Kefir and Metabolic Syndrome

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03966846
• Other study ID #: 152114
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: July 2017

Study information

• Verified date: May 2019
• Source: Izmir Katip Celebi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperlipidemias
• Hyperlipoproteinemias
• Hypertension
• Insulin Resistance
• Metabolic Syndrome
• Obesity
• Syndrome

Intervention

Dietary Supplement:
• Kefir

• Milk

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Izmir Katip Celebi University	Ege University, Hacettepe University, Turkey Council of Higher Education Teaching Stuff Training Program

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in lipid profile	Measurement of lipid profile (HDL cholesterol, triglyceride levels)	baseline, week 4, week 8 and week 12
Primary	Changes in glycemic profile	Measurement of fasting glucose, insulin, and calculation of HOMA-IR	baseline, week 4, week 8 and week 12
Primary	Changes in gut microbiota	Determine the profile of gut flora (% abundance of various bacterial phyla, families, genera and species)	week 0- week 12
Secondary	Changes in Inflammatory Parametres	Measurement of serum cytokines levels (high sensitive serum C- reactive protein ,TNF-a, IL-6, IL-10 ve IFN-?)	baseline and week 12
Secondary	Changes in serum cholesterol levels	Measurement of total cholesterol and its fractions (mg/dl)	baseline, week 4, week 8 and week 12
Secondary	Changes in triglycerides	Measurement of serum triglyceride (mg/dl)	baseline, week 4, week 8 and week 12
Secondary	Changes in lipoproteins	Measurement of lipoproteins (mg/dl) (apolipoprotein A1, apolipoprotein B, lipoprotein (a))	baseline and week 12
Secondary	Changes in homocysteine	Measurement of homocysteine (umol/L)	baseline and week 12
Secondary	Changes in glycated hemoglobin	Measurement of HbA1c (%)	baseline and week 12
Secondary	Changes in blood pressure	Measurement of systolic and diastolic blood pressure (mm Hg)	baseline, week 4, week 8 and week 12
Secondary	Changes in waist circumference	Measurement of waist circumference (cm)	baseline, week 4, week 8 and week 12
Secondary	Changes in Body Fat	Measurement of % body fat with BIA	baseline, week 4, week 8 and week 12
Secondary	Changes in BMI	weight and height will be measured to report BMI in kg/m2	baseline, week 4, week 8 and week 12