Using African traditional fermented foods to control blood sugar in pre-diabetic adults

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

This study is testing if eating traditional African fermented foods can help people with pre-diabetes control their blood sugar better than standard medical care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 252 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Aga Khan University (Academic / other)
• Locations: 2 sites (Kiambu and 1 other locations)
• Trial ID: NCT05960019 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of African traditional fermented foods in managing blood glucose levels among adults diagnosed with pre-diabetes. It involves a multi-centre, parallel, randomized controlled trial comparing a fermented milk product, a fermented cereal-based product, and standard medical care. A total of 252 pre-diabetic adults will be recruited from 12 treatment facilities across four counties in Kenya. The primary outcome measured will be the change in glycated hemoglobin, with secondary outcomes including changes in weight, waist circumference, fasting plasma glucose levels, and lipid profiles.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 years who have been clinically diagnosed with pre-diabetes within the last six months.

Not a fit: Patients currently on glucose-lowering medications or those with chronic health conditions requiring specific treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel dietary approach to managing blood sugar levels in pre-diabetic patients.

How similar studies have performed: While the use of traditional fermented foods for health benefits is recognized, this specific approach has not been extensively tested in clinical settings, making it a novel investigation.

Eligibility criteria

Inclusion Criteria:

* Clinically diagnosed pre-diabetes (diagnosed less than 6 months ago), defined as HbA1c between 5.7% and 6.4%,
* Both male and female prediabetic individuals
* Aged between 18 and 65 years
* Seeking clinic services at the selected AKU-outreach facilities for at least 3 visits (including seeking services for separate reasons other than pre-diabetes for the purpose of determining affiliation)

Exclusion Criteria:

* Currently on any of the following:

  * glucose lowering medication (including insulin therapy)
  * steroid therapy,
  * immunosuppressive therapy,
  * medication for gastric disease,
  * warfarin or other coumarin derivates,
  * Vitamin C or E, Iron or B12
  * erythropoietin
  * antiretrovirals
  * ribavirin
  * dapsone
* Chronic use (defined as consumption of more than 3 months) of non-steroidal anti-inflammatory drugs or aspirin
* Individuals that have consumed antibiotics in the last month.
* Individuals that regularly consume fermented foods or took nutritional supplements including probiotics during the 3 months prior to screening. Regular consumption shall be defined as consuming at least 250ml of fermented foods on six days in a week.
* Individuals who at the time of enrolment are smokers, regularly consume alcohol (defined as having had at least 12 drinks in the past year but 3 drinks or fewer per week, on average over the past year) or are suffering from drug addiction including chronic opiate use.
* Individuals with a history of gastrointestinal surgery (gastrectomy, bariatric surgery, or colostomy), splenectomy or gastrointestinal malignancy.
* Individuals known to be:

  * HIV+ve,
  * suffering from blood disorders such as Reticulocytosis or any form of Anaemia (including Iron deficiency, B12 Deficiency) or Haemoglobinopathies.
  * Pregnant or lactating,
  * with serious organic or metabolic conditions \[such as malignant disease, pancreatitis, endocarditis, liver, or severe kidney disease (serum creatinine level above the normal range or macroalbuminuria including chronic renal failure), severe pulmonary or heart disease\], splenomegaly, rheumatoid arthritis, hypertriglyceridemia, in a terminal stage of illness, or experiencing acute or severe episodes of mental illness at the time of enrolment.
* Individuals with allergies to dairy or cereal products such as millet.

Where this trial is running

Kiambu and 1 other locations

• Aga Khan Outreach Facilities — Kiambu, Kenya (Recruiting)
• Aga Khan Outreach Facilities — Nairobi, Kenya (Recruiting)

Study contacts

• Principal investigator: Rosebella A Iseme-Ondiek, PhD — Aga Khan University
• Study coordinator: Rosebella A Iseme-Ondiek, PhD

Conditions PreDiabetes