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Pediatric Obesity Related Metabolite Profile and Gut Microbiota

Interplay Between Pediatric Obesity Related Plasma Metabolite Profile and Gut Microbiota

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03812497
Enrollment
60
Registered
2019-01-23
Start date
2018-06-28
Completion date
2021-06-28
Last updated
2020-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Childhood

Keywords

Microbiome, Metabolome

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.

Interventions

BEHAVIORALIndividualized Education Program

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

Sponsors

Hallym University Kangnam Sacred Heart Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

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

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in gut microbiome composition in stool samplesup to 3 months after enrollmentBacterial diversity and composition using 16s rRNA sequencing. Especially Bacteroidetes and Firmicutes populations in fecal microbiome will be analyzed related with obesity.

Secondary

MeasureTime frameDescription
Changes in short chain fatty acids of fecal samplesup to 12 months after enrollmentThe main metabolites produced by gut microbiome, short chain fatty acids using gas chromatography- mass-spectrometry.

Other

MeasureTime frameDescription
The relationship between gut microbiome composition and fecal short chain fatty acidup to 12 months after enrollmentThe relationship between gut microbiome composition and metabolites will be analyzed by canonical correspondence analysis

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026