Healthy pre-and post-menopausal Japanese women who took a supplement of SE5-OH containing Natural S-equol, a novel soy germ-based ingredient under development for the management of menopausal symptoms, had measures of reproductive hormones that stayed within normal limits throughout the study. These peer-reviewed safety data were presented at the American Medical Women’s Association (AMWA) 2010 annual meeting. A second safety study presented at AMWA documented that SE5-OH containing Natural S-equol consumption did not change the length of menstrual cycles in healthy pre-menopausal Japanese women. An earlier peer-review study in postmenopausal Japanese women documented that those receiving SE5-OH containing Natural S-equol reduced the frequency of hot flashes significantly compared to the women in the same study receiving a placebo (p=0.0092).
“SE5-OH containing Natural S-equol may be an appropriate dietary supplement ingredient for women undergoing menopause, as it has recently been studied in clinical trials for its benefits for relief of hot flushes in U.S. and Japanese women. The new safety data documents that in healthy women SE5-OH containing Natural S-equol does not appear to influence the normal concentrations of endocrine hormones, the normal endometrium thickness or normal menstrual cycle length and appears to be well tolerated,” said Belinda H. Jenks, Ph.D., director of Scientific Affairs & Nutrition Education at Pharmavite LLC, and an author of the study.
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 AMWA, and complete reports of the data from both safety studies 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 …