Clinical trial NCT03966846: 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
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Obesity
Hypertension
Hyperlipidemias
Insulin Resistance
Keywords: probiotics
dairy products
kefir
gut microbiota
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
Collaborators: name: Hacettepe University
name: Turkey Council of Higher Education Teaching Stuff Training Program
name: Ege University
First posted: 2019-05-29
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There were two experimental groups. The kefir group, that received orally kefir, and the control group received milk
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Changes in lipid profile
timeFrame: baseline, week 4, week 8 and week 12
measure: Changes in glycemic profile
timeFrame: baseline, week 4, week 8 and week 12
measure: Changes in gut microbiota
timeFrame: week 0- week 12
Secondary outcomes:
measure: Changes in Inflammatory Parametres
timeFrame: baseline and week 12
measure: Changes in serum cholesterol levels
timeFrame: baseline, week 4, week 8 and week 12
measure: Changes in triglycerides
timeFrame: baseline, week 4, week 8 and week 12
measure: Changes in lipoproteins
timeFrame: baseline and week 12
measure: Changes in homocysteine
timeFrame: baseline and week 12
measure: Changes in glycated hemoglobin
timeFrame: baseline and week 12
measure: Changes in blood pressure
timeFrame: baseline, week 4, week 8 and week 12
measure: Changes in waist circumference
timeFrame: baseline, week 4, week 8 and week 12
measure: Changes in Body Fat
timeFrame: baseline, week 4, week 8 and week 12
measure: Changes in BMI
timeFrame: baseline, week 4, week 8 and week 12
Other outcomes:
Locations:
Study officials:
References:
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.