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Nutritional Intake and Gut Microbiome

Nutritional Intake, Metabolic Abnormalities and Gut Microbiome in Children

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03388411
Enrollment
61
Registered
2018-01-03
Start date
2017-10-18
Completion date
2018-10-12
Last updated
2019-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Childhood

Keywords

Microbiome, Gut

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.

Interventions

DIAGNOSTIC_TESTGut microbiome profiling

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

Sponsors

Hallym University Kangnam Sacred Heart Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 12 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation of fecal microbial profile with childhood obesityvisit 1dayAnalysis of fecal microbial profile using 16s rRNA sequencing
Correlation of fecal microbial profile with nutrient intake data using feeding diaryvisit 1dayNutritional intake analysis of total calorie, carbohydrate, fiber, fat, and protein from feeding dairy for two days

Secondary

MeasureTime frameDescription
Correlation of childhood obesity with metabolic abnomalities using blood samplingvisit 1dayGlucose, AST, ALT, uric acid, triglyceride, HDL-cholesterol, LDL-cholesterol, total cholesterol, insulin, hsCRP, 25(OH)-Vitamin D3, hemoglobin, ferritin, and HbA1c

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026