Kefir for vascular and immune health in people with or at risk for type 2 diabetes

Improving Health Outcomes With Kefir

This 12-week test will see if drinking 350 mL of traditional kefir each day helps improve blood vessel and immune health in adults aged 24–70 who have or are at higher risk for type 2 diabetes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 156 (estimated)
• Ages: 24 Years to 70 Years
• Sex: All
• Sponsor: University of Alberta (Academic / other)
• Drugs / interventions: methotrexate
• Locations: 1 site (Edmonton, Alberta)
• Trial ID: NCT06695221 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind intervention will enroll adults aged 24–70 in the Edmonton area who are overweight and either at higher risk for or living with type 2 diabetes. Participants will be randomly assigned to drink 350 mL daily of traditional fermented kefir or 350 mL of a milk placebo for 12 weeks, with participants and study coordinators blinded to assignment. Researchers will collect vascular health measures, immune markers, and gut microbiota samples at baseline and follow-up to compare changes between groups. Dietary habits and recent medication use will be monitored, and people with recent high fermented-food intake, GI disorders, pregnancy, or certain recent medications are excluded.

Who should consider this trial

Good fit: Adults aged 24–70 living within driving distance of Edmonton who are overweight or obese and either have diagnosed type 2 diabetes or meet lab criteria for higher diabetes risk are the ideal candidates.

Not a fit: People with gastrointestinal disorders, recent antibiotic or immunosuppressive drug use, high habitual intake of fermented foods, pregnancy or breastfeeding, or major comorbid conditions are unlikely to qualify or benefit from the intervention.

Why it matters

Potential benefit: If successful, daily kefir could improve vascular function and immune-related markers, potentially lowering cardiovascular risk or complications in people with or at risk for type 2 diabetes.

How similar studies have performed: Small clinical and animal studies of kefir and other fermented foods have shown mixed improvements in metabolic and inflammatory markers, but large, well-controlled trials are limited.

Eligibility criteria

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."

Where this trial is running

Edmonton, Alberta

• University of Alberta — Edmonton, Alberta, Canada (Recruiting)

Study contacts

• Study coordinator: Paulina Aldana Hernandez, PhD

Conditions Systemic Inflammatory Response; Diabetes Mellitus, Type 2; Cardiovascular Diseases; Kefir; Systemic inflammation; Vascular markers; Gut microbiota; Fermented Foods