Blood Glucose Control Using African Traditional Fermented Foods (ATFF)
PreDiabetes
About this trial
This is an interventional treatment trial for PreDiabetes
Eligibility Criteria
Inclusion Criteria: Clinically diagnosed pre-diabetes (diagnosed less than 6 months ago), defined as HbA1c between 5.7% and 6.4%, Both male and female prediabetic individuals Aged between 18 and 65 years Seeking clinic services at the selected AKU-outreach facilities for at least 3 visits (including seeking services for separate reasons other than pre-diabetes for the purpose of determining affiliation) Exclusion Criteria: 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 Chronic use (defined as consumption of more than 3 months) of non-steroidal anti-inflammatory drugs or aspirin Individuals that have consumed antibiotics in the last month. 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. 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. Individuals with a history of gastrointestinal surgery (gastrectomy, bariatric surgery, or colostomy), splenectomy or gastrointestinal malignancy. 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. Individuals with allergies to dairy or cereal products such as millet.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
Fermented milk product
Fermented cereal based porridge
Standard of Care
Dietary supplement (Maziwa Mala) This is a type of cultured dairy milk, that is prepared through mesophilic fermentation of milk that is widely available in Kenya. Participants will be expected to consume 250ml of the mala each day for breakfast.
Dietary supplement (Uji) 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. Participants will be expected to consume 250ml of the porridge each day for breakfast.
Standard of care shall comprise behavioural (lifestyle) modification counselling delivered monthly. This shall consist of provision of counselling on lifestyle modification in an effort to help the participants 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 for pre-diabetics by a study doctor.