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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04554901
Recruitment Status : Unknown
Verified September 2020 by Naveen Seecheran, The University of The West Indies.
Recruitment status was:  Recruiting
First Posted : September 18, 2020
Last Update Posted : September 18, 2020
Sponsor:
Information provided by (Responsible Party):
Naveen Seecheran, The University of The West Indies

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).

Condition or disease Intervention/treatment Phase
Platelet Dysfunction Dietary Supplement: Cocoa Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: The Effect of Cocoa on Platelet Function Profiles in Patients With Stable Coronary Artery Disease in Trinidad and Tobago: The ECLAIR Study
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. P2Y12 Reaction Units [ Time Frame: 2-weeks ]
    P2Y12 Reaction Units pre- and post-Cocoa



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04554901


Contacts
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Contact: Naveen A Seecheran, MBBS, MSc 18686634332 ext 00000 nseecheran@gmail.com
Contact: Lakshmipatty Peram, MBBS 18687600369 ext 00000 lakshperam@yahoo.com

Locations
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Trinidad and Tobago
The University of the West Indies Recruiting
Saint Augustine, North, Trinidad and Tobago, 000000
Contact: Naveen A Seecheran, MBBS, MSc    868-753-7686 ext 0000    naveen.seecheran@sta.uwi.edu   
Contact: Laksh Peram, MBBS    868-760-0369    lakshperam@yahoo.com   
Sponsors and Collaborators
The University of The West Indies
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Naveen Seecheran, Principal Investigator, The University of The West Indies
ClinicalTrials.gov Identifier: NCT04554901    
Other Study ID Numbers: CREC-SA.0351/05/2020
First Posted: September 18, 2020    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data that support the findings of this study are available from the corresponding author on request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Naveen Seecheran, The University of The West Indies:
Platelet Dysfunction
Cocoa
Polyphenol
Additional relevant MeSH terms:
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Blood Platelet Disorders
Hematologic Diseases