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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:
Information provided by (Responsible Party):

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
Primary Completion Date : February 2008
Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

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 :
  1. 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, Senior)
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):
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