Systemic Inflammatory ResponseNCT06695221
Improving Health Outcomes With Kefir
A study testing Traditional Kefir in people with Systemic Inflammatory Response and Diabetes Mellitus, Type 2, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 70 years
- Conditions the study is for
- Systemic Inflammatory Response, Diabetes Mellitus, Type 2, Cardiovascular Diseases
- What is being tested?
- Traditional Kefir
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteCanada
- Study dates
- 24 Mar 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%).
Who cannot join
- 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."
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Alberta
Edmonton, Alberta, T6G 2E1
Paulina Aldana Hernandez, PhD, 780-492-9506, paldana@ualberta.ca
Benjamin Willing, PhD
About this study
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.
Read the detailed 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.
- Being tested
- Traditional Kefir, Milk (placebo)
- Keywords
- Kefir, Systemic inflammation, Vascular markers, Gut microbiota, Fermented Foods
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional KefirDietary supplement
350 mL/day of traditional fermented/prepared kefir
Milk (placebo)Dietary supplement
350 mL/day of commercial 2% fat milk
| Study group | Role | What they receive |
|---|---|---|
| Participants living with T2D | Experimental | Randomly assigned to consume either traditional kefir or milk as a placebo. Receives: Dietary Supplement: Traditional Kefir; Dietary Supplement: Milk (placebo) |
| Participants with higher risk of T2D | Experimental | Randomly assigned to consume either traditional kefir or milk as a placebo. Receives: Dietary Supplement: Traditional Kefir; Dietary Supplement: Milk (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 weeks, 12 weeks
Secondary outcomes (10)
Change in Fasting Plasma Glucose Levels (mmol/L)
This outcome measures the change in fasting plasma glucose levels using standard blood glucose analysis. The assessment at multiple time points will provide insights into the short-term impact of our traditional kefir on fasting glucose regulation.
Measured: Baseline, 6 weeks, 12 weeks
Change in Total Cholesterol (mmol/L)
This outcome evaluates changes in total cholesterol concentration, providing insights into the effect of our traditional kefir on lipid metabolism and cardiovascular risk. It will be measured in serum samples using standard laboratory methods.
Measured: Baseline, 6 weeks, 12 weeks
Change in Low-Density Lipoprotein Cholesterol (LDL-C) (mmol/L)
This outcome measures the change in LDL-C levels, a primary marker of cardiovascular health, to assess the potential cardiovascular benefits of our traditional kefir. It will be measured in serum samples using standard laboratory methods.
Measured: Baseline, 6 weeks, 12 weeks
Change in High-Density Lipoprotein Cholesterol (LDL-C) (mmol/L)
This outcome assesses the change in HDL-C concentration to evaluate whether our traditional kefir consumption has beneficial effects on lipid profiles. It will be measured in serum samples using standard laboratory methods.
Measured: Baseline, 6 weeks, 12 weeks
Change in Triglyceride levels (mmol/L)
This outcome measures the change in triglyceride concentration to determine the effect of our traditional kefir on lipid metabolism and metabolic health. It will be measured in serum samples using standard laboratory methods.
Measured: Baseline, 6 weeks, 12 weeks
Change in Circulating C-Reactive Protein (CRP) Levels (mg/L)
This outcome measures changes in CRP, a systemic inflammation marker, providing insight into whether our traditional kefir impacts inflammatory responses in participants. It will be measured in plasma samples using standard laboratory methods.
Measured: Baseline, 6 weeks, 12 weeks
Change in Interleukin-2 (IL-2) in Supernatant of Ex Vivo Stimulated Cells from Whole Blood (pg/mL)
This outcome measures changes in IL-2 levels in the supernatant of ex vivo-stimulated cells derived from whole blood, serving as a surrogate marker of T-cell proliferation. IL-2 will be quantified using cytokine analysis of cell culture supernatants following mitogen stimulation. This assessment provides insight into immune function and response.
Measured: Baseline, 6 weeks, 12 weeks
Change in T Helper Cell Response Measured by Interferon-Gamma (IFN-γ) Levels in Supernatant of Ex Vivo Stimulated Cells from Whole Blood (pg/mL)
This outcome evaluates changes in interferon-gamma (IFN-γ) levels in the supernatant of ex vivo-stimulated cells derived from whole blood. IFN-γ is a key cytokine secreted by T helper cells, serving as an indicator of cellular immune response and Th1 activity. IFN-γ will be quantified using cytokine analysis of cell culture supernatants following mitogen stimulation.
Measured: Baseline, 6 weeks, 12 weeks
Change in Tumor Necrosis Factor-Alpha (TNF-α) Levels in Supernatant of Ex Vivo Stimulated Cells from Whole Blood (pg/mL)
This outcome measures changes in TNF-α levels in the supernatant of ex vivo-stimulated cells derived from whole blood. TNF-α is a pro-inflammatory cytokine and serves as a marker of immune system activation. TNF-α will be quantified using cytokine analysis of cell culture supernatants following mitogen stimulation.
Measured: Baseline, 6 weeks, 12 weeks
Change in Gut Microbiome Composition and Functional Capacity (Relative Abundance)
This outcome examines changes in the composition and functional capacity of the gut microbiome using 16S rRNA gene sequencing or metagenomic analysis. The analysis will focus on relative abundance and diversity of bacterial taxa and functional pathways associated with metabolic health.
Measured: Baseline, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start24 Mar 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Systemic Inflammatory ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695221
- Sponsor's protocol ID
- Pro00139307
- Status last verified
- May 2026
- First submitted
- 13 Nov 2024
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34256014Savaiano 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.
PubMed 32447398Braga 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.
PubMed 37727636Bourrie 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.
PubMed 27199969Bourrie, 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
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.
PubMed 32472367Bourrie 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.
PubMed 32684173Bourrie 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.
PubMed 36504827Bourrie 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.
PubMed 37224566
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Health Outcomes With Kefir
- ClinicalTrials.gov ID
- NCT06695221
- Acronym / sponsor ID
- Pro00139307
- Keywords
- Kefir, Systemic inflammation, Vascular markers, Gut microbiota, Fermented Foods
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants living with T2D | Experimental | Dietary Supplement: Traditional Kefir, Dietary Supplement: Milk (placebo)Randomly assigned to consume either traditional kefir or milk as a placebo. |
| Participants with higher risk of T2D | Experimental | Dietary Supplement: Traditional Kefir, Dietary Supplement: Milk (placebo)Randomly assigned to consume either traditional kefir or milk as a placebo. |
Who may qualify
- Ages
- 24 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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%).
Key exclusion criteria (7 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Kefir350 mL/day of traditional fermented/prepared kefir | Dietary supplement | Participants living with T2D, Participants with higher risk of T2D |
| Milk (placebo)350 mL/day of commercial 2% fat milk | Dietary supplement | Participants living with T2D, Participants with higher risk of T2D |
Primary outcome
Change in Glycated Hemoglobin (HbA1c) Levels (Percentage)
Time frame: Baseline, 6 weeks, 12 weeks
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.
10 secondary outcomes
Change in Fasting Plasma Glucose Levels (mmol/L)
Time frame: Baseline, 6 weeks, 12 weeks
Change in Total Cholesterol (mmol/L)
Time frame: Baseline, 6 weeks, 12 weeks
Change in Low-Density Lipoprotein Cholesterol (LDL-C) (mmol/L)
Time frame: Baseline, 6 weeks, 12 weeks
Change in High-Density Lipoprotein Cholesterol (LDL-C) (mmol/L)
Time frame: Baseline, 6 weeks, 12 weeks
Change in Triglyceride levels (mmol/L)
Time frame: Baseline, 6 weeks, 12 weeks
Change in Circulating C-Reactive Protein (CRP) Levels (mg/L)
Time frame: Baseline, 6 weeks, 12 weeks
Change in Interleukin-2 (IL-2) in Supernatant of Ex Vivo Stimulated Cells from Whole Blood (pg/mL)
Time frame: Baseline, 6 weeks, 12 weeks
Change in T Helper Cell Response Measured by Interferon-Gamma (IFN-γ) Levels in Supernatant of Ex Vivo Stimulated Cells from Whole Blood (pg/mL)
Time frame: Baseline, 6 weeks, 12 weeks
Change in Tumor Necrosis Factor-Alpha (TNF-α) Levels in Supernatant of Ex Vivo Stimulated Cells from Whole Blood (pg/mL)
Time frame: Baseline, 6 weeks, 12 weeks
Change in Gut Microbiome Composition and Functional Capacity (Relative Abundance)
Time frame: Baseline, 6 weeks, 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Background: PubMed 34256014Wastyk 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.
- Background: PubMed 32447398Savaiano 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.
- Background: PubMed 37727636Braga 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.
- Background: PubMed 27199969Bourrie 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.
- BackgroundBourrie, 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: PubMed 32472367Bourrie 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.
- Background: PubMed 32684173Bourrie 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.
- Background: PubMed 36504827Bourrie 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.
- Background: PubMed 37224566Bourrie 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Kefir in people with Systemic Inflammatory Response and Diabetes Mellitus, Type 2, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paulina Aldana Hernandez, PhD (780-492-9506, paldana@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glycated Hemoglobin (HbA1c) Levels (Percentage) (time frame: Baseline, 6 weeks, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06695221, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.