Responses to Exposure to Low Levels of Concentrated Ambient Particles in Healthy Young Adults

NCT03232086 | Completed

• 1 other identifier: 16-1548
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: To determine whether exposure to levels of fine particles that are close to the current standard will cause cardiovascular changes in healthy individuals.

Conditions

Exposure to Pollution

Keywords

Controlled Human Exposure Study; Cardiovascular

Outcome Measures

Primary Outcomes (1)

• Changes in heart rate variability

  10 minute electrocardiogram recording (measured by Holter ECG) in which the

  Pre exposure to 24hours post exposure

Secondary Outcomes (3)

• Forced expired volume in the first second (FEV1)

  Pre exposure to 24hours post exposure

• Forced Vital Capacity

  Pre exposure to 24hours post exposure

• Index of inflammatory markers

  Pre exposure to 24hours post exposure

Study Arms (2)

Clean Air

SHAM COMPARATOR

Exposure to clean air will be conducted in an exposure chamber at the EPA Human Studies Facility on the UNC campus.

Other: Clean Air

Concentrated PM2.5

ACTIVE COMPARATOR

Exposure to PM2.5 will be conducted in an exposure chamber at the EPA Human Studies Facility on the UNC campus.

Other: PM2.5

Interventions

Clean Air OTHER

Each subject will be exposed to clean air for 4 hours. Subjects will exercise on a bike or treadmill. Each exercise session will consist of a 15 minute exercise interval at a level of up to 25 L/min/m2BSA followed by a 15 minute rest period.

Clean Air

PM2.5 OTHER

Each subject will be exposed up to 35-50 μg/m3 PM2.5 for 4 hours. Subjects will exercise on a bike or treadmill. Each exercise session will consist of a 15 minute exercise interval at a level of up to 25 L/min/m2BSA followed by a 15 minute rest period.

Concentrated PM2.5

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy individuals ages 18-35 years of age
• Physical conditioning allowing intermittent, moderate exercise for four hours. Ability to complete the exposure exercise regimen without reaching 80% of predicted 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
• Forced vital capacity (FVC) ≥ 80% of that predicted for gender, ethnicity, age and height (according to NHANESIII guidelines).
• Forced expiratory volume in one second (FEV1) ≥ 80%of that predicted for gender,ethnicity, age and height
• FEV1) /FVC ratio≥ 80% of predicted values.
• Oxygen saturation ≥ 96% on room air.

You may not qualify if:

• 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.
• Individuals with clinically diagnosed asthma.
• Individuals who are allergic to chemical vapors or gases.
• Females who are pregnant, attempting to become pregnant, or breastfeeding.
• Individuals who smoke/vape more than 2 times per month and have smoked/vaped within 4 weeks prior to all study visits.
• Individuals living with a smoker who smokes inside the house.
• Individuals with a body mass index (BMI) \>35 or \<18. Body mass index is calculated by dividing the weight in kilograms by the square of the height in meters.
• Individuals with occupational exposures to high levels of vapors, dust, gases, or fumes on an on-going basis.
• Individuals with uncontrolled hypertension (≥150 systolic or ≥90 diastolic).
• Individuals that do not understand or speak English.
• Individuals that are unable to perform the exercise required for the study.
• Individuals that are taking beta blocker medications.
• Individuals with a history of skin allergies to adhesives used in securing EKG electrodes.
• Individuals with unspecified diseases, conditions, or medications that might influence the responses to the exposures, as judged by the medical staff.

Sponsors & Collaborators

• Environmental Protection Agency (EPA): lead

Study Sites (1)

U.S. EPA Human Studies Facility

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (1)

• Wyatt LH, Devlin RB, Rappold AG, Case MW, Diaz-Sanchez D. Low levels of fine particulate matter increase vascular damage and reduce pulmonary function in young healthy adults. Part Fibre Toxicol. 2020 Nov 16;17(1):58. doi: 10.1186/s12989-020-00389-5.

  PMID: 33198760 DERIVED

MeSH Terms

Interventions

Environment, Controlled

Intervention Hierarchy (Ancestors)

Environment; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Clinical Research Branch

Model Details: Clean Air Concentrated PM2.5

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: July 27, 2017
• Study Start: January 16, 2017
• Primary Completion: January 20, 2019
• Study Completion: July 30, 2020
• Last Updated: September 5, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)