Kefir and Metabolic Syndrome
Primary Purpose
Metabolic Syndrome, Obesity, Hypertension
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Kefir
Milk
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome focused on measuring probiotics, dairy products, kefir, gut microbiota
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.
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
NCT ID
NCT03966846
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
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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