Improving Health Outcomes With Kefir

University of Alberta

Status: Enrolling

Conditions: Cardiovascular Diseases; Systemic Inflammatory Response; Diabetes Mellitus, Type 2

Treatments: Dietary Supplement: Traditional Kefir; Dietary Supplement: Milk (placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT06695221

Pro00139307

Details and patient eligibility

About

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.

Full 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.

Enrollment: 156 estimated patients

Sex: All

Ages: 24 to 70 years old

Volunteers: No Healthy Volunteers

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."

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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156 participants in 2 patient groups

Participants living with T2D

Experimental group

Description:

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

Treatment:

Dietary Supplement: Milk (placebo)

Dietary Supplement: Traditional Kefir

Participants with higher risk of T2D

Experimental group

Description:

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

Treatment:

Dietary Supplement: Milk (placebo)

Dietary Supplement: Traditional Kefir