Acute Health Effects of Traffic-Related Air Pollution Exposure

NCT ID: NCT04153539

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-09
• Study Completion Date: 2026-12-31

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.

Conditions

Cardiovascular System; Respiratory System

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Walking along a busy road

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

Group Type: EXPERIMENTAL

Walking along a busy road

Intervention Type: 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

Participants in this group will be asked to walk in a traffic-free park for 4.5 hours.

Group Type: ACTIVE_COMPARATOR

Walking in a traffic-free park

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Haidong Kan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Haidong Kan, PhD

Role: STUDY_DIRECTOR

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

Locations

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

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

FDUEH-6

Identifier Type: -

Identifier Source: org_study_id