Pediatric Obesity Related Metabolite Profile and Gut Microbiota
Primary Purpose
Obesity, Childhood
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Individualized Education Program
Sponsored by
About this trial
This is an interventional supportive care trial for Obesity, Childhood focused on measuring Microbiome, Metabolome
Eligibility Criteria
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
Sites / Locations
- Hallym University Kangnam Sacred Heart Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Obese Children Group
Normal Weight Children Group
Arm 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.
Normal weight children
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03812497
First Posted
January 17, 2019
Last Updated
May 15, 2020
Sponsor
Hallym University Kangnam Sacred Heart Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03812497
Brief Title
Pediatric Obesity Related Metabolite Profile and Gut Microbiota
Official Title
Interplay Between Pediatric Obesity Related Plasma Metabolite Profile and Gut Microbiota
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 28, 2018 (Actual)
Primary Completion Date
June 28, 2021 (Anticipated)
Study Completion Date
June 28, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hallym University Kangnam Sacred Heart Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood
Keywords
Microbiome, Metabolome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Intervention arm: every obese children will have individualized education program about diet control and exercise in usual life.
Control arm: normal weight children
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Obese Children Group
Arm Type
Experimental
Arm 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.
Arm Title
Normal Weight Children Group
Arm Type
No Intervention
Arm Description
Normal weight children
Intervention Type
Behavioral
Intervention Name(s)
Individualized Education Program
Intervention Description
The every participants will have individualized education program about a way of dietary control and exercise in their usual life.
Primary Outcome Measure Information:
Title
Change in gut microbiome composition in stool samples
Description
Bacterial diversity and composition using 16s rRNA sequencing. Especially Bacteroidetes and Firmicutes populations in fecal microbiome will be analyzed related with obesity.
Time Frame
up to 3 months after enrollment
Secondary Outcome Measure Information:
Title
Changes in short chain fatty acids of fecal samples
Description
The main metabolites produced by gut microbiome, short chain fatty acids using gas chromatography- mass-spectrometry.
Time Frame
up to 12 months after enrollment
Other Pre-specified Outcome Measures:
Title
The relationship between gut microbiome composition and fecal short chain fatty acid
Description
The relationship between gut microbiome composition and metabolites will be analyzed by canonical correspondence analysis
Time Frame
up to 12 months after enrollment
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ky Young Cho, Ph.D.
Organizational Affiliation
Kangnam Sacred Heart Hospital, Hallym University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hallym University Kangnam Sacred Heart Hospital
City
Seoul
ZIP/Postal Code
07440
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Study participants will only agree if IPD is not shared.
Citations:
PubMed Identifier
33407104
Citation
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.
Results Reference
derived
Learn more about this trial
Pediatric Obesity Related Metabolite Profile and Gut Microbiota
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