Pediatric Obesity Related Metabolite Profile and Gut Microbiota

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-28

Study Completion Date

2021-06-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obesity, Childhood

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Intervention arm: every obese children will have individualized education program about diet control and exercise in usual life.

Control arm: normal weight children

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Obese Children Group

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.

Group Type EXPERIMENTAL

Individualized Education Program

Intervention Type BEHAVIORAL

The every participants will have individualized education program about a way of dietary control and exercise in their usual life.

Normal Weight Children Group

Normal weight children

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Individualized Education Program

The every participants will have individualized education program about a way of dietary control and exercise in their usual life.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes