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.: PACTR202403551821999 Date of Approval: 13/03/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of exercise intervention and cocoa beverage supplementation on anthropometric parameters and cardio-metabolic indices of overweight/obese adult women living with hypertension
Official scientific title Effect of exercise intervention and cocoa beverage supplementation on anthropometric parameters and cardio-metabolic indices of overweight/obese adult women living with hypertension
Brief summary describing the background and objectives of the trial The prevalence of overweight and obesity among Ghanaian adults are 25.4% and 17.1% respectively, with these figures expected to rise further. More women than men have this unacceptably high prevalence rate. In terms of regional stratification, Ashanti region recorded the second-highest prevalence, trailing behind the Greater Accra region. Overweight and obesity are risk factors associated with chronic non-communicable diseases including hypertension, type 2 diabetes, and dyslipidaemia. Two important strategies that may improve hypertension and obesity outcomes include exercise and dietary interventions especially those containing polyphenols and nitrates such as cocoa powder. Exercise intervention is effective in reducing body weight, BMI, blood pressure, abdominal and visceral fat mass in obese individuals. Consumption of cocoa beverage significantly reduces systolic blood pressure and increases HDL cholesterol concentration. Supplementation of exercise with diet could result in more significant improvement in blood pressure and anthropometric parameters. No study in Ghana has investigated the effect of exercise intervention and cocoa beverage supplementation on anthropometric and cardio-metabolic indices in obese women. It is against this background that this study seeks to investigate the synergistic effect of structured exercise intervention and cocoa beverage consumption on anthropometric parameters and cardio-metabolic indices of obese adults living with hypertension.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ExCo
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 20/03/2024
Actual trial start date
Anticipated date of last follow up 20/05/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 68
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
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Cocoa beverage supplementation 15g of cocoa powder in 200 mL of warm water daily Six(6) weeks There will be a one week run-in period, where participants will be required to abstain from consuming polyphenol-rich foods including cocoa and its products and intensive physical activity engagement. Prior to laboratory visits, participants will be required to undertake an overnight fast at least 10 hours. Venous blood sample, blood pressure (systolic and diastolic blood pressure), resting heart rate, maximum heart rate (HRmax), heart rate reserve and anthropometric measurements including body weight, height, BMI, waist circumference, hip circumference, waist-to-hip ratio, visceral fats, total body fat and lean muscle mass will be taken at baseline and at week 6. At week 3, blood pressure and anthropometric measurements will be taken. Participants will be required to consume 15g of cocoa powder in 200 mL of warm water during the same period. 34 Active-Treatment of Control Group
Experimental Group Exercise and Cocoa beverage Supplementation Moderate intensity aerobic training, 3 days/week for the 1st two weeks, 4 days/week for the subsequent weeks, and intake of 15g of cocoa powder in 200 mL of warm water daily Six (6) weeks There will be a one week run-in period, where participants will be required to abstain from consuming polyphenol-rich foods including cocoa and its products and intensive physical activity engagement. Prior to laboratory visits, participants will be required to undertake an overnight fast of at least 10 hours. Venous blood sample, blood pressure (systolic and diastolic blood pressure), resting heart rate, maximum heart rate (HRmax), heart rate reserve and anthropometric measurements including body weight, height, BMI, waist circumference, hip circumference, waist-to-hip ratio, visceral fats, total body fat and lean muscle mass will be taken at baseline and at week 6. At week 3, blood pressure and anthropometric measurements will be taken. Participants will be required to undertake in a moderate intensity aerobic training, 3days/week for the 1st two weeks and 4 days/week for the subsequent weeks and consume 15g of cocoa powder in 200 mL of warm water during the same period. 34
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Female individuals aged 18 years and older 2. Individuals with BMI ≥25 kg/m2 3. Individuals living with hypertension and taking hypertensive medication 1. Female individuals who consume alcohol more than 2 units or a drink a day 2. Individuals who take medication for lipid 3. Normotensive or hypotensive individuals 4. Individuals who smoke cigarette 5. Pregnant women 6. Individuals with type 1 and type 2 diabetes and Kidney disease 7. Individuals who are allergic to cocoa 8. Individuals with dysphagia or digestive disorders such as Chron's disease, irritable bowel syndrome 9. Individuals with osteoarthritis Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 50 Year(s) Female
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 15/01/2024 Committee on Human Research Publication and Ethics KNUST
Ethics Committee Address
Street address City Postal code Country
Room 7, Block L, School of Medicine and Dentistry, KNUST, Kumasi Kumasi 00233 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Changes in systolic blood pressure and diastolic blood pressure Week 0, week 3, and week 6
Primary Outcome Changes in serum glucose and lipid profile. Week 0 and week 6
Secondary Outcome Changes in body weight, weight to Hip Ratio, BMI, Visceral fats, total body fat and lean muscle mass Week 0, week 3 and week 6
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nkawie Toase Government Hospital P.O Box 60, Nkawie-Toase Government Hospital, Kumasi Kumasi Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
KNUST Research Fund PMB UPO,KNUST, Kumasi Kumasi 00233 Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor KNUST Research Fund KNUST Campus, Kumasi, Ashanti, Ghana Kumasi 00233 Ghana University
COLLABORATORS
Name Street address City Postal code Country
Dr. Isaac Amoah GF 12, Department of Biochemistry and Biotechnology, Aboagye Menyeh Complex, College of Science, KNUST Kumasi 00233 Ghana
Dr. Jia Jiet Lim Human Nutrition Unit, School of Biological Sciences, University of Auckland, Auckland 1024, New Zealand Auckland 1024 New Zealand
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Samuel Anabila sammyanabila@gmail.com +233241221516 Department of Biochemistry and Biotechnology, College of Science, KNUST
City Postal code Country Position/Affiliation
Kumasi 00233 Ghana Student
Role Name Email Phone Street address
Public Enquiries Isaac Amoah isaacamoah@knust.edu.gh +233249183185 Aboagye Menyeh Complex, Department of Biochemistry and Biotechnology, College of Science, GF12 , KNUST
City Postal code Country Position/Affiliation
Kumasi 00233 Ghana Lecturer and Research Supervisor
Role Name Email Phone Street address
Scientific Enquiries Isaac Amoah isaacamoah458@gmail.com +233249183185 Aboagye Menyeh Complex, GF 12,Department of Biochemistry and Biotechnology, College of Science,KNUST
City Postal code Country Position/Affiliation
Kumasi 00233 Ghana Research Supervisor
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 a maximum 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