NCT04554901

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 18, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

August 25, 2023

Status Verified

August 1, 2023

Enrollment Period

1.8 years

First QC Date

September 13, 2020

Last Update Submit

August 23, 2023

Conditions

Platelet Dysfunction

Keywords

Platelet DysfunctionCocoaPolyphenol

Outcome Measures

Primary Outcomes (1)

  • P2Y12 Reaction Units

    P2Y12 Reaction Units pre- and post-Cocoa

    2-weeks

Study Arms (1)

Cocoa

OTHER

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

Dietary Supplement: Cocoa

Interventions

CocoaDIETARY_SUPPLEMENT

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

Cocoa

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with stable coronary artery disease.
  • Patients \> 18y of age.

You may not qualify if:

  • Patients with T2DM.
  • Patients who already ingest any cocoa-based products.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of the West Indies

Saint Augustine, North, 000000, Trinidad and Tobago

Location

Related Publications (1)

  • 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.

    PMID: 36100318DERIVED

MeSH Terms

Interventions

Chocolate

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 13, 2020

First Posted

September 18, 2020

Study Start

September 1, 2020

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

August 25, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

The data that support the findings of this study are available from the corresponding author on request.

Locations

TR(1)