Blood Glucose Control Using African Traditional Fermented Foods

NCT05960019 | Unknown

• 1 other identifier: 2022-104
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 2

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.

Conditions

PreDiabetes

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  Change in levels of glycated haemoglobin

  "12 weeks"

Secondary Outcomes (5)

• Change in lipid profile

  "4 weeks" and "12 weeks"

• Change in weight

  "4 weeks" and "12 weeks"

• Change in CRP levels

  "4 weeks" and "12 weeks"

• Change in waist circumference

  "4 weeks" and "12 weeks"

• Change in FBG

  "4 weeks" and "12 weeks"

Other Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  "from date of randomization through to study completion, an average of 12 weeks"

Study Arms (3)

Fermented milk product

EXPERIMENTAL

Dietary supplement (Maziwa Mala) This is a type of cultured dairy 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.

Dietary Supplement: Fermented milk product

Fermented cereal based porridge

EXPERIMENTAL

Dietary supplement (Uji) 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.

Dietary Supplement: Fermented cereal based product

Standard of Care

ACTIVE COMPARATOR

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 participants 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.

Behavioral: Behavioural modification counselling

Interventions

Fermented milk product DIETARY_SUPPLEMENT

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.

Also known as: Maziwa mala

Fermented milk product

Fermented cereal based product DIETARY_SUPPLEMENT

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.

Also known as: Uji

Fermented cereal based porridge

Behavioural modification counselling BEHAVIORAL

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.

Also known as: Lifestyle modification counselling

Standard of Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aga Khan University: lead
• Linnaeus University: collaborator
• Kenyatta University: collaborator

Study Sites (2)

Aga Khan Outreach Facilities

Kiambu, Kenya

RECRUITING

Aga Khan Outreach Facilities

Nairobi, Kenya

RECRUITING

MeSH Terms

Conditions

Prediabetic State

Interventions

Cultured Milk Products

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Foods; Dairy Products; Food; Food and Beverages

Study Officials

• Rosebella A Iseme-Ondiek, PhD

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosebella A Iseme-Ondiek, PhD

CONTACT

+254706267212; rosebella.ondiek@aku.edu; rosebellaiseme@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: July 25, 2023
• Study Start: January 17, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 17, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

KE (2)