Blood Glucose Control Using African Traditional Fermented Foods

Phase

N/A

Condition

Diabetes And Hypertension

Diabetes Prevention

Treatment

Behavioural modification counselling

Fermented cereal based product

Fermented milk product

Clinical Study ID

NCT05960019

2022-104

Ages 18-65
All Genders

Study 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

Inclusion Criteria:

Clinically diagnosed pre-diabetes (diagnosed less than 6 months ago), defined as HbA1cbetween 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 thepurpose of determining affiliation)

Exclusion

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-steroidalanti-inflammatory drugs or aspirin
Individuals that have consumed antibiotics in the last month.
Individuals that regularly consume fermented foods or took nutritional supplementsincluding probiotics during the 3 months prior to screening. Regular consumption shallbe 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 perweek, on average over the past year) or are suffering from drug addiction includingchronic opiate use.
Individuals with a history of gastrointestinal surgery (gastrectomy, bariatricsurgery, 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 creatininelevel above the normal range or macroalbuminuria including chronic renalfailure), severe pulmonary or heart disease], splenomegaly, rheumatoid arthritis,hypertriglyceridemia, in a terminal stage of illness, or experiencing acute orsevere episodes of mental illness at the time of enrolment.
Individuals with allergies to dairy or cereal products such as millet.

Study Design