Clinical trial NCT06695221: Improving Health Outcomes With Kefir
Official title: Improving Health Outcomes With Kefir
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Systemic Inflammatory Response
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Keywords: Kefir
Systemic inflammation
Vascular markers
Gut microbiota
Fermented Foods
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 130
Sex: ALL
Minimum age (years): 24
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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."

Primary outcomes:
measure: Change in Glycated Hemoglobin (HbA1c) Levels (Percentage)
timeFrame: Baseline, 6 weeks, 12 weeks
Secondary outcomes:
measure: Change in Fasting Plasma Glucose Levels (mmol/L)
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in Total Cholesterol (mmol/L)
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in Low-Density Lipoprotein Cholesterol (LDL-C) (mmol/L)
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in High-Density Lipoprotein Cholesterol (LDL-C) (mmol/L)
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in Triglyceride levels (mmol/L)
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in Circulating C-Reactive Protein (CRP) Levels (mg/L)
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in Interleukin-2 (IL-2) in Supernatant of Ex Vivo Stimulated Cells from Whole Blood (pg/mL)
timeFrame: Baseline, 6 weeks, 12 weeks
measure: 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)
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in Tumor Necrosis Factor-Alpha (TNF-α) Levels in Supernatant of Ex Vivo Stimulated Cells from Whole Blood (pg/mL)
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in Gut Microbiome Composition and Functional Capacity (Relative Abundance)
timeFrame: Baseline, 6 weeks, 12 weeks
Other outcomes:
measure: Changes in Body Weight (Kg)
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in Body Mass Index (BMI) (kg/m²)
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in Waist Circumference (cm)
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in Hip Circumference (cm)
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in Body Composition (Percentage of Fat Mass and Fat-Free Mass) Measured by Bioelectrical Impedance Analysis (BIA)
timeFrame: Baseline, 6 weeks, 12 weeks
Locations:
city: Edmonton
country: Canada
facility: Human Nutrition Research Unit (HNRU)
state: Alberta
Study officials:
affiliation: University of Alberta
name: Benjamin Willing, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: 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.