Environmental Health Effects on Your Physiology

Obesity Clinical Trial

— HYPHY  

Official title:

Exposure to Air Pollutants and Green Space: Implications for the Gut Microbiome and Metabolome in Young Adults Living in Denver, Colorado

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03986814
• Other study ID #: 19-0201
• Status: Active, not recruiting
• Start date: July 18, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2023
• Source: University of Colorado, Boulder
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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).

Related Conditions & MeSH terms

• Obesity

Locations

Country	Name	City	State
United States	Clinical and Translational Research Center	Boulder	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Boulder

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut Microbiome	16S rRNA and Shotgun Sequencing	Measured once at baseline visit date
Primary	Fecal Metabolome	Targeted and/or Un-targeted Metabolomics	Measured once at baseline visit date
Primary	Body mass index (BMI)	Weight and height will be combined to report BMI in kg/m^2	Measured once at baseline visit date
Primary	Body Composition	Waist and hip measurements will be taken	Measured once at baseline visit date
Secondary	Air Pollution	Modeled residential exposure to air pollution	One year before baseline visit date
Secondary	Green Space	Modeled residential exposure to green space	One year before baseline visit date
Secondary	Serum Metabolome	Targeted and/or Un-targeted Metabolomics	Measured once at baseline visit date
Secondary	Diet	Automated Self-Administered 24-Hour (ASA24)	Measured once at baseline
Secondary	Physical Activity	International Physical Activity Questionnaire	Measured once at baseline
Secondary	Fasting Glucose	Fasting Glucose (mg/dl)	Measured once at baseline
Secondary	Fasting Insulin	Fasting insulin (uU/mL)	Measured once at baseline