NCT06695221

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Mar 2026Dec 2027

First Submitted

Initial submission to the registry

November 13, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 19, 2024

Completed
1.3 years until next milestone

Study Start

First participant enrolled

March 24, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

November 13, 2024

Last Update Submit

March 11, 2026

Conditions

Systemic Inflammatory ResponseDiabetes Mellitus, Type 2Cardiovascular Diseases

Keywords

KefirSystemic inflammationVascular markersGut microbiotaFermented Foods

Outcome Measures

Primary Outcomes (1)

  • Change in Glycated Hemoglobin (HbA1c) Levels (Percentage)

    The primary outcome is the change in HbA1c levels, measured as a percentage of total hemoglobin using standard laboratory methods. This measurement assesses average blood glucose levels over the past 2-3 months, providing insight into the effect of our traditional kefir on long-term glucose regulation.

    Baseline, 6 weeks, 12 weeks

Secondary Outcomes (10)

  • Change in Fasting Plasma Glucose Levels (mmol/L)

    Baseline, 6 weeks, 12 weeks

  • Change in Total Cholesterol (mmol/L)

    Baseline, 6 weeks, 12 weeks

  • Change in Low-Density Lipoprotein Cholesterol (LDL-C) (mmol/L)

    Baseline, 6 weeks, 12 weeks

  • Change in High-Density Lipoprotein Cholesterol (LDL-C) (mmol/L)

    Baseline, 6 weeks, 12 weeks

  • Change in Triglyceride levels (mmol/L)

    Baseline, 6 weeks, 12 weeks

  • +5 more secondary outcomes

Other Outcomes (5)

  • Changes in Body Weight (Kg)

    Baseline, 6 weeks, 12 weeks

  • Change in Body Mass Index (BMI) (kg/m²)

    Baseline, 6 weeks, 12 weeks

  • Change in Waist Circumference (cm)

    Baseline, 6 weeks, 12 weeks

  • +2 more other outcomes

Study Arms (2)

Participants living with T2D

EXPERIMENTAL

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

Dietary Supplement: Traditional KefirDietary Supplement: Milk (placebo)

Participants with higher risk of T2D

EXPERIMENTAL

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

Dietary Supplement: Traditional KefirDietary Supplement: Milk (placebo)

Interventions

Traditional KefirDIETARY_SUPPLEMENT

350 mL/day of traditional fermented/prepared kefir

Participants living with T2DParticipants with higher risk of T2D
Milk (placebo)DIETARY_SUPPLEMENT

350 mL/day of commercial 2% fat milk

Participants living with T2DParticipants with higher risk of T2D

Eligibility Criteria

Age24 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • females and males (24-70 years old) living in Edmonton (or Edmonton area/driving distance);
  • overweight or obesity (BMI \>25 Caucasian, \>23 Asian);
  • at higher risk of T2D (fasting blood glucose ≥ 5.6 - 6.9 mmol/L or/and HbA1C ≥ 5.5 - 6.4%); or
  • with diagnosis of T2D (fasting blood glucose ≥ 7.0 mmol/L or/and HbA1C ≥ 6.5%).

You may not qualify if:

  • 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;
  • gastrointestinal (GI) disorders of any kind;
  • being pregnant or breastfeeding;
  • monogenic dyslipidemias and endocrine disorders except for diabetes;
  • use of medications within the last 3 months (i.e., antibiotics or antifungals, corticosteroids, methotrexate, or immunosuppressive cytotoxic agents);
  • 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.);
  • having a pacemaker or any electrical medical device that prevents the individual from undergoing the bioelectrical impedance analysis bioimmunoassay (BIA) test."

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

RECRUITING

Related Publications (9)

  • Wastyk HC, Fragiadakis GK, Perelman D, Dahan D, Merrill BD, Yu FB, Topf M, Gonzalez CG, Van Treuren W, Han S, Robinson JL, Elias JE, Sonnenburg ED, Gardner CD, Sonnenburg JL. Gut-microbiota-targeted diets modulate human immune status. Cell. 2021 Aug 5;184(16):4137-4153.e14. doi: 10.1016/j.cell.2021.06.019. Epub 2021 Jul 12.

    PMID: 34256014BACKGROUND

  • Savaiano DA, Hutkins RW. Yogurt, cultured fermented milk, and health: a systematic review. Nutr Rev. 2021 Apr 7;79(5):599-614. doi: 10.1093/nutrit/nuaa013.

    PMID: 32447398BACKGROUND

  • Braga Tibaes JR, Barreto Silva MI, Makarowski A, Cervantes PB, Richard C. The nutrition and immunity (nutrIMM) study: protocol for a non-randomized, four-arm parallel-group, controlled feeding trial investigating immune function in obesity and type 2 diabetes. Front Nutr. 2023 Sep 1;10:1243359. doi: 10.3389/fnut.2023.1243359. eCollection 2023.

    PMID: 37727636BACKGROUND

  • Bourrie BC, Willing BP, Cotter PD. The Microbiota and Health Promoting Characteristics of the Fermented Beverage Kefir. Front Microbiol. 2016 May 4;7:647. doi: 10.3389/fmicb.2016.00647. eCollection 2016.

    PMID: 27199969BACKGROUND

  • Bourrie, B, Cotter, P, Willing, BP, 2018. Traditional kefir reduces weight gain and improves plasma and liver lipid profiles more successfully than a commercial equivalent in a mouse model of obesity. Journal of Functional Foods, 46: 29-37. https://doi.org/10.1016/j.jff.2018.04.039

    BACKGROUND

  • Bourrie BCT, Richard C, Willing BP. Kefir in the Prevention and Treatment of Obesity and Metabolic Disorders. Curr Nutr Rep. 2020 Sep;9(3):184-192. doi: 10.1007/s13668-020-00315-3.

    PMID: 32472367BACKGROUND

  • Bourrie BCT, Ju T, Fouhse JM, Forgie AJ, Sergi C, Cotter PD, Willing BP. Kefir microbial composition is a deciding factor in the physiological impact of kefir in a mouse model of obesity. Br J Nutr. 2021 Jan 28;125(2):129-138. doi: 10.1017/S0007114520002743. Epub 2020 Jul 20.

    PMID: 32684173BACKGROUND

  • Bourrie BCT, Forgie AJ, Ju T, Richard C, Cotter PD, Willing BP. Consumption of the cell-free or heat-treated fractions of a pitched kefir confers some but not all positive impacts of the corresponding whole kefir. Front Microbiol. 2022 Nov 24;13:1056526. doi: 10.3389/fmicb.2022.1056526. eCollection 2022.

    PMID: 36504827BACKGROUND

  • Bourrie BCT, Forgie AJ, Makarowski A, Cotter PD, Richard C, Willing BP. Consumption of kefir made with traditional microorganisms resulted in greater improvements in LDL cholesterol and plasma markers of inflammation in males when compared to a commercial kefir: a randomized pilot study. Appl Physiol Nutr Metab. 2023 Sep 1;48(9):668-677. doi: 10.1139/apnm-2022-0463. Epub 2023 May 24.

    PMID: 37224566BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Cardiovascular Diseases

Interventions

Milk

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Central Study Contacts

Paulina Aldana Hernandez, PhD

CONTACT

780-492-9506paldana@ualberta.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2024

First Posted

November 19, 2024

Study Start

March 24, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

March 12, 2026

Record last verified: 2026-03

Locations

CA(1)