Pulmonary Effects of 100% Biodiesel Exhaust

Not Applicable

Completed

• Conditions: Inflammation
• Interventions: Other: Bronchoscopy

• Registration Number: NCT02690571
• Lead Sponsor: Umeå University

Brief Summary

Air pollution is a global environmental and health concern, contributing to onset and deterioration of respiratory and cardiovascular diseases. As climate change and dependence on diminishing fossil fuel supplies have taken center stage in political and scientific debates, renewable carbon-neutral fuels like biodiesel receive increasing attention. The most common biodiesel within the European Union, rapeseed oil methyl ester (RME) is perceived to be a "green fuel", as it is sustainable and of biological origin, and therefore is often predicted to be less harmful to human health. Whilst replacing petrodiesel with biodiesel may have advantageous ecological impacts, consequences to respiratory health remained largely unexplored.

The purpose of the current study is to evaluate whether inhalation of 100% RME biodiesel exhaust would result in an acute airway inflammatory response in healthy human subjects, as shown previously following exposure to petrodiesel exhaust.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Study First Submitted: 2016-02-09
• Study First Submitted QC: 2016-02-23
• Study First Posted: 2016-02-24
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-18
• Last Update Posted: 2016-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Normal ECG

Normal Lung function

Normal Blood samples

Exclusion Criteria

Smoking

Pre-existing metabolomic, respiratory and cardiovascular disease

Exposure to high levels of pollutants in occupation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Filtered air exposure	Bronchoscopy	One hour exposure to filtered air during intermittent exercise in controlled chamber, 6 hours after exposure bronchoscopy is performed.
Biodiesel exhaust exposure	Bronchoscopy	One hour exposure to biodiesel exhaust (generated at same running conditions as earlier studies with diesel exhaust at approximate particle matter concentration 300 mcg/m3) during intermittent exercise in controlled chamber. Six hours after exposure bronchoscopy is performed.

Primary Outcome Measures

Name	Time	Method
Cytokines in Bronchial wash (BW)	6 hours	Bronchial wash (BW) collected by bronchoscopy will be analyzed for cytokines (%).
Cell counts in Bronchial Wash	6 hours	Bronchial wash (BW) collected by bronchoscopy will be analyzed for inflammatory cell counts (cells/ml).

Secondary Outcome Measures

Name	Time	Method
Oxylipin Metabolomic profiling	Baseline, 2 hours, 6 hours, 24 hours	Metabolomic testing done with mass spectrometry on blood samples, BW and BAL.
Inflammation in bronchoalveolar lavage (BAL)	6 hour	BAL collected by bronchoscopy will be analyzed for inflammatory markers, such as cell counts (cells/ml).
Inflammation in endomucosal biopsies	6 hours	Biopsies collected by bronchoscopy will be analyzed for inflammatory markers, such as cell counts (cells/mm2).