Acute Health Effects of Traffic-Related Air Pollution Exposure

NCT04153539 | Active Not Recruiting DMC

• 1 other identifier: FDUEH-6
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiovascular System; Respiratory System

Keywords

Traffic-related pollution; Randomized controlled trial; Acute health effects

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Changes of 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 FEV1/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

  7:00 AM on the day of the walking session, half an hour after exposure and 12 hours after exposure (next morning)

Other Outcomes (42)

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

  1 hour after the end of the exposure session

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

  1 hour after the end of the exposure session

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

  1 hour after the end of the exposure session

Study Arms (2)

Walking along a busy road

EXPERIMENTAL

Participants in this group will be asked to walk along a busy road for 4.5 hours.

Behavioral: Walking along a busy road

Walking in a traffic-free park

ACTIVE COMPARATOR

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

Interventions

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 along a busy road

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.

Walking in a traffic-free park

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Interventions

Walking

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Haidong Kan, PhD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 3, 2019
• First Posted: November 6, 2019
• Study Start: October 9, 2019
• Primary Completion: December 8, 2019
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)