Expired Study
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Galveston, Texas 77555


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00204477


Primary Contact:

Principal Investigator
Lee-Jane W Lu, Ph.D.
The University of Texas Medical Branch, Galveston, TX 77555


Backup Contact:

N/A


Location Contact:

Galveston, Texas 77555
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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