Biodiesel Exhaust, Acute Vascular and Endothelial Responses

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Forearm venous occlusion plethysmography study

• Registration Number: NCT01337882
• Lead Sponsor: University of Edinburgh

Brief Summary

Exposure to particulate air pollution has been shown to increase cardiovascular mortality and morbidity, and in previous controlled exposure studies has been shown to have acute cardiovascular and respiratory effects. The last decade has seen an unprecedented drive towards finding a bioeconomical and renewable source of fuel in order to reduce our dependence on fossil fuels. Although both biodiesel and bioethanol have emerged as contenders for future fuels, biodiesel remains as the strongest contender within European markets. In 2007 researchers at the EPA released a commentary, which concluded that the assumed correlation between the chemical composition of biodiesel exhaust and a reduction in health effects was only hypothetical. They suggested that there was a clear need for the study of health effects in humans regarding biofuel exhaust. In this project the investigators aim to investigate the cardiovascular, respiratory and inflammatory responses to biofuel exhaust exposure in healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-15
• Study First Submitted QC: 2011-04-18
• Study First Posted: 2011-04-19
• Primary Completion: 2011-07
• Status Verified: 2011-11
• Study Completion: 2011-11
• Last Update Submitted: 2011-11-30
• Last Update Posted: 2011-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• 20 healthy, non-smoking subjects, age 20-55 year old, both genders.

All subjects undergo a general health examination and are required to have:

Normal clinical examination Normal EKG Normal routine blood tests Normal lung function

Exclusion Criteria

• Cardiovascular disease
• Diabetes Mellitus
• Asthma and/or allergy
• Respiratory infection within 3 weeks of the study
• Antioxidant- and/or vitamin supplementation within 2 weeks prior to, as well as during the course of the study. (incl vitamin C, Acetylcysteine)
• Female subjects will take a urinary pregnancy test before each exposure and will be excluded if this is positive.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Biodiesel exhaust exposure	Forearm venous occlusion plethysmography study	1 hour exposure to dilute biodiesel exhaust (approximate PM10 concentration 300 mcg/m3) during intermittent exercise
Diesel exhaust exposure	Forearm venous occlusion plethysmography study	1 hour exposure to dilute diesel exhaust (approximate PM10 concentration 300 mcg/m3) during intermittent exercise

Primary Outcome Measures

Name	Time	Method
Vascular vasomotor and fibrinolytic function	4-6 hours after exposure	Forearm venous occlusion plethysmography to measure forearm blood flow during unilateral intrabrachial infusion of endothelial-dependent (bradykinin and acetylcholine) and -independent (sodium nitroprusside and verapamil) vasodilators. Fibrinolytic function assessed by blood sampling after infusion of bradykinin for tissue plasminogen activator and plasminogen activator inhibitor-1.

Secondary Outcome Measures

Name	Time	Method
Respiratory function tests	6 hours after exposure	Basic spirometry will be performed at baseline and 6 hours after each exposure
Inflammatory markers	Baseline and up to 24 hours after exposure	Blood samples will be taken and stored as plasma and serum for measurement of inflammatory mediators
Central arterial stiffness	Baseline and post exposure	Central arterial stiffness (PWV and PWA) will be measured at baseline and immediately after the exposure

Trial Locations

Locations (1)

Umeå University Hospital; 🇸🇪 Umeå, Sweden