Pharmacy and Poisons Board
Protocol No: ECCT/23/10/07 Date of Protocol: 16-05-2023
Study Title:

 

A Study of the Hypoglycemic Effect of African Traditonal Fermented Foods amongst Prediabetic Adults.

A Study of the Hypoglycemic effect of Fermented Porridge and Fermented Milk among prediabetic adults: A phase 2 multi centre, randomized, parallel group, superiority trial.

 

Study Objectives:

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 (baseline – 12 weeks) changes in:

  • fasting plasma glucose levels
  • weight and waist circumference
  • serum triglycerides and cholesterol levels
  • plasma levels of inflammatory marker C reactive protein (CRP)

Due to the absence of sufficient literature to fix the superiority margin for the other outcomes, we will compare mean change in the secondary outcome variables between the intervention arms (fermented milk product and fermented cereal-based product) and the control group to define the magnitude of the difference.

We shall additionally examine the safety, acceptability, and experience of regularly consuming African Traditional Fermented Foods as a treatment modality amongst adult pre-diabetic patients.

 
Laymans Summary:

Optimum disease management is challenging for diabetic patients, largely due to poor access to affordable and effective treatment modalities.  Similarly, lifestyle modification is only partly effective, carrying a relative risk reduction with regards to diabetes prevention amongst pre-diabetic patients of 36–54%. Consequently, as many as 70% of individuals with pre-diabetes will develop overt Type 2 Diabetes Mellitus within their lifetime The latter highlights the need to continue the search for new interventions. Fermented foods are widely acknowledged to have a host of health benefitting effects including eradication of invasive bacteria, reduction of inflammation in the body and control of blood sugar. These properties inspire the possibilities of new and affordable treatment approaches for prediabetic and possibly diabetic patients.  Notably, research pertaining to the use of African traditional fermented foods in the treatment of prediabetes is lacking.  Our study is thus aimed at examining whether local fermented dairy and fermented cereal-based products can effectively reduce blood sugar (as well as induce a host of other health benefits) amongst Kenyan prediabetic patients.  The results are expected to add to the literature showing that African traditional fermented foods represent an easily accessible natural remedy that could be used to prevent progression to Type 2 Diabetes Mellitus. 
Abstract of Study:

Title:

A Study of The Hypoglycemic Effect of African Traditional Fermented Foods Amongst Prediabetic Adults

Study Description:

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). 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 (HA). We anticipate the mean difference (superiority margin) between fermented food intervention and control to be 0.5% for our primary outcome (change in HbA1c).

Objectives:

 

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:

  • fasting plasma glucose levels
  • weight and waist circumference
  • serum triglycerides and cholesterol levels
  • plasma levels of inflammatory marker C reactive protein (CRP)

 

 

Due to the absence of sufficient literature to fix the superiority margin for the other outcomes, we will compare mean change in the secondary outcome variables between the intervention arms (fermented milk product and fermented cereal-based product) and the control group to define the magnitude of the difference.

 

We shall additionally examine the safety, acceptability, and experience of regularly consuming African Traditional Fermented Foods as a treatment modality amongst adult pre-diabetic patients.

Endpoints:

Primary endpoint: Change in plasma glycated haemoglobin levels (plasma HbA1c levels baseline - 12 weeks).

 

Secondary Endpoints: Change in:

  • fasting plasma glucose levels (at 4 weeks and 12 weeks)
  • weight and waist circumference (at 4 weeks and 12 weeks)
  • serum triglycerides and cholesterol levels (at 4 weeks and 12 weeks)
  • plasma levels of inflammatory marker C reactive protein (CRP) (at 4 weeks and 12 weeks)

Study Population:

252 prediabetic adults (male and females aged 18 – 65 years inclusive, diagnosed less than 6 months ago) defined as having a HbA1c reading that ranges between 5.7% and 6.4% (at the time of enrolment) who have sought services at the selected AKU-outreach clinics in 4 Counties in Kenya during a total of 3 separate visits in the past (that may or may not have had to do with their pre-diabetic condition for the purpose of determining affiliation and minimizing loss to follow-up).

Phase:

Phase 2

Description of Sites/Facilities Enrolling Participants:

The study shall be undertaken in 4 Counties in Kenya, representing four independent study sites with staggered start times. An equal number of study participants (n=21) shall be randomly sampled from 12 treatment facilities (3 AKU facilities in each site/County) namely:

  • Nairobi County - AKU Outreach clinics located at Valley Arcade; CBD/Town centre; Capital Centre
  • Kiambu County - AKU Outreach clinics located at Kiambu, Thika, Ruiru
  • Kajiado County - AKU Outreach clinics located at Ongata Rongai, Ngong, Kitengela
  • Kilifi County - AKU Outreach clinics located at Kilifi Town, Malindi, Mtwapa

Description of Study Intervention:

All study participants randomised to the intervention arms shall receive either fermented milk or fermented cereal-based porridge. The latter shall be expected to consume their assigned fermented food for a period of 12 weeks. Both fermented milk and fermented cereal-based porridge products are non-alcoholic and drinkable and study participants are expected to consume approximately 250ml of their allocated fermented food daily, i.e., first thing in the morning.

Study Duration:

24 months

Participant Duration:

3 months (12 weeks)