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.: PACTR202305656080789 Date of Approval: 04/05/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title African Traditional Fermented Foods and Pre-diabetes
Official scientific title A Study of the Hypoglycemic Effect of African Traditional Fermented Foods amongst Pre-diabetic Adults.
Brief summary describing the background and objectives of the trial This study shall comprise a multi centre, investigator / outcome assessor blinded, randomized, parallel group, superiority trial of a fermented milk product, a fermented cereal-based product, and standard medical care (lifestyle modification counselling). The primary objective of this research shall be to demonstrate superiority of regular consumption of uniform African Traditional Fermented Foods (fermented milk or fermented cereal-based porridge) provided alongside lifestyle modification counselling compared with provision of standard of care ONLY (, i.e., lifestyle modification counselling ALONE) among prediabetic adults with regards to change in plasma glycated haemoglobin levels (plasma HbA1c levels baseline to 12 weeks) by a margin of 0.5%. The secondary objectives of this research shall be to test whether regular consumption of uniform African Traditional Fermented Foods (fermented milk or fermented cereal-based porridge) provided alongside lifestyle modification counselling are superior to provision of standard of care ONLY (, i.e., lifestyle modification counselling) with regards to short term (baseline – 4 weeks) and long-term change (baseline – 12 weeks) in cardiometabolic risk factors (weight, waist circumference, lipid profile, as well as plasma levels of CRP and glucose. It is our hypothesis that amongst adult pre-diabetic patients confirmed by HbA1c levels, regular consumption of uniform African Traditional Fermented Foods (fermented milk or fermented cereal-based porridge) for 12 weeks alongside provision of lifestyle modification counselling has a superior effect when compared with provision of standard of care ALONE (, i.e., lifestyle modification counselling) with respect to change in HbA1c levels, fasting plasma glucose levels, weight and waist circumference, serum triglycerides and cholesterol levels and plasma CRP levels.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) FFP
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 08/05/2023
Actual trial start date
Anticipated date of last follow up 30/11/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 252
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Fermented milk 250 ml fermented milk consumed daily, first thing in the morning 12 weeks This is a type of cultured milk. The naturally procured milk is skimmed to remove the unwanted fat and then Pasteurized, i.e., it is prepared through mesophilic fermentation of bovine milk. 84
Control Group Lifestyle modification counselling Lifestyle modification counselling will be delivered once a month over a period of 1.5 hr. face to face (in-person) sessions with a diabetes doctor or nurse. 12 weeks The control group shall receive the standard of care ONLY. Standard of care includes attendance at the clinic where clinic staff shall check how the pre-diabetes is being managed, pre-empt any possible future health problems by providing counselling on lifestyle modification in an effort to help the patients prevent progression of the pre-diabetes and provide help with any emerging complications of the disease. Counselling on lifestyle modification shall comprise provision of standard dietary and exercise advice by a study doctor or nurse. Exercise advice shall consist of the study nurse of doctor encouraging study participants to undertake ≥ 150 minutes per week of moderate intensity physical activity (similar to brisk walking, light cycling, dancing or water exercise, jogging, singles tennis or hiking hills), with or without a maximum of 75 minutes of strength training that could be applied toward the total 150 minutes per week of physical activity goal, distributed throughout the week with a minimum frequency of 3 days per week of at least 10 minutes per session of physical activity. Dietary advice shall follow the American Diabetes Association guidelines on a healthy diet for prediabetes patients. In particular ‘The Plate Method’, that suggests half a plate be filled with non-starchy vegetables, a quarter with lean protein and a quarter with carbohydrate foods during main meals (recommendations based on a 9-inch dinner plate) accompanied by water or another zero-calorie beverage will be emphasized alongside recommendations for limiting sugar intake as well as alcohol use. 84 Active-Treatment of Control Group
Experimental Group Fermented porridge 250 ml of fermented porridge consumed daily, first thing in the morning 12 weeks This is a fermented cereal-based porridge prepared from a mix of ground millet and sorghum that is mixed with water into a gruel which is fermented into a non-alcoholic beverage or meal depending on desired thickness. The fermentation process used in the production of the porridge applies spontaneous inoculation, whereby the microbes associated with the raw food material and the processing environment serve as inoculations. 84
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Both male and female individuals aged 18 – 65 years and above who are suffering from clinically diagnosed pre-diabetes (diagnosed less than 6 months ago), defined as HbA1c between 5.7% and 6.4%, who have sought clinic services at the selected AKU-outreach facility for at least 3 visits (including seeking services for separate reasons other than pre-diabetes for the purpose of ascertaining affiliation in an effort to minimize loss to follow). 1. Currently on any of the following: - glucose lowering medication (including insulin therapy) - steroid therapy, - immunosuppressive therapy, - medication for gastric disease, - warfarin or other coumarin derivates, - Vitamin C or E, Iron or B12 - erythropoietin - antiretrovirals - ribavirin - dapsone 2. Chronic use (defined as consumption of more than 3 months) of non-steroidal anti-inflammatory drugs or aspirin 3. Individuals that have consumed antibiotics in the last month. 4. Individuals that regularly consume fermented foods or took nutritional supplements including probiotics during the 3 months prior to screening. Regular consumption shall be defined as consuming at least 250ml of fermented foods on six days in a week. 5. Individuals who at the time of enrolment are smokers, regularly consume alcohol (defined as having had at least 12 drinks in the past year but 3 drinks or fewer per week, on average over the past year) or are suffering from drug addiction including chronic opiate use. 6. Individuals with a history of gastrointestinal surgery (gastrectomy, bariatric surgery, or colostomy), splenectomy or gastrointestinal malignancy. 7. Individuals known to be: - HIV+ve, - suffering from blood disorders such as Reticulocytosis or any form of Anaemia (including Iron deficiency, B12 Deficiency) or Haemoglobinopathies. - Pregnant or lactating, - with serious organic or metabolic conditions [such as malignant disease, pancreatitis, endocarditis, liver, or severe kidney disease (serum creatinine level above the normal range or macroalbuminuria including chronic renal failure), severe pulmonary or heart disease], splenomegaly, rheumatoid arthritis, hypertriglyceridemia, in a terminal stage of illness, or experiencing acute or severe episodes of mental illness at the time of enrolment. 8. Individuals with allergies to dairy or cereal products such as millet. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 26/04/2023 The Aga Khan University Nairobi Institutional Scientific and Ethics Review Committee ISERC
Ethics Committee Address
Street address City Postal code Country
5th Floor, University Centre, 3rd Parklands Avenue Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in plasma glycated haemoglobin levels Change from baseline to 12 weeks
Secondary Outcome Change in plasma glucose levels Change from baseline to 4 weeks and 12 weeks
Secondary Outcome Change in weight Change from baseline to 4 weeks and 12 weeks
Secondary Outcome Change in waist circumference Change from baseline to 4 weeks and 12 weeks
Secondary Outcome Change in levels of inflammatory marker C reactive protein Change from baseline to 4 weeks and 12 weeks
Secondary Outcome Change in lipid metabolism profile Change from baseline to 4 weeks and 12 weeks
Secondary Outcome Adverse events arising due to consumption of African Traditional Fermented Foods Assessed continuously from baseline to end of study period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nairobi Town AKU Medical Centre Mama Ngina Street, Jubilee Exchange Building, 6th Floor Nairobi Kenya
Valley Arcade AKU Medical Centre Gitanga Road, Valley Arcade Shopping Centre, 1st Floor Nairobi Kenya
Capital Centre AKU Medical Centre Capital Centre, 1st Floor, Mombasa Road Nairobi Kenya
Kiambu Town AKU Medical Centre Ground Floor, Standard Chartered Building, Kiambu Road Kiambu Kenya
Thika Town AKU Medical Centre 3rd Floor T-Plaza Kenyatta Highway Kiambu Kenya
Ruiru AKU Medical Centre Kamakis-Viashla Business Centre Building, 2nd Floor, along Eastern Bypass Kiambu Kenya
Ongata Rongai AKU Medical Centre Ground Floor, Ongata Mall Complex, Ongata Rongai Shopping Centre, Kiserian Raod Kajiado Kenya
Ngong AKU Medical Centre Ngong-Kiserian Road, Hiwi Court Building, 1st Floor Kajiado Kenya
Kitengela AKU Medical Centre 1st Floor, Kitengela Capital Centre, Kajiado Road Kajiado Kenya
Malindi AKU Medical Centre 1st Floor, Oasis Mall, Malindi-Lamu Road, Malndi Town Kilifi Kenya
Mtwapa AKU Medical Centre 1st Floor, Mtwapa Mall, Malindi Road, Malindi Kilifi Kenya
Bofa Kilifi AKU Medical Centre Sokoni, Kilifi-Bofa Road, Near Governors Office Kilifi Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Ekhagastiftelsen Foundation P. O. Box 34 012 Stockholm SE-100 26 Sweden
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Rosebella IsemeOndiek 5th Floor, University Centre, 3rd Parklands Avenue Nairobi 00100 Kenya Individual
COLLABORATORS
Name Street address City Postal code Country
Jacob Shabani 5th Floor, Aga Khan University Centre, 3rd Parklands Avenue Nairobi 00100 Kenya
Samuel Mucheru 5th Floor, Aga Khan University Centre, 3rd Parklands Avenue Nairobi 00100 Kenya
Catherine Gathu 5th Floor, Aga Khan University Centre, 3rd Parklands Avenue Nairobi 00100 Kenya
Alex Muia 5th Floor, Aga Khan University Centre, 3rd Parklands Avenue Nairobi 00100 Kenya
Redempta Mutisya 844 Building, Kenyatta University Main Campus, Thika Rd Nairobi 00100 Kenya
Eliphas Gitonga 844 Building, Kenyatta University Main Campus, Thika Rd Nairobi 00100 Kenya
Jalal Safipour University Square 1, Linnaeus University, Vaxjo Kronoberg 35251 Sweden
Cornelia Witthoft University Square 1, Linnaeus University, Vaxjo Kronoberg 35251 Sweden
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rosebella IsemeOndiek rosebella.ondiek@aku.edu +254709931506 5th Floor, Aga Khan University Centre, 3rd Parklands Avenue
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Assistant Professor
Role Name Email Phone Street address
Public Enquiries Rosebella IsemeOndiek rosebella.ondiek@aku.edu +254709931506 5th Floor, University Centre, 3rd Parklands Avenue
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Assistant Professor
Role Name Email Phone Street address
Scientific Enquiries Rosebella IsemeOndiek rosebella.ondiek@aku.edu 254709931506 5th Floor, University Centre, 3rd Parklands Avenue
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Assistant Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in an article after deidentification (text, tables, figures and appendices) will be made publicly available. The documents for publication shall include the study protocol, statistical analysis plan, as well as model consent and data collection forms used as part of this study, alongside study findings. Informed Consent Form,Statistical Analysis Plan,Study Protocol Study documents will be made publicly available within a year of study completion. De-identified study data may be made available upon request submitted to the PI upon completion of the study.
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