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NCT Number: NCT04153539

Acute Health Effects of Traffic-Related Air Pollution Exposure

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cardiovascular System Respiratory System

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Environmental Health, School of Public Health, Fudan University

Shanghai, Shanghai Municipality, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Walking along a busy road

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Changes in FEV1

    Time frame: FEV1 will be examined before exposure, half an hour after exposure and 12 hours after exposure.

    We plan to measure changes in forced expiratory volume in 1 second.

  2. Blood Pressure

    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.

    We plan to measure systolic blood pressure (SBP) and diastolic blood pressure (DBP).

  3. Heart Rate Variability 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.

    We plan to measure heart rate variability (HRV) parameters.

Secondary outcomes

  1. Changes of 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 forced vital capacity

  2. Changes of FEV1/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 the ratio of forced expired volume in 1 second (FEV1) to forced vital capacity (FVC)

  3. Changes of MMEF

    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 maximal mid-expiratory flow

Other outcomes

  1. Differences in DNA methylation levels detected in whole-blood between the two exposures

    Time frame: 1 hour after the end of the exposure session

    Genome-wide DNA methylation in whole-blood were detected using Illumina 850K Beadchip. The study is to identify differential CpG loci after TRAP exposure

  2. Differences in exosome RNA expression levels detected in plasma transcriptomics between the two exposures

    Time frame: 1 hour after the end of the exposure session

    Illumina-based transcriptomics is non-targeted. The study is to find the differentially expressed exosome RNA in plasma after TRAP exposure

  3. Differences in exosome miRNA expression levels detected in plasma transcriptomics between the two exposures

    Time frame: 1 hour after the end of the exposure session

    Illumina-based transcriptomics is non-targeted. The study is to find the differentially expressed exosome miRNA in plasma after TRAP exposure

  4. Differences in protein levels detected in plasma proteomics between the two exposures

    Time frame: 1 hour after the end of the exposure session

    Mass spectrometry-based plasma proteomics is non-targeted. The study is to find the differentially expressed proteins in plasma after TRAP exposure

  5. Differences in metabolic profiling detected in serum mass spectrometry-based non-targeted metabolomics between the two exposures

    Time frame: 1 hour after the end of the exposure session

    The study is to explore the differential metabolic profiling in serum after TRAP exposure.

  6. Differences in metabolic profiling detected in urine mass spectrometry-based non-targeted metabolomics between the two exposures

    Time frame: 1 hour after the end of the exposure session

    The study is to explore the differential metabolic profiling in urine after TRAP exposure.

  7. Differences in lipids levels detected in serum lipidomics between the two exposures

    Time frame: 1 hour after the end of the exposure session

    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

  8. Differences in protein levels detected in targeted serum proteomic chip between the two exposures

    Time frame: 1 hour after the end of the exposure session

    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

  9. Differences in metabolic profiling detected in airway mass spectrometry-based non-targeted metabolomics between the two exposures

    Time frame: 1 hour after the end of the exposure session

    The study is to explore the differential metabolic profiling in exhaled breath condensate after TRAP exposure.

  10. Change in CRP concentrations

    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 the serum concentrations of C-reactive protein

  11. Change in ITAC concentrations

    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 the serum concentrations of Interferon-induced T-cell alpha chemoattractant

  12. Change in GM-CSF concentrations

    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 the serum concentrations of Granulocyte-macrophage colony-stimulating factor

  13. Change in IFN-gamma concentrations

    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 the serum concentrations of Interferon-gamma

  14. Change in IL-10 concentrations

    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 the serum concentrations of Interlukin-10

  15. Change in IL-17A concentrations

    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 the serum concentrations of Interleukin-17A

  16. Change in IL-1 beta concentrations

    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 the serum concentrations of Interlukin-1 beta

  17. Change in IL-23 concentrations

    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 the serum concentrations of Interleukin-23

  18. Change in IL-6 concentrations

    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 the serum concentrations of Interleukin-6

  19. Change in IL-8 concentrations

    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 the serum concentrations of Interleukin-8

  20. Change in TNF alpha concentrations

    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 the serum concentrations of Tumor necrosis factor-α

  21. Change in MDA concentrations

    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 the serum concentrations of Malondialdehyde

  22. Change in 8-OH-DG concentrations

    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 the urine concentrations of 8-hydroxy-2'-deoxyguanosine

  23. Change in ACE concentrations

    Time frame: 7:00 AM on the day of the walking session, 1 hour after the end of the exposure session

    Change in the serum concentrations of Angiotensin converting enzymes

  24. Change in Angiotensin II concentrations

    Time frame: 7:00 AM on the day of the walking session, 1 hour after the end of the exposure session

    Change in the serum concentrations of Angiotensin II

  25. Change in ALD concentrations

    Time frame: 7:00 AM on the day of the walking session, 1 hour after the end of the exposure session

    Change in the urine concentrations of Aldosterone

  26. Change in TF concentrations

    Time frame: 7:00 AM on the day of the walking session, 1 hour after the end of the exposure session

    Change in the serum concentrations of Tissue factor

  27. Change in Fibrinogen concentrations

    Time frame: 7:00 AM on the day of the walking session, 1 hour after the end of the exposure session

    Change in the serum concentrations of Fibrinogen

  28. Change in PAI-1 concentrations

    Time frame: 7:00 AM on the day of the walking session, 1 hour after the end of the exposure session

    Change in the serum concentrations of Plasminogen Activator inhibitor-1

  29. Change in vWF concentrations

    Time frame: 7:00 AM on the day of the walking session, 1 hour after the end of the exposure session

    Change in the serum concentrations of von Willebrand factor

  30. Change in CRF concentrations

    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 the serum concentrations of Corticotropin-Releasing Factor

  31. Change in ACTH concentrations

    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 the serum concentrations of Adrenocorticotropic hormone

  32. Change in Cortisol concentrations

    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 the serum concentrations of Cortisol

  33. Change in Cholesterol concentrations

    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 the serum concentrations of Cholesterol

  34. Change in TAG concentrations

    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 the serum concentrations of Triglyceride

  35. Change in LDL-C concentrations

    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 the serum concentrations of Low-density lipoprotein cholesterol

  36. Change in Glucose concentrations

    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 the serum concentrations of Glucose

  37. Change in Insulin concentrations

    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 the serum concentrations of Insulin

  38. Changes in SP-D concentrations

    Time frame: 7:00 AM on the day of the walking session, 1 hour after the end of the exposure session

    Change in the serum concentrations of surfactant proteins D

  39. Changes in Ezrin concentrations

    Time frame: 7:00 AM on the day of the walking session, 1 hour after the end of the exposure session

    Change in the exhaled breath condensate concentrations of Ezrin

  40. Changes in 8-isoprostane concentrations between the two exposures

    Time frame: 7:00 AM on the day of the walking session, 1 hour after the end of the exposure session

    Change in the exhaled breath condensate concentrations of 8-isoprostane

  41. Changes in TNF-α concentrations

    Time frame: 7:00 AM on the day of the walking session, 1 hour after the end of the exposure session

    Change in the exhaled breath condensate concentrations of tumor necrosis factor-α

  42. Changes of the scores of respiratory symptoms questionnaires

    Time frame: 7:00 AM on the day of the walking session, 1 hour after the end of the exposure session

    Changes of scores of respiratory symptoms questionnaires both the total and each symptom specified

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2026
First posted
Nov 6, 2019
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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