Clinical trial NCT04153539: Acute Health Effects of Traffic-Related Air Pollution Exposure
Official title: Acute Health Effects of Traffic-Related Air Pollution Exposure Among Healthy Young Adults: A Randomized, Crossover Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiovascular System
Respiratory System
Keywords: Traffic-related pollution
Randomized controlled trial
Acute health effects
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Changes in FEV1
timeFrame: FEV1 will be examined before exposure, half an hour after exposure and 12 hours after exposure.
measure: Blood Pressure
timeFrame: 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.
measure: Heart Rate Variability Parameters
timeFrame: 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 outcomes:
measure: Changes of FVC
timeFrame: 7:00 AM on the day of the walking session, half an hour after exposure and 12 hours after exposure (next morning)
measure: Changes of FEV1/FVC
timeFrame: 7:00 AM on the day of the walking session, half an hour after exposure and 12 hours after exposure (next morning)
measure: Changes of MMEF
timeFrame: 7:00 AM on the day of the walking session, half an hour after exposure and 12 hours after exposure (next morning)
Other outcomes:
measure: Differences in DNA methylation levels detected in whole-blood between the two exposures
timeFrame: 1 hour after the end of the exposure session
measure: Differences in exosome RNA expression levels detected in plasma transcriptomics between the two exposures
timeFrame: 1 hour after the end of the exposure session
measure: Differences in exosome miRNA expression levels detected in plasma transcriptomics between the two exposures
timeFrame: 1 hour after the end of the exposure session
measure: Differences in protein levels detected in plasma proteomics between the two exposures
timeFrame: 1 hour after the end of the exposure session
measure: Differences in metabolic profiling detected in serum mass spectrometry-based non-targeted metabolomics between the two exposures
timeFrame: 1 hour after the end of the exposure session
measure: Differences in metabolic profiling detected in urine mass spectrometry-based non-targeted metabolomics between the two exposures
timeFrame: 1 hour after the end of the exposure session
measure: Differences in lipids levels detected in serum lipidomics between the two exposures
timeFrame: 1 hour after the end of the exposure session
measure: Differences in protein levels detected in targeted serum proteomic chip between the two exposures
timeFrame: 1 hour after the end of the exposure session
measure: Differences in metabolic profiling detected in airway mass spectrometry-based non-targeted metabolomics between the two exposures
timeFrame: 1 hour after the end of the exposure session
measure: Change in CRP concentrations
timeFrame: 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
measure: Change in ITAC concentrations
timeFrame: 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
measure: Change in GM-CSF concentrations
timeFrame: 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
measure: Change in IFN-gamma concentrations
timeFrame: 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
measure: Change in IL-10 concentrations
timeFrame: 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
measure: Change in IL-17A concentrations
timeFrame: 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
measure: Change in IL-1 beta concentrations
timeFrame: 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
measure: Change in IL-23 concentrations
timeFrame: 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
measure: Change in IL-6 concentrations
timeFrame: 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
measure: Change in IL-8 concentrations
timeFrame: 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
measure: Change in TNF alpha concentrations
timeFrame: 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
measure: Change in MDA concentrations
timeFrame: 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
measure: Change in 8-OH-DG concentrations
timeFrame: 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
measure: Change in ACE concentrations
timeFrame: 7:00 AM on the day of the walking session, 1 hour after the end of the exposure session
measure: Change in Angiotensin II concentrations
timeFrame: 7:00 AM on the day of the walking session, 1 hour after the end of the exposure session
measure: Change in ALD concentrations
timeFrame: 7:00 AM on the day of the walking session, 1 hour after the end of the exposure session
measure: Change in TF concentrations
timeFrame: 7:00 AM on the day of the walking session, 1 hour after the end of the exposure session
measure: Change in Fibrinogen concentrations
timeFrame: 7:00 AM on the day of the walking session, 1 hour after the end of the exposure session
measure: Change in PAI-1 concentrations
timeFrame: 7:00 AM on the day of the walking session, 1 hour after the end of the exposure session
measure: Change in vWF concentrations
timeFrame: 7:00 AM on the day of the walking session, 1 hour after the end of the exposure session
measure: Change in CRF concentrations
timeFrame: 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
measure: Change in ACTH concentrations
timeFrame: 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
measure: Change in Cortisol concentrations
timeFrame: 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
measure: Change in Cholesterol concentrations
timeFrame: 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
measure: Change in TAG concentrations
timeFrame: 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
measure: Change in LDL-C concentrations
timeFrame: 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
measure: Change in Glucose concentrations
timeFrame: 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
measure: Change in Insulin concentrations
timeFrame: 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
measure: Changes in SP-D concentrations
timeFrame: 7:00 AM on the day of the walking session, 1 hour after the end of the exposure session
measure: Changes in Ezrin concentrations
timeFrame: 7:00 AM on the day of the walking session, 1 hour after the end of the exposure session
measure: Changes in 8-isoprostane concentrations between the two exposures
timeFrame: 7:00 AM on the day of the walking session, 1 hour after the end of the exposure session
measure: Changes in TNF-α concentrations
timeFrame: 7:00 AM on the day of the walking session, 1 hour after the end of the exposure session
measure: Changes of the scores of respiratory symptoms questionnaires
timeFrame: 7:00 AM on the day of the walking session, 1 hour after the end of the exposure session
Locations:
city: Shanghai
country: China
facility: Department of Environmental Health, School of Public Health, Fudan University
state: Shanghai
Study officials:
affiliation: Department of Environmental Health, School of Public Health, Fudan University
name: Haidong Kan, PhD
role: STUDY_DIRECTOR
References: