Pediatric Obesity Related Metabolite Profile and Gut Microbiota

Hallym University Kangnam Sacred Heart Hospital

Status: Unknown

Conditions: Obesity, Childhood

Treatments: Behavioral: Individualized Education Program

Study type: Interventional

Funder types: Other

Identifiers

NCT03812497

Microbiome and metabolome

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Obese Children Group

Experimental group

Description:

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.

Treatment:

Behavioral: Individualized Education Program

Normal Weight Children Group

No Intervention group

Description:

Normal weight children