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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202308889689994 Date of Approval: 08/08/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of cocoa nibs intake on cardiometabolic indices and functional constipation in older Ghanaian adults living with hypertension
Official scientific title Effect of cocoa nibs intake on cardiometabolic indices and functional constipation in older Ghanaian adults living with hypertension
Brief summary describing the background and objectives of the trial Globally, the population of the world is aging and countries in Sub-Saharan Africa including Ghana is no exception. Aging is associated with a lot of comorbidities including; arterial stiffening which is related to hypertension, also, reduced functional activity of the gastrointestinal tract resulting in factors such as impaired absorption of food nutrients and reduced chyme motility. Cocoa nibs is a promising healthier snack that is rich in fibre, polyphenols particularly epicatechin and micronutrients including iron. Consumption of cocoa nibs has the potential to improve cardiometabolic indices especially systolic blood pressure, and constipation in older adults. The study aims to investigate the effect of cocoa nibs’ intake on outcomes such as, blood pressure, constipation, and lipid profile levels in older adults.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,Digestive System,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 18/08/2023
Actual trial start date
Anticipated date of last follow up 29/09/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants)
Recruitment status Not yet 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
Single Group Non-randomised Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Cocoa Nibs Cocoa Nibs: 30 grams 6 weeks Participants will consume 30g of the cocoa nibs daily for 6 weeks. Venous blood samples and blood pressure measurements will be taken after an overnight fast in the morning during the visit to the study site (baseline) and after the six weeks intervention. Intermediate Blood Pressure measurements will be taken in addition to bowel records. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Male or Female aged 50 years and above 2. Individuals living with hypertension and taking medications 1. Individuals on other medications that contribute to constipation 2. Individuals living with diabetes 3. Individuals with loss of teeth or chewing problems 4. Individuals with comorbidities 5. Pregnant women 6. Lactating mothers 7. Individuals with kidney diseases 8. Individuals with normal Blood Pressure 80 and over: 80+ Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 50 Year(s) 80 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 25/05/2023 Committee on Human Research Publication and Ethics
Ethics Committee Address
Street address City Postal code Country
School of Medicine and Dentistry, Kwame Nkrumah University of Science and Technology, Kumasi Kumasi AO-K384 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in systolic and diastolic blood pressures Week 0, Week 3 and Week 6
Secondary Outcome Change in total cholesterol, HDL cholesterol, LDL cholesterol, triglecyrides Week 0 and Week 6
Secondary Outcome Changes in bowel movement Week 0 and Week 6
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tafo Government Hospital P. O. Box TA 1908 Kumasi Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Eunice Oforiwaa Denkyi Department of Biochemistry and Biotechnology, Kwame Nkrumah University of Science and Technology Kumasi AO-K448 Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kwame Nkrumah University of Science and Technology Department of Biochemistry and Biotechnology, Kwame Nkrumah University of Science and Technology, Kumasi - Ghana Kumasi Ghana University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eunice Denkyi edenkyi83@gmail.com +233547437161 Department of Biochemistry and Biotechnology, Kwame Nkrumah University of Science and Technology
City Postal code Country Position/Affiliation
Kumasi Ghana Student
Role Name Email Phone Street address
Scientific Enquiries Isaac Amoah isaacamoah458@gmail.com +233249183185 Department of Biochemistry and Biotechnology, Kwame Nkrumah University of Science and Technology
City Postal code Country Position/Affiliation
Kumasi Ghana Supervisor
Role Name Email Phone Street address
Public Enquiries Phyllis Tawiah ptawiah@gmail.com +233504607888 Department of Medicine, School of Medicine and Dentistry, College of Heath Sciences, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana
City Postal code Country Position/Affiliation
Kumasi Ghana Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes A summary of the study findings will be reported in the form of a manuscript for publication as a journal article. Individual participant data (IPD) will be filed and protected under lock and information from individual participants will be treated as highly confidential. IPD will be retained on an external hard drive and kept for 5 years after the study. IPD will be made accessible to the Committee on Human Research, Publication, and Ethics (CHRPE) and the principal investigators (PIs).Other research staff will have controlled access to the data. All data obtained through the study will be the property of the investigators, and at no point will such data be released without the approval of PIs and ethical and regulatory bodies concerned Informed Consent Form IPD may be shared after publication for a maximum of 5-year period upon reasonable request Researchers and reviewers may request access to the de-identified IPD for the purposes of their own data analysis. The quality of the proposal and the qualifications of requestors willbe reviewed and approved on a case-by-case basis at the discretion of the principal investigators and the primary sponsor, with a requirement to sign a data access 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