Effect of Cocoa Flavanols on Vascular Function

NCT00553774 | Completed Phase 1

• 1 other identifier: CHR#H47369-28112
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

CAD Patients on Optimal Treatment

Outcome Measures

Primary Outcomes (1)

• An improvement of endothelial function as measured by flow-mediated dilation (FMD)

  1 month

Study Arms (2)

Flavanol

EXPERIMENTAL

Cocoa Flavanol

Dietary Supplement: Cocoa Flavanols

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Cocoa Flavanols DIETARY_SUPPLEMENT

Cocoa Flavanols (BD for 21 - 28 days)

Flavanol

Placebo OTHER

Placebo (BD 21 - 28 Days)

Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Contact university for more details.

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of California, Davis: collaborator

Study Sites (1)

University of California

San Francisco, California, 94143, United States

Location

Related Publications (1)

• 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.

  PMID: 20620742 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Yerem Yeghiazarians, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffessor of Clinical Medicine

Study Record Dates

• First Submitted: November 2, 2007
• First Posted: November 6, 2007
• Study Start: March 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: October 27, 2016

Record last verified: 2016-10

Locations

US (1)