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Kefir and Metabolic Syndrome

Primary Purpose

Metabolic Syndrome, Obesity, Hypertension

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Kefir
Milk
Sponsored by
Izmir Katip Celebi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring probiotics, dairy products, kefir, gut microbiota

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Kefir Group

    Control Group

    Arm Description

    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.

    Control group received one bottle of milk (180 ml) daily for 12 weeks.

    Outcomes

    Primary Outcome Measures

    Changes in lipid profile
    Measurement of lipid profile (HDL cholesterol, triglyceride levels)
    Changes in glycemic profile
    Measurement of fasting glucose, insulin, and calculation of HOMA-IR
    Changes in gut microbiota
    Determine the profile of gut flora (% abundance of various bacterial phyla, families, genera and species)

    Secondary Outcome Measures

    Changes in Inflammatory Parametres
    Measurement of serum cytokines levels (high sensitive serum C- reactive protein ,TNF-α, IL-6, IL-10 ve IFN-γ)
    Changes in serum cholesterol levels
    Measurement of total cholesterol and its fractions (mg/dl)
    Changes in triglycerides
    Measurement of serum triglyceride (mg/dl)
    Changes in lipoproteins
    Measurement of lipoproteins (mg/dl) (apolipoprotein A1, apolipoprotein B, lipoprotein (a))
    Changes in homocysteine
    Measurement of homocysteine (umol/L)
    Changes in glycated hemoglobin
    Measurement of HbA1c (%)
    Changes in blood pressure
    Measurement of systolic and diastolic blood pressure (mm Hg)
    Changes in waist circumference
    Measurement of waist circumference (cm)
    Changes in Body Fat
    Measurement of % body fat with BIA
    Changes in BMI
    weight and height will be measured to report BMI in kg/m2

    Full Information

    First Posted
    May 23, 2019
    Last Updated
    May 24, 2019
    Sponsor
    Izmir Katip Celebi University
    Collaborators
    Hacettepe University, Turkey Council of Higher Education Teaching Stuff Training Program, Ege University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03966846
    Brief Title
    Kefir and Metabolic Syndrome
    Official Title
    The Effect of Regular Kefir Consumption on Metabolic Syndrome Parameters, Inflammatory Response, and Gut Microbiota: A Parallel-Group, Randomized, Controlled Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2015 (Actual)
    Primary Completion Date
    July 2017 (Actual)
    Study Completion Date
    July 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Izmir Katip Celebi University
    Collaborators
    Hacettepe University, Turkey Council of Higher Education Teaching Stuff Training Program, Ege University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolic Syndrome, Obesity, Hypertension, Hyperlipidemias, Insulin Resistance
    Keywords
    probiotics, dairy products, kefir, gut microbiota

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    There were two experimental groups. The kefir group, that received orally kefir, and the control group received milk
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    62 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Kefir Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control Group
    Arm Type
    Placebo Comparator
    Arm Description
    Control group received one bottle of milk (180 ml) daily for 12 weeks.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Kefir
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Milk
    Primary Outcome Measure Information:
    Title
    Changes in lipid profile
    Description
    Measurement of lipid profile (HDL cholesterol, triglyceride levels)
    Time Frame
    baseline, week 4, week 8 and week 12
    Title
    Changes in glycemic profile
    Description
    Measurement of fasting glucose, insulin, and calculation of HOMA-IR
    Time Frame
    baseline, week 4, week 8 and week 12
    Title
    Changes in gut microbiota
    Description
    Determine the profile of gut flora (% abundance of various bacterial phyla, families, genera and species)
    Time Frame
    week 0- week 12
    Secondary Outcome Measure Information:
    Title
    Changes in Inflammatory Parametres
    Description
    Measurement of serum cytokines levels (high sensitive serum C- reactive protein ,TNF-α, IL-6, IL-10 ve IFN-γ)
    Time Frame
    baseline and week 12
    Title
    Changes in serum cholesterol levels
    Description
    Measurement of total cholesterol and its fractions (mg/dl)
    Time Frame
    baseline, week 4, week 8 and week 12
    Title
    Changes in triglycerides
    Description
    Measurement of serum triglyceride (mg/dl)
    Time Frame
    baseline, week 4, week 8 and week 12
    Title
    Changes in lipoproteins
    Description
    Measurement of lipoproteins (mg/dl) (apolipoprotein A1, apolipoprotein B, lipoprotein (a))
    Time Frame
    baseline and week 12
    Title
    Changes in homocysteine
    Description
    Measurement of homocysteine (umol/L)
    Time Frame
    baseline and week 12
    Title
    Changes in glycated hemoglobin
    Description
    Measurement of HbA1c (%)
    Time Frame
    baseline and week 12
    Title
    Changes in blood pressure
    Description
    Measurement of systolic and diastolic blood pressure (mm Hg)
    Time Frame
    baseline, week 4, week 8 and week 12
    Title
    Changes in waist circumference
    Description
    Measurement of waist circumference (cm)
    Time Frame
    baseline, week 4, week 8 and week 12
    Title
    Changes in Body Fat
    Description
    Measurement of % body fat with BIA
    Time Frame
    baseline, week 4, week 8 and week 12
    Title
    Changes in BMI
    Description
    weight and height will be measured to report BMI in kg/m2
    Time Frame
    baseline, week 4, week 8 and week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    Citations:
    PubMed Identifier
    35405603
    Citation
    Bellikci-Koyu E, Sarer-Yurekli BP, Karagozlu C, Aydin-Kose F, Ozgen AG, Buyuktuncer Z. Probiotic kefir consumption improves serum apolipoprotein A1 levels in metabolic syndrome patients: a randomized controlled clinical trial. Nutr Res. 2022 Jun;102:59-70. doi: 10.1016/j.nutres.2022.02.006. Epub 2022 Mar 7.
    Results Reference
    derived

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    Kefir and Metabolic Syndrome

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