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Spots Global Cancer Trial Database for Effect of Dietary Soy on Estrogens in Breast Fluid, Blood, and Urine Samples From Healthy Women

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Trial Identification

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

Official Title: Effects of Soy on Estrogens in Breast Fluid and Urine

Study ID: NCT00513916

Interventions

soy isoflavones

Study Description

Brief 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.

Eligibility

Minimum Age: 30 Years

Eligible Ages: ADULT

Sex: FEMALE

Healthy Volunteers: Yes

Locations

Cancer Research Center of Hawaii, Honolulu, Hawaii, United States

Contact Details

Name: Gertraud Maskarinec, MD, PhD

Affiliation: University of Hawaii Cancer Research Center

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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