NCT03698344

Brief Summary

The adverse effects of current ambient air pollution on cardiovascular and respiratory health have been demonstrated in an extensive series of epidemiological, observational and experimental studies. Similar cardiovascular responses seen post diesel exposure have been shown to occur following biodiesel exhaust exposure as well. In the current project the investigators aim to determine whether an acute exposure to biodiesel exhaust (rapeseed methyl ester) causes impacts on sympathetic nervous system activation in healthy volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
20 days until next milestone

Study Start

First participant enrolled

October 29, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2019

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

2 months

First QC Date

October 4, 2018

Last Update Submit

September 27, 2019

Conditions

HealthyExposure to Pollution

Keywords

air pollutionmicroneurographyMNSABiodieselRME

Outcome Measures

Primary Outcomes (1)

  • Microneurography

    Microneurography recording of muscle sympathetic nervous system activity

    1 hour

Study Arms (1)

Biodiesel exhaust exposure

EXPERIMENTAL

A single arm study in which first a filtered air baseline muscle sympathetic nerve activity (MSNA) is recorded with and without an exposure mask. When measurements have been secured exposure to dilute biodiesel exhaust will start.

Other: Biodiesel exhaust exposure

Interventions

Biodiesel exhaust exposureOTHER

Evaluation of sympathetic nervous system activity as assessed by microneurography recording during an acute exposure to dilute biodiesel exhaust via mask.

Biodiesel exhaust exposure

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy (normal ECG, lung function, blood sample, clinical examination)

You may not qualify if:

  • Metabolic disease Cardiovascular disease Respiratory disease BMI ≥ 30 Use of psychoactive medication Infection within 2 weeks of the study Smokers or regular snus usage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Medicine, Lung and Allergy section, University Hospital

Umeå, Sweden

Location

Study Officials

  • Jenny A Bosson, MD;PhD

    Umeå University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 4, 2018

First Posted

October 9, 2018

Study Start

October 29, 2018

Primary Completion

December 21, 2018

Study Completion

February 15, 2019

Last Updated

September 30, 2019

Record last verified: 2019-09

Locations

SE(1)