Improving Health Outcomes With Kefir

May 6, 2026 updated by: University of Alberta
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants who sign the written consent form will undergo a screening process to determine eligibility for study entry. At the baseline visit, recruited participants will be randomized in a double-blind manner (participant and study coordinator) to consume either 350 mL of traditional fermented kefir or 350 mL of a placebo (milk) daily. During the 12 weeks of intervention, health outcomes will be measured and collected for further analysis.

Study Type

Interventional

Enrollment (Estimated)

156

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2E1
        • Recruiting
        • University of Alberta
        • Contact:
        • Principal Investigator:
          • Benjamin Willing, PhD
        • Sub-Investigator:
          • Caroline Richard, PhD
        • Sub-Investigator:
          • Laurie Mereu, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. females and males (24-70 years old) living in Edmonton (or Edmonton area/driving distance);
  2. overweight or obesity (BMI >25 Caucasian, >23 Asian);
  3. at higher risk of T2D (fasting blood glucose ≥ 5.6 - 6.9 mmol/L or/and HbA1C ≥ 5.5 - 6.4%); or
  4. with diagnosis of T2D (fasting blood glucose ≥ 7.0 mmol/L or/and HbA1C ≥ 6.5%).

Exclusion Criteria:

  1. 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;
  2. gastrointestinal (GI) disorders of any kind;
  3. being pregnant or breastfeeding;
  4. monogenic dyslipidemias and endocrine disorders except for diabetes;
  5. use of medications within the last 3 months (i.e., antibiotics or antifungals, corticosteroids, methotrexate, or immunosuppressive cytotoxic agents);
  6. any health conditions deemed to interfere with primary outcomes at the investigator's discretion (e.g., kidney disease, liver disease, cancer, GI surgery, heavy alcohol consumption, etc.);
  7. having a pacemaker or any electrical medical device that prevents the individual from undergoing the bioelectrical impedance analysis bioimmunoassay (BIA) test."

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants living with T2D
Randomly assigned to consume either traditional kefir or milk as a placebo.
Dietary supplement: Traditional Kefir
350 mL/day of traditional fermented/prepared kefir
Dietary supplement: Milk (placebo)
350 mL/day of commercial 2% fat milk
Experimental: Participants with higher risk of T2D
Randomly assigned to consume either traditional kefir or milk as a placebo.
Dietary supplement: Traditional Kefir
350 mL/day of traditional fermented/prepared kefir
Dietary supplement: Milk (placebo)
350 mL/day of commercial 2% fat milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Glycated Hemoglobin (HbA1c) Levels (Percentage)
Time Frame: Baseline, 6 weeks, 12 weeks
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.
Baseline, 6 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fasting Plasma Glucose Levels (mmol/L)
Time Frame: Baseline, 6 weeks, 12 weeks
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.
Baseline, 6 weeks, 12 weeks
Change in Total Cholesterol (mmol/L)
Time Frame: Baseline, 6 weeks, 12 weeks
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.
Baseline, 6 weeks, 12 weeks
Change in Low-Density Lipoprotein Cholesterol (LDL-C) (mmol/L)
Time Frame: Baseline, 6 weeks, 12 weeks
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.
Baseline, 6 weeks, 12 weeks
Change in High-Density Lipoprotein Cholesterol (LDL-C) (mmol/L)
Time Frame: Baseline, 6 weeks, 12 weeks
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.
Baseline, 6 weeks, 12 weeks
Change in Triglyceride levels (mmol/L)
Time Frame: Baseline, 6 weeks, 12 weeks
This outcome measures the change in triglyceride concentration to determine the effect of our traditional kefir on lipid metabolism and metabolic health. It will be measured in serum samples using standard laboratory methods.
Baseline, 6 weeks, 12 weeks
Change in Circulating C-Reactive Protein (CRP) Levels (mg/L)
Time Frame: Baseline, 6 weeks, 12 weeks
This outcome measures changes in CRP, a systemic inflammation marker, providing insight into whether our traditional kefir impacts inflammatory responses in participants. It will be measured in plasma samples using standard laboratory methods.
Baseline, 6 weeks, 12 weeks
Change in Interleukin-2 (IL-2) in Supernatant of Ex Vivo Stimulated Cells from Whole Blood (pg/mL)
Time Frame: Baseline, 6 weeks, 12 weeks
This outcome measures changes in IL-2 levels in the supernatant of ex vivo-stimulated cells derived from whole blood, serving as a surrogate marker of T-cell proliferation. IL-2 will be quantified using cytokine analysis of cell culture supernatants following mitogen stimulation. This assessment provides insight into immune function and response.
Baseline, 6 weeks, 12 weeks
Change in T Helper Cell Response Measured by Interferon-Gamma (IFN-γ) Levels in Supernatant of Ex Vivo Stimulated Cells from Whole Blood (pg/mL)
Time Frame: Baseline, 6 weeks, 12 weeks
This outcome evaluates changes in interferon-gamma (IFN-γ) levels in the supernatant of ex vivo-stimulated cells derived from whole blood. IFN-γ is a key cytokine secreted by T helper cells, serving as an indicator of cellular immune response and Th1 activity. IFN-γ will be quantified using cytokine analysis of cell culture supernatants following mitogen stimulation.
Baseline, 6 weeks, 12 weeks
Change in Tumor Necrosis Factor-Alpha (TNF-α) Levels in Supernatant of Ex Vivo Stimulated Cells from Whole Blood (pg/mL)
Time Frame: Baseline, 6 weeks, 12 weeks
This outcome measures changes in TNF-α levels in the supernatant of ex vivo-stimulated cells derived from whole blood. TNF-α is a pro-inflammatory cytokine and serves as a marker of immune system activation. TNF-α will be quantified using cytokine analysis of cell culture supernatants following mitogen stimulation.
Baseline, 6 weeks, 12 weeks
Change in Gut Microbiome Composition and Functional Capacity (Relative Abundance)
Time Frame: Baseline, 6 weeks, 12 weeks
This outcome examines changes in the composition and functional capacity of the gut microbiome using 16S rRNA gene sequencing or metagenomic analysis. The analysis will focus on relative abundance and diversity of bacterial taxa and functional pathways associated with metabolic health.
Baseline, 6 weeks, 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Body Weight (Kg)
Time Frame: Baseline, 6 weeks, 12 weeks
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.
Baseline, 6 weeks, 12 weeks
Change in Body Mass Index (BMI) (kg/m²)
Time Frame: Baseline, 6 weeks, 12 weeks
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.
Baseline, 6 weeks, 12 weeks
Change in Waist Circumference (cm)
Time Frame: Baseline, 6 weeks, 12 weeks
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.
Baseline, 6 weeks, 12 weeks
Change in Hip Circumference (cm)
Time Frame: Baseline, 6 weeks, 12 weeks
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.
Baseline, 6 weeks, 12 weeks
Change in Body Composition (Percentage of Fat Mass and Fat-Free Mass) Measured by Bioelectrical Impedance Analysis (BIA)
Time Frame: Baseline, 6 weeks, 12 weeks
Body composition will be assessed using BIA to determine changes in fat mass and fat-free mass as percentages of total body weight. Participants will be measured in a fasted state with consistent hydration levels for accuracy.
Baseline, 6 weeks, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Investigators

  • Principal Investigator: Benjamin Willing, PhD, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

November 13, 2024

First Submitted That Met QC Criteria

November 15, 2024

First Posted (Actual)

November 19, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00139307

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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