The Effects of Kefir on Pediatric Obesity

NCT06500104 | Enrolling By Invitation DMC

• 1 other identifier: CMUH112-REC2-145
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Kefir, a traditional fermented dairy product in the North Caucasus region, is produced through the fermentation of milk by lactic acid bacteria and yeast. In murine studies, it has been observed that consumption of kefir by obese mice resulted in significantly reduced body weight compared to non-kefir-consuming obese mice. Furthermore, insulin resistance and fatty liver conditions showed improvement in the kefir-fed obese mice. Kefir was found to have its effects on obesity-related conditions through the inhibition of lipid synthesis, stimulation of fatty acid oxidation, elevation of basal metabolic rate, and modulation of oxidative damage. Obesity has emerged as a global epidemic, and its prevalence in pediatric population is rapidly increasing. Obesity is defined as having a body mass index (BMI) above the 95th percentile for the age. According to statistics from the Health Promotion Administration in Taiwan, the prevalence of obesity among elementary and junior high school students in 2021 was 27.1% and 31.2%, respectively. This implies that approximately one out of every three to four students is obese. Insulin resistance and fatty liver are two common manifestations of childhood obesity. Insulin resistance is found closely linked to type 2 diabetes. Prolonged and chronic fatty liver can progress to cirrhosis and even hepatocellular carcinoma. Effective management of obesity holds the occurrence of these diseases. The objective of this study is to analyze the potential benefits of incorporating kefir into the diet of obese children regarding the improvement of obesity-related outcomes.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• BMI

  BMI

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

Kefir

EXPERIMENTAL

Daily oral kefir peptide (KEFPEP®) intake, dosage: 1.2 gram per day for 12 weeks

Dietary Supplement: Kefir peptide

Placebo

PLACEBO COMPARATOR

Daily oral glucose powder intake, dosage: 805mg per day for 12 weeks

Dietary Supplement: Placebo

Interventions

Kefir peptide DIETARY_SUPPLEMENT

Dosage: 1.2 gram kefir peptide daily oral intake for 12 weeks

Kefir

Placebo DIETARY_SUPPLEMENT

Glucose powder

Placebo

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• body weight above 40 kilograms, body mass index (BMI)-for-age above the 95th percentile

You may not qualify if:

• diabetes mellitus, liver diseases other than non-alcoholic fatty liver disease, cardiovascular diseases other than hypertension and dyslipidemia, renal diseases, neurologic diseases, growth hormone deficiency, thyroid diseases, adrenal disorders, any use of medication for more than 6 months before or during this study, and any adverse responses to dairy products.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Children's Hospital

Taichung, 404, Taiwan

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 15, 2024
• Study Start: July 6, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

TW (1)