NCT00513916

Effect of Dietary Soy on Estrogens in Breast Fluid, Blood, and Urine Samples From Healthy Women

Effects of Soy on Estrogens in Breast Fluid and Urine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Hawaii Cancer Research Center · Academic / Other
• Sex: Female
• Age: 30 Years – 45 Years
• Healthy volunteers: Accepted

Summary

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. Eating a diet high in isoflavones, compounds found in soy foods, may keep cancer from forming. PURPOSE: This randomized phase III trial is studying the effects of dietary soy on estrogens in breast fluid, blood, and urine samples from healthy women.

Detailed description

OBJECTIVES: * Examine the effects of two daily servings of soy on estrogen levels in nipple aspirate fluid (NAF) and serum. * Investigate cytologic patterns of epithelial breast cells obtained from NAF as a measure of proliferation in relation to soy intake. * Explore the effect of two daily servings of soy on cytochrome alterations of estrogen metabolism as expressed in the formation of urinary 2-, 16α-, and 4-hydroxy estrogen metabolites. * Compare estrogen levels in NAF and serum measured at the same time during the luteal phase. OUTLINE: This is a multicenter study. Participants are randomized to 1 of 2 intervention arms. * Arm I: Participants partake in a high soy diet consisting of 2 daily soy servings (approximately 50mg isoflavones). The choice of soy foods will include ½ cup of tofu, ¾ cup of soy milk, or ¼ cup of soy nuts. Replacement of currently consumed foods with soy foods will be encouraged. * Arm II: Participants will be asked to keep their soy intake below 3 servings per week. The participants will also receive general nutrition counseling. In both arms, intervention continues for 6 months. After 6 months, participants undergo a 1-month washout period and then cross-over to the other intervention arm. Nipple aspirate fluid, urine, and blood samples are collected periodically to measure laboratory endpoints.

Conditions

• Breast Cancer
• Healthy, no Evidence of Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	soy isoflavones	High or low dose of soy isoflavones in the diet.

Timeline

• Start date: 2006-07-01
• Primary completion: 2011-02-01
• Completion: 2012-02-01
• First posted: 2007-08-09
• Last updated: 2013-12-19

Locations

1 site across 1 country: United States