Effect of Cocoa Flavanols on Vascular Function

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Cocoa Flavanols on Vascular Function in Optimally Treated Coronary Artery Disease Patients: Interaction Between Endothelial Progenitor Cells, Reactivity of Micro- and Macrocirculation

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Dietary Supplement: Cocoa Flavanols
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CAD patients over 18 years of age Contact university for more details. Exclusion Criteria: Contact university for more details.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flavanol<br>Cocoa Flavanol | Dietary Supplement: Cocoa Flavanols<br>* Cocoa Flavanols (BD for 21 - 28 days)<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Placebo (BD 21 - 28 Days)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| An improvement of endothelial function as measured by flow-mediated dilation (FMD) |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CAD Patients on Optimal Treatment