Clinical trial · Interventional
Soy Protein and Breast Cancer Risk Reduction
Soybean Diet and Breast Density
NCT00204477CI-TRIAL-00073210completedPhase 2Results postedClinicalTrials.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)
Soy consumption has been associated with reduced risk for developing breast cancer. Ovarian hormones and breast density are considered breast cancer risk markers. We propose to test the hypothesis that consumption of soy protein reduces ovarian steroid hormones and results in a corresponding reduction in breast density comparing to casein protein.
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cow's milk | Dietary Supplement | — | UNRESOLVED |
| soy milk | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Soy milk
- description
- Subjects will consume two soy milk drinks from the content of 2 sachets (40 g isoflavone-free soy protein and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g soy protein and 300 mg calcium. Content of sachets will be mixed with \~1.6 liter of water for ingestion.
- interventionNames
- Dietary Supplement: soy milk
- type
- PLACEBO_COMPARATOR
- label
- Cow's milk
- description
- Subjects will consume two cow's milk drinks from the content of 2 sachets (40 g cow's milk protein, casein, and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g cow's milk protein and 300 mg calcium. Content of sachets will be mixed with \~1.6 liter of water for ingestion. Casein is free of ovarian hormones.
- interventionNames
- Dietary Supplement: cow's milk
Primary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * healthy premenopausal women * 30 to 40 years old * normal mammograms * regular menstrual cycles Exclusion Criteria: * abnormal mammograms * first degree relatives with breast cancer * pregnant or lactating * peri- or post-menopause * breast augmentation, reduction, and lifting * on oral contraceptive medications or exogenous hormones * medically prescribed diets * allergic reaction to soy or cow's milk
References
Publications (2)
- DERIVEDLu LJ, Nishino TK, Johnson RF, Nayeem F, Brunder DG, Ju H, Leonard MH, Grady JJ, Khamapirad T. Comparison of breast tissue measurements using magnetic resonance imaging, digital mammography and a mathematical algorithm. Phys Med Biol. 2012 Nov 7;57(21):6903-27. doi: 10.1088/0031-9155/57/21/6903. Epub 2012 Oct 9. PMID 23044556
- DERIVEDNayeem F, Anderson KE, Nagamani M, Grady JJ, Lu LJ. Alkaline phosphatase and percentage body fat predict circulating C-reactive protein in premenopausal women. Biomarkers. 2010 Dec;15(8):663-70. doi: 10.3109/1354750X.2010.509811. Epub 2010 Sep 29. PMID 20874659