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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
Sponsor:
Information provided by (Responsible Party):
Ky Young Cho, Hallym University Kangnam Sacred Heart Hospital

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.

Condition or disease Intervention/treatment Phase
Obesity, Childhood Behavioral: Individualized Education Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
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

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
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Contact: Ky Young Cho, Ph.D. 82-2-829-5142 choky96@hallym.or.kr

Locations
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Korea, Republic of
Hallym University Kangnam Sacred Heart Hospital Recruiting
Seoul, Korea, Republic of, 07440
Contact: Ky Young Cho, Ph.D.       choky96@hallym.or.kr   
Sponsors and Collaborators
Hallym University Kangnam Sacred Heart Hospital
Investigators
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Principal Investigator: Ky Young Cho, Ph.D. Kangnam Sacred Heart Hospital, Hallym University College of Medicine

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Responsible Party: Ky Young Cho, Associate professor, Hallym University Kangnam Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT03812497     History of Changes
Other Study ID Numbers: Microbiome and metabolome
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Study participants will only agree if IPD is not shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ky Young Cho, Hallym University Kangnam Sacred Heart Hospital:
Microbiome
Metabolome

Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms