Clinical trial NCT03986814: Environmental Health Effects on Your Physiology
Official title: Exposure to Air Pollutants and Green Space: Implications for the Gut Microbiome and Metabolome in Young Adults Living in Denver, Colorado
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
First posted: 2019-06-14
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young adults from Denver, Colorado.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Gut Microbiome
timeFrame: Measured once at baseline visit date
measure: Fecal Metabolome
timeFrame: Measured once at baseline visit date
measure: Body mass index (BMI)
timeFrame: Measured once at baseline visit date
measure: Body Composition
timeFrame: Measured once at baseline visit date
Secondary outcomes:
measure: Air Pollution
timeFrame: One year before baseline visit date
measure: Green Space
timeFrame: One year before baseline visit date
measure: Serum Metabolome
timeFrame: Measured once at baseline visit date
measure: Diet
timeFrame: Measured once at baseline
measure: Physical Activity
timeFrame: Measured once at baseline
measure: Fasting Glucose
timeFrame: Measured once at baseline
measure: Fasting Insulin
timeFrame: Measured once at baseline
Other outcomes:
Locations:
city: Boulder
country: United States
facility: Clinical and Translational Research Center
state: Colorado
Study officials:
References: