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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Alberta
  Edmonton, Alberta, Canada Recruiting

Study contacts

• Study coordinator: Paulina Aldana Hernandez, PhD
• Email: paldana@ualberta.ca
• Phone: 780-492-9506

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.