Effect of Cocoa Flavanols on Vascular Function (Cocoa)

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ClinicalTrials.gov Identifier: NCT00553774

Recruitment Status : Completed

First Posted : November 6, 2007

Last Update Posted : October 27, 2016

Sponsor:

Collaborator:

University of California, Davis

Information provided by (Responsible Party):

Yerem Yeghiazarians, University of California, San Francisco

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease	Dietary Supplement: Cocoa Flavanols Other: Placebo	Phase 1

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	16 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double (Participant, 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
Study Start Date :	March 2007
Actual Primary Completion Date :	February 2008
Actual Study Completion Date :	February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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)

Outcome Measures

Primary Outcome Measures :

An improvement of endothelial function as measured by flow-mediated dilation (FMD) [ Time Frame: 1 month ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 100 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

CAD patients over 18 years of age
Contact university for more details.

Exclusion Criteria:

Contact university for more details.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00553774

Locations


United States, California
University of California
San Francisco, California, United States, 94143

Sponsors and Collaborators

University of California, San Francisco

University of California, Davis

Investigators


Principal Investigator:	Yerem Yeghiazarians, MD	University of California, San Francisco

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Heiss C, Jahn S, Taylor M, Real WM, Angeli FS, Wong ML, Amabile N, Prasad M, Rassaf T, Ottaviani JI, Mihardja S, Keen CL, Springer ML, Boyle A, Grossman W, Glantz SA, Schroeter H, Yeghiazarians Y. Improvement of endothelial function with dietary flavanols is associated with mobilization of circulating angiogenic cells in patients with coronary artery disease. J Am Coll Cardiol. 2010 Jul 13;56(3):218-24. doi: 10.1016/j.jacc.2010.03.039.


Responsible Party:	Yerem Yeghiazarians, Proffessor of Clinical Medicine, University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00553774 History of Changes
Other Study ID Numbers:	CHR#H47369-28112
First Posted:	November 6, 2007 Key Record Dates
Last Update Posted:	October 27, 2016
Last Verified:	October 2016

Keywords provided by Yerem Yeghiazarians, 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

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