Clinical trial · Interventional
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
NCT00513916CI-TRIAL-00013104completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Healthy, no Evidence of Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| soy isoflavones | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- 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.
- interventionNames
- Dietary Supplement: soy isoflavones
- type
- ACTIVE_COMPARATOR
- label
- Arm II
- description
- Participants will be asked to keep their soy intake below 3 servings per week. The participants will also receive general nutrition counseling.
- interventionNames
- Dietary Supplement: soy isoflavones
Primary outcomes (4)
- measure
- Effect of two daily servings of soy on estrogen levels in nipple aspirate fluid (NAF) and serum
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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
References
Publications (3)
- RESULTSen 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. PMID 22331037
- RESULTMaskarinec 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. PMID 21325473
- DERIVEDMaskarinec 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. PMID 24127645