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

June 7, 2026 updated by: Chulalongkorn University

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

165

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Chulalongkorn University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 15 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inulin
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
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.
Other Names:
  • Maltodextrin
Placebo Comparator: Maltodextrin
Group B received isocaloric maltodextrin.
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.
Other Names:
  • Maltodextrin
Active Comparator: Dietary fiber
Group C will receive dietary fiber advice aimed to match age-appropriate intake recommendations.
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.
Other Names:
  • Maltodextrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
From the enrollment to the end of intervention at 6 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Interleukin-15 at 6 Months (Inulin Group)
Time Frame: From enrollment to the end of intervention at 6 months.
Mean change in serum Interleukin-15 (IL-15) concentration from baseline to 6 months. IL-15 was quantified using ELISA as part of an exploratory mechanistic analysis to investigate the gut-muscle axis. For this specific exploratory assessment, data were analyzed for the inulin group to evaluate within-group changes.
From enrollment to the end of intervention at 6 months.
Change From Baseline in Creatinine/Cystatin C Ratio at 6 Months (Inulin Group)
Time Frame: From enrollment to the end of intervention at 6 months.
This mechanistic exploratory analysis primarily focused on the inulin intervention group. A small subset of participants from the placebo and dietary fiber groups (n=5 per group) was included for internal comparison. Summary statistics are reported for the inulin group.
From enrollment to the end of intervention at 6 months.
Change From Baseline in Amino Acids and Biogenic Amines at 6 Months
Time Frame: From the enrollment to the end of intervention at 6 months
Variable Importance in Projection (VIP) scores were derived from Orthogonal Projections to Latent Structures Discriminant Analysis (OPLS-DA) to assess the contribution of each metabolite to group separation. VIP scores are continuous, non-negative values with a theoretical minimum of 0. There is no theoretical maximum or fixed upper limit for a VIP score. A value greater than 1.0 is a universally accepted threshold indicating that a metabolite contributes significantly to the model's projection. For this analysis, VIP scores are reported as single, group-level cumulative metrics derived directly from the overall multivariate OPLS-DA model. Because these are model-derived descriptive values reflecting whole-group patterns rather than participant-level summary statistics, individual-level variance does not exist, and standard deviations are not applicable.
From the enrollment to the end of intervention at 6 months
Change From Baseline in Body Mass Index (BMI) Z-score at 6 Months
Time Frame: From the enrollment to the end of intervention at 6 months.
Change in BMI Z-score from baseline to 6 months. BMI Z-score (standard deviation score) was calculated based on age and sex using the WHO child growth standards.
From the enrollment to the end of intervention at 6 months.
Change From Baseline in Inflammatory Cytokines (IL-1β, TNF-α and IL-6) at 6 Months
Time Frame: From the enrollment to the end of intervention at 6 months.
Changes in serum concentrations of Interleukin-1 beta (IL-1β), Tumor Necrosis Factor-alpha (TNF-α), and Interleukin-6 (IL-6) from baseline to 6 months, measured using ELISA. These markers were assessed to evaluate the effect of the intervention on systemic inflammation.
From the enrollment to the end of intervention at 6 months.
Serum Peptide YY (PYY) at Baseline and 6 Months
Time Frame: Baseline and Month 6
Serum concentrations of Peptide YY (PYY) measured at baseline and at the end of the 6-month intervention using ELISA. The data are reported as the mean and standard deviation for each time point to evaluate the response of this appetite-regulating hormone to the intervention.
Baseline and Month 6
Serum Glucagon-like Peptide-1 (GLP-1) at Baseline and 6 Months
Time Frame: Baseline and Month 6
Serum concentrations of Glucagon-like peptide-1 (GLP-1) measured at baseline and at the end of the 6-month intervention using ELISA. The data are reported as the mean and standard deviation for each time point to assess changes in this satiety-related hormone.
Baseline and Month 6
Gut Microbiome Enterotype Classification at 6 Months
Time Frame: At 6 months
Distribution of gut microbiota enterotypes (e.g., Bacteroides vs. Prevotella) among participants at 6 months, determined by clustering analysis of 16S rRNA sequencing data.
At 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Investigators

  • Principal Investigator: Chonnikant Visuthranukul, M.D., Chulalongkorn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

July 9, 2020

Study Registration Dates

First Submitted

May 9, 2019

First Submitted That Met QC Criteria

May 27, 2019

First Posted (Actual)

May 30, 2019

Study Record Updates

Last Update Posted (Actual)

July 2, 2026

Last Update Submitted That Met QC Criteria

June 7, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 639/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

IPD Sharing Time Frame

Data will become available in 2022 and will share for 1 year.

IPD Sharing Access Criteria

Data will be made available upon request pending application and approval.

IPD Sharing Supporting Information Type

  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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