Hyperlipidemias, Hypertension, Insulin Resistance, Metabolic Syndrome, Obesity
Conditions
Keywords
probiotics, dairy products, kefir, gut microbiota
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.
Interventions
DIETARY_SUPPLEMENTKefir
DIETARY_SUPPLEMENTMilk
Sponsors
Hacettepe University
Turkey Council of Higher Education Teaching Stuff Training Program
Ege University
Izmir Katip Celebi University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
There were two experimental groups. The kefir group, that received orally kefir, and the control group received milk
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in lipoproteins | baseline and week 12 | Measurement of lipoproteins (mg/dl) (apolipoprotein A1, apolipoprotein B, lipoprotein (a)) |
| Changes in homocysteine | baseline and week 12 | Measurement of homocysteine (umol/L) |
| Changes in glycated hemoglobin | baseline and week 12 | Measurement of HbA1c (%) |
| 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 waist circumference | baseline, week 4, week 8 and week 12 | Measurement of waist circumference (cm) |
| Changes in Body Fat | baseline, week 4, week 8 and week 12 | Measurement of % body fat with BIA |
| Changes in BMI | baseline, week 4, week 8 and week 12 | weight and height will be measured to report BMI in kg/m2 |
| Changes in blood pressure | baseline, week 4, week 8 and week 12 | Measurement of systolic and diastolic blood pressure (mm Hg) |
| 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) |
Outcome results
None listed