Although African traditional fermented foods have been linked to health benefits, research pertaining to the use of uniform products in the control of blood glucose is lacking. This study is aimed at assessing the effectiveness of African traditional fermented foods at reducing blood sugar amongst adult pre-diabetic patients. This study shall comprise a multi-centre parallel (3-arm) randomized controlled trial of a fermented milk product, a fermented cereal-based product, and standard medical care. 252 pre-diabetic adults shall be recruited from 12 treatment facilities located at 4 Counties (3 clinics from each County) across Kenya. The primary outcome is change in glycated haemoglobin. Secondary outcomes shall include, change in weight (BMI), waist circumference, levels of fasting plasma glucose, C reactive protein and lipid profile. Safety as well as the acceptability and experience of fermented foods as a treatment modality for pre-diabetes will additionally be assessed amongst study participants. At each study site, data comprising clinical measurements and responses from self-report questionnaires shall be collected over a follow-up period of 12 weeks. Two focus group discussions shall additionally be held in week 13. Comparison of the mean changes between the three groups shall be carried out using Analysis of Variance (ANOVA). Pairwise comparisons shall additionally be undertaken using linear mixed regression models.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
252
This is a type of cultured bovine 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.
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 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 for pre-diabetics by a study doctor.
Aga Khan Outreach Facilities
Kiambu, Kenya
RECRUITINGAga Khan Outreach Facilities
Nairobi, Kenya
RECRUITINGChange in HbA1c
Change in levels of glycated haemoglobin
Time frame: "12 weeks"
Change in lipid profile
Change in levels of total cholesterol, triglycerides, HDL, LDL
Time frame: "4 weeks" and "12 weeks"
Change in weight
Change in weight
Time frame: "4 weeks" and "12 weeks"
Change in CRP levels
Change in levels of inflammatory marker C reactive protein
Time frame: "4 weeks" and "12 weeks"
Change in waist circumference
Change in waist circumference
Time frame: "4 weeks" and "12 weeks"
Change in FBG
Change in levels of fasting blood glucose
Time frame: "4 weeks" and "12 weeks"
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