An interventional study of Walking along a busy road and Walking in a traffic-free park in Cardiovascular System and Respiratory System, sponsored by Fudan University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Fudan University · Not applicable, Interventional, and Prevention
This study aims to assess the effects of acute exposure to traffic-related air pollution and the underlying mechanisms.
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.
Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.
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Exclusion Criteria:
Participants in this group will be asked to walk along a busy road for 4.5 hours.
Behavioral: Walking along a busy road
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 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.
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.
Changes in FEV1
We plan to measure changes in forced expiratory volume in 1 second.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Changes of FVC
Changes of forced vital capacity
Time frame: 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)
Time frame: 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
Time frame: 7:00 AM on the day of the walking session, half an hour after exposure and 12 hours after exposure (next morning)
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 1 hour after the end of the exposure session
Change in CRP concentrations
Change in the serum concentrations of C-reactive protein
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 7:00 AM on the day of the walking session, 1 hour after the end of the exposure session
Plan to share: No
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