Pediatric Obesity Related Metabolite Profile and Gut Microbiota

NCT03812497 | Unknown

• 1 other identifier: Microbiome and metabolome
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Childhood

Keywords

Microbiome; Metabolome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in short chain fatty acids of fecal samples

  up to 12 months after enrollment

Other Outcomes (1)

• The relationship between gut microbiome composition and fecal short chain fatty acid

  up to 12 months after enrollment

Study Arms (2)

Obese Children Group

EXPERIMENTAL

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

Normal Weight Children Group

NO INTERVENTION

Normal weight children

Interventions

Individualized Education Program BEHAVIORAL

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

Obese Children Group

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hallym University Kangnam Sacred Heart Hospital: lead

Study Sites (1)

Hallym University Kangnam Sacred Heart Hospital

Seoul, 07440, South Korea

Location

Related Publications (1)

• 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.

  PMID: 33407104 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Ky Young Cho, Ph.D.

  Kangnam Sacred Heart Hospital, Hallym University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

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

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: January 23, 2019
• Study Start: June 28, 2018
• Primary Completion: June 28, 2021
• Study Completion: June 28, 2021
• Last Updated: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)