Effect of Soy Bread on Markers of Bone Metabolism and Cardiovascular Disease

This study has been completed.
Sponsor:
Collaborator:
Ohio State University
Information provided by (Responsible Party):
Mary A.M. Rogers, University of Michigan
ClinicalTrials.gov Identifier:
NCT00366860
First received: August 17, 2006
Last updated: December 1, 2014
Last verified: December 2014
  Purpose

A study was designed with two specific aims: (1) to assess the effect of soy bread, compared with wheat bread, on markers of bone metabolism and cardiovascular health, and (2) to evaluate whether soy bread consumption affects the metabolism of phytoestrogens. To answer Aim 1, a double-blind randomized crossover trial was conducted. Individuals with an ability to metabolize a specific isoflavone, daidzein, consumed 3 slices of bread (either soy or wheat) daily over a 12-week period. After a 4-week wash-out period, subjects consumed 3 slices/day of the other type of bread. Markers of bone metabolism and cardiovascular health were evaluated before and after each time period. To answer Aim 2, individuals who did not metabolize daidzein at baseline entered a double-blind randomized trial of soy bread with or without fructooligosaccharide (a type of dietary fiber) over an 8-week period. Subjects were evaluated regarding their ability to metabolize daidzein to equol.


Condition Intervention Phase
Osteoporosis
Cardiovascular Diseases
Behavioral: Soy bread
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Soy Bread on Markers of Bone Metabolism and Cardiovascular Disease

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • deoxypyridinoline [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Urinary deoxypyridinoline


Secondary Outcome Measures:
  • N-telopeptides, bone-specific alkaline phosphatase, osteocalcin, cholesterol, triglycerides, apolipoproteins, C-reactive protein, HbA1c [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: January 2004
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Soy bread
Soy bread (75-100 mg isoflavone/day) for 12 weeks
Behavioral: Soy bread
Active Comparator: Wheat bread
Wheat bread for 12 weeks
Behavioral: Soy bread

Detailed Description:

Soy beans are rich in isoflavones, such as genistein and daidzein, which exhibit estrogenic activity. While the cardiovascular benefits of isoflavones in soy have been recognized, the effects on bone metabolism are less well known. The National Aeronautics and Space Administration expressed an interest in the effects of soy on bone loss and a former NASA scientist developed a soy product, soy bread, which may be more palatable for most Americans than currently available soy foods. A two-treatment two-period crossover trial was conducted to assess the effects of soy bread consumption on deoxypyridinoline, N-telopeptides, bone-specific alkaline phosphatase, osteocalcin, calcium, leptin, insulin-like growth factor-1, luteinizing hormone, follicle-stimulating hormone, testosterone, cholesterol (total, HDL, LDL), triglycerides, apolipoprotein AI, apolipoprotein B, C-reactive protein, and glycosylated hemoglobin. The crossover trial was conducted in subjects identified as having the ability to metabolize daidzein to equol. The treatment was 3 servings of soy bread daily over a 12-week period. The control period included 3 servings of a placebo wheat bread over a 12-week period. For subjects who did not metabolize daidzein to equol at baseline, a pretest-posttest trial of soy bread consumption over an 8-week period was conducted to examine whether 3 servings/day of soy bread increased urinary equol concentrations and whether the addition of fructooligosaccharide enhanced this excretion.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Post-menopausal women and men who were 50 years of age or older.

Exclusion Criteria:

  • Allergy to soy, wheat, and/or nuts. Use of hormone replacement therapy within the past 6 months. Diagnosis of osteoporosis or use of bone loss medications. Use of drugs within the past 3 months which increase the risk of osteoporosis. End-stage renal disease or other nephropathies. Chemotherapy within the past 6 months. Active gastrointestinal disorders. Diagnosis of thyroid disorder. Use of cholesterol-lowering medications within the past month. Vitamin, mineral, protein, and/or calorie deficiency. Alcoholism, acute or chronic hepatitis, cirrhosis. Use of systemic antibiotics within the past 6 months. Currently under dietary restrictions that would conflict with the intervention. Anticipated mental or physical incapability of adhering to the dietary protocol during the time period of the study (e.g. expected travel).
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00366860

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Ohio State University
Investigators
Principal Investigator: Mary A.M. Rogers, PhD University of Michigan
  More Information

No publications provided

Responsible Party: Mary A.M. Rogers, Research Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT00366860     History of Changes
Other Study ID Numbers: GCRC Protocol #1971
Study First Received: August 17, 2006
Last Updated: December 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
soy
isoflavones
bone resorption
osteogenesis
diet
hyperlipidemia

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 01, 2015