Health Effects of Repeated Exposure to Low Levels of Concentrated Ambient Particles in Healthy Yo… (NCT05323240) | Clinical Trial Compass
UnknownNot Applicable
Health Effects of Repeated Exposure to Low Levels of Concentrated Ambient Particles in Healthy Young Volunteers
United States20 participantsStarted 2022-05-12
Plain-language summary
Purpose: To determine whether 3-day consecutive exposures to levels of fine particulate matter (PM2.5) that are close to the current 24-hr national standard will cause changes in inflammatory and cardiopulmonary endpoints in healthy young individuals.
Participants: 20 healthy males and females aged 18-35 years.
Procedures (methods): Subjects will be randomly exposed to three consecutive days of filtered air (4 hr/day) and three consecutive days of PM2.5 (approximately 35 µg/m3; 4 hr/day) in an exposure chamber. Blood collection for inflammatory factors such as C-reactive protein (CRP), clotting factors; heart rate variability (HRV); spirometry; and a symptom questionnaire will be conducted before and after each exposure.
Who can participate
Age range18 Years – 35 Years
SexALL
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Inclusion criteria
✓. . Age 18-35 years old healthy male and female (BMI values between 19 and 30).
✓. . Physical conditioning allowing intermittent, moderate exercise for 2 hours, and ability to complete the exposure exercise regimen to induce a minute ventilation rate of 20 L/min/m2 for 15 min without exceeding 80% of projected maximal heart rate. Predicted maximal heart rate will be calculated using the equation \[described by Tanaka et al.: (2001) J. Am. Coll. Cardiol: 208bpm-((0.7) x (age in years))\]
✓. . Normal baseline 12-lead EKG.
✓. . Normal lung function based on NHANES III reference values. i. Forced vital capacity (FVC) ≥ 80% of that predicted for age, gender, ethnicity, and height.
✓. . Oxygen saturation greater than 94% at the time of physical exam.
Exclusion criteria
✕. . Individuals with a diagnosis of COVID-19 and/or hospitalized for COVID-19.
✕. . Individuals not vaccinated for COVID-19, or, not 14 days beyond the final dose of receiving a COVID-19 vaccine.
✕
What they're measuring
1
Blood inflammation marker, CRP, will be measured 2 hours before each air exposure day and follow up day in 20 subjects
Timeframe: Four days
2
Blood inflammation marker, CRP, will be measured 2 hours before each PM exposure day and follow up day in 20 subjects
Timeframe: Four days
3
Blood inflammation marker, CRP, will be measured 1 hour after each air exposure day in 20 subjects
Timeframe: Three days
4
Blood inflammation marker, CRP, will be measured 1 hour after each PM exposure day in 20 subjects
. . Individuals with a history of acute or chronic cardiovascular disease, chronic respiratory disease, diabetes, rheumatologic diseases, or immunodeficiency state.
✕. . Individuals with a CVD risk score greater than 10% using the ACC/AHA ASCVD risk calculator (based on the 10-year risk of heart disease or stroke using the Atherosclerotic Cardiovascular Disease algorithm published in 2013 American College of Cardiology/American Heart Association Guideline on the Assessment of Cardiovascular risk.
✕. . Individuals with asthma and a history of asthma.
✕. . Individuals who are allergic to chemical vapors or gases.
✕. . Females who are pregnant, attempting to become pregnant, or breastfeeding.
✕. . Individuals who are currently smoking (including vaping, hookah, e-cigarette) or have a smoking history within 1 year of study.