Pediatric Obesity Related Metabolite Profile and Gut Microbiota

Interplay Between Pediatric Obesity Related Plasma Metabolite Profile and Gut Microbiota

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.

Study Overview

• Status: Unknown
• Conditions: Obesity, Childhood
• Intervention / Treatment: Behavioral: Individualized Education Program

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 07440
    • Hallym University Kangnam Sacred Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Individualized Education Program; The every participants will have individualized education program about a way of dietary control and exercise in their usual life.
No Intervention: Normal Weight Children Group; Normal weight children

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The relationship between gut microbiome composition and fecal short chain fatty acid	The relationship between gut microbiome composition and metabolites will be analyzed by canonical correspondence analysis	up to 12 months after enrollment

Collaborators and Investigators

• Sponsor: Hallym University Kangnam Sacred Heart Hospital
• Investigators: Principal Investigator: Ky Young Cho, Ph.D., Kangnam Sacred Heart Hospital, Hallym University College of Medicine

Publications and helpful links

General Publications

• Cho KY. Lifestyle modifications result in alterations in the gut microbiota in obese children. BMC Microbiol. 2021 Jan 6;21(1):10. doi: 10.1186/s12866-020-02002-3.

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2018
• Primary Completion (Anticipated): June 28, 2021
• Study Completion (Anticipated): June 28, 2021

Study Registration Dates

• First Submitted: January 17, 2019
• First Submitted That Met QC Criteria: January 19, 2019
• First Posted (Actual): January 23, 2019

Study Record Updates

• Last Update Posted (Actual): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 15, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Microbiome; Metabolome
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: Microbiome and metabolome

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study participants will only agree if IPD is not shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No