CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 165 enrolled
Drug / intervention
Inulindietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03968003
NCT03968003N/ACompleted

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

Chulalongkorn University·interventional·Posted May 30, 2019·Updated May 9, 2025

In Brief

A clinical study evaluating Inulin for Obesity. Completed, enrolled 165 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesThailand
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMay 30, 2019
Enrollment StartAug 1, 2017
Primary CompletionJun 30, 2020
Study CompletionJul 9, 2020
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 7.1 years ago

Interventions

Inulindietary

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.