Kefir and Metabolic Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Regular Kefir Consumption on Metabolic Syndrome Parameters, Inflammatory Response, and Gut Microbiota: A Parallel-Group, Randomized, Controlled Clinical Study

Conditions
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Metabolic Syndrome, Obesity, Hypertension, Hyperlipidemias, Insulin Resistance

Intervention / Treatment
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* Dietary Supplement: Kefir
* Dietary Supplement: Milk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-65 years old subjects Subjects diagnosed with metabolic syndrome according to the International Diabetes Federation (IDF) criteria. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There were two experimental groups. The kefir group, that received orally kefir, and the control group received milk
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kefir Group<br>Kefir group received one bottle of kefir (180 ml) daily for 12 weeks. Microbial composition of the kefir included Lactococcus lactis ssp. lactis, Lactococcus lactis ssp. cremoris, Lactococcus lactis ssp. diacetylactis, Leuconostoc mesenteroides ssp. cremoris, Lactobacillus kefyr, Kliyveromyces marxianus, and Saccharomyces unisporus. | Dietary Supplement: Kefir<br> <br> |
| Placebo Comparator: Control Group<br>Control group received one bottle of milk (180 ml) daily for 12 weeks. | Dietary Supplement: Milk<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in lipid profile | Measurement of lipid profile (HDL cholesterol, triglyceride levels) | baseline, week 4, week 8 and week 12 | 
| Changes in glycemic profile | Measurement of fasting glucose, insulin, and calculation of HOMA-IR | baseline, week 4, week 8 and week 12 | 
| Changes in gut microbiota | Determine the profile of gut flora (% abundance of various bacterial phyla, families, genera and species) | week 0- week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Inflammatory Parametres | Measurement of serum cytokines levels (high sensitive serum C- reactive protein ,TNF-α, IL-6, IL-10 ve IFN-γ) | baseline and week 12 | 
| Changes in serum cholesterol levels | Measurement of total cholesterol and its fractions (mg/dl) | baseline, week 4, week 8 and week 12 | 
| Changes in triglycerides | Measurement of serum triglyceride (mg/dl) | baseline, week 4, week 8 and week 12 | 
| Changes in lipoproteins | Measurement of lipoproteins (mg/dl) (apolipoprotein A1, apolipoprotein B, lipoprotein (a)) | baseline and week 12 | 
| Changes in homocysteine | Measurement of homocysteine (umol/L) | baseline and week 12 | 
| Changes in glycated hemoglobin | Measurement of HbA1c (%) | baseline and week 12 | 
| Changes in blood pressure | Measurement of systolic and diastolic blood pressure (mm Hg) | baseline, week 4, week 8 and week 12 | 
| Changes in waist circumference | Measurement of waist circumference (cm) | baseline, week 4, week 8 and week 12 | 
| Changes in Body Fat | Measurement of % body fat with BIA | baseline, week 4, week 8 and week 12 | 
| Changes in BMI | weight and height will be measured to report BMI in kg/m2 | baseline, week 4, week 8 and week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotics, dairy products, kefir, gut microbiota