Kefir and Metabolic Syndrome
- Conditions
- Metabolic SyndromeHypertensionObesityHyperlipidemiasInsulin Resistance
- Interventions
- Dietary Supplement: MilkDietary Supplement: Kefir
- Registration Number
- NCT03966846
- Lead Sponsor
- Izmir Katip Celebi University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
- 18-65 years old subjects
- Subjects diagnosed with metabolic syndrome according to the International Diabetes Federation (IDF) 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Group Milk Control group received one bottle of milk (180 ml) daily for 12 weeks. Kefir Group Kefir 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.
- Primary Outcome Measures
Name Time Method Changes in lipid profile baseline, week 4, week 8 and week 12 Measurement of lipid profile (HDL cholesterol, triglyceride levels)
Changes in glycemic profile baseline, week 4, week 8 and week 12 Measurement of fasting glucose, insulin, and calculation of HOMA-IR
Changes in gut microbiota week 0- week 12 Determine the profile of gut flora (% abundance of various bacterial phyla, families, genera and species)
- Secondary Outcome Measures
Name Time Method Changes in glycated hemoglobin baseline and week 12 Measurement of HbA1c (%)
Changes in Body Fat baseline, week 4, week 8 and week 12 Measurement of % body fat with BIA
Changes in serum cholesterol levels baseline, week 4, week 8 and week 12 Measurement of total cholesterol and its fractions (mg/dl)
Changes in triglycerides baseline, week 4, week 8 and week 12 Measurement of serum triglyceride (mg/dl)
Changes in homocysteine baseline and week 12 Measurement of homocysteine (umol/L)
Changes in Inflammatory Parametres baseline and week 12 Measurement of serum cytokines levels (high sensitive serum C- reactive protein ,TNF-α, IL-6, IL-10 ve IFN-γ)
Changes in lipoproteins baseline and week 12 Measurement of lipoproteins (mg/dl) (apolipoprotein A1, apolipoprotein B, lipoprotein (a))
Changes in blood pressure baseline, week 4, week 8 and week 12 Measurement of systolic and diastolic blood pressure (mm Hg)
Changes in waist circumference baseline, week 4, week 8 and week 12 Measurement of waist circumference (cm)
Changes in BMI baseline, week 4, week 8 and week 12 weight and height will be measured to report BMI in kg/m2