Effects of a 2-Year Randomized Soy Intervention on Sex Hormone Levels in Premenopausal Women

Objective: Several epidemiologic studies have de-scribed protective effects of soy consumption against breast cancer. The goal of this trial among premeno-pausal women was to examine the effect of soy foods on menstrual cycle length and circulating sex hormone levels. Methods: This 2-year dietary intervention randomized 220 healthy premenopausal women. The intervention group consumed two daily servings of soy foods containing f50 mg of isoflavones; the control group maintained their regular diet. Five blood samples (obtained in months 0, 3, 6, 12, and 24) were taken 5 days after ovulation as determined by an ovulation kit. The serum samples were analyzed for estrone, estradiol, sex hormone binding globulin, androstenedione, and progesterone by immunoassay. Results: At baseline, both groups had similar demo-graphic, anthropometric, and nutritional characteristics. The dropout rates of 15.6 % (17 of 109) in the interven-tion group and 12.6 % (14 of 111) in the control group did not differ significantly. According to soy intake logs, 24-hour recalls, and urinary isoflavone excretion, the women closely adhered to the study regimen. Menstrual cycles became slightly shorter in both groups but did not differ by group. Mixed general linear models indicated no significant intervention effect on any of the serum hormones. However, androstenedione and progesterone decreased significantly over time in both groups. Conclusions: The results of this study suggest that the preventive effects of soy on breast cancer risk in premenopausal women may not be mediated by circu-lating sex hormone levels. Different mechanisms of actions or effects of exposure earlier in life are alternate hypotheses that require further investigation. (Cancer Epidemiol Biomarkers Prev 2004;13(11):1736–44