The Effect of Regular Kefir Consumption on Metabolic Syndrome Parameters, Inflammatory Response, and Gut Microbiota: A Parallel-Group, Randomized, Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 主要终点
- Changes in lipid profile
研究概览
简要总结
Metabolic syndrome is a cluster of metabolic disorders which increases the risk for diabetes and cardiovascular disease. In recent years, research has shown that probiotics may have positive effects on metabolic syndrome components. Although several health-promoting effects of kefir, have been suggested, there is limited evidence for its potential effect on metabolic syndrome. Therefore, it is necessary to clarify the effects of kefir on metabolic disorders including obesity, dyslipidemia, diabetes, and hypertension. To address the research gap, this study aimed to investigate the effects of daily kefir consumption on metabolic syndrome components, inflammatory response and gut microbiota composition in adults with MetS. The study was planned as a randomized, controlled, parallel design and completed with a total of 62 individuals who were diagnosed with metabolic syndrome according to the International Diabetes Federation (IDF) criteria. Participants were randomized into two groups and received daily 180 ml of kefir (n=31) or milk (as control) (n=31) for 12 weeks. Participants were assessed at baseline, week 4, week 8, and week 12 and at all controls dietary records, anthropometric measurements, and blood samples were collected. At baseline and 12th-week fecal samples were also collected in order to analyze gut microbiota composition.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years old subjects
- •Subjects diagnosed with metabolic syndrome according to the International Diabetes Federation (IDF) criteria.
排除标准
- •Existence of lactose intolerance
- •Existence of type 1 diabetes
- •Existence of abnormal thyroid hormone levels
- •Existence of chronic gastrointestinal system disease
- •Existence of cancer
- •Existence of severe liver disease
- •Existence of kidney insufficiency
- •Existence of immunodeficiency
- •Taking medication to regulate blood glucose (except metformin) or lipid levels
- •Taking antibiotics prior to one month of the study
- •Consuming regular probiotic food or supplement
- •Taking supplement which may affect the metabolic outcomes such as prebiotic or omega-3
- •Dieting for weight loss or for another disease
- •Being pregnant and breastfeeding.
结局指标
主要结局
Changes in lipid profile
时间窗: baseline, week 4, week 8 and week 12
Measurement of lipid profile (HDL cholesterol, triglyceride levels)
Changes in glycemic profile
时间窗: baseline, week 4, week 8 and week 12
Measurement of fasting glucose, insulin, and calculation of HOMA-IR
Changes in gut microbiota
时间窗: week 0- week 12
Determine the profile of gut flora (% abundance of various bacterial phyla, families, genera and species)
次要结局
- Changes in glycated hemoglobin(baseline and week 12)
- Changes in Body Fat(baseline, week 4, week 8 and week 12)
- Changes in serum cholesterol levels(baseline, week 4, week 8 and week 12)
- Changes in triglycerides(baseline, week 4, week 8 and week 12)
- Changes in homocysteine(baseline and week 12)
- Changes in Inflammatory Parametres(baseline and week 12)
- Changes in lipoproteins(baseline and week 12)
- Changes in blood pressure(baseline, week 4, week 8 and week 12)
- Changes in waist circumference(baseline, week 4, week 8 and week 12)
- Changes in BMI(baseline, week 4, week 8 and week 12)
研究者
Ezgi Bellikci Koyu
Assistant Professor
Izmir Katip Celebi University