Obesity, ChildhoodNCT03812497
Pediatric Obesity Related Metabolite Profile and Gut Microbiota
A study testing Individualized Education Program in people with Obesity, Childhood, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Individualized Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Jun 2018to 28 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Obese children: Children ≥95 ‰
- Non-obese children: 5‰<BMI <85 ‰
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hallym University Kangnam Sacred Heart Hospital
Seoul, 07440
About this study
Official title: Interplay Between Pediatric Obesity Related Plasma Metabolite Profile and Gut Microbiota
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.
Read the 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.
- Conditions
- Obesity, Childhood
- Being tested
- Individualized Education Program
- Keywords
- Microbiome, Metabolome
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Education ProgramBehavioural
The every participants will have individualized education program about a way of dietary control and exercise in their usual life.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Individualized Education Program |
| Normal Weight Children Group | No intervention | Normal weight children |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 3 months after enrollment
Secondary outcomes (1)
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.
Measured: up to 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start28 Jun 2018
- Primary completion28 Jun 2021 (estimated)
- Study completion28 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Factorial
- 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)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hallym University Kangnam Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ky Young Cho, Hallym University Kangnam Sacred Heart Hospital
- Investigators
- Ky Young Cho, Ph.D., Principal investigator, Kangnam Sacred Heart Hospital, Hallym University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812497
- Sponsor's protocol ID
- Microbiome and metabolome
- Status last verified
- May 2020
- First submitted
- 17 Jan 2019
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study participants will only agree if IPD is not shared.
Publications
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.
PubMed 33407104
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interplay Between Pediatric Obesity Related Plasma Metabolite Profile and Gut Microbiota
- ClinicalTrials.gov ID
- NCT03812497
- Acronym / sponsor ID
- Microbiome and metabolome
- Conditions
- Obesity, Childhood
- Keywords
- Microbiome, Metabolome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hallym University Kangnam Sacred Heart HospitalUniversity, hospital or other
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 28 Jun 2021 (estimated)
- Study completion
- 28 Jun 2021 (estimated)
- First posted
- 23 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Obese Children Group | Experimental | Behavioral: Individualized Education ProgramTo 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 Group | No intervention | –Normal weight children |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Obese children: Children ≥95 ‰
- Non-obese children: 5‰<BMI <85 ‰
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized Education ProgramThe every participants will have individualized education program about a way of dietary control and exercise in their usual life. | Behavioural | Obese Children Group |
Primary outcome
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.
1 secondary outcome
Changes in short chain fatty acids of fecal samples
Time frame: up to 12 months after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Derived from this study: PubMed 33407104Cho 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.
- Individual participant dataSharing planned: No. Study participants will only agree if IPD is not shared.
Related trials for Obesity, Childhood
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
Obesity, Adolescent, Oxytocin
Not yet recruitingObservational study
Brain and Obesity Longitudinal Development: Neurobiological Mechanisms of Semaglutide Treatment of Adolescent Obesity
Pediatric Obesity, Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ky Young Cho, Ph.D. principal investigator
Kangnam Sacred Heart Hospital, Hallym University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Education Program in people with Obesity, Childhood, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gut microbiome composition in stool samples (time frame: up to 3 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03812497, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020.