Effects of Soy on Estrogens in Breast Fluid and Urine
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.
Interventional
Allocation: Randomized, Primary Purpose: Prevention
Effect of two daily servings of soy on estrogen levels in nipple aspirate fluid (NAF) and serum
No
Gertraud Maskarinec, MD, PhD
Study Chair
University of Hawaii Cancer Research Center
United States: Federal Government
CDR0000560821
NCT00513916
July 2006
Name | Location |
---|---|
Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |