Clinical trial · Interventional
Soy Isoflavones and Breast Cancer Risk Reduction
Mammographic Density and Soy Isoflavones
NCT00204490CI-TRIAL-00077164completedPhase 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. Soy contains isoflavones which are weak estrogens. The roles of soy isoflavones in reducing breast cancer risk are currently unclear. Breast density has been considered as a breast cancer risk marker. We hypothesize that because isoflavones have estrogen-like activities, breast density and possibly bone density will be lower in women on soy-isoflavones.
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 |
|---|---|---|---|
| carbohydrate | Dietary Supplement | — | UNRESOLVED |
| isoflavones | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- soy isoflavones
- interventionNames
- Dietary Supplement: isoflavones
- type
- PLACEBO_COMPARATOR
- label
- 2
- description
- carbohydrates (maltodextrin)
- interventionNames
- Dietary Supplement: carbohydrate
Primary outcomes (2)
- measure
- Fibroglandular Tissue in Total Breast (FGBT%)
- timeFrame
- baseline, and after year 1 and 2 of supplementation
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 42 Years
Show eligibility criteria text
Inclusion Criteria: * healthy premenopausal women * 30 to 42 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 or lifting * on oral contraceptive medications or exogenous hormones * medically prescribed diets * allergic reaction to soy products
References
Publications (4)
- DERIVEDLu LW, Chen NW, Brunder DG, Nayeem F, Nagamani M, Nishino TK, Anderson KE, Khamapirad T. Soy isoflavones decrease fibroglandular breast tissue measured by magnetic resonance imaging in premenopausal women: A 2-year randomized double-blind placebo controlled clinical trial. Clin Nutr ESPEN. 2022 Dec;52:158-168. doi: 10.1016/j.clnesp.2022.10.007. Epub 2022 Oct 26. PMID 36513449
- DERIVEDLu LW, Chen NW, Nayeem F, Nagamani M, Anderson KE. Soy isoflavones interact with calcium and contribute to blood pressure homeostasis in women: a randomized, double-blind, placebo controlled trial. Eur J Nutr. 2020 Sep;59(6):2369-2381. doi: 10.1007/s00394-019-02085-3. Epub 2019 Sep 18. PMID 31535213
- DERIVEDLu LW, Chen NW, Nayeem F, Ramanujam VS, Kuo YF, Brunder DG, Nagamani M, Anderson KE. Novel effects of phytoestrogenic soy isoflavones on serum calcium and chloride in premenopausal women: A 2-year double-blind, randomized, placebo-controlled study. Clin Nutr. 2018 Dec;37(6 Pt A):1862-1870. doi: 10.1016/j.clnu.2017.11.002. Epub 2017 Nov 11. PMID 29183775
- 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