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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251104003
Enrollment
165
Registered
2025-11-04
Start date
2017-08-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity Prebiotics, Intestinal Microbiota

Interventions

Group A consumed 10 g of inulin extracted from Thai Jerusalem artichoke by our patent technique (Patent no. 15858) administered once daily before dinner.,Group B received isocaloric maltodextrin.,Grou
Experimental Dietary Supplement,Placebo Comparator Dietary Supplement,Active Comparator Dietary Supplement
Inulin,Maltodextrin,Dietary fiber

Sponsors

The Ratchadapisek Somphot Fund
Lead Sponsor
NSTDA Research Fund
Collaborator

Eligibility

Sex/Gender
All
Age
7 Years to 15 Years

Inclusion criteria

Inclusion criteria: 1. Children, age 7 to 15 years 2. Body mass index (BMI) is equal to or greater than median + 2 Standard deviations (SDs)

Exclusion criteria

Exclusion criteria: 1. Underlying disease of syndromic obesity and monogenic obesity 2. Endocrine causes of obesity (e.g. hypothyroidism, growth hormone deficiency) 3. Use of drugs that influence appetite or body weight (e.g. corticosteroids) 4. Attending other concurrent weight reduction programs

Design outcomes

Primary

MeasureTime frame
Gut microbiota From the enrollment to the end of intervention at 6 months 16S rRNA gene sequencing

Secondary

MeasureTime frame
Body mass index (BMI) z-score From the enrollment to monthly visit and the end of intervention at 6 months BMI was calculated as weight in kilograms divided by the square of height in meters (kg/m2). The BMI z-score was calculated based on the WHO growth reference.,Fat mass index (FMI), fat-free mass index (FFMI), Trunk FMI, and visceral fat area From the enrollment to the end of intervention at 6 months FMI and FFMI were calculated. Trunk FMI and visceral fat area were measured using standard clinical techniques. ,Inflammatory cytokines (Interleukin-1 beta, Tumor Necrosis Factor-alpha, and Interleukin-6) From the enrollment to the end of intervention at 6 months The ELISA method (Enzyme-Linked Immunosorbent Assay),Children Eating Behaviors From the enrollment to the end of intervention at 6 months Children Eating Behavior Questionnaires (CEBQs),Serum GLP-1 hormone From enrollment to the end of intervention at 6 months The ELISA method (Enzyme-Linked Immunosorbent Assay),PYY hormone From enrollment to the end of intervention at 6 months The ELISA method (Enzyme-Linked Immunosorbent Assay),Myokine (interleukin-15) From enrollment to the end of intervention at 6 months The ELISA method (Enzyme-Linked Immunosorbent Assay),Creatinine/cystatin C ratio From enrollment to the end of intervention at 6 months Serum creatinine is measured using an enzymatic method on the Alinity C analyzers (mg/dL), and cystatin C assessed using particle-enhanced immunonephelometry using the BN Systems (mg/L).,Amino acids and biogenic amines From the enrollment to the end of intervention at 6 months Liquid Chromatography - Mass Spectrometry (LC-MS/MS),Gut Microbiome Enterotype Classification From the enrollment to the end of intervention at 6 months A robust clustering approach combining Bray-Curtis dissimilarity (Hierarchical Clustering) and NMF-transformed loadings (Spectral Clustering)

Countries

Thailand

Contacts

Public ContactChonnikant Visuthranukul

Faculty of Medicine, Chulalongkorn University

chonnikant.v@chula.ac.th6622564951

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026