Soy Protein and Breast Cancer Risk Reduction

NCT ID: NCT00204477

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 321 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-04-30
• Study Completion Date: 2023-05-29

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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

soy milk

Intervention Type: DIETARY_SUPPLEMENT

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.

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.

Group Type: PLACEBO_COMPARATOR

cow's milk

Intervention Type: DIETARY_SUPPLEMENT

Each drink contained casein, fat, carbohydrates, calcium and phosphorous to give a total energy of 178.6 kcal. Subjects took two drinks per day.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Not applicable, research product; Not applicable, research product

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

U.S. Army Medical Research and Development Command

FED

Sponsor Role: collaborator

National Center for Research Resources (NCRR)

NIH

Sponsor Role: collaborator

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lee-Jane W Lu, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Medical Branch, Galveston, TX 77555

Locations

General Clinical Research Center, The University of Texas Medical Branch

Galveston, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 23044556 (View on PubMed)

Nayeem 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.

Reference Type: DERIVED

PMID: 20874659 (View on PubMed)

Other Identifiers

Army's HSRRB log no. A-10926

Identifier Type: OTHER

Identifier Source: secondary_id

UTMB GCRC 533

Identifier Type: OTHER

Identifier Source: secondary_id

DAMD17-01-1-0417

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

M01RR000073

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1UL1RR029876-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

02-422

Identifier Type: -

Identifier Source: org_study_id