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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Hawaii
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Honolulu, Hawaii, United States, 96813
- Cancer Research Center of Hawaii
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Healthy participant
- No diagnosis of cancer
PATIENT CHARACTERISTICS:
- Premenopausal
- Regular menstrual cycles
PRIOR CONCURRENT THERAPY:
- Not taking birth control pills or other hormones
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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. |
High or low dose of soy isoflavones in the diet.
|
|
Active Comparator: Arm II
Participants will be asked to keep their soy intake below 3 servings per week.
The participants will also receive general nutrition counseling.
|
High or low dose of soy isoflavones in the diet.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
Effect of two daily servings of soy on estrogen levels in nipple aspirate fluid (NAF) and serum
|
|
Cytologic patterns of epithelial breast cells obtained from NAF
|
|
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
|
|
Comparison of estrogen levels in NAF and serum measured at the same time during luteal phase
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Gertraud Maskarinec, MD, PhD, University of Hawaii Cancer Research Center
Publications and helpful links
General Publications
- Sen C, Morimoto Y, Heak S, Cooney RV, Franke AA, Maskarinec G. Soy foods and urinary isoprostanes: results from a randomized study in premenopausal women. Food Funct. 2012 May;3(5):517-21. doi: 10.1039/c2fo10251j. Epub 2012 Feb 14.
- Maskarinec G, Morimoto Y, Conroy SM, Pagano IS, Franke AA. The volume of nipple aspirate fluid is not affected by 6 months of treatment with soy foods in premenopausal women. J Nutr. 2011 Apr 1;141(4):626-30. doi: 10.3945/jn.110.133769. Epub 2011 Feb 16.
- Maskarinec G, Suzuki S, Pagano IS, Morimoto Y, Franke AA, Ehya H. Cytology in nipple aspirate fluid during a randomized soy food intervention among premenopausal women. Nutr Cancer. 2013;65(8):1116-21. doi: 10.1080/01635581.2013.833638. Epub 2013 Oct 15.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000560821
- UHM-CHS-4116
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