Soy Isoflavones and Breast Cancer Risk Reduction
May 8, 2024 updated by: The University of Texas Medical Branch, Galveston
Mammographic Density and Soy Isoflavones
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a randomized, double-blind study, with two arms and 100 women in each arm.
Premenopausal women will be recruited and randomly allocated to take one of the two different dietary supplements in pills daily for 2 years.
The two supplements are soy isoflavones (treatment) and placebo (carbohydrates).
Both treatment and placebo pills will contain multi-vitamins and minerals.
Multiple blood, urine, and breast fluid samples will be obtained before and during the dietary supplement periods and analyzed for biomarkers of breast cancer risk.
At baseline and after the intervention period, breast density and bone density will be assessed by radiologic techniques.
The efficacy of the dietary intervention will be determined by comparing mean changes of serum markers for breast cancer risk,dense breast tissue, and bone mineral density over the two year dietary intervention period in the two supplement groups with adjustment for baseline values and individual patient characteristics of interest.
We predict that 2 years of soy isoflavone supplement will reduce breast density, which may be explained by individual changes in serum markers of breast cancer risk.
Study Type
Interventional
Enrollment (Actual)
197
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Galveston, Texas, United States, 77555-0264
- General Clinical Reserach Center, The University of Texas Medical Branch
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 42 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
soy isoflavones
|
soy isoflavones: Each tablet contains 246 mg Novasoy, 676 mg calcium, 15 mg riboflavin, and other innert materials to a total weight of 1000 mg.
Subject takes two isoflavone tablets plus 1 multi-vitamin per day for five days per week for upto 2 years.
Other Names:
|
|
Placebo Comparator: 2
carbohydrates (maltodextrin)
|
carbohydrate: 246 mg maltodextrin, 676 mg calcium, 15 mg riboflavin and other innert ingredients to a total weight of 1000 mg per tablet.
subject takes two tablets plus one multivitamin per day for five days per week for upto 2 years.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fibroglandular Tissue in Total Breast (FGBT%)
Time Frame: baseline, and after year 1 and 2 of supplementation
|
Effects of 1 and 2 years of treatment with isoflavones on percent of changes in FGBT%.
|
baseline, and after year 1 and 2 of supplementation
|
|
Breast Density by Mammography
Time Frame: baseline, and after year 1 and 2 of supplementation
|
Area of FGBT in mammogram.
The timepoints were combined and summed.
|
baseline, and after year 1 and 2 of supplementation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bone Mineral Density
Time Frame: one and two years after dietary supplement
|
Bone mineral density of hip, spine and whole body bone mineral density as measured by dual x-ray absorptiometry.
The timepoints were combined and summed.
|
one and two years after dietary supplement
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lee-Jane W Lu, Ph.D., The University of Teas Medical Branch
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lu 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.
- Lu 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.
- Lu 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2004
Primary Completion (Actual)
December 10, 2012
Study Completion (Actual)
May 31, 2023
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimated)
September 20, 2005
Study Record Updates
Last Update Posted (Actual)
May 16, 2024
Last Update Submitted That Met QC Criteria
May 8, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03-260
- M01RR000073 (U.S. NIH Grant/Contract)
- 1UL1RR029876-01 (U.S. NIH Grant/Contract)
- UTMB GCRC #635 (Other Identifier: UTMB ITSCRC)
- R01CA095545 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.