At enrollment, the women had not experienced a menstrual period in the previous 12 months and their levels of follicle stimulating hormone (FSH) were 40 or more milli international units/milliliter, a marker of menopause. The women were in good health. Investigators did not enroll anyone with a history of breast, ovarian or uterine cancer or endometrial hyperplasia, with a body mass index of 33 kilograms per meters squared or more or who had used hormone replacement therapy within 90 days of the study or soy, phytoestrogens or certain other supplements within 30 days of the study, as well as fitting certain other exclusion criteria.
Investigators randomized the 102 women into four groups to consume twice daily either the isoflavone (26 women) or one of the three doses of the S-equol supplement (24 in the 10 mg, 27 in the 20 mg and 25 in the 40 mg groups). The lowest dose of S-equol used, 10 mg, was based on preliminary studies that investigated the relationship between S-equol and menopausal symptoms including hot flashes in Japanese women, while the higher doses were used to reflect the larger body mass in Western women and to establish a dose response. The S-equol supplement tablets each contained 5.0 mg S-equol, 1.0 mg daidzein, 1.1 mg genistein, and 2.5 mg glycitein. The soy isoflavone tablets contained 24 mg daidzein, 22 mg genistein, and 2.0 mg glycitein as aglycone equivalent. The placebo tablets contained lactose.
The women had diets controlled for soy foods, isoflavones and lignans, compounds found in certain plants that are known as phytoestrogens because of their estrogen-like properties. The study included a seven-day period before the treatment weeks to allow for elimination of any women who responded to a placebo. Women also were tested to determine their ability to pro
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