Environmental Health Effects on Your Physiology (HYPHY)

May 8, 2023 updated by: Tanya Alderete, University of Colorado, Boulder

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

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

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Colorado
      • Boulder, Colorado, United States, 80309
        • Clinical and Translational Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Young adults from Denver, Colorado.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2019

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

June 10, 2019

First Submitted That Met QC Criteria

June 12, 2019

First Posted (Actual)

June 14, 2019

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 19-0201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

3
Subscribe