African Traditional Fermented Foods and Pre-diabetes

Phase 2

• Conditions: Nutritional, Metabolic, Endocrine

• Registration Number: PACTR202305656080789
• Lead Sponsor: Rosebella IsemeOndiek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-04-28
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

Both male and female individuals aged 18 – 65 years and above who are suffering from clinically diagnosed pre-diabetes (diagnosed less than 6 months ago), defined as HbA1c between 5.7% and 6.4%, who have sought clinic services at the selected AKU-outreach facility for at least 3 visits (including seeking services for separate reasons other than pre-diabetes for the purpose of ascertaining affiliation in an effort to minimize loss to follow).

Exclusion Criteria

1. 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

2. Chronic use (defined as consumption of more than 3 months) of non-steroidal anti-inflammatory drugs or aspirin

3. Individuals that have consumed antibiotics in the last month.

4. 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.

5. 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.

6. Individuals with a history of gastrointestinal surgery (gastrectomy, bariatric surgery, or colostomy), splenectomy or gastrointestinal malignancy.

7. 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.

8. Individuals with allergies to dairy or cereal products such as millet.

Study & Design

• Study Type: Interventional
• Study Design: Not specified