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NCT00366860 · ClinicalTrials.gov registry record · Phase 1
Effect of Soy Bread on Markers of Bone Metabolism and Cardiovascular Disease
A Phase 1 study, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT00366860 is a Phase 1 study that has completed, run by University of Michigan. The registered enrollment target is 18 participants.
The verdict
NCT00366860, a Phase 1 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
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.
Interventions
- BEHAVIORAL Soy bread
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2004-01 |
| Est. Completion | 2008-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00366860
The ClinicalTrials.gov registry entry for NCT00366860 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Soy bread is the first listed.
NCT00366860 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00366860 about?
NCT00366860 is a clinical study titled "Effect of Soy Bread on Markers of Bone Metabolism and Cardiovascular Disease". 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 randomiz...
What is the current status of trial NCT00366860?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2004-01. Estimated completion is 2008-05.
What interventions are being tested in trial NCT00366860?
The interventions under investigation include: Soy bread (BEHAVIORAL).
Who is sponsoring clinical trial NCT00366860?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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