Clinical trial NCT05960019: Blood Glucose Control Using African Traditional Fermented Foods
Official title: A Study of the Hypoglycemic Effect of African Traditional Fermented Foods Amongst Pre-diabetic Adults.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PreDiabetes
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: Linnaeus University
name: Kenyatta University
First posted: 2023-07-25
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although African traditional fermented foods have been linked to health benefits, research pertaining to the use of uniform products in the control of blood glucose is lacking. This study is aimed at assessing the effectiveness of African traditional fermented foods at reducing blood sugar amongst adult pre-diabetic patients. This study shall comprise a multi-centre parallel (3-arm) randomized controlled trial of a fermented milk product, a fermented cereal-based product, and standard medical care. 252 pre-diabetic adults shall be recruited from 12 treatment facilities located at 4 Counties (3 clinics from each County) across Kenya. The primary outcome is change in glycated haemoglobin. Secondary outcomes shall include, change in weight (BMI), waist circumference, levels of fasting plasma glucose, C reactive protein and lipid profile. Safety as well as the acceptability and experience of fermented foods as a treatment modality for pre-diabetes will additionally be assessed amongst study participants. At each study site, data comprising clinical measurements and responses from self-report questionnaires shall be collected over a follow-up period of 12 weeks. Two focus group discussions shall additionally be held in week 13. Comparison of the mean changes between the three groups shall be carried out using Analysis of Variance (ANOVA). Pairwise comparisons shall additionally be undertaken using linear mixed regression models.


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.

Primary outcomes:
measure: Change in HbA1c
timeFrame: "12 weeks"
Secondary outcomes:
measure: Change in lipid profile
timeFrame: "4 weeks" and "12 weeks"
measure: Change in weight
timeFrame: "4 weeks" and "12 weeks"
measure: Change in CRP levels
timeFrame: "4 weeks" and "12 weeks"
measure: Change in waist circumference
timeFrame: "4 weeks" and "12 weeks"
measure: Change in FBG
timeFrame: "4 weeks" and "12 weeks"
Other outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: "from date of randomization through to study completion, an average of 12 weeks"
Locations:
city: Kiambu
country: Kenya
facility: Aga Khan Outreach Facilities
city: Nairobi
country: Kenya
facility: Aga Khan Outreach Facilities
Study officials:
affiliation: Aga Khan University
name: Rosebella A Iseme-Ondiek, PhD
role: PRINCIPAL_INVESTIGATOR
References: