Acute Health Effects of Traffic-Related Air Pollution Exposure

August 31, 2026 updated by: Haidong Kan, Fudan University

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
69

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Department of Environmental Health, School of Public Health, Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Walking along a busy road
Participants in this group will be asked to walk along a busy road for 4.5 hours.
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.
Active Comparator: Walking in a traffic-free park
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 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
FEV1 will be examined before exposure, half an hour after exposure and 12 hours after exposure.
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).
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
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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)
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
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
7:00 AM on the day of the walking session, half an hour after exposure and 12 hours after exposure (next morning)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
1 hour after the end of the exposure session
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
1 hour after the end of the exposure session
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
1 hour after the end of the exposure session
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
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
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.
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
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.
1 hour after the end of the exposure session
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
1 hour after the end of the exposure session
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
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
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.
1 hour after the end of the exposure session
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
7:00 AM on the day of the walking session, 1 hour after the end of the exposure session
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
7:00 AM on the day of the walking session, 1 hour after the end of the exposure session
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
7:00 AM on the day of the walking session, 1 hour after the end of the exposure session
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
7:00 AM on the day of the walking session, 1 hour after the end of the exposure session
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
7:00 AM on the day of the walking session, 1 hour after the end of the exposure session
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
7:00 AM on the day of the walking session, 1 hour after the end of the exposure session
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
7:00 AM on the day of the walking session, 1 hour after the end of the exposure session
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
7:00 AM on the day of the walking session, 1 hour after the end of the exposure session
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
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
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
7:00 AM on the day of the walking session, 1 hour after the end of the exposure session
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
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
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
7:00 AM on the day of the walking session, 1 hour after the end of the exposure session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fudan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Haidong Kan, PhD, Department of Environmental Health, School of Public Health, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 9, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 8, 2019

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FDUEH-6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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