Acute Health Effects of Traffic-Related Air Pollution Exposure

Cardiovascular System Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04153539
• Other study ID #: FDUEH-6
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 9, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2022
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 69
• Est. completion date: December 31, 2022
• Est. primary completion date: December 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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;

Related Conditions & MeSH terms

• Cardiovascular System
• Respiratory System

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Department of Environmental Health, School of Public Health, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Change in TNF alpha concentrations	Change in the serum concentrations of Tumor necrosis factor-a	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Changes in TNF-a concentrations	Change in the exhaled breath condensate concentrations of tumor necrosis factor-a	7:00 AM on the day of the walking session, 1 hour after the end of the exposure session
Other	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
Primary	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.
Primary	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.
Primary	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	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)
Secondary	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)
Secondary	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)