NCT05960019

Blood Glucose Control Using African Traditional Fermented Foods

A Study of the Hypoglycemic Effect of African Traditional Fermented Foods Amongst Pre-diabetic Adults.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 252 (estimated)
• Sponsor: Aga Khan University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• PreDiabetes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Fermented milk product	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.
DIETARY_SUPPLEMENT	Fermented cereal based product	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.
BEHAVIORAL	Behavioural modification counselling	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.

Timeline

• Start date: 2024-01-17
• Primary completion: 2024-11-30
• Completion: 2024-12-17
• First posted: 2023-07-25
• Last updated: 2024-01-30

Locations

2 sites across 1 country: Kenya