Blood Glucose Control Using African Traditional Fermented Foods (ATFF)

• ClinicalTrials.gov Identifier: NCT05960019
• Recruitment Status: Recruiting
• First Posted: July 25, 2023
• Last Update Posted: January 30, 2024
• Sponsor: Aga Khan University
• Collaborators: Linnaeus University; Kenyatta University
• Information provided by (Responsible Party): Rosebella Iseme-Ondiek, Aga Khan University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
PreDiabetes	Dietary Supplement: Fermented milk product; Dietary Supplement: Fermented cereal based product; Behavioral: Behavioural modification counselling	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 252 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Study of the Hypoglycemic Effect of African Traditional Fermented Foods Amongst Pre-diabetic Adults.
• Actual Study Start Date: January 17, 2024
• Estimated Primary Completion Date: November 30, 2024
• Estimated Study Completion Date: December 17, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Fermented milk product; 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; 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.; Other Name: Maziwa mala
Experimental: Fermented cereal based porridge; 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; 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.; Other Name: Uji
Active Comparator: Standard of Care; 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; 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.; Other Name: Lifestyle modification counselling

Outcome Measures

Primary Outcome Measures :

1. Change in HbA1c [ Time Frame: "12 weeks" ]
   Change in levels of glycated haemoglobin

Secondary Outcome Measures :

1. Change in lipid profile [ Time Frame: "4 weeks" and "12 weeks" ]
   Change in levels of total cholesterol, triglycerides, HDL, LDL
2. Change in weight [ Time Frame: "4 weeks" and "12 weeks" ]
   Change in weight
3. Change in CRP levels [ Time Frame: "4 weeks" and "12 weeks" ]
   Change in levels of inflammatory marker C reactive protein
4. Change in waist circumference [ Time Frame: "4 weeks" and "12 weeks" ]
   Change in waist circumference
5. Change in FBG [ Time Frame: "4 weeks" and "12 weeks" ]
   Change in levels of fasting blood glucose

Other Outcome Measures:

1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: "from date of randomization through to study completion, an average of 12 weeks" ]
   Adverse events occurring due to consumption of allocated fermented food

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Rosebella A Iseme-Ondiek, PhD; +254706267212 ext +254709931506; rosebella.ondiek@aku.edu; rosebellaiseme@gmail.com

Locations

Kenya

Aga Khan Outreach Facilities; Recruiting

Kiambu, Kenya

Aga Khan Outreach Facilities; Recruiting

Nairobi, Kenya

Sponsors and Collaborators

Aga Khan University

Linnaeus University

Kenyatta University

Investigators

• Principal Investigator: Rosebella A Iseme-Ondiek, PhD; Aga Khan University

More Information

• Responsible Party: Rosebella Iseme-Ondiek, Assistant Professor, Aga Khan University
• ClinicalTrials.gov Identifier: NCT05960019
• Other Study ID Numbers: 2022-104
• First Posted: July 25, 2023
• Last Update Posted: January 30, 2024
• Last Verified: January 2024

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Prediabetic State; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases