Dietary supplements

Abstract

The present invention relates to dietary supplements containing low doses of phytoestrogens for supplementing the specific phytochemical dietary needs of perimenopausal and menopausal women.

What is claimed is:  
     
         1 . A dietary supplement for supplementing the nutritional needs of pre-perimenopausal women comprising about 200 to about 500 mg calcium, about 100 to about 200 mg magnesium, about 0.5 to about 1.5 mg boron, about 0.5 to about 1.5 mg copper, about 2 to about 2.6 mg manganese, about 10 to about 13 mg zinc, about 200 to about 300 IU vitamin D, about 12 to about 18 mg iron, about 400 to about 440 μg folic acid, about 2 to about 10 μg vitamin B 12 , about 50 to about 100 mg vitamin B 6 , about 50 to about 100 μg chromium, about 100 to about 200 IU vitamin E, about 100 to about 1000 mg vitamin C and about 8 to less than 50 mg phytoestrogen in admixture with a biologically acceptable carrier.  
     
     
         2 . The dietary supplement of  claim 1  which further comprises from about 400 to about 1200 μg RE preformed vitamin A and mixed carotenoids.  
     
     
         3 . The dietary supplement of  claim 1  wherein said supplement is formulated in tablet, powder, liquid, capsule or gel form, or dietary bar.  
     
     
         4 . The dietary supplement of  claim 3  wherein said supplement is formulated for once daily administration.  
     
     
         5 . The dietary supplement of  claim 1  comprising about 200 to about 300 mg calcium, about 100 to about 150 mg magnesium, about 0.7 to about 1.3 mg boron, about 0.7 to about 1.3 mg copper, about 2 to about 2.4 mg manganese, about 10 to about 12 mg zinc, about 200 to about 250 IU vitamin D, about 16 to about 18 mg iron, about 400 to about 420 μg folic acid, about 2 to about 4 μg vitamin B 12 , about 50 to about 65 mg vitamin B 6 , about 50 to about 75 μg chromium, about 100 to about 150 IU vitamin E, about 100 to about 150 mg vitamin C and about 8 to about 12 mg phytoestrogen in admixture with a biologically acceptable carrier.  
     
     
         6 . The dietary supplement of  claim 1  comprising about 200 mg calcium, about 100 mg magnesium, about 1 mg boron, about 1 mg copper, about 2 mg manganese, about 10 mg zinc, about 200 IU vitamin D, about 18 mg iron, about 400 μg folic acid, about 2 μg vitamin B 12 , about 50 mg vitamin B 6 , about 50 μg chromium, about 100 IU vitamin E, about 100 mg vitamin C and about 10 mg phytoestrogen in admixture with a biologically acceptable carrier.  
     
     
         7 . A dietary supplement for supplementing the nutritional needs of perimenopausal and menopausal women comprising from about 200 to about 1000 mg calcium; from about 100 to about 200 mg magnesium; from about 1.5 to about 2.5 mg boron; from about 1.5 to about 2.5 mg copper; from about 2.4 to about 3.6 mg manganese; from about 12 to about 15 mg zinc; from about 300 to about 400 IU vitamin D; from about 10 to about 15 mg iron; from about 400 to about 440 μg folic acid; from about 2 to about 15 μg vitamin B 12 ; from about 50 to about 100 mg vitamin B 6 ; from about 75 to about 200 μg chromium; from about 200 to about 400 IU vitamin E; from about 200 to about 1000 mg vitamin C; and from about 10 to less than 50 mg phytoestrogen in admixture with a biologically acceptable carrier.  
     
     
         8 . The dietary supplement of  claim 7  which further comprises from about 800 to about 1600 μg RE preformed vitamin A and mixed carotenoids.  
     
     
         9 . The dietary supplement of  claim 7  wherein said supplement is formulated in tablet, powder, liquid, capsule or gel form, or dietary bar.  
     
     
         10 . The dietary supplement of  claim 7  wherein said supplement is formulated for once daily administration.  
     
     
         11 . The dietary supplement of  claim 7  comprising from about 300 to about 400 mg calcium; from about 100 to about 150 mg magnesium; from about 1.7 to about 2.3 mg boron; from about 1.7 to about 2.3 mg copper; from about 2.6 to about 3.4 mg manganese; from about 12 to about 14 mg zinc; from about 300 to about 350 IU vitamin D; from about 13 to about 15 mg iron; from about 400 to about 420 μg folic acid; from about 2 to about 6 μg vitamin B 12 ; from about 50 to about 65 mg vitamin B 6 ; from about 75 to about 100 μg chromium; from about 200 to about 300 IU vitamin E; from about 200 to about 300 mg vitamin C; and from about 12 to about 17 mg phytoestrogen in admixture with a biologically acceptable carrier.  
     
     
         12 . The dietary supplement of  claim 7  wherein said supplement comprises about 300 mg calcium, about 150 mg magnesium, about 2 mg boron, about 2 mg copper, about 3 mg manganese, about 12 mg zinc, about 300 IU vitamin D, about 15 mg iron, about 400 μg folic acid, about 2 μg vitamin B 12 , about 50 mg vitamin B 6 , about 75 μg chromium, about 200 IU vitamin E, about 200 mg vitamin C, and about 15 mg phytoestrogen.  
     
     
         13 . A dietary supplement for supplementing the nutritional needs of post-menopausal women comprising about 200 to about 1500 mg calcium, about 150 to about 250 mg magnesium, about 2.5 to about 3.5 mg boron, about 2.5 to about 3.5 mg copper, about 4.4 to about 5.6 mg manganese, about 15 to about 18 mg zinc, about 300 to about 800 IU vitamin D, about 5 to about 10 mg iron, about 400 to about 440 μg folic acid, about 2 to about 18 μg vitamin B 12 , about 1.6 to about 10 mg vitamin B 6 , about 100 to about 200 μg chromium, about 350 to about 800 IU vitamin E, about 300 to about 1000 mg vitamin C and about 10 to less than 50 mg phytoestrogen in admixture with a biologically acceptable carrier.  
     
     
         14 . The dietary supplement of  claim 13  which further comprises from about 1200 to about 2000 μg RE preformed vitamin A and mixed carotenoids.  
     
     
         15 . The dietary supplement of  claim 13  wherein said supplement is formulated in tablet, powder, liquid, capsule, patch or gel form, or dietary bar.  
     
     
         16 . The dietary supplement of  claim 13  wherein said supplement is formulated for once daily administration.  
     
     
         17 . The dietary supplement of  claim 13  wherein said supplement comprises about 300 to about 500 mg calcium, about 150 to about 200 mg magnesium, about 2.7 to about 3.3 mg boron, about 2.7 to about 3.3 mg copper, about 4.6 to about 5.4 mg manganese, about 15 to about 17 mg zinc, about 350 to about 400 IU vitamin D, about 8 to about 10 mg iron, about 400 to about 420 μg folic acid, about 2 to about 8 μg vitamin B 12 , about 1.6 to about 3.2 mg vitamin B 6 , about 100 to about 150 μg chromium, about 350 to about 450 IU vitamin E, about 350 to about 450 mg vitamin C and about 12 to about 17 mg phytoestrogen in admixture with a biologically acceptable carrier.  
     
     
         18 . The dietary supplement of  claim 13  wherein said supplement comprises about 400 mg calcium, about 200 mg magnesium, about 3 mg boron, about 3 mg copper, about 5 mg manganese, about 15 mg zinc, about 400 IU vitamin D, about 10 mg iron, about 400 μg folic acid, about 2 μg vitamin B 12 , about 1.6 mg vitamin B 6 , about 100 μg chromium, about 400 IU vitamin E, about 400 mg vitamin C, and about 15 mg phytoestrogen in admixture with a biologically acceptable carrier.  
     
     
         19 . A series of nutritional supplements formulated for the lifestage associated nutritional needs of a woman comprising at least two of 
 (A) a composition for preperimenopausal women comprising about 200 to about 500 mg calcium, about 100 to about 200 mg magnesium, about 0.5 to about 1.5 mg boron, about 0.5 to about 1.5 mg copper, about 2 to about 2.6 mg manganese, about 10 to about 13 mg zinc, about 200 to about 300 IU vitamin D, about 12 to about 18 mg iron, about 400 to about 440 μg folic acid, about 2 to about 10 μg vitamin B 12 , about 50 to about 100 mg vitamin B 6 , about 50 to about 100 μg chromium, about 100 to about 200 IU vitamin E, about 100 to about 1000 mg vitamin C and about 8 to less than 50 mg phytoestrogen in admixture with a biologically acceptable carrier;    (B) a composition for perimenopausal and menopausal women comprising from about 200 to about 1000 mg calcium; from about 100 to about 200 mg magnesium; from about 1.5 to about 2.5 mg boron; from about 1.5 to about 2.5 mg copper; from about 2.4 to about 3.6 mg manganese; from about 12 to about 15 mg zinc; from about 300 to about 400 IU vitamin D; from about 10 to about 15 mg iron; from about 400 to about 440 μg folic acid; from about 2 to about 15 μg vitamin B 12 ; from about 50 to about 100 mg vitamin B 6 ; from about 75 to about 200 μg chromium; from about 200 to about 400 IU vitamin E; from about 200 to about 1000 mg vitamin C; and from about 10 to less than 50 mg phytoestrogen in admixture with a biologically acceptable carrier; and    (C) a composition for post-menopausal women comprising about 200 to about 1500 mg calcium, about 150 to about 250 mg magnesium, about 2.5 to about 3.5 mg boron, about 2.5 to about 3.5 mg copper, about 4.4 to about 5.6 mg manganese, about 15 to about 18 mg zinc, about 300 to about 800 IU vitamin D, about 5 to about 10 mg iron, about 400 to about 440 μg folic acid, about 2 to about 18 μg vitamin B 12 , about 1.6 to about 10 mg vitamin B 6 , about 100 to about 200 μg chromium, about 350 to about 800 IU vitamin E, about 300 to about 1000 mg vitamin C and about 10 to less than 50 mg phytoestrogen in admixture with a biologically acceptable carrier;    whereby the changing nutritional needs of a woman during preperimenopause, perimenopause and menopause, and post-menopause are supplemented.    
     
     
         20 . A once daily dietary supplement for supplementing the nutritional needs of peri-menopausal and/or menopausal women comprising less than about 20 mg phytoestrogen and a biologically acceptable carrier.  
     
     
         21 . The dietary supplement of  claim 20  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 thereof.  
     
     
         22 . The dietary supplement of  claim 20  wherein the phytoestrogen comprises about 4.726 mg daidzin, about 1.257 mg glycitin, about 5.312 mg genistin, about 0.586 mg malonyl daidzin, about 0.217 mg malonyl glycitin, about 0.510 mg malonyl genistin, about 0.670 mg acetyl daidzin, about 0.082 mg acetyl glycitin, about 0.595 mg acetyl genistin, about 0.0726 mg daidzein, about 0.062 mg glycitein, and about 0.060 mg genistein.  
     
     
         23 . The dietary supplement of  claim 20  wherein the phytoestrogen comprises about 31 to 35 wt % daidzin, about 8 to 10 wt % glycitin, about 36 to 40 wt % genistin, about 3 to 5 wt % malonyl daidzin, about 0.5 to 2.5 wt % malonyl glycitin, about 2.6 to 4.6 wt % malonyl genistin, about 3.7 to 5.7 wt % acetyl daidzin, about 0.1 to 1.1 wt % acetyl glycitin, about 3.2 to 5.2 wt % acetyl genistin, about 0.1 to 1.0 wt % daidzein, about 0.1 to 1.0 wt % glycitein, and about 0.1 to 0.9 wt % genistein.  
     
     
         24 . The dietary supplement of  claim 20  wherein the phytoestrogen is obtained from whole soybean extract.  
     
     
         25 . The dietary supplement of  claim 20  wherein the supplement comprises less than about 10 to about 15 mg phytoestrogen.  
     
     
         26 . The dietary supplement of  claim 20  wherein the supplement is formulated as a tablet, capsule, patch, gel, cream, chewing gum, powder, beverage, confectionary bar or cereal.  
     
     
         27 . 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 phytoestrogen per day.  
     
     
         28 . The method of  claim 26  wherein the amount of phytoestrogen administered is less than about 15 mg per day.  
     
     
         29 . The method of  claim 26  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 thereof.  
     
     
         30 . The method of  claim 26  wherein the phytoestrogen is obtained from whole soybean extract.  
     
     
         31 . The method of  claim 26  wherein the phytoestrogen comprises about 4.726 mg daidzin, about 1.257 mg glycitin, about 5.312 mg genistin, about 0.586 mg malonyl daidzin, about 0.217 mg malonyl glycitin, about 0.510 mg malonyl genistin, about 0.670 mg acetyl daidzin, about 0.082 mg acetyl glycitin, about 0.595 mg acetyl genistin, about 0.0726 mg daidzein, about 0.062 mg glycitein, and about 0.060 mg genistein.  
     
     
         32 . The dietary supplement of  claim 20  wherein the phytoestrogen comprises about about 31 to 35 wt % daidzin, about 8 to 10 wt % glycitin, about 36 to 40 wt % genistin, about 3 to 5 wt % malonyl daidzin, about 0.5 to 2.5 wt % malonyl glycitin, about 2.6 to 4.6 wt % malonyl genistin, about 3.7 to 5.7 wt % acetyl daidzin, about 0.1 to 1.1 wt % acetyl glycitin, about 3.2 to 5.2 wt % acetyl genistin, about 0.1 to 1.0 wt % daidzein, about 0.1 to 1.0 wt % glycitein, and about 0.1 to 0.9 wt % genistein.