Environmental Health Effects on Your Physiology

Completed

• Conditions: Obesity

• Registration Number: NCT03986814
• Lead Sponsor: University of Colorado, Boulder

Brief Summary

This study evaluates the associations between exposure to air pollutants, green space, and the gut microbiome and metabolome.

Detailed Description

A rapidly evolving field of study suggests a link between the gut microbiome and fecal metabolome with obesity. Recent studies show that environmental exposures, such as ambient air pollution (AAP) exposure can affect gut bacteria and modify risk for obesity. Additionally, proximity to green space has been shown to reduce exposure to air pollutants and increase gut microbial diversity. The investigator's preliminary work has shown that near-roadway air pollution exposure was positively correlated with gut microbial taxa that have been linked with obesity. These findings suggest that air pollution exposure may increase susceptibility to obesity through alterations in the composition and function of the gut microbiome. Despite this, no studies have systematically examined the impact of air pollutants and green space on the gut microbiome and metabolome among adolescents. The overall goal of this research is to determine whether exposure to air pollutants and/or green space affect the gut microbiome and metabolome in young adults residing in Denver, Colorado. This study will examine residential-based estimates of air pollution exposure and green space and also perform detailed gut microbial and metabolite profiling in 100 adolescent and young adults.

Study Timeline

• Study First Submitted: 2019-06-10
• Study First Submitted QC: 2019-06-12
• Study First Posted: 2019-06-14
• Study Start: 2019-07-18
• Primary Completion: 2022-02-13
• Study Completion: 2022-02-13
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• The participant population includes young adults (18-25 years of age) who live in Denver, Colorado.

Exclusion Criteria

• Exclusion criteria include physical, mental, or cognitive disability that prevents participation
• Current incarceration
• Antibiotic usage in the previous month
• Pregnant or nursing
• Non-English speaking
• Any medical conditions known to affect body composition, insulin secretion, or the gut microbiota (i.e., type 1 or 2 diabetes, intestinal bowel disease, Crohn's Disease, kidney disease, heart disease, autoimmune disease).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body mass index (BMI)	Measured once at baseline visit date	Weight and height will be combined to report BMI in kg/m\^2
Gut Microbiome	Measured once at baseline visit date	16S rRNA and Shotgun Sequencing
Fecal Metabolome	Measured once at baseline visit date	Targeted and/or Un-targeted Metabolomics
Body Composition	Measured once at baseline visit date	Waist and hip measurements will be taken

Secondary Outcome Measures

Name	Time	Method
Physical Activity	Measured once at baseline	International Physical Activity Questionnaire
Fasting Insulin	Measured once at baseline	Fasting insulin (uU/mL)
Air Pollution	One year before baseline visit date	Modeled residential exposure to air pollution
Green Space	One year before baseline visit date	Modeled residential exposure to green space
Serum Metabolome	Measured once at baseline visit date	Targeted and/or Un-targeted Metabolomics
Diet	Measured once at baseline	Automated Self-Administered 24-Hour (ASA24)
Fasting Glucose	Measured once at baseline	Fasting Glucose (mg/dl)

Trial Locations

Locations (1)

Clinical and Translational Research Center; 🇺🇸 Boulder, Colorado, United States