PACTR202305656080789

African Traditional Fermented Foods and Pre-diabetes

A Study of the Hypoglycemic Effect of African Traditional Fermented Foods amongst Pre-diabetic Adults.
Rosebella IsemeOndiek·Phase 2·Pan Africa Clinical Trials Registry·otherNot yet recruiting
Study focus
Intervention type
other
Sponsor & location
Primary sponsor
Rosebella IsemeOndiek
Funder
Ekhagastiftelsen Foundation
Location
Kenya
Timeline & enrollment
Phase
Phase 2
Start date
Jan 01, 1900
End date
Jan 01, 1900
Summary

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.

ICD-10 classifications
Endocrine, nutritional and metabolic diseasesPersonal history of endocrine, nutritional and metabolic diseasesOther postprocedural endocrine and metabolic disordersFamily history of other endocrine, nutritional and metabolic diseasesPostprocedural endocrine and metabolic disorders, not elsewhere classified
Data source
Registry
Pan Africa Clinical Trials Registry
Trial ID
PACTR202305656080789
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to Pan Africa Clinical Trials Registry data, helping medical device and pharmaceutical companies navigate clinical research efficiently.