Acute Health Effects of Traffic-Related Air Pollution Exposure

Acute Health Effects of Traffic-Related Air Pollution Exposure Among Healthy Young Adults: A Randomized, Crossover Trial

This study aims to assess the effects of acute exposure to traffic-related air pollution and the underlying mechanisms.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular System; Respiratory System
• Intervention / Treatment: Behavioral: Walking along a busy road; Behavioral: Walking in a traffic-free park

Detailed Description

The investigators will conduct a randomized, crossover trial among 72 healthy young adults in Shanghai, China. The eligible participants will be randomly divided into 2 groups (36 volunteers per group). During the first stage, participants will be requested to take one walking task (from 13:00 to 17:30). The exposed group will walk along a busy road and be exposed to traffic-related air pollution, while the control group will walk in a traffic-free park. During the first 3 hours, all participants will rest for 30 minutes after each 15-minute walking. From 16:00, participants will stop walking and rest for 1.5 hours. Then both groups will enter a 2-week washout period. In the second stage, there will also be one walking task (from 13:00 to 17:30). The two groups will exchange their walking sites and repeat the previous trial. Physical examinations will be performed both before and after each walking task. Besides, we will ask volunteers to stay in school during the two days before walking. Health examinations include symptoms questionnaires, blood pressure tests, Holter monitoring, and spirometry. We plan to collect blood, urine, oropharyngeal swabs, and exhaled breath condensate before exposure, about one hour after exposure, and next morning.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Department of Environmental Health, School of Public Health, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Living in Shanghai during the study period;
• Body mass index > 18.5 and ≤ 28;
• Non-smoking, no history of alcohol or drug abuse;
• Completing the walking task we required.

Exclusion Criteria:

• Current or ever smokers;
• Subjects with allergic disease, such as allergic rhinitis, allergic asthma, and atopy;
• Subjects with cardiovascular disease, such as congenital heart disease, pulmonary heart disease, and hypertension;
• Subjects with respiratory disease, such as asthma, chronic bronchitis, and chronic obstructive pulmonary disease;
• Subjects wih chronic disease, such as diabetes, chronic hepatitis, and kidney disease;
• Subjects with a history of major surgery;
• Abnormal spirometry (FEV1 and FVC ≤ 75% of predicted and FEV1/FVC ≤ 0.65);
• Medication use or dietary supplements intake in recent two months;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Walking along a busy road; Participants in this group will be asked to walk along a busy road for 4.5 hours.	Behavioral: Walking along a busy road; The intervention group will walk along a busy road and be exposed to traffic-related air pollution for 4.5 hours (from 13:00 to 17:30), while alternating 15-minute walking and 30-minute rest periods.
Active Comparator: Walking in a traffic-free park; Participants in this group will be asked to walk in a traffic-free park for 4.5 hours.	Behavioral: Walking in a traffic-free park; The control group will walk in a traffic-free park for 4.5 hours (from 13:00 to 17:30), while alternating 15-minute walking and 30-minute rest periods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in FEV1	We plan to measure changes in forced expiratory volume in 1 second.	FEV1 will be examined before exposure, half an hour after exposure and 12 hours after exposure.
Blood Pressure	We plan to measure systolic blood pressure (SBP) and diastolic blood pressure (DBP).	Blood pressure will be measured for 24 hours from 8:00 am on the morning of intervention to 8:00 am on the next morning.
Heart Rate Variability Parameters	We plan to measure heart rate variability (HRV) parameters.	Volunteers will be asked to wear electrographic Holter monitors for 24 hours from 8:00 am on the morning of intervention to 8:00 am on the next morning.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of FVC	Changes of forced vital capacity	7:00 AM on the day of the walking session, half an hour after exposure and 12 hours after exposure (next morning)
Changes of FEV1/FVC	Changes of the ratio of forced expired volume in 1 second (FEV1) to forced vital capacity (FVC)	7:00 AM on the day of the walking session, half an hour after exposure and 12 hours after exposure (next morning)
Changes of MMEF	Changes of maximal mid-expiratory flow	7:00 AM on the day of the walking session, half an hour after exposure and 12 hours after exposure (next morning)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in DNA methylation levels detected in whole-blood between the two exposures	Genome-wide DNA methylation in whole-blood were detected using Illumina 850K Beadchip. The study is to identify differential CpG loci after TRAP exposure	1 hour after the end of the exposure session
Differences in exosome RNA expression levels detected in plasma transcriptomics between the two exposures	Illumina-based transcriptomics is non-targeted. The study is to find the differentially expressed exosome RNA in plasma after TRAP exposure	1 hour after the end of the exposure session
Differences in exosome miRNA expression levels detected in plasma transcriptomics between the two exposures	Illumina-based transcriptomics is non-targeted. The study is to find the differentially expressed exosome miRNA in plasma after TRAP exposure	1 hour after the end of the exposure session
Differences in protein levels detected in plasma proteomics between the two exposures	Mass spectrometry-based plasma proteomics is non-targeted. The study is to find the differentially expressed proteins in plasma after TRAP exposure	1 hour after the end of the exposure session
Differences in metabolic profiling detected in serum mass spectrometry-based non-targeted metabolomics between the two exposures	The study is to explore the differential metabolic profiling in serum after TRAP exposure.	1 hour after the end of the exposure session
Differences in metabolic profiling detected in urine mass spectrometry-based non-targeted metabolomics between the two exposures	The study is to explore the differential metabolic profiling in urine after TRAP exposure.	1 hour after the end of the exposure session
Differences in lipids levels detected in serum lipidomics between the two exposures	Mass spectrometry-based serum lipids is non-targeted. The study is to find the differential lipids in serum between the road scenario and the park scenario	1 hour after the end of the exposure session
Differences in protein levels detected in targeted serum proteomic chip between the two exposures	Targeted serum proteomic chip was conducted using the RayBio Biotin Label-based Human Antibody Array, which covers a total of 507 human proteins, including cytokines, inflammatory proteins, growth factors, cell adhesion molecules, soluble receptors and chemokines, and proteins related to angiogenesis and atherosclerosis. The study is to find the differential proteins in serum between the road scenario and the park scenario	1 hour after the end of the exposure session
Differences in metabolic profiling detected in airway mass spectrometry-based non-targeted metabolomics between the two exposures	The study is to explore the differential metabolic profiling in exhaled breath condensate after TRAP exposure.	1 hour after the end of the exposure session
Change in CRP concentrations	Change in the serum concentrations of C-reactive protein	7:00 AM on the day of the walking session, 1 hour after the end of the exposure session, and 7:00 AM in the next morning
Change in ITAC concentrations	Change in the serum concentrations of Interferon-induced T-cell alpha chemoattractant	7:00 AM on the day of the walking session, 1 hour after the end of the exposure session, and 7:00 AM in the next morning
Change in GM-CSF concentrations	Change in the serum concentrations of Granulocyte-macrophage colony-stimulating factor	7:00 AM on the day of the walking session, 1 hour after the end of the exposure session, and 7:00 AM in the next morning
Change in IFN-gamma concentrations	Change in the serum concentrations of Interferon-gamma	7:00 AM on the day of the walking session, 1 hour after the end of the exposure session, and 7:00 AM in the next morning
Change in IL-10 concentrations	Change in the serum concentrations of Interlukin-10	7:00 AM on the day of the walking session, 1 hour after the end of the exposure session, and 7:00 AM in the next morning
Change in IL-17A concentrations	Change in the serum concentrations of Interleukin-17A	7:00 AM on the day of the walking session, 1 hour after the end of the exposure session, and 7:00 AM in the next morning
Change in IL-1 beta concentrations	Change in the serum concentrations of Interlukin-1 beta	7:00 AM on the day of the walking session, 1 hour after the end of the exposure session, and 7:00 AM in the next morning
Change in IL-23 concentrations	Change in the serum concentrations of Interleukin-23	7:00 AM on the day of the walking session, 1 hour after the end of the exposure session, and 7:00 AM in the next morning
Change in IL-6 concentrations	Change in the serum concentrations of Interleukin-6	7:00 AM on the day of the walking session, 1 hour after the end of the exposure session, and 7:00 AM in the next morning
Change in IL-8 concentrations	Change in the serum concentrations of Interleukin-8	7:00 AM on the day of the walking session, 1 hour after the end of the exposure session, and 7:00 AM in the next morning
Change in TNF alpha concentrations	Change in the serum concentrations of Tumor necrosis factor-α	7:00 AM on the day of the walking session, 1 hour after the end of the exposure session, and 7:00 AM in the next morning
Change in MDA concentrations	Change in the serum concentrations of Malondialdehyde	7:00 AM on the day of the walking session, 1 hour after the end of the exposure session, and 7:00 AM in the next morning
Change in 8-OH-DG concentrations	Change in the urine concentrations of 8-hydroxy-2'-deoxyguanosine	7:00 AM on the day of the walking session, 1 hour after the end of the exposure session, and 7:00 AM in the next morning
Change in ACE concentrations	Change in the serum concentrations of Angiotensin converting enzymes	7:00 AM on the day of the walking session, 1 hour after the end of the exposure session
Change in Angiotensin II concentrations	Change in the serum concentrations of Angiotensin II	7:00 AM on the day of the walking session, 1 hour after the end of the exposure session
Change in ALD concentrations	Change in the urine concentrations of Aldosterone	7:00 AM on the day of the walking session, 1 hour after the end of the exposure session
Change in TF concentrations	Change in the serum concentrations of Tissue factor	7:00 AM on the day of the walking session, 1 hour after the end of the exposure session
Change in Fibrinogen concentrations	Change in the serum concentrations of Fibrinogen	7:00 AM on the day of the walking session, 1 hour after the end of the exposure session
Change in PAI-1 concentrations	Change in the serum concentrations of Plasminogen Activator inhibitor-1	7:00 AM on the day of the walking session, 1 hour after the end of the exposure session
Change in vWF concentrations	Change in the serum concentrations of von Willebrand factor	7:00 AM on the day of the walking session, 1 hour after the end of the exposure session
Change in CRF concentrations	Change in the serum concentrations of Corticotropin-Releasing Factor	7:00 AM on the day of the walking session, 1 hour after the end of the exposure session, and 7:00 AM in the next morning
Change in ACTH concentrations	Change in the serum concentrations of Adrenocorticotropic hormone	7:00 AM on the day of the walking session, 1 hour after the end of the exposure session, and 7:00 AM in the next morning
Change in Cortisol concentrations	Change in the serum concentrations of Cortisol	7:00 AM on the day of the walking session, 1 hour after the end of the exposure session, and 7:00 AM in the next morning
Change in Cholesterol concentrations	Change in the serum concentrations of Cholesterol	7:00 AM on the day of the walking session, 1 hour after the end of the exposure session, and 7:00 AM in the next morning
Change in TAG concentrations	Change in the serum concentrations of Triglyceride	7:00 AM on the day of the walking session, 1 hour after the end of the exposure session, and 7:00 AM in the next morning
Change in LDL-C concentrations	Change in the serum concentrations of Low-density lipoprotein cholesterol	7:00 AM on the day of the walking session, 1 hour after the end of the exposure session, and 7:00 AM in the next morning
Change in Glucose concentrations	Change in the serum concentrations of Glucose	7:00 AM on the day of the walking session, 1 hour after the end of the exposure session, and 7:00 AM in the next morning
Change in Insulin concentrations	Change in the serum concentrations of Insulin	7:00 AM on the day of the walking session, 1 hour after the end of the exposure session, and 7:00 AM in the next morning
Changes in SP-D concentrations	Change in the serum concentrations of surfactant proteins D	7:00 AM on the day of the walking session, 1 hour after the end of the exposure session
Changes in Ezrin concentrations	Change in the exhaled breath condensate concentrations of Ezrin	7:00 AM on the day of the walking session, 1 hour after the end of the exposure session
Changes in 8-isoprostane concentrations between the two exposures	Change in the exhaled breath condensate concentrations of 8-isoprostane	7:00 AM on the day of the walking session, 1 hour after the end of the exposure session
Changes in TNF-α concentrations	Change in the exhaled breath condensate concentrations of tumor necrosis factor-α	7:00 AM on the day of the walking session, 1 hour after the end of the exposure session
Changes of the scores of respiratory symptoms questionnaires	Changes of scores of respiratory symptoms questionnaires both the total and each symptom specified	7:00 AM on the day of the walking session, 1 hour after the end of the exposure session

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Study Director: Haidong Kan, PhD, Department of Environmental Health, School of Public Health, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2019
• Primary Completion (Actual): December 8, 2019
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: November 3, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (Actual): November 6, 2019

Study Record Updates

• Last Update Posted (Actual): March 16, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Traffic-related pollution; Acute health effects
• Other Study ID Numbers: FDUEH-6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No