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Completed

NCT Number: NCT03986814

Environmental Health Effects on Your Physiology

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

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical and Translational Research Center

Boulder, Colorado, 80309, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Gut Microbiome

    Time frame: Measured once at baseline visit date

    16S rRNA and Shotgun Sequencing

  2. Fecal Metabolome

    Time frame: Measured once at baseline visit date

    Targeted and/or Un-targeted Metabolomics

  3. 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

  4. Body Composition

    Time frame: Measured once at baseline visit date

    Waist and hip measurements will be taken

Secondary outcomes

  1. Air Pollution

    Time frame: One year before baseline visit date

    Modeled residential exposure to air pollution

  2. Green Space

    Time frame: One year before baseline visit date

    Modeled residential exposure to green space

  3. Serum Metabolome

    Time frame: Measured once at baseline visit date

    Targeted and/or Un-targeted Metabolomics

  4. Diet

    Time frame: Measured once at baseline

    Automated Self-Administered 24-Hour (ASA24)

  5. Physical Activity

    Time frame: Measured once at baseline

    International Physical Activity Questionnaire

  6. Fasting Glucose

    Time frame: Measured once at baseline

    Fasting Glucose (mg/dl)

  7. Fasting Insulin

    Time frame: Measured once at baseline

    Fasting insulin (uU/mL)

Sponsors and collaborators

Lead sponsor

University of Colorado, Boulder

Other

Registry information

Official study title

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

Acronym: HYPHY

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 14, 2019
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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