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Effect of cocoa (Theobroma cacao L.) on platelet function testing profiles in patients with coronary artery disease: ECLAIR pilot study.

  • 2022-09
  • Open heart 9(2)
    • Naveen Anand Seecheran
    • Darin Sukha
    • Kathryn Grimaldos
    • Gabriella Grimaldos
    • Srivane Richard
    • Aleena Ishmael
    • Ceylon Gomes
    • Lirmala Kampradi
    • Rajeev Seecheran
    • Valmiki Seecheran
    • Lakshmipathi Peram
    • Darren Dookeeram
    • Stanley Giddings
    • Sherry Sandy
    • Anil Ramlackhansingh
    • Sadi Raza
    • Pathmanathan Umaharan
    • Antonio Tello-Montoliu
    • David Schneider

Study Design

Type
Clinical Trial
Sample size
n = 20
Population
20 patients with stable coronary artery disease (CAD) on maintenance dual antiplatelet therapy of aspirin 81 mg/day and clopidogrel 75 mg/day
Methods
prospective pharmacodynamic nutraceutical study; 1-week trial of 30 g/day of 65% cocoa consumption intervention; platelet function evaluated with VerifyNow P2Y12 reaction unit and aspirin reaction unit assays; results compared with paired t-test
Blinding
Open-label
Duration
1 week
Funding
Unclear

Introduction

This prospective pharmacodynamic nutraceutical study assessed the effect of a 1-week trial of 30 g/day of 65% cocoa (dark chocolate) (Theobroma cacao L.) consumption intervention on platelet reactivity.

Methods

Patients with stable coronary artery disease (CAD) (n=20) who were on maintenance dual antiplatelet therapy of aspirin (ASA) 81 mg/day and clopidogrel 75 mg/day were recruited. Platelet function was evaluated with the VerifyNow P2Y12 reaction unit (PRU) and aspirin reaction unit (ARU) assays (Werfen, Bedford, Massachusetts, USA) and assessed prior to initiation of and after a 1-week trial of 30 g/day of 65% cocoa consumption intervention. Results were compared with a paired t-test.

Results

Cocoa augmented the inhibitory effect of clopidogrel, demonstrated by a reduction of 11.9% (95% CI 5.7% to 18.0%, p value 0.001), significantly decreasing the PRU by 26.85 (95% CI 12.22 to 41.48, p value 0.001). The inhibitory effect of ASA was not impacted by cocoa, reflected by a non-significant reduction in ARU of 17.65 (95% CI 21.00 to 56.3, p value 0.351). No patients experienced any serious adverse events.

Conclusions

Cocoa augmented the inhibitory effect of clopidogrel but not ASA. This nutraceutical study could be potentially informative and applicable for patients with stable CAD. Further long-term studies are required to confirm these exploratory findings.

Trial registration number

NCT04554901.

Research Insights

  • cocoa→Increased Platelet Count

    Cocoa augmented the inhibitory effect of clopidogrel, demonstrated by a reduction of 11.9% (95% CI 5.7% to 18.0%, p value 0.001), significantly decreasing the PRU by 26.85 (95% CI 12.22 to 41.48, p value 0.001).

    Effect
    Beneficial
    Effect size
    Small
    Dose
    30 g/day of 65% cocoa (dark chocolate)
  • cocoa→Reduced Platelet Reactivity

    The inhibitory effect of ASA was not impacted by cocoa, reflected by a non-significant reduction in ARU of 17.65 (95% CI 21.00 to 56.3, p value 0.351).

    Effect
    Neutral
    Effect size
    Small
    Dose
    30 g/day of 65% cocoa (dark chocolate)

Adverse Events Reported

  • cocoa→Overall tolerability

    No patients experienced any serious adverse events.

    Finding
    Reported
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