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.: PACTR201710002620173 Date of Approval: 13/09/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Role of increasing soluble dietary fibre content of grains
Official scientific title Glycaemic And Pan increasing soluble dietary fibre content of grains
Brief summary describing the background and objectives of the trial Fibre content of meals has been found to be beneficial in the prevention and management of carbohydrate intolerance including Diabetes Mellitus. Using two commonly consumed grains namely fonio, Digitaria exilis and wheat, Triticum aestivum, this proposed research will determine the impact of grain fibre type and content on glycaemic and pancreatic beta cell response.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Prediabetes,Diabetes
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 23/09/2017
Actual trial start date
Anticipated date of last follow up 14/10/2017
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
nil known Pan African Clinical Trials Registry
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 randondomisation using a table of random numbers Numbered containers Masking/blinding used
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randondomisation using a table of random numbers created by a computer software program Numbered containers Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Anhydrous Glucose 50grams 2hours Study subjects will ingest 50 grams of glucose over 10 minutes and samples of blood glucose,insulin and c-petide taken over 2 hours 20
Experimental Group Wheat(Triticum Spp) 50 grams 2 Hours Study subjects will ingest 50 grams of wheat grain over 10minutes and serum glucose,insulin and c-peptide measured over hours 20
Experimental Group White Fonio(Digitaria Exilis) 50 grams 2 Hours Study subjects will ingest 50grams of white fonio over 10minutes and samples of serum glucose,insulin and c-peptide taken over 2 hours 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age 20 years -60 years Apparently healthy individals Subjects with a body mass index of 20-24.9kg/m² Age <20years and > 60 years Patients with prediabetes or Diabetes mellitus Subjects with gastrointestinal disturbances such as intolerance to milk, malabsorption or diarrheal illnesses Subjects who decline consent. 20 Year(s) 60 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 27/05/2016 Usmanu Danfodiyo University Teaching Hospital Sokoto Health Research Ethics Commitee
Ethics Committee Address
Street address City Postal code Country
Uduth Road,Gawon Nama,Sokoto,Nigeria Sokoto 840232 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Glycaemic Control Time 0 hours(Fasting) Time 30 minutes Time 60 minutes Time 90 minutes Time 120 minutes
Primary Outcome Insulin Response Time 0 Hours Time 30 minutes Time 60 minutes Time 90 minutes Time 120 minutes
Primary Outcome C--Peptide Time 0 minutes Time 30 minutes Time 60 minutes Time 90 minutes Time 120 minutes
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Usmanu Danfodyo University Teaching Hosital Sokoto Uduth Road Gawon Nama 840232 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Muhammad Idris Uduth Road,Gawon Nama Sokoto Sokoto 840232 Nigeria
Usmanu Danfodiyo University Teaching Hospital Sokoto Uduth Road,Gawon Nama Sokoto Sokoto 840232 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Muhammad Idris Uduth Road,Gawon Nama Sokoto Sokoto 840232 Nigeria Hospital
Secondary Sponsor Usmanu Danfodiyo University Teaching Hospital Sokoto Uduth Road,Gawon Nama Sokoto Sokoto 840232 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Professor A E Ohwovoriole university of Lagos /Lagos University Teaching Hospitaly Lagos 100254 Nigeria
Dr Anas Sabir Uduth Road,Gawon Nama Sokoto Sokoto 840232 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Muhammad Idris amuhammadidris@yahoo.com 2348069678461 Uduth Road,Gawon Nama,Sokoto
City Postal code Country Position/Affiliation
Sokoto 840232 Nigeria Resident in Endocrinology
Role Name Email Phone Street address
Public Enquiries Muhammad Idris amuhammadidris@yahoo.com 2348069678461 Uduth Road,Gawon Nama,Sokoto
City Postal code Country Position/Affiliation
Sokoto 840232 Nigeria Resident in Endocrinology
Role Name Email Phone Street address
Scientific Enquiries Muhammad Idris amuhammadidris@yahoo.com 2348069678461 Uduth Road,Gawon Nama,Sokoto
City Postal code Country Position/Affiliation
Sokoto 840232 Nigeria Resident in Endocrinology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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