The Effect of Cocoa on Platelet Function Profiles in Patients

NCT ID: NCT04554901

Last Updated: 2023-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2022-06-30

Brief Summary

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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

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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.

Conditions

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Platelet Dysfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cocoa

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

Group Type OTHER

Cocoa

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Cocoa

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of The West Indies

OTHER

Sponsor Role lead

Responsible Party

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Naveen Seecheran

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The University of the West Indies

Saint Augustine, North, Trinidad and Tobago

Site Status

Countries

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Trinidad and Tobago

References

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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.

Reference Type DERIVED
PMID: 36100318 (View on PubMed)

Other Identifiers

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CREC-SA.0351/05/2020

Identifier Type: -

Identifier Source: org_study_id

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