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NCT04554901 Clinical Trial

The Effect of Cocoa on Platelet Function Profiles in Patients

Platelet Dysfunction Clinical Trial

— ECLAIR  

Official title:
The Effect of Cocoa on Platelet Function Profiles in Patients With Stable Coronary Artery Disease in Trinidad and Tobago: The ECLAIR Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04554901
Other study ID # CREC-SA.0351/05/2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date June 30, 2022

Study information
Verified date August 2023
Source The University of The West Indies
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The effects of chocolate on cardiovascular health are still a matter of debate. It can potentially favor cardiovascular health through the antioxidative effects of cocoa ingredients, such as polyphenols (present in dark but not white chocolate).

Description:

Epidemiologic studies have shown inverse associations between dietary polyphenols (present in dark chocolate and cocoa) and mortality from coronary heart disease. However, the basis for this protective association is uncertain. Food polyphenols such as in cocoa reportedly have antioxidant properties and decrease platelet function in vitro. The goal of the present study was to investigate whether the beneficial antioxidant effect of polyphenol-rich cocoa can induce an improvement of endothelial and platelet function in patients with stable coronary artery disease with known platelet hyperreactivity.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date June 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patients with stable coronary artery disease. 2. Patients > 18y of age. Exclusion Criteria: 1. Patients with T2DM. 2. Patients who already ingest any cocoa-based products.

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Cocoa
2-week, once-daily 70%, 50g cocoa bar manufactured by The UWI Cocoa Research Institute (14 bars)

Locations
Country Name City State
Trinidad and Tobago The University of the West Indies Saint Augustine North

Sponsors (1)
Lead Sponsor Collaborator
The University of The West Indies

Country where clinical trial is conducted

Trinidad and Tobago, 

Outcome
Type Measure Description Time frame Safety issue
Primary P2Y12 Reaction Units P2Y12 Reaction Units pre- and post-Cocoa 2-weeks
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