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

NCT03968003 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2025-05-09

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Inulin

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.

Sponsors & Collaborators

  • Chulalongkorn University

    lead OTHER

Principal Investigators

  • Chonnikant Visuthranukul, M.D. · Chulalongkorn University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2020-06-30
Completion
2020-07-09

Countries

  • Thailand

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03968003 on ClinicalTrials.gov