Nutritional Intake and Gut Microbiome

Completed

• Conditions: Obesity, Childhood
• Interventions: Diagnostic Test: Gut microbiome profiling

• Registration Number: NCT03388411
• Lead Sponsor: Hallym University Kangnam Sacred Heart Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-18
• Study First Submitted: 2017-12-19
• Study First Submitted QC: 2017-12-24
• Study First Posted: 2018-01-03
• Primary Completion: 2018-10-12
• Study Completion: 2018-10-12
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obese children	Gut microbiome profiling	Children ≥95 ‰ between age 7 and 12 years
Non-obese children	Gut microbiome profiling	5‰\< BMI \<85 ‰ for children between the ages of 7 and 12 years

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hallym University Kangnam Sacred Heart Hospital; 🇰🇷 Seoul, Korea, Republic of