Kefir and Metabolic Syndrome

NCT03966846 | Completed

• 1 other identifier: 152114
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metabolic Syndrome; Obesity; Hypertension; Hyperlipidemias; Insulin Resistance

Keywords

probiotics; dairy products; kefir; gut microbiota

Outcome Measures

Primary Outcomes (3)

• Changes in lipid profile

  Measurement of lipid profile (HDL cholesterol, triglyceride levels)

  baseline, week 4, week 8 and week 12

• Changes in glycemic profile

  Measurement of fasting glucose, insulin, and calculation of HOMA-IR

  baseline, week 4, week 8 and week 12

• Changes in gut microbiota

  Determine the profile of gut flora (% abundance of various bacterial phyla, families, genera and species)

  week 0- week 12

Secondary Outcomes (10)

• Changes in Inflammatory Parametres

  baseline and week 12

• Changes in serum cholesterol levels

  baseline, week 4, week 8 and week 12

• Changes in triglycerides

  baseline, week 4, week 8 and week 12

• Changes in lipoproteins

  baseline and week 12

• Changes in homocysteine

  baseline and week 12

Study Arms (2)

Kefir Group

EXPERIMENTAL

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

Control Group

PLACEBO COMPARATOR

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

Dietary Supplement: Milk

Interventions

Kefir DIETARY_SUPPLEMENT

Kefir Group

Milk DIETARY_SUPPLEMENT

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old subjects
• Subjects diagnosed with metabolic syndrome according to the International Diabetes Federation (IDF) criteria.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Izmir Katip Celebi University: lead
• Hacettepe University: collaborator
• Turkey Council of Higher Education Teaching Stuff Training Program: collaborator
• Ege University: collaborator

Related Publications (1)

• 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.

  PMID: 35405603 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Obesity; Hypertension; Hyperlipidemias; Insulin Resistance

Interventions

Kefir; Milk

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Fermented Beverages; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Cultured Milk Products; Fermented Foods; Dairy Products; Food; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: There were two experimental groups. The kefir group, that received orally kefir, and the control group received milk

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 29, 2019
• Study Start: March 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: May 29, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL