EPA Human Studies Facility
Chapel Hill, North Carolina, 27514, United States
NCT Number: NCT05843370
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.
Interested in participating?
Request Info25 year–70 year
All sexes
Observational
Chapel Hill, North Carolina, 27514, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Temporary Exclusion Criteria :
Time frame: Through study completion, an average of 1-2 years
Time-domain measurement: standard deviation of the normal-to-normal (SDNN) in milliseconds
This outcome is measured repeatedly to assess change in HRV associated with change in ambient air pollution exposure
Time frame: Through study completion, an average of 1-2 years
Time-domain measurement: root-mean squared of successive differences (rMSSD) in milliseconds
This outcome is measured repeatedly to assess change in HRV associated with change in ambient air pollution exposure
Time frame: Through study completion, an average of 1-2 years
Frequency-domain measurement: Low frequency power (LF, 0.04-0.15 Hz) in ms squared divided by cycles per second (ms2/Hz).
This outcome is measured repeatedly to assess change in HRV associated with change in ambient air pollution exposure
Time frame: Through study completion, an average of 1-2 years
Frequency-domain measurement: Very Low frequency power (VLF, 0.0033-0.04 Hz) in ms squared divided by cycles per second (ms2/Hz).
This outcome is measured repeatedly to assess change in HRV associated with change in ambient air pollution exposure
Time frame: Through study completion, an average of 1-2 years
Frequency-domain measurement: High frequency power (HF, 0.15-0.40 Hz) in ms squared divided by cycles per second (ms2/Hz).
This outcome is measured repeatedly to assess change in HRV associated with change in ambient air pollution exposure
Time frame: Through study completion, an average of 1-2 years
Frequency-domain measurement: ratio of LF power divided by HF power, expressed as ratio
This outcome is measured repeatedly to assess change in HRV associated with change in ambient air pollution exposure
Time frame: Through study completion, an average of 1-2 years
Forced vital capacity (FVC) measured in Liters (L) measured via Sensor Medic Vmax pulmonary function system (dry rolling seal spirometer).
This outcome is measured repeatedly to assess change in lung function associated with change in ambient air pollution exposure
Time frame: Through study completion, an average of 1-2 years
Forced Expiratory Volume in 1 second (FEV1) measured in Liters (L) measured via Sensor Medic Vmax pulmonary function system (dry rolling seal spirometer).
This outcome is measured repeatedly to assess change in lung function associated with change in ambient air pollution exposure
Time frame: Through study completion, an average of 1-2 years
the ratio of Forced Expiratory Volume in 1 second (FEV1) measured in Liters (L) divided by Forced Vital Capacity (FVC) measured in Liters (L) measured via Sensor Medic Vmax pulmonary function system (dry rolling seal spirometer). Expressed as a percentage
This outcome is measured repeatedly to assess change in lung function associated with change in ambient air pollution exposure
Time frame: Through study completion, an average of 1-2 years
Total cholesterol measured in plasma in milligrams per deciliter (mg/dL)
This outcome is measured repeatedly to assess change in blood lipids associated with change in ambient air pollution exposure
Time frame: Through study completion, an average of 1-2 years
High density lipoproteins measured in plasma in milligrams per deciliter (mg/dL)
This outcome is measured repeatedly to assess change in blood lipids associated with change in ambient air pollution exposure
Time frame: Through study completion, an average of 1-2 years
Low density lipoproteins measured in plasma in milligrams per deciliter (mg/dL)
This outcome is measured repeatedly to assess change in blood lipids associated with change in ambient air pollution exposure
Time frame: Through study completion, an average of 1-2 years
Very Low density lipoproteins measured in plasma in milligrams per deciliter (mg/dL)
This outcome is measured repeatedly to assess change in blood lipids associated with change in ambient air pollution exposure
Time frame: Through study completion, an average of 1-2 years
Triglycerides measured in plasma in milligrams per deciliter (mg/dL)
This outcome is measured repeatedly to assess change in blood lipids associated with change in ambient air pollution exposure
Time frame: Through study completion, an average of 1-2 years
C Reactive Protein measured in plasma in milligrams per deciliter (mg/dL)
This outcome is measured repeatedly to assess change in inflammatory markers associated with change in ambient air pollution exposure
Time frame: Through study completion, an average of 1-2 years
Cytokine IL1B measured in plasma in picograms per milliliter (pg/mL)
This outcome is measured repeatedly to assess change in inflammatory markers associated with change in ambient air pollution exposure
Time frame: Through study completion, an average of 1-2 years
Cytokine IL6 measured in plasma in picograms per milliliter (pg/mL)
This outcome is measured repeatedly to assess change in inflammatory markers associated with change in ambient air pollution exposure
Time frame: Through study completion, an average of 1-2 years
Cytokine IL8 measured in plasma in picograms per milliliter (pg/mL)
This outcome is measured repeatedly to assess change in inflammatory markers associated with change in ambient air pollution exposure
Time frame: Through study completion, an average of 1-2 years
Cytokine TNFa measured in plasma in picograms per milliliter (pg/mL)
This outcome is measured repeatedly to assess change in inflammatory markers associated with change in ambient air pollution exposure
Time frame: Through study completion, an average of 1-2 years
Retinal images taken via non-mydriatic fundus camera are analyzed for central retinal artery equivalent (CRAE) measured in micrometer (um)
This outcome is measured repeatedly to assess change in retinal vasculature associated with change in ambient air pollution exposure
Time frame: Through study completion, an average of 1-2 years
Retinal images taken via non-mydriatic fundus camera are analyzed for central retinal venous equivalent (CRAE) measured in micrometer (um)
This outcome is measured repeatedly to assess change in retinal vasculature associated with change in ambient air pollution exposure
Time frame: Through study completion, an average of 1-2 years
Retinal images taken via non-mydriatic fundus camera are analyzed for arteriole to venule ratio (AVR), which is central retinal venous equivalent (CRAE) measured in micrometer (um) divided by central retinal artery equivalent (CRAE). Expressed as a ratio T wave complexity
Time frame: Through study completion, an average of 1-2 years
Measurement of SVOCs sorbed to silicone wrist bands
Environmental Protection Agency (EPA)
Fed
Acronym: SENSE
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