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出境医 / 临床实验 / Kefir and Metabolic Syndrome

Kefir and Metabolic Syndrome

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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Obesity Hypertension Hyperlipidemias Insulin Resistance Dietary Supplement: Kefir Dietary Supplement: Milk Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: There were two experimental groups. The kefir group, that received orally kefir, and the control group received milk
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Regular Kefir Consumption on Metabolic Syndrome Parameters, Inflammatory Response, and Gut Microbiota: A Parallel-Group, Randomized, Controlled Clinical Study
Actual Study Start Date : March 2015
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017
Arms and Interventions
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
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date  ICMJE May 23, 2019
First Posted Date  ICMJE May 29, 2019
Last Update Posted Date May 29, 2019
Actual Study Start Date  ICMJE March 2015
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2019)
  • Changes in lipid profile [ Time Frame: baseline, week 4, week 8 and week 12 ]
    Measurement of lipid profile (HDL cholesterol, triglyceride levels)
  • Changes in glycemic profile [ Time Frame: baseline, week 4, week 8 and week 12 ]
    Measurement of fasting glucose, insulin, and calculation of HOMA-IR
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2019)
  • 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)
  • Changes in serum cholesterol levels [ Time Frame: baseline, week 4, week 8 and week 12 ]
    Measurement of total cholesterol and its fractions (mg/dl)
  • Changes in triglycerides [ Time Frame: baseline, week 4, week 8 and week 12 ]
    Measurement of serum triglyceride (mg/dl)
  • Changes in lipoproteins [ Time Frame: baseline and week 12 ]
    Measurement of lipoproteins (mg/dl) (apolipoprotein A1, apolipoprotein B, lipoprotein (a))
  • Changes in homocysteine [ Time Frame: baseline and week 12 ]
    Measurement of homocysteine (umol/L)
  • Changes in glycated hemoglobin [ Time Frame: baseline and week 12 ]
    Measurement of HbA1c (%)
  • Changes in blood pressure [ Time Frame: baseline, week 4, week 8 and week 12 ]
    Measurement of systolic and diastolic blood pressure (mm Hg)
  • Changes in waist circumference [ Time Frame: baseline, week 4, week 8 and week 12 ]
    Measurement of waist circumference (cm)
  • Changes in Body Fat [ Time Frame: baseline, week 4, week 8 and week 12 ]
    Measurement of % body fat with BIA
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Kefir and Metabolic Syndrome
Official Title  ICMJE The Effect of Regular Kefir Consumption on Metabolic Syndrome Parameters, Inflammatory Response, and Gut Microbiota: A Parallel-Group, Randomized, Controlled Clinical Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
There were two experimental groups. The kefir group, that received orally kefir, and the control group received milk
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Metabolic Syndrome
  • Obesity
  • Hypertension
  • Hyperlipidemias
  • Insulin Resistance
Intervention  ICMJE
  • Dietary Supplement: Kefir
  • Dietary Supplement: Milk
Study Arms  ICMJE
  • 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.
    Intervention: Dietary Supplement: Kefir
  • Placebo Comparator: Control Group
    Control group received one bottle of milk (180 ml) daily for 12 weeks.
    Intervention: Dietary Supplement: Milk
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 24, 2019) 		62
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03966846
Other Study ID Numbers  ICMJE 152114
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Responsible Party Ezgi Bellikci Koyu, Izmir Katip Celebi University
Study Sponsor  ICMJE Izmir Katip Celebi University
Collaborators  ICMJE
  • Hacettepe University
  • Turkey Council of Higher Education Teaching Stuff Training Program
  • Ege University
Investigators  ICMJE Not Provided
PRS Account Izmir Katip Celebi University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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