NCT00204477

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
321

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Apr 2002

Longer than P75 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2011

Completed
11.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2023

Completed
8 months until next milestone

Results Posted

Study results publicly available

January 23, 2024

Completed
Last Updated

January 23, 2024

Status Verified

December 1, 2023

Enrollment Period

9.3 years

First QC Date

September 9, 2005

Results QC Date

December 7, 2023

Last Update Submit

December 27, 2023

Conditions

Breast Cancer

Keywords

soy dietbreast cancerovarian hormonesbreast densityprevention

Outcome Measures

Primary Outcomes (9)

  • Mammographic Density (Baseline)

    Breast images were acquired by digital mammography. Fibroglandular tissue were segmented from fatty breast tissue. The total breast area is the sum of the fibroglandular tissue area and fatty breast tissue area. Mammographic density (breast density) is the percentage of fibroglandular tissue in the total breast.

    Baseline

  • Mammographic Density (1 Year)

    Breast images were acquired by digital mammography. Fibroglandular tissue were segmented from fatty breast tissue. The total breast area is the sum of the fibroglandular tissue area and fatty breast tissue area. Mammographic density (breast density) is the percentage of fibroglandular tissue in the total breast.

    1 Year

  • Mammographic Density (2 Years)

    Breast images were acquired by digital mammography. Fibroglandular tissue were segmented from fatty breast tissue. The total breast area is the sum of the fibroglandular tissue area and fatty breast tissue area. Mammographic density (breast density) is the percentage of fibroglandular tissue in the total breast.

    2 years

  • Breast Tissue Composition Measured by MRI

    Breast images acquired by breast magnetic resonance imaging (MRI). The amount of fatty breast tissue,(cc), glandular breast tissue(cc ), total breast (cc), and percentage of glandular tissue in total breast (%) were estimated.

    Baseline

  • Breast Tissue Composition Measured by MRI

    Breast images acquired by breast magnetic resonance imaging (MRI). The amount of fatty breast tissue,(cc), glandular breast tissue(cc ), total breast (cc), and percentage of glandular tissue in total breast (%) were estimated.

    1 Year

  • Breast Tissue Composition Measured by MRI

    Breast images acquired by breast magnetic resonance imaging (MRI). The amount of fatty breast tissue,(cc), glandular breast tissue(cc ), total breast (cc), and percentage of glandular tissue in total breast (%) were estimated.

    2 years

  • Percentage of Grandular Tissue in Total Breast Measured by MRI

    Breast images acquired by breast magnetic resonance imaging (MRI). The amount of fatty breast tissue,(cc), glandular breast tissue(cc ), total breast (cc), and percentage of glandular tissue in total breast (%) were estimated.

    Baseline

  • Percentage of Grandular Tissue in Total Breast Measured by MRI

    Breast images acquired by breast magnetic resonance imaging (MRI). The amount of fatty breast tissue,(cc), glandular breast tissue(cc ), total breast (cc), and percentage of glandular tissue in total breast (%) were estimated.

    1 Year

  • Percentage of Grandular Tissue in Total Breast Measured by MRI

    Breast images acquired by breast magnetic resonance imaging (MRI). The amount of fatty breast tissue,(cc), glandular breast tissue(cc ), total breast (cc), and percentage of glandular tissue in total breast (%) were estimated.

    2 years

Other Outcomes (2)

  • Blood Will be Measured for Standard Clinical Chemistries

    4 measurements at baseline and once every three months after protein drink supplements for up to 2 years.

  • Progesterone (ng/ml)

    4 measurements at baseline and once every three months after protein drink supplements for up to 2 years.

Study Arms (2)

Soy milk

ACTIVE COMPARATOR

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

Cow's milk

PLACEBO COMPARATOR

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

Interventions

soy milkDIETARY_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.

Also known as: Not applicable, research product
Soy milk
cow's milkDIETARY_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.

Also known as: Not applicable, research product
Cow's milk

Eligibility Criteria

Age30 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly females with regular monthly menstrual cycles, not expecting to become pregnancy, not breast feeding, and not on contraceptives
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy premenopausal women
  • to 40 years old
  • normal mammograms
  • regular menstrual cycles

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Clinical Research Center, The University of Texas Medical Branch

Galveston, Texas, 77555-0264, United States

Location

Related Publications (2)

  • 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.

    PMID: 23044556DERIVED

  • 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.

    PMID: 20874659DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Soy MilkMilk

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Milk SubstitutesBeveragesDiet, Food, and NutritionPhysiological PhenomenaSoy FoodsVegetable ProductsVegetablesFoodFood and BeveragesDairy Products

Results Point of Contact

Title
Leejane W. Lu
Organization
University of Texas Medical Branch Galveston
llu@utmb.edu
(409)772-1011

Study Officials

  • Lee-Jane W Lu, Ph.D.

    The University of Texas Medical Branch, Galveston, TX 77555

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, double-blind, placebo controlled, 2 parallel groups
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 20, 2005

Study Start

April 1, 2002

Primary Completion

July 22, 2011

Study Completion

May 29, 2023

Last Updated

January 23, 2024

Results First Posted

January 23, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Will not share as this required financial resources.

Locations

US(1)