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.: PACTR201911694067122 Date of Approval: 18/11/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Glycemic effect of different fruits in diabetes patients
Official scientific title Glycemic effect of tropical fruits in type 2 diabetes patients in a low resource setting: A randomized control trial
Brief summary describing the background and objectives of the trial A couple of studies have examined the glycemic effect of fruits in low resource settings but none has applied randomised cross-over design to address between-patient differences. We plan to compare the glycemic effect of different fruits on blood sugar level.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) None
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 25/11/2019
Actual trial start date
Anticipated date of last follow up 30/04/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 17
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group pawpaw Fruit that contains an equivalent of 50g of glucose will be received once per participant Once - during one hospital visit Participants will be asked to visit our general outpatient clinic once per week for 5 weeks. For every visit, each participant will be served different fruits (depending on the sequence they were assigned) and their blood sugar level will be monitored and recorded over 120 minutes 17
Experimental Group pineapple Fruit that contains an equivalent of 50g of glucose will be received once per participant once - during one hospital visit Participants will be asked to visit our general outpatient clinic once per week for 5 weeks. For every visit, each participant will be served different fruits (depending on the sequence they were assigned) and their blood sugar level will be monitored and recorded over 120 minutes 17
Experimental Group banana Fruit that contains an equivalent of 50g of glucose will be received once per participant Once - during one hospital visit Participants will be asked to visit our general outpatient clinic once per week for 5 weeks. For every visit, each participant will be served different fruits (depending on the sequence they were assigned) and their blood sugar level will be monitored and recorded over 120 minutes 17
Experimental Group Orange Fruit that contains an equivalent of 50g of glucose will be received once per participant Once - during one hospital visit Participants will be asked to visit our general outpatient clinic once per week for 5 weeks. For every visit, each participant will be served different fruits (depending on the sequence they were assigned) and their blood sugar level will be monitored and recorded over 120 minutes 17
Control Group Glucose 50g of glucose Once - during one hospital visit Participants will be asked to visit our general outpatient clinic once per week for 5 weeks. For every visit, each participant will be served different fruits (depending on the sequence they were assigned) and their blood sugar level will be monitored and recorded over 120 minutes 17 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult type 2 diabetes patient Willingness to give informed consent Uncontrol type 2 diabetes patient 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 100 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 31/08/2019 The Federal Medical Centre Bida Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Government Reserved Area Bida 912101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The average increase in blood glucose after taking each fruit Every 30 minutes after taking each of the fruit during hospital visit
Secondary Outcome The maximal increase in blood glucose after taking each fruit Every 30 minutes after taking each fruit during hospital visit
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical Centre Government reserved area Bida Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Oluwakemi Jokotola Federal Medical Centre Bida 912101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Oluwakemi H. Jokotola Federal Medical Centre Bida 912101 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Samuel Adefemi Federal Medical Centre Bida 912101 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Oluwakemi Jokotola gakayode@yahoo.co.uk 2348034146030 Government Reserved Area
City Postal code Country Position/Affiliation
Bida 912101 Nigeria Federal Medical Centre
Role Name Email Phone Street address
Public Enquiries Oluwakemi Jokotola gakayode@yahoo.co.uk +2348034709067 GRA
City Postal code Country Position/Affiliation
Bida 912101 Nigeria Federal Medical Centre
Role Name Email Phone Street address
Scientific Enquiries Oluwakemi Jokotola gakayode@yahoo.co.uk +2348034709067 GRA
City Postal code Country Position/Affiliation
Bida 912101 Nigeria Federal Medical Centre
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes it will be provided Study Protocol Within 12 months after completing the trial Will be provided once the trial is completed
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