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

NCT00366860 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2014-12-02

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Soy bread

Sponsors & Collaborators

Principal Investigators

  • Mary A.M. Rogers, PhD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00366860 on ClinicalTrials.gov