Effect of Cocoa Flavanols on Vascular Function
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Dietary Supplement: Cocoa Flavanols Other: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Supportive Care |
| Official Title: | Effect of Cocoa Flavanols on Vascular Function in Optimally Treated Coronary Artery Disease Patients: Interaction Between Endothelial Progenitor Cells, Reactivity of Micro- and Macrocirculation |
- An improvement of endothelial function as measured by flow-mediated dilation (FMD) [ Time Frame: 1 month ]
| Estimated Enrollment: | 25 |
| Study Start Date: | March 2007 |
| Study Completion Date: | February 2008 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Flavanol
Cocoa Flavanol
|
Dietary Supplement: Cocoa Flavanols
Cocoa Flavanols (BD for 21 - 28 days)
|
| Placebo Comparator: Placebo |
Other: Placebo
Placebo (BD 21 - 28 Days)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- CAD patients over 18 years of age
- Contact university for more details.
Exclusion Criteria:
- Contact university for more details.
Contacts and Locations| United States, California | |
| University of California | |
| San Francisco, California, United States, 94143 | |
| Principal Investigator: | Yerem Yeghiazarians, MD | University of California, San Francisco |
More Information
No publications provided by University of California, San Francisco
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr. Yerem Yeghiazarians., UCSF |
| ClinicalTrials.gov Identifier: | NCT00553774 History of Changes |
| Other Study ID Numbers: | CHR#H47369-28112 |
| Study First Received: | November 2, 2007 |
| Last Updated: | May 5, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Francisco:
|
CAD Patients on Optimal Treatment |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013