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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00366860
• Other study ID #: GCRC Protocol #1971
• Status: Completed
• Phase: Phase 1
• First received: August 17, 2006
• Last updated: December 1, 2014
• Start date: January 2004
• Est. completion date: May 2008

Study information

• Verified date: December 2014
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Osteoporosis

Intervention

Behavioral:
• Soy bread

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	deoxypyridinoline	Urinary deoxypyridinoline	12 weeks	No
Secondary	N-telopeptides, bone-specific alkaline phosphatase, osteocalcin, cholesterol, triglycerides, apolipoproteins, C-reactive protein, HbA1c		12 weeks	No