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Completed

NCT Number: NCT03966846

Kefir and Metabolic Syndrome

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.

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Key information

Conditions

Metabolic Syndrome Body Weight Cardiovascular Diseases Dyslipidemias Glucose Metabolism Disorders Hyperinsulinism Hyperlipidemias Hypertension Insulin Resistance Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Kefir

Dietary Supplement

Milk

Dietary Supplement

Primary outcomes

  1. Changes in lipid profile

    Time frame: baseline, week 4, week 8 and week 12

    Measurement of lipid profile (HDL cholesterol, triglyceride levels)

  2. Changes in glycemic profile

    Time frame: baseline, week 4, week 8 and week 12

    Measurement of fasting glucose, insulin, and calculation of HOMA-IR

  3. 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)

Secondary outcomes

  1. 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)

  2. Changes in serum cholesterol levels

    Time frame: baseline, week 4, week 8 and week 12

    Measurement of total cholesterol and its fractions (mg/dl)

  3. Changes in triglycerides

    Time frame: baseline, week 4, week 8 and week 12

    Measurement of serum triglyceride (mg/dl)

  4. Changes in lipoproteins

    Time frame: baseline and week 12

    Measurement of lipoproteins (mg/dl) (apolipoprotein A1, apolipoprotein B, lipoprotein (a))

  5. Changes in homocysteine

    Time frame: baseline and week 12

    Measurement of homocysteine (umol/L)

  6. Changes in glycated hemoglobin

    Time frame: baseline and week 12

    Measurement of HbA1c (%)

  7. Changes in blood pressure

    Time frame: baseline, week 4, week 8 and week 12

    Measurement of systolic and diastolic blood pressure (mm Hg)

  8. Changes in waist circumference

    Time frame: baseline, week 4, week 8 and week 12

    Measurement of waist circumference (cm)

  9. Changes in Body Fat

    Time frame: baseline, week 4, week 8 and week 12

    Measurement of % body fat with BIA

  10. 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

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 29, 2019
Registry last updated
May 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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