Nutritional Intake and Gut Microbiome

Study Overview
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Brief Summary
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Pediatric obesity has been increasing in prevalence, but concerns have been raised around the world because no treatment has been found. Recently, however, research on gut microbiome has begun to become a new alternative. It has been shown that changes in the microbiome in adults may induce obesity. However, the results on children are still scarce. Unlike adults, children have few external factors such as alcohol, tobacco, stress, and cancer, making them suitable for obesity-related gut microbiome studies. The investigators will use Illumina MiSeq platform for 16s rRNA metagenomics profiling in children. In this study, the investigators aimed to analyze the relationship between pediatric obesity, gut microbiome profile, blood biomarkers relevant to metabolic syndrome, and nutrient intake data.

Official Title
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Nutritional Intake, Metabolic Abnormalities and Gut Microbiome in Children

Conditions
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Obesity, Childhood

Intervention / Treatment
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* Diagnostic Test: Gut microbiome profiling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obese children: Children ≥95 ‰ between age 7 and 12 years Non-obese children: 5‰<BMI <85 ‰ for children between the ages of 7 and 12 years Exclusion Criteria: Taking antibiotics, probiotics, or steroids for a month before visit Taking probiotics-like products including yogurt for seven days before visit Having enteritis symptoms including diarrhea for a month before visit Chronic heart disease, chronic bowel disease, chronic liver disease, chronic kidney disease, endocrine disease, genetic diseases or congenital metabolic disorder

Ages Eligible for Study
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Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obese children<br>Children ≥95 ‰ between age 7 and 12 years | Diagnostic Test: Gut microbiome profiling<br>* Gut microbial profiling will be done with next-generation sequencing targeting bacterial 16s rRNA genes.<br>* Other names: 16s metagenomic analysis;|
| Non-obese children<br>5‰< BMI <85 ‰ for children between the ages of 7 and 12 years | Diagnostic Test: Gut microbiome profiling<br>* Gut microbial profiling will be done with next-generation sequencing targeting bacterial 16s rRNA genes.<br>* Other names: 16s metagenomic analysis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of fecal microbial profile with childhood obesity | Analysis of fecal microbial profile using 16s rRNA sequencing | visit 1day | 
| Correlation of fecal microbial profile with nutrient intake data using feeding diary | Nutritional intake analysis of total calorie, carbohydrate, fiber, fat, and protein from feeding dairy for two days | visit 1day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of childhood obesity with metabolic abnomalities using blood sampling | Glucose, AST, ALT, uric acid, triglyceride, HDL-cholesterol, LDL-cholesterol, total cholesterol, insulin, hsCRP, 25(OH)-Vitamin D3, hemoglobin, ferritin, and HbA1c | visit 1day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microbiome, Gut