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

NCT03968003 | Completed Results

• 1 other identifier: 639/2017
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obesity

Keywords

Prebiotics; Intestinal Microbiota

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Month 6

Secondary Outcomes (2)

• Change From Baseline in Fat Mass Index (FMI) and Fat-Free Mass Index (FFMI) at 6 Months

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

• Change From Baseline in Children's Eating Behaviors and at 6 Months

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

Other Outcomes (8)

• Change From Baseline in Interleukin-15 at 6 Months (Inulin Group)

  From enrollment to the end of intervention at 6 months.

• Change From Baseline in Creatinine/Cystatin C Ratio at 6 Months (Inulin Group)

  From enrollment to the end of intervention at 6 months.

• Change From Baseline in Amino Acids and Biogenic Amines at 6 Months

  From the enrollment to the end of intervention at 6 months

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

Inulin DIETARY_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 fiber; Inulin; Maltodextrin

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Chulalongkorn University

Bangkok, 10330, Thailand

Location

Related Publications (8)

• 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.

  PMID: 40796902 BACKGROUND

• 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: 38755201 BACKGROUND

• 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: 35637874 BACKGROUND

• 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: 35906473 BACKGROUND

• 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: 33510908 BACKGROUND

• 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.

  BACKGROUND

• 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: 39033197 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: 41057493 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Inulin; maltodextrin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides

Limitations and Caveats

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.

Results Point of Contact

• Title: Chonnikant Visuthranukul
• Organization: Division of Nutrition, Department of Pediatrics Faculty of Medicine, Chulalongkorn University 1873 Rama IV Road, Pathumwan, Bangkok 10330, Thailand

deknet@gmail.com

+662564951

Study Officials

• Chonnikant Visuthranukul, M.D.

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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.

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: July 2, 2026
• Results First Posted: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)