Effect of Cocoa Flavanols on Vascular Function (Cocoa)

• ClinicalTrials.gov Identifier: NCT00553774
• Recruitment Status: Completed
• First Posted: November 6, 2007
• Last Update Posted: October 27, 2016
• Sponsor: University of California, San Francisco
• Collaborator: University of California, Davis
• Information provided by (Responsible Party): Yerem Yeghiazarians, University of California, San Francisco

Tracking Information

• First Submitted Date: November 2, 2007
• First Posted Date: November 6, 2007
• Last Update Posted Date: October 27, 2016
• Study Start Date: March 2007
• Actual Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 5, 2007): An improvement of endothelial function as measured by flow-mediated dilation (FMD) [ Time Frame: 1 month ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Cocoa Flavanols on Vascular Function
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Supportive Care
• Condition: Coronary Artery Disease

Intervention

• Dietary Supplement: Cocoa Flavanols
  Cocoa Flavanols (BD for 21 - 28 days)
• Other: Placebo
  Placebo (BD 21 - 28 Days)

Study Arms

• Experimental: Flavanol
  Cocoa Flavanol
  Intervention: Dietary Supplement: Cocoa Flavanols
• Placebo Comparator: Placebo
  Intervention: Other: Placebo

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 25, 2016): 16
• Original Estimated Enrollment (submitted: November 5, 2007): 25
• Actual Study Completion Date: February 2008
• Actual Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Contact university for more details.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 100 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00553774
• Other Study ID Numbers: CHR#H47369-28112
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Yerem Yeghiazarians, University of California, San Francisco
• Study Sponsor: University of California, San Francisco
• Collaborators: University of California, Davis

Investigators

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

• PRS Account: University of California, San Francisco
• Verification Date: October 2016