NCT03968003

Brief Summary

This study evaluates the changes of gut microbiota composition and diversity, gut-muscle axis, body weight, body fat, children eating behaviours, SCFAs, plasma amino acids, satiety hormones (Peptide-YY(PYY) and glucagon-like peptide 1(GLP-1)), Inflammatory cytokines (Interleukin-1β(IL-1β), Tumor necrosis factor-α (TNF-α) and Interleukin-6(IL-6)) after 6-month studied period in obese Thai children.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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 30, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2020

Completed
Last Updated

May 9, 2025

Status Verified

July 1, 2020

Enrollment Period

2.9 years

First QC Date

May 9, 2019

Last Update Submit

May 6, 2025

Conditions

Obesity

Keywords

PrebioticsIntestinal Microbiota

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in gut microbiota (16S rRNA sequencing) at 3 and 6 months

    Gut microbial taxa, including Bifidobacterium, Blautia, Megasphaera, and several butyrate-producing bacteria, including Agathobacter, Eubacterium coprostanoligenes, and Subdoligranulum are being assessed.

    From the enrollment to 3 months and the end of intervention at 6 months.

Secondary Outcomes (9)

  • Change from baseline in Body mass index (BMI) at 1,2,3,4,5 and 6 months

    From the enrollment to monthly visit and the end of intervention at 6 months.

  • Change from baseline in fat mass index (FMI) at 6 months

    From the enrollment to 3 months and the end of intervention at 6 months.

  • Change from baseline in fecal short chain fatty acids (SCFAs) at 3 and 6 months

    From the enrollment to 3 months and the end of intervention at 6 months.

  • Change from baseline in Inflammatory cytokines (ELISA method)(IL-1β, TNF-α and IL-6) at 6 months

    From the enrollment to the end of intervention at 6 months.

  • Change from baseline in Children Eating Behaviors at 3 and 6 months

    From the enrollment to 3 months and the end of intervention at 6 months.

  • +4 more secondary outcomes

Study Arms (3)

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.

Dietary Supplement: Inulin

Maltodextrin

PLACEBO COMPARATOR

Group B received isocaloric maltodextrin.

Dietary Supplement: Inulin

Dietary fiber

ACTIVE COMPARATOR

Group C will receive dietary fiber advice aimed to match age-appropriate intake recommendations.

Dietary Supplement: Inulin

Interventions

InulinDIETARY_SUPPLEMENT

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.

Also known as: Maltodextrin
Dietary fiberInulinMaltodextrin

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chulalongkorn University

Bangkok, 10330, Thailand

Location

Related Publications (8)

  • 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.

    PMID: 38755201RESULT

  • 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.

    PMID: 39033197RESULT

  • 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.

    PMID: 35637874RESULT

  • 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.

    PMID: 35906473RESULT

  • Visuthranukul C, Kwanbunbumpen T, Chongpison Y, Chamni S, Panichsillaphakit E, Uaariyapanichkul J, Maholarnkij S, Chomtho S. The Impact of Dietary Fiber as a Prebiotic on Inflammation in Children with Obesity. Foods. 2022 Sep 15;11(18):2856. doi: 10.3390/foods11182856.

    PMID: 36140983RESULT

  • 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.

    PMID: 33510908RESULT

  • 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.

    RESULT

  • 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.

    PMID: 41057493DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Inulinmaltodextrin

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

StarchGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesFructansPolysaccharides

Study Officials

  • Chonnikant Visuthranukul, M.D.

    Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2019

First Posted

May 30, 2019

Study Start

August 1, 2017

Primary Completion

June 30, 2020

Study Completion

July 9, 2020

Last Updated

May 9, 2025

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

Informed Consent Form will be available to share with other researchers.

Shared Documents
ICF
Time Frame
Data will become available in 2022 and will share for 1 year.
Access Criteria
Data will be made available upon request pending application and approval.

Locations

TH(1)