Anaheim, Calif. (April 30, 2010) — Natural S-equol, a novel soy germ-based compound, is very likely the primary ingredient for reducing hot flushes in the dietary supplement SE5-OH, which is under development for reduction of menopause symptoms, according to pre-clinical efficacy data from studies using an animal model presented at the Experimental Biology (EB) 2010 annual meeting. SE5-OH is in advanced studies in menopausal women, and peer-reviewed reports have previously documented that postmenopausal Japanese women receiving SE5-OH containing Natural S-equol significantly reduced the frequency of their hot flushes compared to women in the same study receiving a placebo (P=0.0092).
“Recent clinical trials have documented the benefits of SE5-OH containing Natural S-equol for relief of hot flushes in U.S. and Japanese women. SE5-OH containing Natural S-equol is made by the fermentation of soy, and our new data strongly suggest that it is the Natural S-equol in SE5-OH that may be responsible for the beneficial effects on menopausal symptoms,” said Belinda H. Jenks, Ph.D., director of Scientific Affairs & Nutrition Education at Pharmavite LLC.
Pharmavite LLC, the makers of NatureMade® vitamins and minerals and a subsidiary of Otsuka Pharmaceutical Co., Ltd., is studying in clinical trials SE5-OH containing Natural S-equol in supplement form for the management of menopausal symptoms. Saga Nutraceuticals Research Institute of Otsuka Pharmaceutical Co., Ltd. developed the ingredient and has an ongoing research program to study SE5-OH containing Natural S-equol. Otsuka Pharmaceutical Co., Ltd., supported the research and data presented at the Experimental Biology annual meeting, and complete reports of the data from the study will be submitted for peer-review publication.
Soybeans contain a naturally occurring compound called daidzein that certain bacteria living within the human digestive tract can metabolize, or convert, into S-equol [7-hydroxy-3-(4′-hydroxyphenyl)-chroman]. 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 equol. Studies in Japan have documented an association between milder menopausal symptoms in equol producers as compared to non-producers.
Natural S-Equol in SE5-OH thought to be a critical component in reducing hot flushes
Investigators consider Natural S-Equol in SE5-OH to be the primary component in SE5-OH to reduce hot flushes based on measurement of modeled hot flushes in an animal study. The study also measured two reproductive hormones, estradiol (E2) and follicle stimulating hormone (FSH), as well as uterine weight in healthy female rats from which the ovaries had been surgically removed to simulate menopause and those that underwent a sham surgery, in which their ovaries were not removed, to account for the effects from the stress of the surgery. Treatments included SE5-OH containing Natural S-equol, purified Natural S-equol, a placebo and a conjugated estrogen, a drug approved by the U.S. Food and Drug Administration for the treatment of moderate to severe vasomotor symptoms due to menopause. Animal menopause studies commonly use conjugated estrogen as a comparison treatment to examine the efficacy of new potential treatments for the reduction of menopausal symptoms including hot flushes. All treatments began three days after the rats’ surgery and lasted for 38 days.
The study used a recognized validated animal model that simulates hot flush symptoms women can experience during menopause and post-menopause. The animal model involves measuring changes in the average temperatures of the rats’ tails, known as tail skin temperature (TST). In the study, rats underwent TST measures prior to ovary-removal or the sham surgery and then at weeks three, four and five after surgery during the treatment period. The average TST of a female rat is about 27 degrees Celsius (C), (about 80.6 degrees Fahrenheit). After ovary-removal surgery, the average TST increases for approximately seven weeks, resembling the human symptoms of hot flushes that temporarily occur after estrogen withdrawal because of menopause, and then cease with the time. A hot flush includes an intense sensation of heat along with the body’s activation of ways to dissipate heat, including the dilatation of skin blood vessels and sweating.
Daily doses of SE5-OH containing 11.7 milligrams (mg) per kilogram(kg) of body weight of Natural S-equol and of 11.7 mg/kg purified Natural S-equol were equally effective in suppressing the elevation of TST induced by the ovary-removal surgery. Both groups of rats had average TSTs significant below that of the rats receiving ovary-removal surgery and placebo, (27.1, 27.1 and 27.5 C, respectively at week three, P<0.05). Also, the rats receiving the conjugated estrogen drug as well as rats receiving placebo after sham surgery had significant suppression of average TST compared to that of rats receiving a placebo after ovary-removal surgery, (26.6, 26.9 and 27.5 C, respectively at week three, P<0.05). The significant differences in average TSTs between groups also occurred at weeks four and five.
SE5-OH containing Natural S-equol and purified Natural S-equol had no effects on the average levels of the two reproductive hormones E2 and FSH. E2 is the primary naturally occurring estrogen in women and is formed primarily in the ovary. FSH stimulates production of eggs and E2 during the first half of the menstrual cycle. Specifically, the rats receiving SE5-OH containing Natural S-equol, purified Natural S-equol and placebo after ovary-removal surgery had E2 levels of 14, 12 and 11 nanograms (ng) per milliliter (ml) of plasma respectively at the end of the study. Rats receiving conjugated estrogen drug or placebo after sham surgery had respective E2 levels of 4,016 and 44 ng/ml, both significantly different from the rats who received placebo after ovary-removal surgery, P<0.05 for both. FSH measures were 0.93, 0.91 and 0.81 ng/ml for rats receiving, respectively, SE5-OH containing Natural S-equol, purified Natural S-equol or placebo after ovary-removal surgery. Rats receiving conjugated estrogen drug, or placebo after sham surgery, had respective FSH levels of 0.39 and 0.04 ng/ml, both significantly different from rats who received placebo after ovary-removal surgery, p<0.05 for both.
The average weight of the rats’ uteruses did not differ between those who received SE5-OH containing Natural S-equol or purified Natural S-equol, 0.13 and 0.14 grams, respectively. The average weight of the rats receiving placebo after ovary-removal surgery was 0.12 grams. In contrast, rats receiving conjugated estrogen drug had dramatically greater average uterine weights due to its estrogenic effects, 0.61grams. The rats receiving placebo after sham surgery also had larger average uterine weights, 0.55 grams.
How SE5-OH is made
SE5-OH for the study was created under current Good Manufacturing Practices using the equol-producing lactic acid bacterial strain Lactococcus 20-92 in a patented and proprietary process by the Otsuka Pharmaceutical Co., Ltd. The patented fermentation process converts daidzein, a naturally occurring compound in soy germ, to Natural S-equol, steadily increasing the concentration of Natural S-equol until reaching a maximum concentration at 72 to 96 hours and decreasing daidzein by 95 percent. Following fermentation, the SE5-OH powder undergoes a sterilization process using heat denaturation that deactivates the bacteria. The process is designed to produce a product rich in Natural S-equol that can be used as a nutraceutical ingredient.
EB Presentation
Tuesday April 27, 2010, Poster # A80
Effects of fermented soy food containing natural S-equol on tail skin temperature in ovariectomized rats
Takeshi Yoneda, Ph.D., Tomomi Ueno, M.S., Soh Iwashita, Ph.D., and Shigeto Uchiyama, M.S., (Saga Nutraceuticals Research Institute, Otsuka Pharmaceutical Co, LTD, in Saga, Japan).
About the Experimental Biology 2010 meeting
The six sponsoring societies for Experimental Biology 2010 are: the American Association of Anatomists (AAA), The American Physiological Society (APS), American Society for Biochemistry and Molecular Biology (ASBMB), American Society for Investigative Pathology (ASIP), American Society for Nutrition (ASN) and American Society for Pharmacology and Experimental Therapeutics (ASPET).
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 153 companies and employs approximately 36,000 people in 23 countries and regions worldwide. Otsuka and its consolidated subsidiaries earned ¥955.9 billion (approx. US $9.7 billion*) in annual revenues in fiscal 2008. * Exchange rate as of March 31, 2009.
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