Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05843370
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-02-20
First Post:
2023-03-24
Brief Title:
Modification of Ambient Air Pollution Exposure and Cardiopulmonary Outcomes by Socioeconomic Status and Nutrition
Sponsor:
Environmental Protection Agency EPA
Organization:
Environmental Protection Agency EPA
Study Overview
Official Title:
Modification of Ambient Air Pollution Exposure and Cardiopulmonary Outcomes by Socioeconomic Status and Nutrition
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SENSE
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None