African Traditional Fermented Foods and Pre-diabetes
- Disease/Condition
- Nutritional, Metabolic, Endocrine
- Intervention type
- other
- Primary sponsor
- Rosebella IsemeOndiek
- Funder
- Ekhagastiftelsen Foundation
- Location
- Kenya
- Phase
- Phase 2
- Start date
- Jan 01, 1900
- End date
- Jan 01, 1900
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.
- Registry
- Pan Africa Clinical Trials Registry
- Trial ID
- PACTR202305656080789
- Type
- Non-Device Trial
Access comprehensive clinical trial information for PACTR202305656080789 through Pure Global AI's free database. This Phase 2 trial is sponsored by Rosebella IsemeOndiek and is currently Not yet recruiting. The study focuses on Nutritional, Metabolic, Endocrine.
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