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Soy Protein and Breast Cancer Risk Reduction

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ClinicalTrials.gov Identifier: NCT00204477
Recruitment Status : Active, not recruiting
First Posted : September 20, 2005
Last Update Posted : July 9, 2018
Sponsor:
Collaborators:
U.S. Army Medical Research and Materiel Command
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Dietary Supplement: soy milk Dietary Supplement: cow's milk Phase 2

Detailed Description:
The aims will be tested by conducting 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 two different dietary supplements daily for 2 years. The two test diets soy protein drink and caseinate protein drink. Multiple blood, urine, and breast fluid samples will be obtained before and during the dietary intervention period and analyzed for ovarian hormones. At baseline and after the intervention period, breast density, and bone density will be assessed by radiological techniques at baseline and 1 yr and 2 yr after protein drink supplementation. The efficacy of the dietary intervention will be determined by comparing mean changes of ovarian steroids, and density of the breast and bone tissues over the 2 year dietary intervention period in the two diet groups with adjustment for baseline values and individual patient characteristics of interest. We predict that 2 years of soya dietary supplements will reduce breast density, which will be explained by individual hormonal changes.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 313 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind, placebo controlled, 2 parallel groups
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

Research pharmacist dispensed blinded assigned sachets according to a pre-generated randomization list. Pharmacists were blinded to all other aspects of the research protocols.

Subjects, investigators, research staff, and statisticians were all blinded to treatment assignment.

Primary Purpose: Prevention
Official Title: Soybean Diet and Breast Density
Actual Study Start Date : April 2002
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: Soy milk
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.
Dietary Supplement: soy milk
Each drink contained soy protein, fat, and carbohydrates calcium and phosphorous to give a total energy of 177.8 kcal. Subjects took two drinks per day.
Other Name: Not applicable, research product

Placebo Comparator: Cow's milk
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.
Dietary Supplement: cow's milk
Each drink contained casein, fat, carbohydrates, calcium and phosphorous to give a total energy of 178.6 kcal. Subjects took two drinks per day.
Other Name: Not applicable, research product




Primary Outcome Measures :
  1. mammographic density [ Time Frame: once per year for two years ]
    breast images to be measured by digital mammography and breast magnetic resonance imaging protocol, breast density is percent of fibroglandular tissue (radiologically dense) in whole breast tissue

  2. bone density [ Time Frame: once per year for two years ]
    Bone mineral content (gm) or bone mineral density (gm/cm2) to be measured by dual energy x-ray absorptiometry (DEXA) once at baseline, and then yearly after supplementation for up to 2 years.


Secondary Outcome Measures :
  1. Estradiol (pg/ml) [ Time Frame: 4 measurements at baseline and once every three months after protein drink supplements for up to 2 years. ]
    Serum will be measured for estrogen (pg/ml), 4 times at baseline, and thereafter at 3-monthly interval for up to 2 years of protein drink supplementation

  2. Progesterone (ng/ml) [ Time Frame: 4 measurements at baseline and once every three months after protein drink supplements for up to 2 years. ]
    Serum will be measured for progesterone (ng/ml), 4 times at baseline, and thereafter at 3-monthly interval for up to 2 years of protein drink supplementation

  3. Blood will be measured for standard clinical chemistries [ Time Frame: 4 measurements at baseline and once every three months after protein drink supplements for up to 2 years. ]
    Serum will be measured for for blood chemistries , 4 times at baseline, and thereafter at 3-monthly interval for up to 2 years of protein drink supplementation



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Ages Eligible for Study:   30 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only females with regular monthly menstrual cycles, not expecting to become pregnancy, not breast feeding, and not on contraceptives
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00204477


Locations
United States, Texas
General Clinical Research Center, The University of Texas Medical Branch
Galveston, Texas, United States, 77555-0264
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
U.S. Army Medical Research and Materiel Command
National Center for Research Resources (NCRR)
Investigators
Principal Investigator: Lee-Jane W Lu, Ph.D. The University of Texas Medical Branch, Galveston, TX 77555

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT00204477     History of Changes
Other Study ID Numbers: 02-422
Army's HSRRB log no. A-10926 ( Other Identifier: USA MRMC Human Research Protection Office (HRPO) )
UTMB GCRC 533 ( Other Identifier: UTMB ITSCRC )
DAMD17-01-1-0417 ( Other Grant/Funding Number: USA MRMC )
M01RR000073 ( U.S. NIH Grant/Contract )
1UL1RR029876-01 ( U.S. NIH Grant/Contract )
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Will not share as this required financial resources.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The University of Texas Medical Branch, Galveston:
soy diet
breast cancer
ovarian hormones
breast density
prevention

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs