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

Nutrition, Healthy Clinical Trial

— SENSE  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05843370
• Other study ID #: 23-0428
• Status: Enrolling by invitation
• Start date: August 21, 2023
• Est. completion date: December 2027

Study information

• Verified date: February 2024
• Source: Environmental Protection Agency (EPA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 82
• Est. completion date: December 2027
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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 ß-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.

Related Conditions & MeSH terms

• Air Pollution
• Pollution; Exposure

Locations

Country	Name	City	State
United States	EPA Human Studies Facility	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Environmental Protection Agency (EPA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Concentration of Air Toxics via Silicone Wrist Band	Measurement of SVOCs sorbed to silicone wrist bands	Through study completion, an average of 1-2 years
Primary	Heart Rate Variability - SDNN	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	Through study completion, an average of 1-2 years
Primary	Heart Rate Variability - rMSSD	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	Through study completion, an average of 1-2 years
Primary	Heart Rate Variability - LF absolute power	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	Through study completion, an average of 1-2 years
Primary	Heart Rate Variability - VLF absolute power	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	Through study completion, an average of 1-2 years
Primary	Heart Rate Variability - HF absolute power	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	Through study completion, an average of 1-2 years
Primary	Heart Rate Variability - LF/HF power	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	Through study completion, an average of 1-2 years
Secondary	Pulmonary Function - FVC	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	Through study completion, an average of 1-2 years
Secondary	Pulmonary Function - FEV1	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	Through study completion, an average of 1-2 years
Secondary	Pulmonary Function - FEV1/FVC	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	Through study completion, an average of 1-2 years
Secondary	Peripheral Venous Blood - Total Cholesterol	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	Through study completion, an average of 1-2 years
Secondary	Peripheral Venous Blood - HDL	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	Through study completion, an average of 1-2 years
Secondary	Peripheral Venous Blood - LDL	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	Through study completion, an average of 1-2 years
Secondary	Peripheral Venous Blood - VLDL	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	Through study completion, an average of 1-2 years
Secondary	Peripheral Venous Blood - Triglycerides	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	Through study completion, an average of 1-2 years
Secondary	Peripheral Venous Blood - CRP	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	Through study completion, an average of 1-2 years
Secondary	Peripheral Venous Blood - IL1B	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	Through study completion, an average of 1-2 years
Secondary	Peripheral Venous Blood - IL6	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	Through study completion, an average of 1-2 years
Secondary	Peripheral Venous Blood - IL8	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	Through study completion, an average of 1-2 years
Secondary	Peripheral Venous Blood - TNFa	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	Through study completion, an average of 1-2 years
Secondary	Retinal Vasculature - CRAE	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	Through study completion, an average of 1-2 years
Secondary	Retinal Vasculature - CRVE	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	Through study completion, an average of 1-2 years
Secondary	Retinal Vasculature - AVR	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	Through study completion, an average of 1-2 years