Pediatric Obesity Related Metabolite Profile and Gut Microbiota

Not Applicable

• Conditions: Obesity, Childhood
• Interventions: Behavioral: Individualized Education Program

• Registration Number: NCT03812497
• Lead Sponsor: Hallym University Kangnam Sacred Heart Hospital

Brief Summary

In this study, the investigators aimed to observe changes in the gut microbial composition before and after the weight-loss intervention, including dietary control and exercise, in obese children. The main metabolites produced by gut microbiome, short chain fatty acids (SCFAs) will be also analysed. The investigators will analyse the change of gut microbiome composition and metabolites related with weight-loss intervention and the relationship between microbiome composition and metabolites.

Detailed Description

Many recent studies have suggested that dysbiosis of the gut microbiome might related to obesity. There is growing evidence that the composition of gut microbiome changes in childhood obesity compared to normal-weight children, and it is attracting attention as an adjustable environmental factor in obesity treatment. It has been reported that gut microbiome could be changed due to environmental influences such as diet and exercise. In this study, the investigators aimed to observe changes in the gut microbial composition before and after the weight-loss intervention, including dietary control and exercise, in obese children. The main metabolites produced by gut microbiome, short chain fatty acids (SCFAs) would be also analysed to investigate the relationship with gut microbiome and with weight-loss intervention. Intervention is not performed for normal-weight children, and samples from normal-weight children will be used as a control for gut microbiome and biochemical tests.

Study Timeline

• Study Start: 2018-06-28
• Study First Submitted: 2019-01-17
• Study First Submitted QC: 2019-01-19
• Study First Posted: 2019-01-23
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-15
• Last Update Posted: 2020-05-19
• Primary Completion: 2021-06-28
• Study Completion: 2021-06-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Obese children: Children ≥95 ‰
• Non-obese children: 5‰<BMI <85 ‰

Exclusion Criteria

• Taking antibiotics, probiotics, or steroids for a month before visit
• Taking probiotics-like products including yogurt for seven days before visit
• Having enteritis symptoms including diarrhea for a month before visit
• Chronic heart disease, chronic bowel disease, chronic liver disease, chronic kidney disease, endocrine disease, genetic diseases or congenital metabolic disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Obese Children Group	Individualized Education Program	To reduce the weight, every obese children will receive individualized education program about a way of dietary control and exercise in their usual life. This individualized education program, developed by investigators, specialized dietitian and exercise teacher, is scheduled once a month.

Primary Outcome Measures

Name	Time	Method
Change in gut microbiome composition in stool samples	up to 3 months after enrollment	Bacterial diversity and composition using 16s rRNA sequencing. Especially Bacteroidetes and Firmicutes populations in fecal microbiome will be analyzed related with obesity.

Secondary Outcome Measures

Name	Time	Method
Changes in short chain fatty acids of fecal samples	up to 12 months after enrollment	The main metabolites produced by gut microbiome, short chain fatty acids using gas chromatography- mass-spectrometry.

Trial Locations

Locations (1)

Hallym University Kangnam Sacred Heart Hospital; 🇰🇷 Seoul, Korea, Republic of