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NCT00553774 · ClinicalTrials.gov registry record · Phase 1
Effect of Cocoa Flavanols on Vascular Function
A Phase 1 study of Coronary Artery Disease, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT00553774: Completed Phase 1 study of Coronary Artery Disease, sponsored by University of California, San Francisco.
NCT00553774 is a Phase 1 study of Coronary Artery Disease that has completed, run by University of California, San Francisco. The registered enrollment target is 16 participants, below the 1,287-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00553774, a Phase 1 study of Coronary Artery Disease, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
Endothelial dysfunction is associated with a higher incidence of adverse cardiovascular events in patients with coronary artery disease (CAD). CAD patients also show impaired function and number of endothelial progenitor cells (EPCs, adult stem cells) which circulate in adult blood and contribute to endothelial repair. Clinical studies suggest that endothelial function can be improved in CAD patients by consumption of flavanol-rich cocoa. Yet, the mechanism is not known. It is also not known whether flavanol-rich cocoa provides an additive, positive effect in patients who are already receiving the maximal recommended therapies for risk factor modification. Therefore, the researchers propose to perform an investigator-initiated, randomized controlled cross-over study administering flavanol-rich cocoa or a placebo for two months in CAD patients on optimal medical therapy. An improvement of endothelial function as measured by flow-mediated dilation (FMD) will be the primary endpoint of this study. The researchers propose to also measure determinants of FMD such as microvascular response, inflammatory markers, metabolites of nitric oxide, as well as the number and function of EPCs in the blood. Importantly, detailed food questionnaires and plasma flavanols/metabolites will help to further support a causal link between flavanol-intake and improved vascular function.
Conditions Studied
Interventions
- OTHER Placebo
- DIETARY_SUPPLEMENT Cocoa Flavanols
Study Locations (1)
California
- University of California - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2007-03 |
| Est. Completion | 2008-02 |
| Phase | Phase 1 |
What the finished NCT00553774 record still lists
NCT00553774 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 1,287-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00553774 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT00553774 about?
NCT00553774 is a clinical study titled "Effect of Cocoa Flavanols on Vascular Function". Endothelial dysfunction is associated with a higher incidence of adverse cardiovascular events in patients with coronary artery disease (CAD). CAD patients also show impaired function and number of endothelial progenitor cells (EPCs, adult stem cells) which circulate in adult blood and contribute to...
What is the current status of trial NCT00553774?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2007-03. Estimated completion is 2008-02.
What conditions does trial NCT00553774 study?
This clinical trial studies the following conditions: Coronary Artery Disease.
What interventions are being tested in trial NCT00553774?
The interventions under investigation include: Placebo (OTHER), Cocoa Flavanols (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00553774?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00553774 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00553774's enrollment target sits among peer trials
16 213th of 219 higher than 7 of 219 other Coronary Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Coronary Artery Disease 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.
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