Modification of Ambient Air Pollution Exposure and Cardiopulmonary Outcomes by Socioeconomic Status and Nutrition

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
Environmental Protection Agency (EPA)
Study ID
NCT05843370
Status
Enrolling By Invitation

Conditions

  • Air Pollution
  • Nutrition, Healthy
  • Pollution; Exposure

Eligibility Criteria

Sex
ALL
Age
25 Years - 70 Years
Healthy Volunteers
Accepted

Study Details

The goal of this observational study is to compare the effects of air pollution exposure and nutrition between neighborhoods with high and low social vulnerability scores. The main questions this study aims to answer are: * Does living in a neighborhood with high or low vulnerability influence the response of the heart, lungs, and immune system to air pollution. * Does nutritional status alter the association between air pollution exposure and changes in the heart, lungs, and immune system. Participants (age 25-70 years) that live in neighborhoods ranked high or low on the Social Vulnerability Index (SVI) will take part in 3 visits. Each visit involves the following: * Measurements of heart activity, lung function, and blood to measure changes that may be caused by air pollution. * Questionnaires about the types of food eaten and activities that may modify exposure to air pollution. * Estimation of air pollution exposure using a study iPhone. Participants will carry a study iPhone with them for 24 hours at each visit. The study iPhone runs an application (app) that estimates the amount of air pollution each participant is exposed to. * Wearing silicone wristbands for a week before each study visit. Silicone wristbands absorb air pollutants and are later measured see the types and amounts of chemicals participants are exposed to.

Key Dates

Start date
Aug 21, 2023
Status verified
Feb 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2027

Study Design

Enrollment
82 participants (estimated)

Arms

  • Arm: High SVI
    Participants reside in neighborhood zip code clusters that rank at the top of the social vulnerability index (most vulnerable)
  • Arm: Low SVI
    Participants reside in neighborhood zip code clusters that rank at the bottom of the social vulnerability index (least vulnerable)

Primary Outcome Measure

Heart Rate Variability - SDNN [ Time Frame: Through study completion, an average of 1-2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
EPA Human Studies FacilityChapel HillNorth Carolina27514-

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EPA Human Studies Facility· Chapel Hill, NC

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