Kefir and Metabolic Syndrome

May 24, 2019 updated by: Ezgi Bellikci Koyu, Izmir Katip Celebi University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Kefir Group
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
Placebo Comparator: Control Group
Control group received one bottle of milk (180 ml) daily for 12 weeks.
Dietary supplement: Milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in lipid profile
Time Frame: baseline, week 4, week 8 and week 12
Measurement of lipid profile (HDL cholesterol, triglyceride levels)
baseline, week 4, week 8 and week 12
Changes in glycemic profile
Time Frame: baseline, week 4, week 8 and week 12
Measurement of fasting glucose, insulin, and calculation of HOMA-IR
baseline, week 4, week 8 and week 12
Changes in gut microbiota
Time Frame: week 0- week 12
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
Time Frame: baseline and week 12
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
Time Frame: baseline, week 4, week 8 and week 12
Measurement of total cholesterol and its fractions (mg/dl)
baseline, week 4, week 8 and week 12
Changes in triglycerides
Time Frame: baseline, week 4, week 8 and week 12
Measurement of serum triglyceride (mg/dl)
baseline, week 4, week 8 and week 12
Changes in lipoproteins
Time Frame: baseline and week 12
Measurement of lipoproteins (mg/dl) (apolipoprotein A1, apolipoprotein B, lipoprotein (a))
baseline and week 12
Changes in homocysteine
Time Frame: baseline and week 12
Measurement of homocysteine (umol/L)
baseline and week 12
Changes in glycated hemoglobin
Time Frame: baseline and week 12
Measurement of HbA1c (%)
baseline and week 12
Changes in blood pressure
Time Frame: baseline, week 4, week 8 and week 12
Measurement of systolic and diastolic blood pressure (mm Hg)
baseline, week 4, week 8 and week 12
Changes in waist circumference
Time Frame: baseline, week 4, week 8 and week 12
Measurement of waist circumference (cm)
baseline, week 4, week 8 and week 12
Changes in Body Fat
Time Frame: baseline, week 4, week 8 and week 12
Measurement of % body fat with BIA
baseline, week 4, week 8 and week 12
Changes in BMI
Time Frame: baseline, week 4, week 8 and week 12
weight and height will be measured to report BMI in kg/m2
baseline, week 4, week 8 and week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir Katip Celebi University

Collaborators

Hacettepe University
Ege University
Turkey Council of Higher Education Teaching Stuff Training Program

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

May 23, 2019

First Submitted That Met QC Criteria

May 24, 2019

First Posted (Actual)

May 29, 2019

Study Record Updates

Last Update Posted (Actual)

May 29, 2019

Last Update Submitted That Met QC Criteria

May 24, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 152114

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Study Protocol

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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