Back to resultsThe Effect of Cocoa on Platelet Function Profiles in Patients (ECLAIR)
Primary Purpose
Platelet Dysfunction
Status
Completed
Phase
Not Applicable
Locations
Trinidad and Tobago
Study Type
Interventional
Intervention
Cocoa
Sponsored by
About this trial
This is an interventional treatment trial for Platelet Dysfunction focused on measuring Platelet Dysfunction, Cocoa, Polyphenol
Eligibility Criteria
Inclusion Criteria:
- Patients with stable coronary artery disease.
- Patients > 18y of age.
Exclusion Criteria:
- Patients with T2DM.
- Patients who already ingest any cocoa-based products.
Sites / Locations
- The University of the West Indies
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Cocoa
Arm Description
2-week, once-daily 70%, 50g cocoa bar manufactured by The UWI Cocoa Research Institute (14 bars)
Outcomes
Primary Outcome Measures
P2Y12 Reaction Units
P2Y12 Reaction Units pre- and post-Cocoa
Secondary Outcome Measures
Full Information
NCT ID
NCT04554901
First Posted
September 13, 2020
Last Updated
August 23, 2023
Sponsor
The University of The West Indies
1. Study Identification
Unique Protocol Identification Number
NCT04554901
Brief Title
The Effect of Cocoa on Platelet Function Profiles in Patients
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of The West Indies
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Platelet Dysfunction
Keywords
Platelet Dysfunction, Cocoa, Polyphenol
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Blood samples will be collected from participants in 2 separate instances. Initially, a baseline VerifyNow P2Y12 PRU test assay, followed by a subsequent repeat test 2-week after a 2-week, once-daily 70%, 50g cocoa bar manufactured by The UWI Cocoa Research Institute (14 bars).
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cocoa
Arm Type
Other
Arm Description
2-week, once-daily 70%, 50g cocoa bar manufactured by The UWI Cocoa Research Institute (14 bars)
Intervention Type
Dietary Supplement
Intervention Name(s)
Cocoa
Intervention Description
2-week, once-daily 70%, 50g cocoa bar manufactured by The UWI Cocoa Research Institute (14 bars)
Primary Outcome Measure Information:
Title
P2Y12 Reaction Units
Description
P2Y12 Reaction Units pre- and post-Cocoa
Time Frame
2-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with stable coronary artery disease.
Patients > 18y of age.
Exclusion Criteria:
Patients with T2DM.
Patients who already ingest any cocoa-based products.
Facility Information:
Facility Name
The University of the West Indies
City
Saint Augustine
State/Province
North
ZIP/Postal Code
000000
Country
Trinidad and Tobago
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The data that support the findings of this study are available from the corresponding author on request.
Citations:
PubMed Identifier
36100318
Citation
Seecheran NA, Sukha D, Grimaldos K, Grimaldos G, Richard S, Ishmael A, Gomes C, Kampradi L, Seecheran R, Seecheran V, Peram L, Dookeeram D, Giddings S, Sandy S, Ramlackhansingh A, Raza S, Umaharan P, Tello-Montoliu A, Schneider D. Effect of cocoa (Theobroma cacao L.) on platelet function testing profiles in patients with coronary artery disease: ECLAIR pilot study. Open Heart. 2022 Sep;9(2):e002066. doi: 10.1136/openhrt-2022-002066.
Results Reference
derived
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The Effect of Cocoa on Platelet Function Profiles in Patients
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