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Completed

NCT Number: NCT03388411

Nutritional Intake and Gut Microbiome

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.

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Key information

Conditions

Obesity, Childhood Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

Up to 12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hallym University Kangnam Sacred Heart Hospital

Seoul, 07440, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gut microbiome profiling

Diagnostic Test

Gut microbial profiling will be done with next-generation sequencing targeting bacterial 16s rRNA genes.

Other names: 16s metagenomic analysis

Primary outcomes

  1. Correlation of fecal microbial profile with childhood obesity

    Time frame: visit 1day

    Analysis of fecal microbial profile using 16s rRNA sequencing

  2. Correlation of fecal microbial profile with nutrient intake data using feeding diary

    Time frame: visit 1day

    Nutritional intake analysis of total calorie, carbohydrate, fiber, fat, and protein from feeding dairy for two days

Secondary outcomes

  1. Correlation of childhood obesity with metabolic abnomalities using blood sampling

    Time frame: visit 1day

    Glucose, AST, ALT, uric acid, triglyceride, HDL-cholesterol, LDL-cholesterol, total cholesterol, insulin, hsCRP, 25(OH)-Vitamin D3, hemoglobin, ferritin, and HbA1c

Sponsors and collaborators

Lead sponsor

Hallym University Kangnam Sacred Heart Hospital

Other

Registry information

Official study title

Nutritional Intake, Metabolic Abnormalities and Gut Microbiome in Children

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 3, 2018
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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