Effect of Dietary Soy on Estrogens in Breast Fluid, Blood, and Urine Samples From Healthy Women
NCT ID: NCT00513916
Last Updated: 2013-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
100 participants
INTERVENTIONAL
2006-07-31
2012-02-29
Brief Summary
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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
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* 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
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Keywords
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Study Design
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RANDOMIZED
PREVENTION
Study Groups
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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.
soy isoflavones
High or low dose of soy isoflavones in the diet.
Arm II
Participants will be asked to keep their soy intake below 3 servings per week. The participants will also receive general nutrition counseling.
soy isoflavones
High or low dose of soy isoflavones in the diet.
Interventions
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soy isoflavones
High or low dose of soy isoflavones in the diet.
Eligibility Criteria
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Inclusion Criteria
* Healthy participant
* No diagnosis of cancer
PATIENT CHARACTERISTICS:
* Premenopausal
* Regular menstrual cycles
PRIOR CONCURRENT THERAPY:
* Not taking birth control pills or other hormones
30 Years
45 Years
FEMALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
University of Hawaii Cancer Research Center
OTHER
Responsible Party
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Cancer Research Center of Hawaii
Principal Investigators
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Gertraud Maskarinec, MD, PhD
Role: STUDY_CHAIR
University of Hawaii Cancer Research Center
Locations
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Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
Countries
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References
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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.
Other Identifiers
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UHM-CHS-4116
Identifier Type: -
Identifier Source: secondary_id
CDR0000560821
Identifier Type: -
Identifier Source: org_study_id