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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05843370
Acronym
SENSE
Enrollment
82
Registered
2023-05-06
Start date
2023-08-21
Completion date
2027-12-31
Last updated
2024-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Air Pollution, Nutrition, Healthy, Pollution; Exposure

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.

Interventions

None listed

Sponsors

Environmental Protection Agency (EPA)
Lead SponsorFED

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Heart Rate Variability - LF/HF powerThrough study completion, an average of 1-2 yearsFrequency-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
Heart Rate Variability - SDNNThrough study completion, an average of 1-2 yearsTime-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
Heart Rate Variability - rMSSDThrough study completion, an average of 1-2 yearsTime-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
Heart Rate Variability - LF absolute powerThrough study completion, an average of 1-2 yearsFrequency-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
Heart Rate Variability - VLF absolute powerThrough study completion, an average of 1-2 yearsFrequency-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
Heart Rate Variability - HF absolute powerThrough study completion, an average of 1-2 yearsFrequency-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

Secondary

MeasureTime frameDescription
Peripheral Venous Blood - LDLThrough study completion, an average of 1-2 yearsLow 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
Peripheral Venous Blood - VLDLThrough study completion, an average of 1-2 yearsVery 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
Peripheral Venous Blood - TriglyceridesThrough study completion, an average of 1-2 yearsTriglycerides 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
Peripheral Venous Blood - CRPThrough study completion, an average of 1-2 yearsC 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
Peripheral Venous Blood - IL1BThrough study completion, an average of 1-2 yearsCytokine 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
Peripheral Venous Blood - IL8Through study completion, an average of 1-2 yearsCytokine 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
Peripheral Venous Blood - TNFaThrough study completion, an average of 1-2 yearsCytokine 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
Retinal Vasculature - CRAEThrough study completion, an average of 1-2 yearsRetinal 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
Retinal Vasculature - CRVEThrough study completion, an average of 1-2 yearsRetinal 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
Retinal Vasculature - AVRThrough study completion, an average of 1-2 yearsRetinal 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
Peripheral Venous Blood - IL6Through study completion, an average of 1-2 yearsCytokine 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
Pulmonary Function - FVCThrough study completion, an average of 1-2 yearsForced 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
Pulmonary Function - FEV1Through study completion, an average of 1-2 yearsForced 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
Pulmonary Function - FEV1/FVCThrough study completion, an average of 1-2 yearsthe 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
Peripheral Venous Blood - Total CholesterolThrough study completion, an average of 1-2 yearsTotal 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
Peripheral Venous Blood - HDLThrough study completion, an average of 1-2 yearsHigh 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

Other

MeasureTime frameDescription
Concentration of Air Toxics via Silicone Wrist BandThrough study completion, an average of 1-2 yearsMeasurement of SVOCs sorbed to silicone wrist bands

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026