Recruiting

Kefir

Sponsor:

University of Alberta

Code:

NCT06695221

Conditions

Systemic Inflammatory Response

Diabetes Mellitus, Type 2

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 24 - 70

Healthy Volunteers: Not accepted

Interventions

Traditional Kefir

Milk (placebo)

Study Details

Brief summary:

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.

Conditions

Systemic Inflammatory Response

Diabetes Mellitus, Type 2

Cardiovascular Diseases

Study ID

NCT06695221

Start date

Mar 24, 2026

Status verified date

May, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 24 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

156 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Participants living with T2D

Randomly assigned to consume either traditional kefir or milk as a placebo.

experimental: Participants with higher risk of T2D

Randomly assigned to consume either traditional kefir or milk as a placebo.

Interventions

Traditional Kefir

350 mL/day of traditional fermented/prepared kefir

Milk (placebo)

350 mL/day of commercial 2% fat milk

Primary outcome measure

  • Change in Glycated Hemoglobin (HbA1c) Levels (Percentage) [ Time Frame: Baseline, 6 weeks, 12 weeks ]

Central Contacts and Locations

Central contacts

Paulina Aldana Hernandez, PhD

780-492-9506paldana@ualberta.ca

Locations

University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G 2E1

Contacts

Paulina Aldana Hernandez, PhD

780-492-9506paldana@ualberta.ca

Principal Investigator:

Benjamin Willing, PhD

More Information

Sponsor

University of Alberta

Last update posted

May 8, 2026

Last verified

May, 2026

Keywords

  • Kefir
  • Systemic inflammation
  • Vascular markers
  • Gut microbiota
  • Fermented Foods

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-05-08.