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Dietary Supplement
Soy Protein for Breast Cancer Risk Reduction
Phase 2
Waitlist Available
Led By Lee-Jane W Lu, Ph.D.
Research Sponsored by The University of Texas Medical Branch, Galveston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will compare the effects of soy and casein proteins on ovarian hormones and breast density in premenopausal women.
Who is the study for?
This trial is for healthy premenopausal women aged 30 to 40 with normal mammograms and regular menstrual cycles. It's not for those on hormonal treatments, with a family history of breast cancer, abnormal mammograms, menopause symptoms, dietary restrictions, soy or cow's milk allergies, pregnancy or breastfeeding, or who've had certain breast procedures.Check my eligibility
What is being tested?
The study is examining if drinking soy milk instead of cow's milk can reduce hormones linked to breast cancer and decrease breast density—a potential risk factor. Participants will consume either soy protein or casein protein to see the effects on their bodies.See study design
What are the potential side effects?
While the trial primarily involves dietary changes (soy vs. cow's milk), side effects may include digestive discomfort due to intolerance or allergy to soy products in individuals who are unaware of such sensitivities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Breast Tissue Composition Measured by MRI
Mammographic Density (1 Year)
Mammographic Density (2 Years)
+2 moreSecondary outcome measures
Blood will be measured for standard clinical chemistries
Estradiol (pg/ml)
Other outcome measures
Blood Will be Measured for Standard Clinical Chemistries
Progesterone (ng/ml)
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Soy milkActive Control1 Intervention
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.
Group II: Cow's milkPlacebo Group1 Intervention
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.
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Who is running the clinical trial?
U.S. Army Medical Research and Development CommandFED
287 Previous Clinical Trials
245,588 Total Patients Enrolled
4 Trials studying Breast Cancer
665 Patients Enrolled for Breast Cancer
National Center for Research Resources (NCRR)NIH
537 Previous Clinical Trials
316,695 Total Patients Enrolled
5 Trials studying Breast Cancer
680 Patients Enrolled for Breast Cancer
The University of Texas Medical Branch, GalvestonLead Sponsor
246 Previous Clinical Trials
56,479 Total Patients Enrolled
9 Trials studying Breast Cancer
517 Patients Enrolled for Breast Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are between 30 and 40 years old.You have had surgery on your breasts to make them bigger, smaller, or lifted.Your close family members have had breast cancer.You have unusual results on your mammogram.You have received normal results from your mammogram.You are around the age when women typically stop having their monthly period, or you have already stopped having it.You are currently following a specific diet prescribed by a doctor.You are allergic to soy or cow's milk.Women who are not yet going through menopause and are in good health.You have a regular period.
Research Study Groups:
This trial has the following groups:- Group 1: Cow's milk
- Group 2: Soy milk
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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