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

Enrolling by invitation

Conditions studied: Air Pollution, Pollution; Exposure, Nutrition, Healthy

In brief

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 facts

Study ID

NCT05843370

Run by

Environmental Protection Agency (EPA)

People needed

82

Starts

2023-08-21

Expected to finish

2027-12-01

Last updated by the study team

2024-02-20

Who can join

Age: 25 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Aged 25-70 years old males and females.
• Residing in Zip Code Tabulation Area in Raleigh-Durham great triangle area representing high or low social vulnerability index (SVI).
• Continuous residence at the same address during previous one year.

You may not qualify if…

• Individuals with a diagnosis of COVID-19 and have persistent symptoms due to that infection (e.g., shortness of breath) or symptoms consistent with "long COVID".
• Individuals not "up to date" on their vaccinations for COVID-19. [which means a person who has received all recommended COVID-19 vaccines, including any booster dose(s) when eligible].
• Individuals who have difficulty to come to the HSF medical station on a weekday for data collection without assistance.
• Individuals have a history of heart arrhythmia, a pacemaker user, been diagnosed with arrhythmia and prescribed a medication to treat arrhythmia.
• Individuals have uncontrolled hypertension (>180 systolic, >110 diastolic)
• Individuals who are currently smoking (including vaping, hookah, e-cigarettes, including marijuana, CBD, and/or THC products) or have a smoking history within 1 year of study (defined as more than 1 pk/yr in the past year) or have a greater than/equal to a 5-pack year smoking history.
• Individuals living with a smoker who smokes inside the house.
• Individuals who are regularly exposed to high levels of vapors, dust, gases, smoke, or fumes.
• Individuals who do not understand or speak English.
• Individuals who are taking β-blocker medications.
• Individuals who are on specific extreme diets, such as liquid diet, weight loss diet, or single diet.
• Individuals who are unwilling or unable to maintain their current dietary and medication pattern for the whole study.
• Individuals with bleeding or clotting disorders.
• Individuals who have skin allergy to tape or electrodes.
• Individuals who are pregnant or attempting to become pregnant.
• Individuals currently on dialysis
• Individuals who have unspecified illnesses, which in the judgment of the investigators might increase the risk associated with clinical procedures will be a basis for exclusion.
• Temporary Exclusion Criteria :
• Individuals who have had recent (within 6 months) abdominal and/or eye surgery, or been diagnosed with any type of hernia, as well as any other contraindications for raised intra-abdominal pressure.
• Individuals who have prolonged chest pain at rest (severe uncompensated angina pectoris) or inability to carry out any physical activity without chest discomfort.
• Individuals who have difficulty breathing when at rest or performing activities at daily living.
• Individuals who are having an acute respiratory illness within two weeks prior to any of the study visits.

Where it is running

• EPA Human Studies Facility — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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