Home/Get Matched/NCT06695221
Recruiting
View on ClinicalTrials.gov

Testing Traditional Kefir for systemic inflammatory response

Official title: Improving Health Outcomes With Kefir

Condition: Systemic Inflammatory ResponseSponsor: University of AlbertaTarget enrollment: 156
  • 2 groups
  • One site, in Edmonton
  • Recruiting
University of Alberta, Edmonton, Alberta

Interventions

  • Other intervention

    Traditional Kefir

    350 mL/day of traditional fermented/prepared kefir

  • Other intervention

    Milk (placebo)

    350 mL/day of commercial 2% fat milk

Canadian Sites (1)

1 of 1 recruiting

  • University of Alberta

    Edmonton, Alberta

    Recruiting

Eligibility Criteria

See who this study is looking for11 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

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

Exclusion

  • 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;
  • 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);
  • having a pacemaker or any electrical medical device that prevents the individual from undergoing the bioelectrical impedance analysis bioimmunoassay (BIA) test."
  • being pregnant or breastfeeding;
  • any health conditions deemed to interfere with primary outcomes at the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s discretion (e.g., kidney disease, liver disease, cancer, GI surgery, heavy alcohol consumption, etc.);
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a treatment for a condition.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 2 groups in this study.

Groups A and B receive one or more of: Traditional Kefir and Milk (placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →).

Registry label: A: Participants living with T2D · B: Participants with higher risk of T2D

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

Neither you nor the study team would know which group you are in until the study ends.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it — alongside the other treatment that group is given.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists an age range of 24 years to 70 years.

The study is open to people of any sex.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 156 people.

The study is currently expected to finish around December 2027.

The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, 6 weeks, 12 weeks.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Change in Glycated Hemoglobin (HbA1c) Levels (Percentage) — measured over BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, 6 weeks, 12 weeks.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT06695221 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About Traditional KefirDietary supplement

350 mL/day of traditional fermented/prepared kefir

From the trial registry — its own words, unedited.

What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.

Read the full explanation → · in clinical review

About Milk (placebo)Dietary supplement

350 mL/day of commercial 2% fat milk

From the trial registry — its own words, unedited.

What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: an age range of 24 years to 70 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

Yes. One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it — alongside the other treatment that group is given.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

Neither you nor the study team would know which group you are in until the study ends.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists an age range of 24 years to 70 years.

It is open to people of any sex.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, 6 weeks, 12 weeks.

The study as a whole is currently expected to finish around 2027-12.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 156 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: Edmonton, Alberta, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About 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.

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.