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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: Completed Phase 1 study, sponsored by University of Michigan.
NCT00366860 is a Phase 1 study that has completed, run by University of Michigan. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Urinary deoxypyridinoline
Interventions
- BEHAVIORAL Soy bread
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2004-01 |
| Est. Completion | 2008-05 |
| Phase | Phase 1 |
What the finished NCT00366860 record still lists
NCT00366860 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which Soy bread is the first listed.
NCT00366860 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00366860's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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