Cardiovascular Diseases, Diabetes Mellitus, Type 2, Systemic Inflammatory Response
Conditions
Keywords
Kefir, Systemic inflammation, Vascular markers, Gut microbiota, Fermented Foods
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.
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.
Interventions
DIETARY_SUPPLEMENTTraditional Kefir
350 mL/day of traditional fermented/prepared kefir
DIETARY_SUPPLEMENTMilk (placebo)
350 mL/day of commercial 2% fat milk
Sponsors
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
24 Years to 70 Years
Healthy volunteers
No
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."
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycated Hemoglobin (HbA1c) Levels (Percentage) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fasting Plasma Glucose Levels (mmol/L) | Baseline, 6 weeks, 12 weeks | 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. |
| Change in Total Cholesterol (mmol/L) | Baseline, 6 weeks, 12 weeks | 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. |
| Change in Low-Density Lipoprotein Cholesterol (LDL-C) (mmol/L) | Baseline, 6 weeks, 12 weeks | 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. |
| Change in High-Density Lipoprotein Cholesterol (LDL-C) (mmol/L) | Baseline, 6 weeks, 12 weeks | 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. |
| Change in Triglyceride levels (mmol/L) | Baseline, 6 weeks, 12 weeks | 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. |
| Change in Circulating C-Reactive Protein (CRP) Levels (mg/L) | Baseline, 6 weeks, 12 weeks | 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. |
| Change in Interleukin-2 (IL-2) in Supernatant of Ex Vivo Stimulated Cells from Whole Blood (pg/mL) | Baseline, 6 weeks, 12 weeks | 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. |
| 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) | Baseline, 6 weeks, 12 weeks | 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. |
| Change in Tumor Necrosis Factor-Alpha (TNF-α) Levels in Supernatant of Ex Vivo Stimulated Cells from Whole Blood (pg/mL) | Baseline, 6 weeks, 12 weeks | 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. |
| Change in Gut Microbiome Composition and Functional Capacity (Relative Abundance) | Baseline, 6 weeks, 12 weeks | 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. |
Countries
Canada
Contacts
CONTACTPaulina Aldana Hernandez, PhD
Outcome results
None listed