Obesity
Conditions
Keywords
Prebiotics, Intestinal Microbiota
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.
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.
Interventions
DIETARY_SUPPLEMENTInulin
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
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
7 Years to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abundance (Z-score) of Bifidobacterium at Baseline and Month 6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| Change From Baseline in Children's Eating Behaviors and at 6 Months | 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. |
Countries
Thailand
Contacts
PRINCIPAL_INVESTIGATORChonnikant Visuthranukul, M.D.
Chulalongkorn University
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 155 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Bifidobacterium abundance standardized score | 1.812 Z-score STANDARD_DEVIATION 4.48 |
| Fat-free mass index | 16.18 kg/m2 STANDARD_DEVIATION 1.9 |
| Fat mass index | 11.8 kg/m2 STANDARD_DEVIATION 3 |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 28 Participants |
| Trunk fat mass index | 5.7 kg/m2 STANDARD_DEVIATION 1.4 |
| Visceral fat area | 130.1 cm2 STANDARD_DEVIATION 42.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 51 | 0 / 51 |
| other Total, other adverse events | 0 / 52 | 0 / 51 | 0 / 51 |
| serious Total, serious adverse events | 0 / 52 | 0 / 51 | 0 / 51 |
Outcome results
None listed