Breast Cancer Clinical Trial
Soy Protein and Breast Cancer Risk Reduction
Summary
Soy consumption has been associated with reduced risk for developing breast cancer. Ovarian hormones and breast density are considered breast cancer risk markers. We propose to test the hypothesis that consumption of soy protein reduces ovarian steroid hormones and results in a corresponding reduction in breast density comparing to casein protein.
Full Description
The aims will be tested by conducting a randomized, double-blind study, with two arms and 100 women in each arm. Premenopausal women will be recruited and randomly allocated to take one of two different dietary supplements daily for 2 years. The two test diets soy protein drink and caseinate protein drink. Multiple blood, urine, and breast fluid samples will be obtained before and during the dietary intervention period and analyzed for ovarian hormones. At baseline and after the intervention period, breast density, and bone density will be assessed by radiological techniques at baseline and 1 yr and 2 yr after protein drink supplementation. The efficacy of the dietary intervention will be determined by comparing mean changes of ovarian steroids, and density of the breast and bone tissues over the 2 year dietary intervention period in the two diet groups with adjustment for baseline values and individual patient characteristics of interest. We predict that 2 years of soya dietary supplements will reduce breast density, which will be explained by individual hormonal changes.
Eligibility Criteria
Inclusion Criteria:
healthy premenopausal women
30 to 40 years old
normal mammograms
regular menstrual cycles
Exclusion Criteria:
abnormal mammograms
first degree relatives with breast cancer
pregnant or lactating
peri- or post-menopause
breast augmentation, reduction, and lifting
on oral contraceptive medications or exogenous hormones
medically prescribed diets
allergic reaction to soy or cow's milk
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There is 1 Location for this study
Galveston Texas, 77555, United States
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