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Blood Glucose Control Using African Traditional Fermented Foods (ATFF)

Primary Purpose

PreDiabetes

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fermented milk product
Fermented cereal based product
Behavioural modification counselling
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PreDiabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Fermented milk product

    Fermented cereal based porridge

    Standard of Care

    Arm Description

    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 (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.

    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.

    Outcomes

    Primary Outcome Measures

    Change in HbA1c
    Change in levels of glycated haemoglobin

    Secondary Outcome Measures

    Change in lipid profile
    Change in levels of total cholesterol, triglycerides, HDL, LDL
    Change in weight
    Change in weight
    Change in CRP levels
    Change in levels of inflammatory marker C reactive protein
    Change in waist circumference
    Change in waist circumference
    Change in FBG
    Change in levels of fasting blood glucose

    Full Information

    First Posted
    April 19, 2023
    Last Updated
    July 21, 2023
    Sponsor
    Aga Khan University
    Collaborators
    Linnaeus University, Kenyatta University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05960019
    Brief Title
    Blood Glucose Control Using African Traditional Fermented Foods
    Acronym
    ATFF
    Official Title
    A Study of the Hypoglycemic Effect of African Traditional Fermented Foods Amongst Pre-diabetic Adults.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 31, 2023 (Anticipated)
    Primary Completion Date
    November 30, 2024 (Anticipated)
    Study Completion Date
    December 17, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Aga Khan University
    Collaborators
    Linnaeus University, Kenyatta University

    4. Oversight

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

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    PreDiabetes

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    252 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Fermented milk product
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Fermented cereal based porridge
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Standard of Care
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Fermented milk product
    Other Intervention Name(s)
    Maziwa mala
    Intervention Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Fermented cereal based product
    Other Intervention Name(s)
    Uji
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Behavioural modification counselling
    Other Intervention Name(s)
    Lifestyle modification counselling
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in HbA1c
    Description
    Change in levels of glycated haemoglobin
    Time Frame
    "12 weeks"
    Secondary Outcome Measure Information:
    Title
    Change in lipid profile
    Description
    Change in levels of total cholesterol, triglycerides, HDL, LDL
    Time Frame
    "4 weeks" and "12 weeks"
    Title
    Change in weight
    Description
    Change in weight
    Time Frame
    "4 weeks" and "12 weeks"
    Title
    Change in CRP levels
    Description
    Change in levels of inflammatory marker C reactive protein
    Time Frame
    "4 weeks" and "12 weeks"
    Title
    Change in waist circumference
    Description
    Change in waist circumference
    Time Frame
    "4 weeks" and "12 weeks"
    Title
    Change in FBG
    Description
    Change in levels of fasting blood glucose
    Time Frame
    "4 weeks" and "12 weeks"
    Other Pre-specified Outcome Measures:
    Title
    Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
    Description
    Adverse events occurring due to consumption of allocated fermented food
    Time Frame
    "from date of randomization through to study completion, an average of 12 weeks"

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rosebella A Iseme-Ondiek, PhD
    Phone
    +254706267212
    Ext
    +254709931506
    Email
    rosebella.ondiek@aku.edu; rosebellaiseme@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rosebella A Iseme-Ondiek, PhD
    Organizational Affiliation
    Aga Khan University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Blood Glucose Control Using African Traditional Fermented Foods

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