The Effect of Cocoa on Platelet Function Profiles in Patients (ECLAIR)

August 23, 2023 updated by: Naveen Seecheran, The University of The West Indies

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Trinidad and Tobago
    • North
      • Saint Augustine, North, Trinidad and Tobago, 000000
        • The University of The West Indies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Cocoa
2-week, once-daily 70%, 50g cocoa bar manufactured by The UWI Cocoa Research Institute (14 bars)
Dietary supplement: Cocoa
2-week, once-daily 70%, 50g cocoa bar manufactured by The UWI Cocoa Research Institute (14 bars)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
P2Y12 Reaction Units
Time Frame: 2-weeks
P2Y12 Reaction Units pre- and post-Cocoa
2-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of The West Indies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

September 13, 2020

First Submitted That Met QC Criteria

September 17, 2020

First Posted (Actual)

September 18, 2020

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 23, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREC-SA.0351/05/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data that support the findings of this study are available from the corresponding author on request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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