Improving Health Outcomes With Kefir
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age24-70
SponsorUniversity of Alberta
About this trial
The purpose of the study is to ascertain whether traditional kefir not only enhances vascular health but also contributes to improved immune outcomes in both male and female participants at higher risk or living with Type 2 Diabetes (T2D) after 12 weeks of treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
females and males (24-70 years old) living in Edmonton (or Edmonton area/driving distance);
overweight or obesity (BMI >25 Caucasian, >23 Asian);
at higher risk of T2D (fasting blood glucose ≥ 5.6 - 6.9 mmol/L or/and HbA1C ≥ 5.5 - 6.4%); or
with diagnosis of T2D (fasting blood glucose ≥ 7.0 mmol/L or/and HbA1C ≥ 6.5%).
Disqualifiers
a usual high intake (maximum intake 3 servings/week) of fermented foods excluding cheese (i.e., kefir, kombucha, kimchi, etc.) for the past 3 months;
gastrointestinal (GI) disorders of any kind;
being pregnant or breastfeeding;
monogenic dyslipidemias and endocrine disorders except for diabetes;
Trial design
Design model
Parallel
Treatments tested in this trial
Traditional Kefir
Dietary supplement350 mL/day of traditional fermented/prepared kefir
Milk (placebo)
Dietary supplement350 mL/day of commercial 2% fat milk
Treatment groups
156 Participants
are divided into 2 treatment groupsGroup A: Participants living with T2DExperimental treatment 2 interventions
Group B: Participants with higher risk of T2DExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in Glycated Hemoglobin (HbA1c) Levels (Percentage)
The primary outcome is the change in HbA1c levels, measured as a percentage of total hemoglobin using standard laboratory methods. This measurement assesses average blood glucose levels over the past 2-3 months, providing insight into the effect of our traditional kefir on long-term glucose regulation.
Time frame
Baseline, 6 weeks, 12 weeksSecondary outcomes
1
Change in Fasting Plasma Glucose Levels (mmol/L)
This outcome measures the change in fasting plasma glucose levels using standard blood glucose analysis. The assessment at multiple time points will provide insights into the short-term impact of our traditional kefir on fasting glucose regulation.
Time frame
Baseline, 6 weeks, 12 weeks2
Change in Total Cholesterol (mmol/L)
This outcome evaluates changes in total cholesterol concentration, providing insights into the effect of our traditional kefir on lipid metabolism and cardiovascular risk. It will be measured in serum samples using standard laboratory methods.
Time frame
Baseline, 6 weeks, 12 weeks3
Change in Low-Density Lipoprotein Cholesterol (LDL-C) (mmol/L)
This outcome measures the change in LDL-C levels, a primary marker of cardiovascular health, to assess the potential cardiovascular benefits of our traditional kefir. It will be measured in serum samples using standard laboratory methods.
Time frame
Baseline, 6 weeks, 12 weeks4
Change in High-Density Lipoprotein Cholesterol (LDL-C) (mmol/L)
This outcome assesses the change in HDL-C concentration to evaluate whether our traditional kefir consumption has beneficial effects on lipid profiles. It will be measured in serum samples using standard laboratory methods.
Time frame
Baseline, 6 weeks, 12 weeksOther outcomes
1
Changes in Body Weight (Kg)
This outcome measures changes in body weight using a calibrated digital scale. Participants' weight will be assessed while wearing light clothing and no shoes. This measurement evaluates the effect of our traditional kefir on overall body mass.
Time frame
Baseline, 6 weeks, 12 weeks2
Change in Body Mass Index (BMI) (kg/m²)
BMI will be calculated using body weight (kg) and height (m) measurements. Height will be measured using a stadiometer at baseline only, and BMI will be monitored to assess changes in body composition.
Time frame
Baseline, 6 weeks, 12 weeks3
Change in Waist Circumference (cm)
This outcome evaluates changes in waist circumference, measured at the umbilical level using a non-elastic tape. This measurement serves as an indicator of central adiposity and fat distribution.
Time frame
Baseline, 6 weeks, 12 weeks4
Change in Hip Circumference (cm)
Hip circumference will be measured at the widest part of the hips using a non-elastic tape. This outcome helps determine changes in fat distribution and body shape.
Time frame
Baseline, 6 weeks, 12 weeksSponsors and contacts
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Source ClinicalTrials.gov