Improving Health Outcomes With Kefir
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Change in Glycated Hemoglobin (HbA1c) Levels (Percentage)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 24 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%).
排除标准
- •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."
研究组 & 干预措施
Participants living with T2D
Randomly assigned to consume either traditional kefir or milk as a placebo.
干预措施: Traditional Kefir (Dietary Supplement)
Participants living with T2D
Randomly assigned to consume either traditional kefir or milk as a placebo.
干预措施: Milk (placebo) (Dietary Supplement)
Participants with higher risk of T2D
Randomly assigned to consume either traditional kefir or milk as a placebo.
干预措施: Traditional Kefir (Dietary Supplement)
Participants with higher risk of T2D
Randomly assigned to consume either traditional kefir or milk as a placebo.
干预措施: Milk (placebo) (Dietary Supplement)
结局指标
主要结局
Change in Glycated Hemoglobin (HbA1c) Levels (Percentage)
时间窗: 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.
次要结局
- Change in Fasting Plasma Glucose Levels (mmol/L)(Baseline, 6 weeks, 12 weeks)
- Change in Total Cholesterol (mmol/L)(Baseline, 6 weeks, 12 weeks)
- Change in Low-Density Lipoprotein Cholesterol (LDL-C) (mmol/L)(Baseline, 6 weeks, 12 weeks)
- Change in High-Density Lipoprotein Cholesterol (LDL-C) (mmol/L)(Baseline, 6 weeks, 12 weeks)
- Change in Triglyceride levels (mmol/L)(Baseline, 6 weeks, 12 weeks)
- Change in Circulating C-Reactive Protein (CRP) Levels (mg/L)(Baseline, 6 weeks, 12 weeks)
- Change in Interleukin-2 (IL-2) in Supernatant of Ex Vivo Stimulated Cells from Whole Blood (pg/mL)(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)(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)(Baseline, 6 weeks, 12 weeks)
- Change in Gut Microbiome Composition and Functional Capacity (Relative Abundance)(Baseline, 6 weeks, 12 weeks)