Trial record 1 of 1 for:    NCT00553774
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Effect of Cocoa Flavanols on Vascular Function

This study has been completed.
Sponsor:
Collaborator:
University of California, Davis
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00553774
First received: November 2, 2007
Last updated: May 5, 2008
Last verified: February 2007
  Purpose

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 Intervention Phase
Coronary Artery Disease
Dietary Supplement: Cocoa Flavanols
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by University of California, San Francisco:

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

Estimated Enrollment: 25
Study Start Date: March 2007
Study Completion Date: February 2008
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of California, San Francisco

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Yerem Yeghiazarians., UCSF
ClinicalTrials.gov Identifier: NCT00553774     History of Changes
Other Study ID Numbers: CHR#H47369-28112
Study First Received: November 2, 2007
Last Updated: May 5, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
CAD Patients on Optimal Treatment

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014