Blood Glucose Control Using African Traditional Fermented Foods

PreDiabetes Clinical Trial

— ATFF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05960019
• Other study ID #: 2022-104
• Status: Recruiting
• Phase: N/A
• Start date: January 17, 2024
• Est. completion date: December 17, 2024

Study information

• Verified date: January 2024
• Source: Aga Khan University
• Contact: Rosebella A Iseme-Ondiek, PhD
• Phone: +254706267212
• Email: rosebella.ondiek[@]aku.edu; rosebellaiseme[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 252
• Est. completion date: December 17, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• PreDiabetes
• Prediabetic State

Intervention

Dietary Supplement:
• Fermented milk product
This is a type of cultured bovine milk, that is prepared through mesophilic fermentation of milk, that is widely available in Kenya. Participants will be expected to consume 250ml of the mala each day for breakfast.
• Fermented cereal based product
This is a fermented cereal-based porridge prepared from a mix of ground millet and sorghum that is mixed with water into a gruel which is fermented into a non-alcoholic beverage or meal depending on desired thickness. Participants will be expected to consume 250ml of the porridge each day for breakfast.

Behavioral:
• Behavioural modification counselling
Standard of care shall comprise behavioural (lifestyle) modification counselling delivered monthly. This shall consist of provision of counselling on lifestyle modification in an effort to help the patients prevent progression of the pre-diabetes and provide help with any emerging complications of the disease. Counselling on lifestyle modification shall comprise provision of standard dietary and exercise advice for pre-diabetics by a study doctor.

Locations

Country	Name	City	State
Kenya	Aga Khan Outreach Facilities	Kiambu
Kenya	Aga Khan Outreach Facilities	Nairobi

Sponsors (3)

Lead Sponsor	Collaborator
Aga Khan University	Kenyatta University, Linnaeus University

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Adverse events occurring due to consumption of allocated fermented food	"from date of randomization through to study completion, an average of 12 weeks"
Primary	Change in HbA1c	Change in levels of glycated haemoglobin	"12 weeks"
Secondary	Change in lipid profile	Change in levels of total cholesterol, triglycerides, HDL, LDL	"4 weeks" and "12 weeks"
Secondary	Change in weight	Change in weight	"4 weeks" and "12 weeks"
Secondary	Change in CRP levels	Change in levels of inflammatory marker C reactive protein	"4 weeks" and "12 weeks"
Secondary	Change in waist circumference	Change in waist circumference	"4 weeks" and "12 weeks"
Secondary	Change in FBG	Change in levels of fasting blood glucose	"4 weeks" and "12 weeks"