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Soybean Diet and Breast Density

Phase 2
30 Years
40 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Soybean Diet and Breast Density

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 will be assessed by
radiological techniques. The efficacy of the dietary intervention will be determined by
comparing mean changes of ovarian steroids and dense breast tissue 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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

mammographic density

Outcome Time Frame:

once per year for two years

Safety Issue:


Principal Investigator

Lee-Jane W Lu, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Texas Medical Branch, Galveston, TX 77555


United States: Federal Government

Study ID:




Start Date:

April 2002

Completion Date:

January 2015

Related Keywords:

  • Breast Cancer
  • soy diet
  • breast cancer
  • ovarian hormones
  • breast density
  • prevention
  • Breast Neoplasms



General Clinical Research Center, The University of Texas Medical Branch Galveston, Texas  77555-0264