Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202506573782241 Date of Registration: 26/06/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Polyphenol-rich cocoa in reducing diabetes-related complications
Official scientific title Polyphenol-rich cocoa in reducing diabetes-related vascular and pulmonary dysfunction
Brief summary describing the background and objectives of the trial Diabetes related vascular and pulmonary complications remain prevalent, affecting about 80% of individuals with diabetes and accounting for over two-thirds of deaths in affected individuals. To date, interventions and treatments targeting vascular and pulmonary complications, including controlling the conventional risk factors, have yielded limited results. Existing data suggest that low-grade inflammation is an important driver of diabetes-related complications. Therefore, therapies targeting low-grade inflammation could improve or halt the accelerated decline in vascular and pulmonary complications in individuals with diabetes. One potential candidate therapy is naturally occurring polyphenols. Polyphenols may enhance vascular and pulmonary function via their antioxidant, anti-inflammatory, and anti-atherogenic activities. Important gaps remain in the existing literature on the role of polyphenol-rich cocoa in vascular or pulmonary health. This proposed study will seek to answer these questions by evaluating the potential vascular and pulmonary benefits of polyphenols in Ghanaian adults with diabetes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,Kidney Disease,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 08/07/2024
Actual trial start date 08/07/2024
Anticipated date of last follow up 30/09/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group polyphenol group 500 mg of polyphenol in 10 grams of cocoa powder once a day Three months 500 mg of polyphenol in 10 grams of cocoa products every morning for three months in addition to their usual clinical care by the physicians at the National Diabetes Management and Research Centre 100
Control Group Control group 1 gram of identical looking food color (brown) once a day Three months An identical-appearing placebo once daily for three months, in addition to their usual clinical care by the physicians at the National Diabetes Management and Research Centre 100 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Ghanaian ethnic background Aged ≥ 18 years as of last birthday. Established diagnosis of diabetes (fasting plasma glucose (FPG) ≥ 7.0mmol/l and/or 2–hour plasma glucose ≥ 11.1mmol/l and/or on glucose-lowering therapy) and managed at the NDMRC. Known or self-reported pregnancy Known allergy to cocoa or polyphenols. Contraindications to spirometry testing based on the guidelines of the American Thoracic Society / European Respiratory Society Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 90 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/11/2023 Institutional Review Board of the Korle Bu Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
Korle Bu Teaching Hospital Accra 233 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Reduction in the decline in pulmonary function from baseline At baseline, on day 30, day 60, and and day 90
Primary Outcome Reduction in the decline in microvascular function from baseline At baseline, on day 30, day 60, and and day 90
Primary Outcome Reduction in the decline in macrovascular function from baseline At baseline, on day 30, day 60, and and day 90
Secondary Outcome Metabolic control At baseline, on day 30, day 60, and and day 90
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Diabetes Management and Research Centre Korle Bu Teaching Hospital Accra Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Ghana Cocoa Board Kwame Nkrumah Avenue, Accra, Ghana Accra Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ghana Academy of Arts and Science 1 Second Food Research Rd, Accra Accra Ghana Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator George Obeng Adjei gadjei@ug.edu.gh +233208114973 University of Ghana Medical School, Korle Bu Campus
City Postal code Country Position/Affiliation
Accra Ghana Professor
Role Name Email Phone Street address
Scientific Enquiries Charles Hayfron Benjamin chayfron-benjamin@ug.edu.gh +233244080358 University of Ghana Medical School, Korle Bu Campus
City Postal code Country Position/Affiliation
Accra Ghana Associate Professor
Role Name Email Phone Street address
Public Enquiries Edward Amporful amporful221065@yahoo.com +233249140881 Cocoa Clinic 15 Orgle Rd
City Postal code Country Position/Affiliation
Accra Ghana Chief Pharmacist
Role Name Email Phone Street address
Public Enquiries Lade Wosornu ladewosornu@gmail.com +233246525552 Ghana Academy of Arts and Sciences
City Postal code Country Position/Affiliation
Accra Ghana Professor and Fellow of Ghana Academy of Arts and Sciences
Role Name Email Phone Street address
Public Enquiries George Obeng Adjei gadjei@ug.edu.gh +233208114973 University of Ghana Medical School
City Postal code Country Position/Affiliation
Accra Ghana Professor at University of Ghana Medical School
Role Name Email Phone Street address
Scientific Enquiries George Obeng Adjei gadjei@ug.edu.gh +233208114973 University of Ghana Medical School
City Postal code Country Position/Affiliation
Accra Ghana Professor at University of Ghana Medical School
Role Name Email Phone Street address
Public Enquiries Charles Hayfron Benjamin chayfron-benjamin@ug.edu.gh +233244080358 University of Ghana Medical School
City Postal code Country Position/Affiliation
Accra Ghana Associate Professor at University of Ghana Medical School
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Plan to Share IPD: Yes Plan Description: Data from this study may be provided to qualified researchers upon reasonable request made to the study group. Data shared will be coded, with no protected health information included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party. Informed Consent Form,Statistical Analysis Plan,Study Protocol Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan, and execution of a data sharing agreement
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 26/06/2025 PACTR Admin Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s) Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 26/06/2025 PACTR Admin Experimental Group, Intervention group, 500 mg of polyphenol in 10 grams of cocoa powder once a day , Three months, 500 mg of polyphenol in 10 grams of cocoa products every morning for three months in addition to their usual clinical care by the physicians at the National Diabetes Management and Research Centre , 100, Experimental Group, polyphenol group, 500 mg of polyphenol in 10 grams of cocoa powder once a day , Three months, 500 mg of polyphenol in 10 grams of cocoa products every morning for three months in addition to their usual clinical care by the physicians at the National Diabetes Management and Research Centre , 100,