Soy Protein and Breast Cancer Risk Reduction
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 30 - 40 |
| Updated: | 3/17/2019 |
| Start Date: | April 2002 |
| End Date: | April 30, 2020 |
Soybean Diet and Breast Density
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.
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.
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.
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.
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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