The Effect of Cocoa on Platelet Function Profiles in Pati... | NCT04554901

Studies
The Effect of Cocoa on Platelet Function Profiles in Patients

NCT04554901

Sponsor

The University of The West Indies

Status

Completed

Last Update Posted

Aug 25, 2023Actual

Enrollment

25Actual

Phase

Not Applicable

Conditions

Platelet Dysfunction

Interventions

Cocoa

Countries

Trinidad and Tobago

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2020Actual

Primary Completion Date

Jun 30, 2022Actual

Completion Date

Jun 30, 2022Actual

First Submitted Date

Sep 13, 2020

First Submission Date that Met QC Criteria

Sep 17, 2020

First Posted Date

Sep 18, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 23, 2023

Last Update Posted Date

Aug 25, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Naveen Seecheran, Principal Investigator, The University of The West IndiesPrincipal Investigator

Lead Sponsor

The University of The West IndiesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cocoa	Other	2-week, once-daily 70%, 50g cocoa bar manufactured by The UWI Cocoa Research Institute (14 bars)	Dietary Supplement: Cocoa

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cocoa	Dietary Supplement	2-week, once-daily 70%, 50g cocoa bar manufactured by The UWI Cocoa Research Institute (14 bars)	Cocoa

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of the West Indies		Saint Augustine	North	000000	Trinidad and Tobago

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36100318	Derived	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.

ID	Term
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D019602	Food and Beverages