Kefir for Type 2 Diabetes

Overseen By Caroline Richard, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Must not be taking: Antibiotics, Antifungals, Corticosteroids, others

Disqualifiers: GI disorders, Pregnancy, Endocrine disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial excludes people who have used certain medications like antibiotics, antifungals, corticosteroids, methotrexate, or immunosuppressive agents in the last 3 months. It seems you might need to stop these medications to participate, but the protocol doesn't specify for other medications.

How does kefir differ from other treatments for type 2 diabetes?

Kefir is unique because it is a probiotic fermented milk that may help control blood sugar and improve lipid profiles in type 2 diabetes patients. It contains beneficial microbes that can enhance glucose homeostasis and potentially aid in weight loss, making it a novel dietary supplement option compared to traditional medications. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Traditional Kefir for Type 2 Diabetes?

Research shows that kefir, a probiotic fermented milk, can help control blood sugar and improve cholesterol levels in people with type 2 diabetes. In one study, a diabetic patient who consumed kefir experienced weight loss and a reduction in HbA1c (a measure of long-term blood sugar levels), suggesting potential benefits for managing diabetes. ^{2 3 4 5 6}

Who Is on the Research Team?

Benjamin Willing, PhD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

This trial is for men and women at high risk of or living with Type 2 Diabetes who may also have cardiovascular issues. Participants should be interested in testing if kefir can improve their vascular health and immune system over a 12-week period.

Inclusion Criteria

My blood sugar or HbA1C levels indicate I'm at high risk for type 2 diabetes.

I have been diagnosed with Type 2 Diabetes.

Overweight or obesity (BMI >25 for Caucasian, >23 for Asian)

Exclusion Criteria

Being pregnant or breastfeeding

I haven't taken antibiotics, steroids, or immune-suppressing drugs in the last 3 months.

Usual high intake (maximum intake 3 servings/week) of fermented foods excluding cheese (i.e., kefir, kombucha, kimchi, etc.) for the past 3 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants consume either 350 mL of traditional fermented kefir or 350 mL of a placebo (milk) daily for 12 weeks

12 weeks

Baseline, 6 weeks, 12 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Traditional Kefir

Trial Overview The study is examining the effects of traditional kefir compared to milk (which serves as a placebo) on vascular and immune health outcomes in individuals with or at high risk for Type 2 Diabetes.

How Is the Trial Designed?

Group I: Participants with higher risk of T2D Experimental Treatment 2 Interventions

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

Group II: Participants living with T2D Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Kefir in the Prevention and Treatment of Obesity and Metabolic Disorders. [2021]

2. Indonesia pubmed.ncbi.nlm.nih.gov

The effects of oral plain kefir supplementation on proinflammatory cytokine properties of the hyperglycemia Wistar rats induced by streptozotocin. [2013]

3. Iran pubmed.ncbi.nlm.nih.gov

Effect of probiotic fermented milk (kefir) on glycemic control and lipid profile in type 2 diabetic patients: a randomized double-blind placebo-controlled clinical trial. [2022]

4. Iran pubmed.ncbi.nlm.nih.gov

Traditional Probiotic (Kefir) Effects on Glycated Hemoglobin A Level and Weight of an Indexed Diabetic Patient. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Dual function of Lactobacillus kefiri DH5 in preventing high-fat-diet-induced obesity: direct reduction of cholesterol and upregulation of PPAR-α in adipose tissue. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Anti-Diabetic Effect of Lactobacillus Paracasei Isolated from Malaysian Water Kefir Grains. [2023]