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Tip sheet: Soy-based natural S-equol supplement data presented from 4 studies at the North American Menopause Society Annual Meeting

First US study documenting reduced menopausal hot flashes and muscle and joint pain, additional data on bone health, cholesterol effects and safety

Porter Novelli

Four clinical studies that add to the evidence about the use of a new nutritional supplement containing the whole soy germ-based ingredient Natural S-equol to improve health were presented at the North American Menopause Society (NAMS) Annual Meeting. These studies include a poster about a first-of-its-kind study in U.S. women that documents the effectiveness of Natural S-equol in reducing the frequency of moderate to severe hot flashes and reducing muscle and joint pain. A second poster reported the first clinical study about Natural S-equol contributions to bone health. Additional studies examined the supplement's effect on "bad" LDL-cholesterol and its safety. The findings are summarized below. Additional information about Natural S-equol, including how it is made, is at www.naturalequol.com.

The data will be presented in the Poster Session, Thursday, Oct. 7, 2010 5:15 PM CDT (6:15 PM EDT).

Natural S-equol Supplement Reduces Menopausal Hot Flashes in U.S. Women
Eight weeks of daily doses of a whole soy germ -based supplement containing Natural S-equol were better or similar to daily doses of soy isoflavones in reducing the frequency of moderate to severe hot flashes, in the first comparison study of its kind among U.S. postmenopausal women. More women taking Natural S-equol achieved a 50 percent or more reduction in their average daily hot flash frequency than those receiving the isoflavones. Moreover, muscle and joint pain reduced more for those taking Natural S-equol compared to those taking the isoflavones.
Poster P-22
Efficacy and safety of natural S-equol supplement in US postmenopausal women.
Belinda H. Jenks of Scientific Affairs, Pharmavite LLC, Northridge, CA, et.al.

Natural S-equol Inhibits Bone Break Down, Prevents Bone Mineral Density Loss
In the first study to document evidence in postmenopausal Japanese women that the Natural S-equol supplement given for 12 months significantly inhibited bone break down, or resorption, the supplement also significantly prevented a decrease in whole body bone mineral density, compared to a placebo.
Poster P-79
Effect of natural S-equol on bone metabolism in equol non-producing postmenopausal Japanese women: a pilot randomized placebo-controlled trial.
Tomomi Ueno of Saga Nutraceutricals Research Institute, Otsuka Pharmaceutical Co., Ltd., Japan, et.al.

Natural S-equol Lowers "Bad" LDL-Cholesterol in the Obese
After three months of daily doses of the Natural S-equol supplement, obese Japanese adult men and women significantly lowered their blood levels of "bad" low-density lipoprotein (LDL), compared to those receiving a placebo.
Poster P-78
The effect of equol on obesity and metabolic syndrome in Japanese, from the standpoint of gender and equol producing capability.
Shigeto Uchiyama of Saga Nutraceuticals Research Institute, Otsuka Pharmaceutical Co., Ltd., Japan, et. al.

Safety Data from 12-Week Study of Natural S-equol Use in Japanese Women
Investigators identified no safety problems or serious adverse events, particularly in the female reproductive system, among healthy Japanese postmenopausal women who took daily doses of the Natural S-equol supplement for 12 weeks, compared to those receiving a placebo. The investigators found no abnormal changes in blood concentrations of five hormones when measured at the study start and at weeks four, eight and 12 of the study. Also, ultrasound measures of the thickness of the lining of the uterus and cellular studies of the tissue lining the vagina identified no biological effects of the supplement on the women's reproductive organs. Furthermore, mammography results documented no differences among the women.
Poster P-46
Japan safety assessments of natural S-equol supplement by consecutive ingestion to postmenopausal Japanese women.
Ayuko Oyama of Saga Nutraceuticals Research Institute, Otsuka Pharmaceutical Co., Ltd., Japan, et. al.

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About Natural S-equol

S-equol is a compound resulting -- when certain bacteria are present in the digestive tract -- from the natural metabolism, or conversion, of daidzein, an isoflavone found in whole soybeans. Not everyone can produce S-equol after soy consumption, as the production depends on the types of bacteria present in the large intestine and may be influenced by the amount of soy consumed. About 50 percent of Asians and 20 to 30 percent of North Americans and Europeans, who in general consume less soy than Asians, have the ability to produce S-equol. Research indicates that Japanese women have documented milder menopausal symptoms in those who are S-equol producers compared to nonproducers. Also, previous clinical trials have documented the effectiveness of Natural S-equol to manage menopausal symptoms in Japanese women who are S-equol nonproducers. S-equol selectively binds to the receptors for the naturally occurring female sex hormone estrogen, with a strong affinity to the estrogen receptor beta. On binding to these receptors, S-equol mimics some, but not all, activities of natural estrogen. Because of these actions at the receptor, it has been proposed that S-equol may alleviate some of the symptoms caused by diminished estrogen production during menopause.

How SE5-OH is Made

All four studies presented at NAMS used supplement tablets that contained Natural S-equol. The SE5-OH is the product of fermentation of whole soy germ by the bacterial strain Lactococcus 20-92 using a patented and proprietary process by the Otsuka Pharmaceutical Co., Ltd. The process results in the conversion of the daidzein to S-equol. SE5-OH is created under current Good Manufacturing Practices. Following fermentation, the bacteria undergo heat denaturation and are deactivated. The process is designed to produce a Natural S-equol rich product, or nutraceutical ingredient. The ingredient has self-affirmed GRAS (Generally Recognized As Safe) status.

Development and ongoing research of SE5-OH containing Natural S-equol is conducted by the Saga Nutraceuticals Research Institute of Otsuka Pharmaceutical Co., Ltd. Pharmavite LLC, the makers of Nature Made® vitamins and minerals and a subsidiary of Otsuka, is studying SE5-OH containing Natural S-equol in supplement form for the management of menopausal symptoms.

About Pharmavite LLC: For almost 40 years, Pharmavite has earned and maintained the trust of healthcare professionals, consumers, and retailers by manufacturing high-quality vitamins, minerals, herbs and other dietary supplements that are safe, effective and science-based. Nature Made® is the number one selling dietary supplement brand in the food, drug, club and mass channels. The dietary supplement industry is regulated by the U.S. Food and Drug Administration and the Federal Trade Commission, as well as by government agencies in each of the 50 states.

About Otsuka Pharmaceutical Co., Ltd.: Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: 'Otsuka-people creating new products for better health worldwide.' Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and consumer products for the maintenance of everyday health. Otsuka is committed to being a corporation that creates global value, adhering to the high ethical standards required of a company involved in human health and life, maintaining a dynamic corporate culture, and working in harmony with local communities and the natural environment. Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., the holding company for the Otsuka Group. The Otsuka Group comprises 145 companies and employs approximately 39,000 people in 23 countries and regions worldwide. Otsuka and its consolidated subsidiaries earned ¥1,084.2 billion (approx. US $11.7 billion*) in annual revenues in fiscal 2009. Visit Otsuka Pharmaceutical Co., Ltd. at www.otsuka-global.com.

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