Pediatric Obesity Related Metabolite Profile and Gut Microbiota
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|ClinicalTrials.gov Identifier: NCT03812497|
Recruitment Status : Recruiting
First Posted : January 23, 2019
Last Update Posted : January 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Obesity, Childhood||Behavioral: Individualized Education Program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Factorial Assignment|
|Intervention 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)|
|Primary Purpose:||Supportive Care|
|Official Title:||Interplay Between Pediatric Obesity Related Plasma Metabolite Profile and Gut Microbiota|
|Actual Study Start Date :||June 28, 2018|
|Estimated Primary Completion Date :||June 28, 2021|
|Estimated Study Completion Date :||June 28, 2021|
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
- Change in gut microbiome composition in stool samples [ Time Frame: up to 3 months after enrollment ]Bacterial diversity and composition using 16s rRNA sequencing. Especially Bacteroidetes and Firmicutes populations in fecal microbiome will be analyzed related with obesity.
- Changes in short chain fatty acids of fecal samples [ Time Frame: up to 12 months after enrollment ]The main metabolites produced by gut microbiome, short chain fatty acids using gas chromatography- mass-spectrometry.
- The relationship between gut microbiome composition and fecal short chain fatty acid [ Time Frame: up to 12 months after enrollment ]The relationship between gut microbiome composition and metabolites will be analyzed by canonical correspondence analysis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03812497
|Contact: Ky Young Cho, Ph.D.||email@example.com|
|Korea, Republic of|
|Hallym University Kangnam Sacred Heart Hospital||Recruiting|
|Seoul, Korea, Republic of, 07440|
|Contact: Ky Young Cho, Ph.D. firstname.lastname@example.org|
|Principal Investigator:||Ky Young Cho, Ph.D.||Kangnam Sacred Heart Hospital, Hallym University College of Medicine|