ObesityNCT03968003

Impact of Dietary Fiber as Prebiotics on Intestinal Microbiota in Obese Thai Children

A study testing Inulin in people with Obesity, run by Chulalongkorn University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study evaluates the changes in gut microbiota composition, body fat, children's eating behaviors, plasma amino acids, and satiety hormones (Peptide-YY and GLP-1) after a 6-month period in obese Thai children. Read more about this study

Who is it for?: Ages 7 to 15 years
Conditions the study is for: Obesity
What is being tested?: Inulin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 165 participants
Where: 1 siteThailand
Study dates: 1 Aug 2017to 9 Jul 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 7 to 15 years
All sexes
No healthy volunteers
Child

Who may be able to join

Children, age 7 to 15 years
Body mass index (BMI) ≥ median + 2 Standard deviation (SD)

Who cannot join

Underlying disease of syndromic obesity and monogenic obesity
Endocrine causes of obesity (e.g. hypothyroidism, growth hormone deficiency)
Use of drugs that influence appetite or body weight (e.g. corticosteroids)
Attending other concurrent weight reduction programs

Trial locations and contacts

1 site in 1 country.

Thailand1 site

Chulalongkorn University
Bangkok, 10330

Other trials in Thailand

About this study

A total of 165 children, aged 7 to 15 years with a Body Mass Index (BMI) ≥ median + 2 standard deviation (SD), were randomized into three groups:

Group A (intervention group) received inulin daily.

Group B received an isocaloric maltodextrin placebo.

Group C received dietary fiber advice aimed to match age-appropriate recommendations.

Read the detailed description

The prevalence of childhood obesity is increasing worldwide and is associated with gut microbiota dysbiosis, which affects energy regulation and systemic inflammation. Childhood obesity management typically involves lifestyle modifications, including dietary changes.

Prebiotics, such as inulin-type fructans, are non-digestible polysaccharides that can modulate the gut microbiota composition, specifically by stimulating the growth of beneficial bacteria like Bifidobacterium. This microbial shift may lead to the production of short-chain fatty acids (SCFAs), which play a role in host physiology and metabolic health.

This study aims to investigate the impact of inulin supplementation on the gut microbiota composition and various health parameters in obese Thai children. Participants were randomized into three groups:

Intervention group receiving inulin extracted from Thai Jerusalem artichoke.

Placebo group receiving isocaloric maltodextrin.

Control group receiving dietary fiber intake advice.

The study focuses on evaluating changes in gut microbial taxa using 16S rRNA gene sequencing and assessing secondary parameters including body composition and satiety hormones over a 6-month period.

Conditions: Obesity
Being tested: Inulin
Keywords: Prebiotics, Intestinal Microbiota
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

InulinDietary supplement
Also called Maltodextrin
The intervention group (group A) consumed 10 g of inulin extracted from Thai Jerusalem artichoke by our patent technique (Patent no. 15858) administered once daily before dinner. The placebo group (group B) received isocaloric maltodextrin, while the dietary fiber advice group (group C) received guidance based on age-appropriate intake recommendations.

Study groups in NCT03968003
Study group	Role	What they receive
Inulin	Experimental	Group A consumed 10 g of inulin extracted from Thai Jerusalem artichoke by our patent technique (Patent no. 15858) administered once daily before dinner. Receives: Dietary Supplement: Inulin
Maltodextrin	Placebo comparator	Group B received isocaloric maltodextrin. Receives: Dietary Supplement: Inulin
Dietary fiber	Active comparator	Group C will receive dietary fiber advice aimed to match age-appropriate intake recommendations. Receives: Dietary Supplement: Inulin

What is being measured

The primary outcome is the main question the study is designed to answer.

Abundance (Z-score) of Bifidobacterium at Baseline and Month 6
The relative abundance of Bifidobacterium was determined using 16S rRNA gene sequencing from stool samples. The abundance values were then transformed into z-scores based on the distribution of the entire study population at baseline. A z-score of 0 represents the mean abundance of the population, while positive or negative values indicate the number of standard deviations above or below the mean, respectively.
Measured: Baseline and Month 6

Secondary outcomes (2)

Change From Baseline in Fat Mass Index (FMI) and Fat-Free Mass Index (FFMI) at 6 Months
Evaluation of body composition changes focusing on Fat Mass Index (FMI) and Fat-Free Mass Index (FFMI). FMI and FFMI were calculated as the weight of fat mass or fat-free mass in kilograms divided by the square of height in meters (kg/m^2). Values reported represent the change from baseline to 6 months. A positive change value indicates an increase in the respective mass index from baseline, while a negative value indicates a decrease. FFMI measures the amount of fat-free mass (including muscle) relative to height.
Measured: From the enrollment to the end of intervention at 6 months.
Change From Baseline in Children's Eating Behaviors and at 6 Months
Change from baseline in Emotional Undereating (EUE) scores at 6 months. EUE is a subscale of the Children's Eating Behavior Questionnaire (CEBQ), consisting of items scored on a 5-point Likert scale (1 = Never, 5 = Always). The score for this subscale is calculated as the mean of its constituent items.
Measured: From the enrollment to the end of intervention at 6 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 20179 Jul 2020

First posted30 May 2019
Study start1 Aug 2017
Primary completion30 Jun 2020
Study completion9 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for ObesityStudies of the same condition, open and under way.
More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 165 participants Children, age 7 to 15 years with Body mass index (BMI) ≥ median + 2 Standard deviation(SD) will be randomized into one of the three arms of 55 participants per group. Group A (intervention group) will receive inulin 10 g. Group B will receive placebo of isocaloric maltodextrin. Group C will receive dietary fiber advice aimed to match the recommended fiber intake for age.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 165 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03968003
Sponsor's protocol ID: 639/2017
Status last verified: Jun 2026
First submitted: 9 May 2019
Last updated: 2 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Panichsillaphakit E, Visuthranukul C, Chongpison Y, Chuaypen N, Kwanbunbumpen T, Uaariyapanichkul J, Chomtho S. The effects of inulin supplementation on eating behaviours in children and adolescents with obesity: a randomized double-blinded placebo-controlled study. Nutr Metab (Lond). 2025 Aug 12;22(1):97. doi: 10.1186/s12986-025-00995-0.
PubMed 40796902
Visuthranukul C, Leelahavanichkul A, Tepaamorndech S, Chamni S, Mekangkul E, Chomtho S. Inulin supplementation exhibits increased muscle mass via gut-muscle axis in children with obesity: double evidence from clinical and in vitro studies. Sci Rep. 2024 May 16;14(1):11181. doi: 10.1038/s41598-024-61781-1.
PubMed 38755201
Visuthranukul C, Sriswasdi S, Tepaamorndech S, Joyjinda Y, Saengpanit P, Kwanbunbumpen T, Panichsillaphakit E, Uaariyapanichkul J, Chomtho S. Association of Human Intestinal Microbiota with Lifestyle Activity, Adiposity, and Metabolic Profiles in Thai Children with Obesity. J Nutr Metab. 2022 May 20;2022:3029582. doi: 10.1155/2022/3029582. eCollection 2022.
PubMed 35637874
Visuthranukul C, Chamni S, Kwanbunbumpen T, Saengpanit P, Chongpison Y, Tepaamorndech S, Panichsillaphakit E, Uaariyapanichkul J, Nonpat N, Chomtho S. Effects of inulin supplementation on body composition and metabolic outcomes in children with obesity. Sci Rep. 2022 Jul 29;12(1):13014. doi: 10.1038/s41598-022-17220-0.
PubMed 35906473
Panichsillaphakit E, Chongpison Y, Saengpanit P, Kwanbunbumpen T, Uaariyapanichkul J, Chomtho S, Pancharoen C, Visuthranukul C. Children's Eating Behavior Questionnaire Correlated with Body Compositions of Thai Children and Adolescents with Obesity: A Pilot Study. J Nutr Metab. 2021 Jan 15;2021:6496134. doi: 10.1155/2021/6496134. eCollection 2021.
PubMed 33510908
Saengpanit P, Chomtho S, Sriswasdi S, Rodpan A, Joyjinda Y, Panichsillaphakit E, Uaariyapanichkul J, Tempark T, Bongsebandhu-phubhakdi C, Suteerojntrakool O, Visuthranukul C. Dietary fiber intake and its relationships with lipid profiles and gut microbiota in obese Thai children: a pilot study. J Med Assoc Thai . 2019;102:1282-8.
Visuthranukul C, Sriswasdi S, Tepaamorndech S, Chamni S, Leelahavanichkul A, Joyjinda Y, Aksornkitti V, Chomtho S. Enhancing gut microbiota and microbial function with inulin supplementation in children with obesity. Int J Obes (Lond). 2024 Dec;48(12):1696-1704. doi: 10.1038/s41366-024-01590-8. Epub 2024 Jul 20.
PubMed 39033197
Andriyas T, Sriswasdi S, Tansawat R, Uaariyapanichkul J, Chomtho S, Visuthranukul C. Inulin supplementation modulates gut microbiota derived metabolites related to brain function in children with obesity. Sci Rep. 2025 Oct 7;15(1):34843. doi: 10.1038/s41598-025-21079-2.
PubMed 41057493

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Dietary Fiber as Prebiotics on Intestinal Microbiota in Obese Thai Children
ClinicalTrials.gov ID: NCT03968003
Acronym / sponsor ID: 639/2017
Conditions: Obesity
Keywords: Prebiotics, Intestinal Microbiota
Study type: Interventional
Recruitment status: Completed
Enrolment: 165 participants (actual)
Lead sponsor: Chulalongkorn UniversityUniversity, hospital or other
Study start: 1 Aug 2017 (actual)
Primary completion: 30 Jun 2020 (actual)
Study completion: 9 Jul 2020 (actual)
First posted: 30 May 2019 (actual)
Results: Posted 2 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A total of 165 children, aged 7 to 15 years with a Body Mass Index (BMI) ≥ median + 2 standard deviation (SD), were randomized into three groups:

Group A (intervention group) received inulin daily.

Group B received an isocaloric maltodextrin placebo.

Group C received dietary fiber advice aimed to match age-appropriate recommendations.

Detailed description

Intervention group receiving inulin extracted from Thai Jerusalem artichoke.

Placebo group receiving isocaloric maltodextrin.

Control group receiving dietary fiber intake advice.

The study focuses on evaluating changes in gut microbial taxa using 16S rRNA gene sequencing and assessing secondary parameters including body composition and satiety hormones over a 6-month period.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3
Model description: 165 participants Children, age 7 to 15 years with Body mass index (BMI) ≥ median + 2 Standard deviation(SD) will be randomized into one of the three arms of 55 participants per group. Group A (intervention group) will receive inulin 10 g. Group B will receive placebo of isocaloric maltodextrin. Group C will receive dietary fiber advice aimed to match the recommended fiber intake for age.

Arm	Type	Receives
Inulin	Experimental	Dietary Supplement: InulinGroup A consumed 10 g of inulin extracted from Thai Jerusalem artichoke by our patent technique (Patent no. 15858) administered once daily before dinner.
Maltodextrin	Placebo comparator	Dietary Supplement: InulinGroup B received isocaloric maltodextrin.
Dietary fiber	Active comparator	Dietary Supplement: InulinGroup C will receive dietary fiber advice aimed to match age-appropriate intake recommendations.

Who may qualify

Ages: 7 to 15 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

Children, age 7 to 15 years
Body mass index (BMI) ≥ median + 2 Standard deviation (SD)

Key exclusion criteria (4 listed)

Underlying disease of syndromic obesity and monogenic obesity
Endocrine causes of obesity (e.g. hypothyroidism, growth hormone deficiency)
Use of drugs that influence appetite or body weight (e.g. corticosteroids)
Attending other concurrent weight reduction programs

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
InulinAlso: MaltodextrinThe intervention group (group A) consumed 10 g of inulin extracted from Thai Jerusalem artichoke by our patent technique (Patent no. 15858) administered once daily before dinner. The placebo group (group B) received isocaloric maltodextrin, while the dietary fiber advice group (group C) received guidance based on age-appropriate intake recommendations.	Dietary supplement	Dietary fiber, Inulin, Maltodextrin

Primary outcome

Abundance (Z-score) of Bifidobacterium at Baseline and Month 6
Time frame: Baseline and Month 6
The relative abundance of Bifidobacterium was determined using 16S rRNA gene sequencing from stool samples. The abundance values were then transformed into z-scores based on the distribution of the entire study population at baseline. A z-score of 0 represents the mean abundance of the population, while positive or negative values indicate the number of standard deviations above or below the mean, respectively.

2 secondary outcomes

Change From Baseline in Fat Mass Index (FMI) and Fat-Free Mass Index (FFMI) at 6 Months
Time frame: From the enrollment to the end of intervention at 6 months.
Change From Baseline in Children's Eating Behaviors and at 6 Months
Time frame: From the enrollment to the end of intervention at 6 months.

Results and safety

Results posted to the registry on 2 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Inulin	55	51
Maltodextrin	55	52
Dietary Fiber	55	52

Primary outcome: Abundance (Z-score) of Bifidobacterium at Baseline and Month 6

Time frame: Baseline and Month 6. Mean (Standard Deviation). Unit: Z-score

Measure	Inulin n = 51	Maltodextrin n = 52	Dietary Fiber n = 52
Baseline	1.812 (4.484)	1.398 (2.463)	1.962 (3.780)
Month 6	3.589 (6.299)	1.852 (3.994)	3.613 (12.305)

Inulin: p = 0.0025, Wilcoxon Signed-Rank Test
Maltodextrin: p = 0.73, Wilcoxon Signed-Rank Test
Dietary Fiber: p = 0.73, Wilcoxon Signed-Rank Test

Population analysed: Intent-to-treat population. Microbiota abundance was analyzed in participants with available stool samples at each time point.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: from enrollment until end of follow-up, up to 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Inulin	0 of 52 (0%)	0 of 52 (0%)	0 of 52
Maltodextrin	0 of 51 (0%)	0 of 51 (0%)	0 of 51
Dietary Fiber	0 of 51 (0%)	0 of 51 (0%)	0 of 51

Limitations and caveats (from the sponsor): The study was conducted alongside an intensive behavioral modification program, which may influence the primary outcomes. The relatively short duration of follow-up (6 months) and the specific pediatric population may limit the generalizability of the findings to other age groups or longer-term interventions. Additionally, the non-systematic assessment of adverse events relied on participant self-reports, which may be subject to recall bias.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 40796902Panichsillaphakit E, Visuthranukul C, Chongpison Y, Chuaypen N, Kwanbunbumpen T, Uaariyapanichkul J, Chomtho S. The effects of inulin supplementation on eating behaviours in children and adolescents with obesity: a randomized double-blinded placebo-controlled study. Nutr Metab (Lond). 2025 Aug 12;22(1):97. doi: 10.1186/s12986-025-00995-0.
Background: PubMed 38755201Visuthranukul C, Leelahavanichkul A, Tepaamorndech S, Chamni S, Mekangkul E, Chomtho S. Inulin supplementation exhibits increased muscle mass via gut-muscle axis in children with obesity: double evidence from clinical and in vitro studies. Sci Rep. 2024 May 16;14(1):11181. doi: 10.1038/s41598-024-61781-1.
Background: PubMed 35637874Visuthranukul C, Sriswasdi S, Tepaamorndech S, Joyjinda Y, Saengpanit P, Kwanbunbumpen T, Panichsillaphakit E, Uaariyapanichkul J, Chomtho S. Association of Human Intestinal Microbiota with Lifestyle Activity, Adiposity, and Metabolic Profiles in Thai Children with Obesity. J Nutr Metab. 2022 May 20;2022:3029582. doi: 10.1155/2022/3029582. eCollection 2022.
Background: PubMed 35906473Visuthranukul C, Chamni S, Kwanbunbumpen T, Saengpanit P, Chongpison Y, Tepaamorndech S, Panichsillaphakit E, Uaariyapanichkul J, Nonpat N, Chomtho S. Effects of inulin supplementation on body composition and metabolic outcomes in children with obesity. Sci Rep. 2022 Jul 29;12(1):13014. doi: 10.1038/s41598-022-17220-0.
Background: PubMed 33510908Panichsillaphakit E, Chongpison Y, Saengpanit P, Kwanbunbumpen T, Uaariyapanichkul J, Chomtho S, Pancharoen C, Visuthranukul C. Children's Eating Behavior Questionnaire Correlated with Body Compositions of Thai Children and Adolescents with Obesity: A Pilot Study. J Nutr Metab. 2021 Jan 15;2021:6496134. doi: 10.1155/2021/6496134. eCollection 2021.
BackgroundSaengpanit P, Chomtho S, Sriswasdi S, Rodpan A, Joyjinda Y, Panichsillaphakit E, Uaariyapanichkul J, Tempark T, Bongsebandhu-phubhakdi C, Suteerojntrakool O, Visuthranukul C. Dietary fiber intake and its relationships with lipid profiles and gut microbiota in obese Thai children: a pilot study. J Med Assoc Thai . 2019;102:1282-8.
Results publication: PubMed 39033197Visuthranukul C, Sriswasdi S, Tepaamorndech S, Chamni S, Leelahavanichkul A, Joyjinda Y, Aksornkitti V, Chomtho S. Enhancing gut microbiota and microbial function with inulin supplementation in children with obesity. Int J Obes (Lond). 2024 Dec;48(12):1696-1704. doi: 10.1038/s41366-024-01590-8. Epub 2024 Jul 20.
Derived from this study: PubMed 41057493Andriyas T, Sriswasdi S, Tansawat R, Uaariyapanichkul J, Chomtho S, Visuthranukul C. Inulin supplementation modulates gut microbiota derived metabolites related to brain function in children with obesity. Sci Rep. 2025 Oct 7;15(1):34843. doi: 10.1038/s41598-025-21079-2.
Individual participant dataSharing planned: No

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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.

Chonnikant Visuthranukul, M.D. principal investigator

Chulalongkorn University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Inulin in people with Obesity, run by Chulalongkorn University at 1 site in Thailand.

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: finished, as of the sponsor's last update on 2 Jul 2026. 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 Thailand. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 2 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Abundance (Z-score) of Bifidobacterium at Baseline and Month 6 (time frame: Baseline and Month 6). 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 NCT03968003, which also lists 8 linked publications.

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 2 Jul 2026.