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.: PACTR202311641040122 Date of Registration: 16/11/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Application of Mediterranean-type diet concept based on Ghanaian food choices in the management of Type 2 Diabetes
Official scientific title The Effect of the Adoption of Mediterranean-Type Diet on Glycemic Control among Type-2 Diabetes Patients in Accra: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Type 2 diabetes is a metabolic disease characterized by high glucose levels in the blood due to insufficient insulin production or activity. Risk factors for T2D include age, family history, genetics, lack of physical activity, and excess weight. The disease affects 9% of the global adult population and requires lifestyle management, pharmacologic treatment, and surgical therapy. Treatment starts with lifestyle management, including nutrition therapy. Diabetes self-management education and support (DSMES) and medical nutrition therapy (MNT), while underutilized, are essential for achieving glycemic goals and preventing diabetes complications. Therefore, the adoption of evidence-based lifestyles, such as healthy eating habits, is essential to diabetes management. Although there is no singular dietary pattern that has been definitively established as superior to others, the Mediterranean diet (MedDiet) stands out as the sole diet that aligns with the dietary recommendations of the ADA, and it is associated with numerous health benefits. The Mediterranean diet (MedDiet) aligns with the ADA's dietary recommendations and offers numerous health benefits. Adherence to Mediterranean dietary patterns may enhance glycemic control, improve insulin sensitivity, and reduce atherogenic factors linked to cardiovascular diseases. However, there is limited information on the effectiveness of the MedDiet in Ghana, particularly in managing T2D. Modifying and adopting the MedDiet concept to fit local food availability and nutritional needs can be a sustainable way to manage T2D. Therefore, the study aims to: a. Determine the effect of the adoption of a Med-type diet on HbA1c levels (glycemic control) among T2D patients over a three-month trial period. b. To compare the effect of the Med-type Diet on outcome measures (HbA1c, BMI, WC, and lipid profile) between two intervention groups (one group supplemented with olive oil and the other with groundnut oil).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Nutritional Education and Support
Anticipated trial start date 03/11/2023
Actual trial start date 03/11/2023
Anticipated date of last follow up 04/01/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 75
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 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Olive Oil Group At least 50g of olive oil (approximately 5 dessert spoonful) per day Three (3) months Intervention participants will complete a three-month Med-type Diet program that includes nutritional education, support (olive oil), and group cooking demonstrations. Multiple 24-hour dietary recalls will be collected from the participants at baseline, midline, and endline of the study to establish dietary intake and monitor adherence to the Med-type diet. Dietitians will use food models and household measurements to cross-check the information collected from the 24-hour recalls. In the group assigned to the Mediterranean diet with olive oil, each participant will be given 1 litre of olive oil, which forms the hallmark of the Mediterranean diet, every two weeks. During the education session, participants will be educated on the daily and weekly recommendations of the Mediterranean diet based on Ghanaian food selections. The recommendations are as follows: a) Fill half of the plate with vegetables for lunch and dinner, and fresh fruits should be about 3 servings per day. b) Eat seafood twice a week. Participants will be advised to consume shellfish, salmon, tuna, herring, and other fish at least three times a week c) Moderate intake of poultry: at least 2 servings (2 small matchbox sizes) per week. d) Cut down on the consumption of red meat at least one serving (1 matchbox size) everyday e) 1-2 servings of dairy products per day f) To use olive oil in cooking and in salad dressings g) Switch from refined or processed products to whole grains products (corn, millet, sorghum, local brown rice) h) Increase raw unsalted nut intake (30g) and legumes (at least 3 servings per week) i) Switch sweet desserts or fried items with healthier snacks (e.g., fresh fruits) In addition, participants will receive instruction on portion management utilising the MyPlate method and will be guided through practical demonstrations illustrating the proper preparation techniques for 'sofrito'. 25
Experimental Group Groundnut Oil Group At least 50g of groundnut oil (approximately 5 dessert spoonful) per day Three (3) months In the group assigned to the Mediterranean diet with groundnut oil, each participant will be given 1 litre of cold-pressed groundnut oil, which forms the hallmark of the Mediterranean diet, every two weeks. In addition, participants will be advised on the daily and weekly recommendations of the Mediterranean diet based on Ghanaian food selections. The recommendations are as follows: a) Fill half of the plate with vegetables for lunch and dinner, and fresh fruits should be about 3 servings per day. b) Eat seafood twice a week. Participants will be advised to consume shellfish, salmon, tuna, herring, and other fish at least three times a week c) Moderate intake of poultry: at least 2 servings (2 small matchbox sizes) per week. d) Cut down on the consumption of red meat at least one serving (1 matchbox size) everyday e) 1-2 servings of dairy products per day f) To use cold-pressed roasted groundnut oil in cooking and in salad dressings g) Switch from refined or processed products to whole grains products (corn, millet, sorghum, local brown rice) h) Increase raw unsalted nut intake (30g) and legumes (at least 3 servings per week) i) Switch sweet desserts or fried items with healthier snacks (e.g., fresh fruits) In addition, participants will receive instruction on portion management utilising the MyPlate method, and will be guided through practical demonstrations illustrating the proper preparation techniques for 'sofrito'. 25
Control Group Control Group No specific oil was given Three (3) months The control group will consist of participants who have received consultations from nutritionists and/or dietitians at their respective healthcare facilities regarding the dietary management of type 2 diabetes. 25 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
18 years of age or older at the time of first diagnosis of T2D, A1C of greater than or equal to 7.0%, Individuals on oral hypoglycemic medications. History of gestational diabetes, Patients with pancreatogenic diabetes, or other secondary diabetes, Previously diagnosis with or hospitalisation due to malignant tumors, Type 1 diabetes (T1D), Latent autoimmune diabetes in adults (LADA), Patients receiving glucocorticoids, Patients on exogenous insulin. 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) 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 27/02/2023 Ghana Health Service Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Dodoo Lane, Osu, Accra Accra 233 Ghana
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 08/02/2023 37 Military Hospital Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Neghelli Barracks, Liberation Road Accra 233 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The main end point is glycemic control, which will be assessed by the mean HbA1c changes. HbA1c changes refers to the difference between HbA1c measured at baseline and at endline of the study. This difference will be compared between the intervention and control groups. At baseline and at endline of the study
Secondary Outcome The clinically relevant measures will be BMI, blood pressure, waist circumference, and lipid profile. The differences between BMI, BP, waist circumference, and lipid profile will be measured at baseline and at endline of the study. These differences will be compared between the intervention and control groups. At baseline and endline of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
37 Military Hospital Neghelli Barracks Accra Ghana
Maamobi General Hospital Abavana Street, Maamobi Accra Ghana
Greater Accra Regional Hospital Castle Rd Accra Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Self New Labadi Villas Accra Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ivy Priscilla Frimpong New Labadi Villas Accra Ghana Individual
COLLABORATORS
Name Street address City Postal code Country
Dr. Charles Addoquaye Brown University of Ghana, Korle-Bu Accra Ghana
Dr. Rebecca K. Steele Dadzie University of Ghana, Korle-Bu Accra Ghana
Dr. Husein Mohammed University of Ghana, Korle-Bu Accra Ghana
Professor George Asare University of Ghana, Korle-Bu Accra Ghana
Professor Lauri Wright 3010 USF Banyan Circle, Tampa, University of South Florida Tampa 33620 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ivy Frimpong ivy.frimpong2@gmail.coom +233244783032 New Labadi Villas
City Postal code Country Position/Affiliation
Accra Ghana Doctoral Candidate. University of Ghana
Role Name Email Phone Street address
Scientific Enquiries Charles Brown cabrown@ug.edu.gh +233268203808 Korle-Bu
City Postal code Country Position/Affiliation
Accra Ghana University of Ghana
Role Name Email Phone Street address
Public Enquiries Thomas Ndanu revtomdata@gmail.com +233244872410 University of Ghana Dental School, Korle-bu
City Postal code Country Position/Affiliation
Accra Ghana University of Ghana
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The individual participant information to be shared for this particular study encompasses a number of data points, including, but not limited to: a. Baseline demographic information of participants. b. Clinical and laboratory measurements taken at various time points. c. Dietary intake data. d. Any additional data collected during the trial deemed relevant for the research objectives. The data will be de-identified to safeguard participant privacy and confidentiality, preventing the disclosure of any direct or indirect identifiable information to researchers. Informed Consent Form,Study Protocol IDP will be available within six months after the primary trial results are published. The data will remain accessible for sharing for a minimum of five years from the date of trial completion. a. Researchers should have a legitimate scientific research purpose that aligns with the aims of our clinical trial. This encompasses a wide range of research areas, including but not limited to those related to the Mediterranean diet, nutrition, and associated health outcomes. b. Researchers must provide a detailed research proposal that outlines a clear plan for ethical data use, including data security and confidentiality. c. Access may be granted to both independent and institutional researchers, provided they meet the criteria mentioned above.
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