vitamin E, about 200 mg of vitamin C, and about 15 mg of phytoestrogen. 1 1.
A food supplement to supplement the nutritional needs of post-menopausal women, comprising from about 200 to about 1500 mg of calcium, about 150 to about 250 mg of magnesium, about 2.5 to about 3.5 mg of boron, about 2.5 to about 3.5 mg of copper, about 4.4 to about 5.6 mg of manganese, about 15 to about 18 mg of zinc, about 300 to about 800 IU of vitamin D, about 5 to about 10 mg of iron, about 400 to about 440 μg of folic acid , about 2 to about 18 μg of vitamin B12, about 1.6 to about 10 mg of vitamin B6, about 100 to about 200 μg of chromium, about 350 to about 800 IU of vitamin E, about 300 to about 1000 mg of vitamin C, and about 10 to less than 50 mg of phytoestrogen in admixture with a biologically acceptable carrier.
The food supplement of claim 1, which further comprises from about 1200 to about 2000 RE of preformed vitamin a and mixed carotenoids.
The food supplement of claim 1, wherein said supplement is formulated in the form of a tablet, powder, liquid, capsule or gel, or food bar.
The food supplement of claim 11, wherein said complement comprises about 300 to about 500 mg of calcium, approximately 150 to approximately 200 mg of magnesium, approximately 2.7 to approximately 3.3 mg of boron, approximately 4.6 to approximately 5.4 mg of manganese, approximately 15 to approximately 17 mg of zinc, approximately 350 to approximately 400 IU of vitamin D, about 8 to about 10 mg of iron, about 400 to about 420 μg of folic acid, about 2 to about 8 μg of vitamin B12, about 1.6 to about 3.2 mg of vitamin B6, about 100 to about 150 μg of chromium , about 350 to about 450 IU of vitamin E, about 350 to about 450 mg of vitamin C and about 12 to about 17 mg of phytoestrogen in admixture with a biologically acceptable carrier.
15. The food supplement of claim 11, wherein said supplement comprises about 400 mg of calcium, about 200 mg of magnesium, about 3 mg of boron, about 3 mg of copper, about 5 mg of manganese, about 15 mg of zinc, about 400 IU of vitamin D, approximately 10 mg of iron, approximately 400 μg of folic acid, approximately 2 μg of vitamin B12, approximately 1.6 mg of vitamin B6, approximately 100 μg of chromium, approximately 400 IU of vitamin E, approximately 400 mg of vitamin C, and approximately 15 mg of phytoestrogen in admixture with a pharmaceutically acceptable carrier.
16. A method to supplement the nutritional needs in an adult woman comprising administering orally to a pre-perimenopausal, perimenopausal and menopausal or post-menopausal woman, an effective amount of an appropriate life-stage food supplement for each stage of life as throughout his life.
The method of claim 16, wherein the food supplement is selected from the group consisting of a Stage I food supplement to supplement the dietary needs of pre-perimenopausal women and to prevent or reduce the risk of fetal neural tube defects, iron deficiency anemia, PMS, osteoporosis, at least one form of cancer, cervical dysplasia and coronary heart disease, comprising effective amounts of calcium, magnesium, copper, boron, manganese, zinc, vitamin D, iron, folic acid, vitamin B12, vitamin B6, chromium, vitamin E, vitamin C and phytoestrogen in mixing with a biologically acceptable carrier; a Stage II food supplement to supplement the dietary needs of perimenopausal and menopausal women, and prevent or reduce the risk of PMS, menopausal symptoms, fetal neural tube defects, iron deficiency anemia, osteoporosis, at least one form of cancer , cervical dysplasia and coronary heart disease, comprising effective amounts of calcium, magnesium, copper, boron, manganese, zinc, vitamin D, iron, folic acid, vitamin B12, vitamin B, chromium, vitamin E, vitamin C and phytoestrogen in mixing with a biologically acceptable carrier; and a food supplement of Stage II I to supplement the dietary needs of post-menopausal women, and to prevent or reduce the risk of coronary heart disease, at least one form of cancer, cervical dysplasia and osteoporosis, comprising effective amounts of calcium, magnesium, copper, boron, manganese, zinc, vitamin D, iron, folic acid, vitamin B1, vitamin B6, chromium, vitamin E, vitamin C and phytoestrogen in admixture with a biologically acceptable carrier.
18. The method of claim 17, wherein (A) the food supplement of Step I comprises about 200 to about 500 mg of calcium, about 100 to about 200 mg of magnesium, about 0.5 to about 1.5 mg of boron, about 0.5. to about 1.5 mg of copper, about 2 to about 2.6 mg of manganese, about 10 to about 13 mg of zinc, about 200 to about 300 IU of vitamin D, about 12 to about 18 mg of iron, about 400 to about 440 μg of folic acid, about 2 to about 10 μg of vitamin B12, about 50 to about 100 mg of vitamin B6, about 50 to about 100 μg of chromium, about 100 to about 200 IU of vitamin E, about 100 to about 1000 mg of vitamin C and about 8 to less than 50 mg of phytoestrogen; (B) the Stage II food supplement comprises about 200 to about 1000 mg of calcium; from about 100 to about 200 mg of magnesium; from about 1.5 to about 2.5 mg of boron; from about 1.5 to about 2.5 mg of copper; from about 2.4 to about 3.6 mg of manganese; from about 12 to about 15 mg of zinc, from about 300 to about 400 IU of vitamin D; from about 10 to about 15 mg of iron; from about 400 to about 440 μg of folic acid; from about 2 to about 15 μg of vitamin B12; from about 50 to about 100 mg of vitamin B6; from about 75 to about 200 μg of chromium; from about 200 to about 400 IU of vitamin E; from about 200 to about 1000 mg of vitamin C; and from about 10 to less than 50 mg of phytoestrogen; Y (C) the Stage III food supplement comprises about 200 to about 1500 mg of calcium, about 150 to about 250 mg of magnesium, about 2.5 to about 3.5 mg of boron, about 2.5 to about 3.5 mg of copper, about 4.4 to about 5.6 mg of manganese, about 15 to about 18 mg of zinc, about 300 to about 800 IU of vitamin D, about 5 to about 10 mg of iron, about 400 to about 440 μg of folic acid, about 2 to about 18 μg of vitamin B12, approximately 1.6 to approximately 10 mg of vitamin B6, approximately 100 to approximately 200 μg of chromium, approximately 350 to approximately 800 IU of vitamin E, approximately 300 to approximately 1000 mg of vitamin C, and approximately 10 to less than 50 mg of phytoestrogen.
The method of claim 18, wherein an appropriate life-stage food supplement is administered during at least two life stages of the woman.
The method of claim 18, wherein each of the appropriate food supplements of life stage is administered throughout the appropriate life stage of the woman.
The method of claim 18, wherein the appropriate life stage food supplement is administered in the form of a tablet, powder, liquid or capsule or gel, or food bar.
22. The method of claim 18, wherein the dietary supplement of Stage I is administered to a woman throughout the pre-perimenopausal life stage of the woman.
The method of claim 18, wherein the Stage II food supplement is administered to the woman throughout the perimenopausal and menopausal stage of the woman.
The method of claim 18, wherein the dietary supplement of Stage II I is administered to the woman throughout the post-menopausal life stage of the woman.
The method of claim 18, wherein (A) the food supplement of Step I comprises about 200 to about 300 mg of calcium, about 100 to about 150 mg of magnesium, about 0.7 to about 1.3 mg of boron, about 0.7 to about 1.3 mg of copper, about 2 to about 2.4 mg of manganese, about 10 to about 12 mg of zinc, about 200 to about 250 IU of vitamin D, about 16 to about 18 mg of iron, about 400 to about 420 μg of folic acid, about 2 to about 4 μg of vitamin B12, about 50 to about 65 mg of vitamin B6, about 50 to about 75 μg of chromium, about 100 to about 150 IU of vitamin E, about 100 to about 150 mg of vitamin C and about 8 to about 12 mg of phytoestrogen; (B) the Stage II food supplement comprises from about 300 to about 400 mg of calcium; from about 100 to about 150 mg of magnesium; from about 1.7 to about 2.3 mg of boron; from about 1.7 to about 2.3 mg of copper; from about 2.6 to about 3.4 mg of manganese; from about 12 to about 14 mg of zinc; from about 300 to about 350 IU of vitamin D; from about 13 to about 15 mg of iron; from about 400 to about 420 μg of folic acid; from about 2 to about 6 μg of vitamin B 2; from about 50 to about 65 mg of vitamin B6; from about 75 to about 100 μg of chromium; from about 200 to about 300 IU of vitamin E; from about 200 to about 300 mg of vitamin C; and from about 12 to about 17 mg of phytoestrogen; (C) the Stage III food supplement comprises about 300 to about 500 mg of calcium, about 150 to about 200 mg of magnesium, about 2.7 to about 3.3 mg of boron, about 4.6 to about 5.4 mg of manganese, about 15 to about 17 mg of zinc, about 350 to about 400 IU of vitamin D, about 8 to about 10 mg of iron, about 400 to about 420 μg of folic acid, about 2 to about 8 μg of vitamin B12, about 1.6 to about 3.2 mg of vitamin B6 , about 100 to about 150 μg of chromium, about 350 to about 450 IU of vitamin E, about 350 to about 450 mg of vitamin C and about 12 to about 17 mg of phytoestrogen.
The method of claim 18, wherein (1) the food supplement of Step I comprises about 200 mg of calcium, about 100 mg of magnesium, about 1 mg of boron, about 1 mg of copper, about 2 mg of manganese , approximately 10 mg of zinc, approximately 200 IU of vitamin D, approximately 18 mg of iron, approximately 400 μg of folic acid, approximately 2 μg of vitamin B? 2, approximately 50 mg of vitamin B6, approximately 50 μg of chromium, approximately 100 IU of vitamin E, approximately 100 mg of vitamin C and approximately 10 mg of phytoestrogen; (2) the Stage II food supplement comprises about 300 mg of calcium, about 150 mg of magnesium, about 2 mg of boron, about 2 mg of copper, about 3 mg of manganese, about 12 mg of zinc, about 300 IU of vitamin D, approximately 15 mg of iron, approximately 400 μg of folic acid, approximately 2 μg of vitamin B 2, approximately 50 mg of vitamin B6, approximately 75 μg of chromium, approximately 200 IU of vitamin E, approximately 200 mg of vitamin C, and approximately 15 mg of phytoestrogen; (3) the Stage III food supplement comprises approximately 400 mg of calcium, approximately 200 mg of magnesium, approximately 3 mg of boron, approximately 3 mg of copper, approximately 5 mg of manganese, approximately 15 mg of zinc, approximately 400 IU of vitamin D, approximately 10 mg of iron, approximately 400 μg of folic acid, approximately 2 μg of vitamin B12, approximately 1.6 mg of vitamin B6, approximately 100 μg of chromium, approximately 400 IU of vitamin E, approximately 400 mg of vitamin C, and approximately 15 mg of phytoestrogen.
27. A method for preventing or reducing the risk of at least one form of cancer, cervical dysplasia, osteoporosis and coronary heart disease comprising administering orally to a pre-perimeponic, perimenopausal and menopausal, and / or post-menopausal woman, a effective amount of an appropriate food supplement of life stage for each stage of life throughout its life.
The method of claim 27, wherein the administration of the appropriate food supplement of the life stage is continued throughout at least two life stages.
29. A method to prevent or reduce the risk of iron deficiency anemia, PMS and fetal neural tube defects, including administering to a pre-perimenopausal woman an effective amount of an appropriate food supplement of life stage.
30. A method for preventing or reducing the risk of PMS, menopausal symptoms, coronary heart disease, some cancers, cervical dysplasia, and osteoporosis, comprising administering to a perimenopausal or menopausal woman an effective amount of an appropriate dietary supplement from lifetime.
31 A method for preventing or reducing risk of coronary heart disease, at least one form of cancer and osteoporosis, comprising administering to a post-menopausal woman an effective amount of an appropriate life-stage food supplement.
32. A series of nutritional supplements formulated for the associated nutritional needs of a woman's life stage, comprising at least two of (A) a nutritional supplement formulated for the pre-perimenopausal life stage; (B) a nutritional supplement formulated for the perimenopausal and menopausal stage of life; and (C) a nutritional supplement formulated for the post-menopausal life stage; through which the changing nutritional needs of a woman are complemented.
33. A series of nutritional supplements according to claim 32, wherein (A) The nutritional supplement for the pre-perimenopausal life stage comprises a composition to supplement the dietary needs of pre-perimenopausal women and to prevent or reduce the risk of fetal neural tube defects, iron deficiency anemia, PMS, osteoporosis, at least one form of cancer, cervical dysplasia and coronary heart disease, comprising effective amounts of calcium, magnesium, copper, boron, manganese, zinc, vitamin D, iron, folic acid, vitamin B12, vitamin B, chromium, vitamin E , vitamin C and phytoestrogen in mixture with a biologically acceptable carrier; (B) the nutritional supplement for the perimenopausal and menopausal stage of life comprises a composition to supplement the dietary needs of perimenopausal and menopausal women, and to prevent or reduce the risk of PMS, menopausal symptoms, fetal neural tube defects, deficiency anemia of iron, osteoporosis, at least one form of cancer, cervical dysplasia and coronary heart disease, comprising effective amounts of calcium, magnesium, copper, boron, manganese, zinc, vitamin D, iron, folic acid, vitamin B12, vitamin B6 , chromium, vitamin E, vitamin C and phytoestrogen in mixture with a biologically acceptable carrier; and (C) the nutritional supplement for the post-menopausal stage of life comprises a composition to supplement the dietary needs of post-menopausal women, and to prevent or reduce the risk of coronary heart disease, at least one form of cancer, dysplasia cervical cancer and osteoporosis, comprising Effective amounts of calcium, magnesium, copper, boron, manganese, zinc, vitamin D, iron, folic acid, vitamin B12, vitamin Bs, chromium, vitamin E, vitamin C and phytoestrogen in admixture with a biologically acceptable carrier.
34. A series of nutritional supplements according to claim 33, wherein (A) the composition for the pre-perimenopausal life stage comprises approximately 200 to approximately 500 mg of calcium, approximately 100 to approximately 200 mg of magnesium, approximately 0.5 to about 1.5 mg of boron, about 0.5 to about 1.5 mg of copper, about 2 to about 2.6 mg of manganese, about 10 to about 13 mg of zinc, about 200 to about 300 IU of vitamin D, about 12 to about 18 mg of iron, about 400 to about 440 μg of folic acid, about 2 to about 10 μg of vitamin B12, about 50 to about 100 mg of vitamin B6, about 50 to about 100 μg of chromium, about 100 to about 200 IU of vitamin E, approximately 100 to aproximadam between 1000 mg of vitamin C and about 8 to less than 50 mg of phytoestrogen in admixture with a biologically acceptable carrier; (B) the composition for the perimenopausal and menopausal stage of life comprises approximately 200 to approximately 1000 mg of calcium; from about 100 to about 200 mg of magnesium; from about 1.5 to about 2.5 mg of boron; from about 1.5 to about 2.5 mg of copper; from about 2.4 to about 3.6 mg of manganese; from about 12 to about 15 mg of zinc, from about 300 to about 400 IU of vitamin D; from about 10 to about 15 mg of iron; from about 400 to about 440 μg of folic acid; from about 2 to about 15 μg of vitamin B12; from about 50 to about 100 mg of vitamin B6; from about 75 to about 200 μg of chromium; from about 200 to about 400 IU of vitamin E; from about 200 to about 1000 mg of vitamin C; and from about 10 to less than 50 mg of phytoestrogen in admixture with a biologically acceptable carrier; and (C) the composition for the post-menopausal life stage comprises about 200 to about 1500 mg of calcium, about 150 to about 250 mg of magnesium, about 2.5 to about 3.5 mg of boron, about 2.5 to about 3.5 mg of copper , about 4.4 to about 5.6 mg of manganese, about 15 to about 18 mg of zinc, about 300 to about 800 IU of vitamin D, about 5 to about 10 mg of iron, about 400 to about 440 μg of folic acid, about 2 to about 18 μg of vitamin B12, about 1.6 to about 10 mg of vitamin B6, about 100 to about 200 μg of chromium, about 350 to about 800 IU of vitamin E, about 300 to about 1000 mg of vitamin C , and about 10 to less than 50 mg of phytoestrogen in admixture with a biologically acceptable carrier.
35. A series of nutritional supplements according to claim 34, wherein (A) the composition for the pre-perimenopausal life stage comprises approximately 200 to approximately 300 mg of calcium, approximately 100 to approximately 150 mg of magnesium, approximately 0.7 to about 1.3 mg of boron, about 0.7 to about 1.3 mg of copper, about 2 to about 2.4 mg of manganese, about 10 to about 12 mg of zinc, about 200 to about 250 IU of vitamin D, about 16 to about about 18 mg of iron, about 400 to about 420 μg of folic acid, about 2 to about 4 μg of vitamin B12, about 50 to about 65 mg of vitamin B6, about 50 to about 75 μg of chromium, about 100 to about 150 Vitamin E UI, approximately 100 to approximately 150 mg of vitamin C and approximately 8 to approximately 12 mg of phytoestrogen; (B) the composition for the perimenopausal and menopausal life stage comprises from about 300 to about 400 mg of calcium; from about 100 to about 150 mg of magnesium; from about 1.7 to about 2.3 mg of boron; from about 1.7 to about 2.3 mg of copper; from about 2.6 to about 3.4 mg of manganese; from about 12 to about 14 mg of zinc; from about 300 to about 350 IU of vitamin D; from about 13 to about 15 mg of iron; from about 400 to about 420 μg of folic acid; from about 2 to about 6 μg of vitamin B12; from about 50 to about 65 mg of vitamin B6; from about 75 to about 100 μg of chromium; from about 200 to about 300 IU of vitamin E; from about 200 to about 300 mg of vitamin C; and from about 12 to about 17 mg of phytoestrogen; (C) the composition for the post-menopausal life stage comprises about 300 to about 500 mg of calcium, about 150 to about 200 mg of magnesium, about 2.7 to about 3.3 mg of boron, about 4.6 to about 5.4 mg of manganese, about 15 to about 17 mg of zinc, about 350 to about 400 IU of vitamin D, about 8 to about 10 mg of iron, about 400 to about 420 μg of folic acid, about 2 to about 8 μg of vitamin B12, about 1.6 to about 3.2 mg of vitamin B6, about 100 to about 150 μg of chromium, about 350 to about 450 IU of vitamin E , about 350 to about 450 mg of vitamin C and about 12 to about 17 mg of phytoestrogen.
36. A series of nutritional supplements according to claim 35, wherein (A) the composition for the pre-perimenopausal life stage comprises approximately 200 mg of calcium, approximately 100 mg of magnesium, approximately 1 mg of boron, approximately 1 mg of copper, approximately 2 mg of manganese, approximately 10 mg of zinc, approximately 200 IU of vitamin D, approximately 18 mg of iron, approximately 400 μg of folic acid, approximately 2 μg of vitamin B12, approximately 50 mg of vitamin B6, approximately 50 μg of chromium, approximately 100 IU of vitamin E, approximately 100 mg of vitamin C and approximately 10 mg of phytoestrogen; (B) the composition for the perimenopausal and menopausal life stage comprises approximately 300 mg of calcium, approximately 150 mg of magnesium, approximately 2 mg of boron, approximately 2 mg of copper, approximately 3 mg of manganese, approximately 12 mg of zinc, approximately 300 IU of vitamin D, approximately 15 mg of iron, approximately 400 μg of folic acid, approximately 2 μg of vitamin B? 2, approximately 50 mg of vitamin B6, approximately 75 μg of chromium, approximately 200 IU of vitamin E, approximately 200 mg of vitamin C, and approximately 15 mg of phytoestrogen; and (C) the composition for the post-menopausal life stage comprises approximately 400 mg of calcium, approximately 200 mg of magnesium, approximately 3 mg of boron, approximately 3 mg of copper, approximately 5 mg of manganese, approximately 15 mg of zinc , approximately 400 IU of vitamin D, approximately 10 mg of iron, approximately 400 μg of folic acid, approximately 2 μg of vitamin B12, approximately 1.6 mg of vitamin B6, approximately 100 μg of chromium, approximately 400 IU of vitamin E, approximately 400 mg of vitamin C, and approximately 15 mg of phytoestrogen.
37. A series of nutritional supplements according to claim 34, wherein the compositions are in the form of a tablet, powder, liquid, capsule or gel, or food bar.
38. A series of nutritional supplements according to claim 35, wherein the compositions are in the form of a tablet, powder, liquid, capsule or gel, or food bar.
39. A series of nutritional supplements according to claim 36, wherein the compositions are in the form of a tablet, powder, liquid, capsule or gel, or food bar.
40. A series of nutritional supplements according to claim 34, wherein the composition for the pre-perimenopausal life stage further comprises from about 400 up to approximately 1200 RE of preformed vitamin A and mixed carotenoids.
41 A series of nutritional supplements according to claim 34, wherein the composition for the perimenopausal and menopausal life stage further comprises from about 800 to about 1600 RE of preformed vitamin A and mixed carotenoids.
42. A series of nutritional supplements according to claim 34, wherein the composition for the post-menopausal life stage further comprises from about 1200 to about 2000 RE of preformed vitamin A and mixed carotenoids.
43. A once-a-day food supplement to supplement the nutritional needs of perimenopausal and / or menopausal women comprising less than about 20 mg of phytoestrogen and a biologically acceptable carrier.
44. The food supplement of claim 43, wherein the phytoestrogen is selected from the group consisting of genistin, giicytin, daidzin, malonyl daidzin, malonyl genistin, malonyl glycitin, acetyl glycitin, acetyl daidzin, acetyl genistin, genistein, glycitein, daidzein and mixtures thereof.
45. The food supplement of claim 43, wherein the phytoestrogen comprises about 4,726 mg of daidzin, about 1,257 mg of glycitin, about 5,312 mg of genistin, about 0.586 mg of malonyl daidzin, about 0.217 mg of malonyl glycitin, about 0.510 mg of malonyl genistin, about 0.670 mg of acetyl daidzin, about 0.082 mg of acetyl glycitin, about 0.595 mg of acetyl genistin, about 0.0726 mg of daidzein, about 0.062 mg of glycitein, and about 0.060 mg of genistein.
46. The food supplement of claim 43, wherein the phytoestrogen comprises about 31 to 35% by weight of daidzin, about 8 to 10% by weight of glycitin, about 36 to 40% by weight of genistin, about 3 to 5% by weight of malonyl daidzin, approximately 0.5 to 2.5% by weight of malonyl glycitin, approximately 2.6 to 4.6% by weight of malonyl genistin, approximately 3.7 to 5.7% by weight of acetyl daidzin, approximately 0.1 to 1.1% by weight of acetyl glycitin, about 3.2 to 5.2% by weight of acetyl genistin, about 0.1 to 1.0% by weight of daidzein, about 0.1 to 1.0% by weight of glycitein, and approximately 0.1 to 0.9% by weight of genistein.
47. The food supplement of claim 43, wherein the phytoestrogen is obtained from the whole soy extract.
48. The food supplement of claim 43, wherein the complement comprises less than about 10 to about 15 mg of phytoestrogen.
49. The food supplement of claim 43, wherein the supplement is formulated as a tablet, capsule, patch, gel, cream, chewing gum, powder, beverage, sweet bar or cereal.
50. A method for supplementing the dietary needs of peri-menopausal and / or menopausal women, said method comprising administering to the woman an amount of less than about 20 mg of phytoestrogen per day.
51 The method of claim 50, wherein the amount of phytoestrogen administered is less than about 15 mg per day.
52. The method of claim 50, wherein the phytoestrogen is selected from the group consisting of genistin, glycitin, daidzin, malonyl daidzin, malonyl genistin, malonyl glycitin, acetyl glycitin, acetyl daidzin, acetyl genistin, genistein, glycitein, daidzein and mixtures of the same.
53. The method of claim 50, wherein the phytoestrogen is obtained from whole soy extract.
54. The method of claim 50, wherein the phytoestrogen comprises about 4,726 mg of daidzin, 1,257 mg of glycitin, approximately 5,312 mg of genistin, approximately 0.586 mg of malonyl daidzin, approximately 0.217 mg of malonyl glycitin, approximately 0.510 mg of malonyl genistin, approximately 0.670 mg of acetyl diadzine, approximately 0.082 mg of acetyl glycitin, approximately 0.595 mg of acetyl genistin, approximately 0.0726 mg of daidzein, approximately 0.062 mg of glycitein, and approximately 0.060 mg of genistein.
55. The method of claim 54, wherein the phytoestrogen comprises about 31 to 35% by weight of daidzin, about 8 to 10% by weight of glycitin, about 36 to 40% by weight of genistin, approximately 3 to 5% by weight of malonyl daidzin, approximately 0.5 to 2.5% by weight of malonyl glycitin, approximately 2.6 to 4.6% by weight of malonyl genistin, approximately 3.7 to 5.7% by weight of acetyl daidzin , about 0.1 to 1.1% by weight of acetyl glycitin, about 3.2 to 5.2% by weight of acetyl genistin, about 0.1 to 1.0% by weight of daidzein, about 0.1 to 1.0% by weight of glycitein, and about 0.1 to 0.9% by weight of genistein. SUMMARY The present invention relates to food supplements to supplement the nutritional needs of women and prevent or reduce health risks associated with stage of life during each of its main stages of adult life (pre-perimenopause, perimenopause and menopause, or post-menopause ). It also refers to a method to supplement the nutritional needs of women, by means of which an effective amount of an appropriate food supplement is given to a woman in each stage of life throughout her life. The present also refers to food supplements to complement the specific phytochemical dietary needs of perimenopausal and menopausal women, which contain low doses of phytoestrogens, and a method for such food supplementation.