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.: PACTR202302498428910 Date of Approval: 08/02/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title ACUTE COCOA SUPPLEMENTATION ON POSTPRANDIAL BLOOD PRESSURE AND GLUCOSE IN ADULTS LIVING WITH HYPERTENSION AFTER CONSUMPTION OF A HIGH-FAT-HIGH-SALT MEAL
Official scientific title ACUTE COCOA SUPPLEMENTATION ON POSTPRANDIAL BLOOD PRESSURE AND GLUCOSE IN ADULTS LIVING WITH HYPERTENSION AFTER CONSUMPTION OF A HIGH-FAT-HIGH-SALT MEAL
Brief summary describing the background and objectives of the trial Cocoa is a rich source of dietary polyphenols, particularly flavanols, and minerals such as potassium. Cocoa intake has been reported to be associated with beneficial cardiovascular disease effects such as reduced blood pressure, improved postprandial glucose, and a lower lipid profile. High salt intake, combined with postprandial hyperglycemia and hyperlipemia, has been linked to the development of hypertension. Therefore, this study aims to investigate the acute effects of cocoa supplementation on postprandial blood pressure, heart rate, and plasma glucose in adults living with hypertension after consumption of a high-fat-high-salt meal.
Type of trial RCT
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 13/02/2023
Actual trial start date 27/02/2023
Anticipated date of last follow up 10/03/2023
Actual Last follow-up date 30/03/2023
Anticipated target sample size (number of participants) 28
Actual target sample size (number of participants) 28
Recruitment status Completed
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program 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 beverage Cocoa beverage: 15 g cocoa powder in 250 ml water 2 hours of digestion Cocoa beverage (15 g cocoa powder in 250 ml water) will be consumed along with high-fat-high-salt meal after an overnight fast in the morning during the visit to the study site (clinic). Venous blood sample and blood pressure measurement will be taken at the time points baseline (-5 min and 0 min), and 15 min, 30 min, 45 min, 60 min, 90 min and 120 min following the consumption of the cocoa beverage and high-fat-high-salt meal. 28
Control Group Water 250 ml water 2 hours of digestion A 250 ml water + 0 g cocoa powder (control) will be consumed along with high-fat-high-salt meal after an overnight fast in the morning during the visit to the study site (clinic). Venous blood sample and blood pressure measurement will be taken at the time points baseline (-5 min and 0 min), and 15 min, 30 min, 45 min, 60 min, 90 min and 120 min following the consumption of the 250 ml water + 0 g cocoa powder and high-fat-high-salt meal. 28 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. male or female aged 18 and above, 2. individual living with hypertension not taking medication 3. BMI between 19-35 kg/m^2 1. people who consume alcohol more than 2 units or a drink a day 2. individuals who take medication for hypertension 3. normotensive or hypotensive individuals 4. individuals who smoke cigarette 5. pregnant women 6. breastfeeding mothers 7. individuals with type 1 and type 2 diabetes 8. kidney disease 9. individuals who are allergic to cocoa 10. individuals with dysphagia or digestive disorders such as Chron's disease, irritable bowel syndrome Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 70 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 23/01/2023 Committee on Human Research Publication and Ethics
Ethics Committee Address
Street address City Postal code Country
Room 7, Block L, School of Medicine and Dentistry, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana Kumasi AOK384 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in systolic and diastolic blood pressures -5 min, 0 min, 15 min, 30 min, 45 min, 60 min, 90 min and 120 min
Secondary Outcome Changes in plasma glucose -5 min, 0 min, 15 min, 30 min, 45 min, 60 min, 90 min and 120 min
Secondary Outcome Changes in serum insulin -5 min, 0 min, 15 min, 30 min, 45 min, 60 min, 90 min and 120 min
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kwame Nkrumah University of Science and Technology Accra road, Kumasi Kumasi Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Emmanuel Ofori Osei Department of Biochemistry and Biotechnology, College of Science, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana Kumasi 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, College of Science, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana Kumasi Ghana University
COLLABORATORS
Name Street address City Postal code Country
Prof. Ibok Nsa Oduro Department of Food Science and Technology, College of Science, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana Kumasi Ghana
Dr. Samuel Lowor Cocoa Research Institute of Ghana, Akim-Tafo Akim Tafo Ghana
Margaret Saka Aduama Larbi Cocoa Research Institute of Ghana, Akim-Tafo Akim Tafo Ghana
Dr. Jia Jiet Lim Human Nutrition Unit, School of Biological Sciences, University of Auckland, Auckland 1024, New Zealand Auckland New Zealand
Dr. Charles Diako School of Food and Advanced Technology, Massey University, Auckland, New Zealand Auckland New Zealand
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Emmanuel Ofori Osei emmanueloforiosei@gmail.com +233242731763 Department of Biochemistry and Biotechnology, College of Science, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana
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, College of Science, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana
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 Health Sciences, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana
City Postal code Country Position/Affiliation
Kumasi Ghana Supervisor
Role Name Email Phone Street address
Scientific Enquiries Jia Jiet Lim jia.jiet.lim@auckland.ac.nz +649301162 Human Nutrition Unit, School of Biological Sciences, University of Auckland, Auckland 1024, New Zealand
City Postal code Country Position/Affiliation
Auckland New Zealand Research Fellow
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes A summary of the study finding will be reported in the form of manuscript for publication as a journal article. Individual participant data (IPD) will be filed and protected under lock and information from individual participant will be treated as highly confidential. IPD will be retained on an external hard drive and kept 5 years after the study. IPD will be made accessible to 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 maximum of a 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 proposal and the qualification of requestors will be 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 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