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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03966846
Other study ID # 152114
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2015
Est. completion date July 2017

Study information

Verified date May 2019
Source Izmir Katip Celebi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date July 2017
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Dietary Supplement:
Kefir

Milk


Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Izmir Katip Celebi University Ege University, Hacettepe University, Turkey Council of Higher Education Teaching Stuff Training Program

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in lipid profile Measurement of lipid profile (HDL cholesterol, triglyceride levels) baseline, week 4, week 8 and week 12
Primary Changes in glycemic profile Measurement of fasting glucose, insulin, and calculation of HOMA-IR baseline, week 4, week 8 and week 12
Primary Changes in gut microbiota Determine the profile of gut flora (% abundance of various bacterial phyla, families, genera and species) week 0- week 12
Secondary Changes in Inflammatory Parametres Measurement of serum cytokines levels (high sensitive serum C- reactive protein ,TNF-a, IL-6, IL-10 ve IFN-?) baseline and week 12
Secondary Changes in serum cholesterol levels Measurement of total cholesterol and its fractions (mg/dl) baseline, week 4, week 8 and week 12
Secondary Changes in triglycerides Measurement of serum triglyceride (mg/dl) baseline, week 4, week 8 and week 12
Secondary Changes in lipoproteins Measurement of lipoproteins (mg/dl) (apolipoprotein A1, apolipoprotein B, lipoprotein (a)) baseline and week 12
Secondary Changes in homocysteine Measurement of homocysteine (umol/L) baseline and week 12
Secondary Changes in glycated hemoglobin Measurement of HbA1c (%) baseline and week 12
Secondary Changes in blood pressure Measurement of systolic and diastolic blood pressure (mm Hg) baseline, week 4, week 8 and week 12
Secondary Changes in waist circumference Measurement of waist circumference (cm) baseline, week 4, week 8 and week 12
Secondary Changes in Body Fat Measurement of % body fat with BIA baseline, week 4, week 8 and week 12
Secondary Changes in BMI weight and height will be measured to report BMI in kg/m2 baseline, week 4, week 8 and week 12
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