Clinical trial NCT05843370: Modification of Ambient Air Pollution Exposure and Cardiopulmonary Outcomes by Socioeconomic Status and Nutrition
Official title: Modification of Ambient Air Pollution Exposure and Cardiopulmonary Outcomes by Socioeconomic Status and Nutrition
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Air Pollution
Pollution; Exposure
Nutrition, Healthy
Lead sponsor: Environmental Protection Agency (EPA)
Sponsor class: FED
First posted: 2023-05-06
Enrollment: 82
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population represents individuals living in neighborhoods ranked either at the top or bottom of the Social Vulnerability Index, a measure of community vulnerability.

Brief summary: 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.

Detailed description: Acute and chronic exposure to air pollution are well-established risk factors for all-cause mortality, mainly driven by cardiovascular and respiratory disease. The health effects of air pollution exposure have been shown to be mediated by a range of community level and personal factors, including the presence of preexisting medical conditions, age, and socioeconomic status (SES). Individuals who reside in lower SES communities are more likely to experience increased air pollution. The effects of air pollution among those residing in less advantaged communities may be further compounded by reduced access to health care and access to nutrition. Research conducted in our facility and others has established that increased levels of micronutrients can improve subclinical indices of cardiopulmonary disease after acute and chronic air pollution. Omega-3 polyunsaturated fatty acids (PUFAs) have been demonstrated to reduce the markers of cardiopulmonary dysfunction, including heart rate variability, cholesterol, and vascular injury markers after air pollution exposure. However, levels of PUFAs, as well as other potentially protective vitamins, have been demonstrated to be significantly reduced among individuals with lower income and lower educational attainment. This may be in part due to reduced access to healthy food options, as lower income and lower educational attainment have been shown to influence access to grocery stores and nutritious foods.

Given the interplay between nutrition, air pollution exposure, SES, and cardiopulmonary disease, the investigators propose the following study to investigate how socioeconomic status can modify ambient air pollution exposure and subclinical indices of cardiovascular and pulmonary disease and inflammation, and if nutritional status can further modify this relationship. Healthy 25-70-year- old male and female subjects will be recruited from communities that are representative of high and low social vulnerability index, a composite measure of urbanicity, educational attainment, owner-occupied housing, poverty, unemployment, non-managerial occupations, single parent households, houses built since 2000, vehicle ownership, and percentage of people who pay \<30% of their income on housing status. Participants will be recruited in the Raleigh-Durham-Cary combined statistical area (CSA) area of North Carolina. Qualified subjects will complete a dietary questionnaire and come to the EPA Human Studies Facility for 3 sessions. The following endpoints will be taken from subjects: blood pressure, heart rate variability (HRV), venous blood, retinal imaging, and spirometry. Blood collected will be assessed for markers of inflammation, oxidative stress, vasoconstriction, coagulation, as well as nutritional status. Air pollution exposure will be assessed for the 24-hour and weeklong period of each visit using area-specific air quality data, provided by stationary air monitors. In addition, participants will be provided with silicone wrist bands to wear for three weeklong intervals during the duration of their study. Silicone wrist bands have been shown to sorb a wide range of volatile and semi-volatile compounds and will serve as a passive personal exposure monitor to air. The investigators hypothesize that residence in a neighborhood with high social vulnerability will increase both personal exposure to air pollution and the associated health effects of air pollution exposure. The investigators further hypothesize that nutrition, specifically components in nutrition demonstrated to be anti-inflammatory, will modulate this relationship and reduce cardiopulmonary outcomes associated with exposure.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Heart Rate Variability - SDNN
timeFrame: Through study completion, an average of 1-2 years
measure: Heart Rate Variability - rMSSD
timeFrame: Through study completion, an average of 1-2 years
measure: Heart Rate Variability - LF absolute power
timeFrame: Through study completion, an average of 1-2 years
measure: Heart Rate Variability - VLF absolute power
timeFrame: Through study completion, an average of 1-2 years
measure: Heart Rate Variability - HF absolute power
timeFrame: Through study completion, an average of 1-2 years
measure: Heart Rate Variability - LF/HF power
timeFrame: Through study completion, an average of 1-2 years
Secondary outcomes:
measure: Pulmonary Function - FVC
timeFrame: Through study completion, an average of 1-2 years
measure: Pulmonary Function - FEV1
timeFrame: Through study completion, an average of 1-2 years
measure: Pulmonary Function - FEV1/FVC
timeFrame: Through study completion, an average of 1-2 years
measure: Peripheral Venous Blood - Total Cholesterol
timeFrame: Through study completion, an average of 1-2 years
measure: Peripheral Venous Blood - HDL
timeFrame: Through study completion, an average of 1-2 years
measure: Peripheral Venous Blood - LDL
timeFrame: Through study completion, an average of 1-2 years
measure: Peripheral Venous Blood - VLDL
timeFrame: Through study completion, an average of 1-2 years
measure: Peripheral Venous Blood - Triglycerides
timeFrame: Through study completion, an average of 1-2 years
measure: Peripheral Venous Blood - CRP
timeFrame: Through study completion, an average of 1-2 years
measure: Peripheral Venous Blood - IL1B
timeFrame: Through study completion, an average of 1-2 years
measure: Peripheral Venous Blood - IL6
timeFrame: Through study completion, an average of 1-2 years
measure: Peripheral Venous Blood - IL8
timeFrame: Through study completion, an average of 1-2 years
measure: Peripheral Venous Blood - TNFa
timeFrame: Through study completion, an average of 1-2 years
measure: Retinal Vasculature - CRAE
timeFrame: Through study completion, an average of 1-2 years
measure: Retinal Vasculature - CRVE
timeFrame: Through study completion, an average of 1-2 years
measure: Retinal Vasculature - AVR
timeFrame: Through study completion, an average of 1-2 years
Other outcomes:
measure: Concentration of Air Toxics via Silicone Wrist Band
timeFrame: Through study completion, an average of 1-2 years
Locations:
city: Chapel Hill
country: United States
facility: EPA Human Studies Facility
state: North Carolina
Study officials:
References: