Clinical study data on Natural S-equol supplement presented at NAMS Annual Meeting

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

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.