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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants living with T2D | Experimental | Randomly assigned to consume either traditional kefir or milk as a placebo. |
|
| Participants with higher risk of T2D | Experimental | Randomly assigned to consume either traditional kefir or milk as a placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional Kefir | Dietary Supplement | 350 mL/day of traditional fermented/prepared kefir |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6 weeks, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Body Weight (Kg) | This outcome measures changes in body weight using a calibrated digital scale. Participants' weight will be assessed while wearing light clothing and no shoes. This measurement evaluates the effect of our traditional kefir on overall body mass. | Baseline, 6 weeks, 12 weeks |
| Change in Body Mass Index (BMI) (kg/m²) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paulina Aldana Hernandez, PhD | Contact | 780-492-9506 | paldana@ualberta.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta | Recruiting | Edmonton | Alberta | T6G 2E1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34256014 | Background | 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. | |
| 32447398 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008892 | Milk |
| ID | Term |
|---|---|
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D003611 | Dairy Products |
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| Milk (placebo) | Dietary Supplement | 350 mL/day of commercial 2% fat milk |
|
| 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline, 6 weeks, 12 weeks |
BMI will be calculated using body weight (kg) and height (m) measurements. Height will be measured using a stadiometer at baseline only, and BMI will be monitored to assess changes in body composition. |
| Baseline, 6 weeks, 12 weeks |
| Change in Waist Circumference (cm) | This outcome evaluates changes in waist circumference, measured at the umbilical level using a non-elastic tape. This measurement serves as an indicator of central adiposity and fat distribution. | Baseline, 6 weeks, 12 weeks |
| Change in Hip Circumference (cm) | Hip circumference will be measured at the widest part of the hips using a non-elastic tape. This outcome helps determine changes in fat distribution and body shape. | Baseline, 6 weeks, 12 weeks |
| Change in Body Composition (Percentage of Fat Mass and Fat-Free Mass) Measured by Bioelectrical Impedance Analysis (BIA) | Body composition will be assessed using BIA to determine changes in fat mass and fat-free mass as percentages of total body weight. Participants will be measured in a fasted state with consistent hydration levels for accuracy. | Baseline, 6 weeks, 12 weeks |
| 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. |
| 37727636 | Background | 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. |
| 27199969 | Background | 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. |
| Background | 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 |
| 32472367 | 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. |
| 32684173 | Background | 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. |
| 36504827 | Background | 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. |
| 37224566 | Background | 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. |
| D004700 | Endocrine System Diseases |
| D005502 |
| Food |
| D019602 | Food and Beverages |