Effect of Cocoa Flavanols on Vascular Function (Cocoa)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cocoa Flavanols
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Coronary Artery Disease focused on measuring CAD Patients on Optimal Treatment
Eligibility Criteria
Inclusion Criteria:
- CAD patients over 18 years of age
- Contact university for more details.
Exclusion Criteria:
- Contact university for more details.
Sites / Locations
- University of California
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Flavanol
Placebo
Arm Description
Cocoa Flavanol
Outcomes
Primary Outcome Measures
An improvement of endothelial function as measured by flow-mediated dilation (FMD)
Secondary Outcome Measures
Full Information
NCT ID
NCT00553774
First Posted
November 2, 2007
Last Updated
October 25, 2016
Sponsor
University of California, San Francisco
Collaborators
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT00553774
Brief Title
Effect of Cocoa Flavanols on Vascular Function
Acronym
Cocoa
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 Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco
Collaborators
University of California, Davis
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
CAD Patients on Optimal Treatment
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Flavanol
Arm Type
Experimental
Arm Description
Cocoa Flavanol
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Cocoa Flavanols
Intervention Description
Cocoa Flavanols (BD for 21 - 28 days)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo (BD 21 - 28 Days)
Primary Outcome Measure Information:
Title
An improvement of endothelial function as measured by flow-mediated dilation (FMD)
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
CAD patients over 18 years of age
Contact university for more details.
Exclusion Criteria:
Contact university for more details.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yerem Yeghiazarians, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20620742
Citation
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.
Results Reference
derived
Learn more about this trial
Effect of Cocoa Flavanols on Vascular Function
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