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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Maltodextrin | Placebo Comparator | Group B received isocaloric maltodextrin. |
|
| Dietary fiber | Active Comparator | Group C will receive dietary fiber advice aimed to match age-appropriate intake recommendations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Fat Mass Index (FMI) and Fat-Free Mass Index (FFMI) 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Interleukin-15 at 6 Months (Inulin Group) | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chonnikant Visuthranukul, M.D. | Chulalongkorn University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chulalongkorn University | Bangkok | 10330 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40796902 | Background | 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. | |
| 38755201 |
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Following informed consent, all participants underwent baseline assessments and received standardized counseling on a low-calorie (1,000-1,200 kcal/day), low-fat diet and recommendations for 60 minutes of non-weight bearing exercise for at least 4-5 days/week. These lifestyle recommendations were provided to all groups equally to standardize behavior before the start of the 6-month product intervention.
A randomized, double-blinded placebo-controlled study was conducted in obese Thai children aged 7-15 years. Participants were assigned to 3 treatment groups for 6 months: 13 grams of extracted inulin powder from Thai Jerusalem artichoke, isocaloric maltodextrin, and dietary fiber advice groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Maltodextrin | Group B received isocaloric maltodextrin. |
| FG002 | Dietary Fiber | Group C will receive dietary fiber advice aimed to match age-appropriate intake recommendations. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Differed due to loss to follow-up and participant withdrawal. Analysis was based on available endpoint data only
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| ID | Title | Description |
|---|---|---|
| BG000 | Inulin | Inulin once daily for 6 months. |
| BG001 | Maltodextrin | Maltodextrin once daily for 6 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Differed due to loss to follow-up and participant withdrawal. Analysis was based on available endpoint data only |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent-to-treat population. Microbiota abundance was analyzed in participants with available stool samples at each time point. | Posted | Mean | Standard Deviation | Z-score | Baseline and Month 6 |
|
from enrollment until end of follow-up, up to 6 months
Adverse events were monitored through participant self-reports, interviews, and clinical assessments during each study visit. All reported events were recorded and evaluated for their relationship to the study interventions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Inulin | Inulin once daily for 6 months. | 0 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chonnikant Visuthranukul | Division of Nutrition, Department of Pediatrics Faculty of Medicine, Chulalongkorn University 1873 Rama IV Road, Pathumwan, Bangkok 10330, Thailand | +662564951 | deknet@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 20, 2025 | Oct 13, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 20, 2025 | Oct 13, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D007444 | Inulin |
| C008315 | maltodextrin |
| ID | Term |
|---|---|
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 |
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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.
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|
|
| From the enrollment to the end of intervention at 6 months. |
| Change From Baseline in Children's Eating Behaviors and 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. |
| Change From Baseline in Creatinine/Cystatin C Ratio at 6 Months (Inulin Group) | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| 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. |
| 35637874 | 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. |
| 35906473 | 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. |
| 33510908 | 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. |
| 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. |
| 39033197 | Result | 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. |
| 41057493 | Derived | 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. |
| BG002 |
| Dietary Fiber |
Dietary fiber advice once daily for 6 months. |
| BG003 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Differed due to loss to follow-up and participant withdrawal. Analysis was based on available endpoint data only | Count of Participants | Participants |
|
| Fat mass index | Differed due to loss to follow-up (LTFU) and participant withdrawal. Analysis was based on available endpoint data only | Mean | Standard Deviation | kg/m2 |
|
| Fat-free mass index | Differed due to loss to follow-up (LTFU) and participant withdrawal. Analysis was based on available endpoint data only | Mean | Standard Deviation | kg/m2 |
|
| Trunk fat mass index | Mean | Standard Deviation | kg/m2 |
|
| Visceral fat area | Mean | Standard Deviation | cm2 |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Bifidobacterium abundance standardized score | Standardized z-score of Bifidobacterium abundance. A z-score of 0 represents the mean abundance of the study population. Higher positive scores indicate a higher abundance compared to the mean, which is generally considered a more favorable microbial profile in preterm infants. Scores are interpreted relative to the population mean; there is no established clinical threshold for z-score values in this context. Use 'Z-score' as the unit of measure. | Mean | Standard Deviation | Z-score |
|
Maltodextrin once daily for 6 months. |
| OG002 | Dietary Fiber | Dietary fiber advice for 6 months. |
|
|
|
| Secondary | Change From Baseline in Fat Mass Index (FMI) and Fat-Free Mass Index (FFMI) 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. | The number analyzed differs from the number assigned due to participant dropouts, loss to follow-up, and withdrawal of consent during the 6-month intervention period. | Posted | Mean | Standard Deviation | kg/m2 | From the enrollment to the end of intervention at 6 months. |
|
|
|
| Secondary | Change From Baseline in Children's Eating Behaviors and 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. | The number analyzed differs from the number assigned due to participant dropouts, loss to follow-up, and withdrawal of consent during the 6-month intervention period. | Posted | Mean | Standard Deviation | Score | From the enrollment to the end of intervention at 6 months. |
|
|
|
|
| Other Pre-specified | Change From Baseline in Interleukin-15 at 6 Months (Inulin Group) | 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. | 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. | Posted | Mean | Standard Deviation | pg/mL | From enrollment to the end of intervention at 6 months. |
|
|
|
| Other Pre-specified | Change From Baseline in Creatinine/Cystatin C Ratio at 6 Months (Inulin Group) | 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. | 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. | Posted | Mean | Standard Deviation | Ratio | From enrollment to the end of intervention at 6 months. |
|
|
|
| Other Pre-specified | Change From Baseline in Amino Acids and Biogenic Amines 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. | All participants who completed the 6-month follow-up and provided blood samples for metabolomics were included in the OPLS-DA S-plot analysis (Inulin n=52, Placebo n=51, and Dietary Fiber Advice n=51). | Posted | Number | VIP Score | From the enrollment to the end of intervention at 6 months |
|
|
|
| Other Pre-specified | Change From Baseline in Body Mass Index (BMI) Z-score 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. | Posted | Mean | Standard Deviation | Z-score | From the enrollment to the end of intervention at 6 months. |
|
|
|
| Other Pre-specified | Change From Baseline in Inflammatory Cytokines (IL-1β, TNF-α and IL-6) 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. | Posted | Mean | Standard Deviation | pg/mL | From the enrollment to the end of intervention at 6 months. |
|
|
|
| Other Pre-specified | Serum Peptide YY (PYY) at Baseline and 6 Months | 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. | Posted | Mean | Standard Deviation | pg/mL | Baseline and Month 6 |
|
|
|
| Other Pre-specified | Serum Glucagon-like Peptide-1 (GLP-1) at Baseline and 6 Months | 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. | Posted | Mean | Standard Deviation | ng/L | Baseline and Month 6 |
|
|
|
| Other Pre-specified | Gut Microbiome Enterotype Classification 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. | Posted | Count of Participants | Participants | At 6 months |
|
|
|
| 52 |
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | Maltodextrin | Maltodextrin once daily for 6 months. | 0 | 51 | 0 | 51 | 0 | 51 |
| EG002 | Dietary Fiber | Dietary fiber advice for 6 months. | 0 | 51 | 0 | 51 | 0 | 51 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005630 | Fructans |
| D011134 | Polysaccharides |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
|
| Mean Difference (Net) |
| -0.24 |
| 2-Sided |
| 95 |
| -0.46 |
| -0.01 |
| Superiority |
|
| IL-6 |
|
|
|
| Title | Measurements |
|---|---|
|
| Escherichia-Shigella |
|
| Megasphaera |
|
| Firmicutes- Mixed |
|