Text Size

Biodiesel Exhaust, Acute Vascular and Endothelial Responses (BEAVER)

This study has been completed.
Sponsor:
Collaborator:
Umeå University
Information provided by (Responsible Party):
Jeremy Langrish, University of Edinburgh
ClinicalTrials.gov Identifier:
NCT01337882
First received: April 15, 2011
Last updated: November 30, 2011
Last verified: November 2011
History of Changes

April 15, 2011
November 30, 2011
April 2011
July 2011   (final data collection date for primary outcome measure)
Vascular vasomotor and fibrinolytic function [ Time Frame: 4-6 hours after exposure ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01337882 on ClinicalTrials.gov Archive Site
  • Respiratory function tests [ Time Frame: 6 hours after exposure ] [ Designated as safety issue: No ]
    Basic spirometry will be performed at baseline and 6 hours after each exposure
  • Inflammatory markers [ Time Frame: Baseline and up to 24 hours after exposure ] [ Designated as safety issue: No ]
    Blood samples will be taken and stored as plasma and serum for measurement of inflammatory mediators
  • Central arterial stiffness [ Time Frame: Baseline and post exposure ] [ Designated as safety issue: No ]
    Central arterial stiffness (PWV and PWA) will be measured at baseline and immediately after the exposure
Same as current
Not Provided
Not Provided
 
Biodiesel Exhaust, Acute Vascular and Endothelial Responses
Inhalation of Dilute Biodiesel Exhaust: Acute Vascular and Endothelial Responses

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Healthy
Other: Forearm venous occlusion plethysmography study
Forearm venous occlusion plethysmography to measure forearm blood flow during unilateral intrabrachial infusion of endothelium-dependent (bradykinin [100, 300 & 1000 pmol/min]; acetylcholine [5, 10 & 20 µg/min]) and -independent [sodium nitroprusside [2, 4 & 8 µg/min]; verapamil [10, 30 & 100 µg/min]) vasodilators. Each drug to be infused for 6 mins at each dose in increasing concentrations. 0.9% sodium chloride will be infused for 20 min between each individual drug to allow washout.
  • Experimental: Diesel exhaust exposure
    1 hour exposure to dilute diesel exhaust (approximate PM10 concentration 300 mcg/m3) during intermittent exercise
    Intervention: Other: Forearm venous occlusion plethysmography study
  • Experimental: Biodiesel exhaust exposure
    1 hour exposure to dilute biodiesel exhaust (approximate PM10 concentration 300 mcg/m3) during intermittent exercise
    Intervention: Other: Forearm venous occlusion plethysmography study
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
November 2011
July 2011   (final data collection date for primary outcome measure)

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.
Both
20 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01337882
BEAVER
No
Jeremy Langrish, University of Edinburgh
University of Edinburgh
Umeå University
Principal Investigator: Jenny A Bosson Damewood, MD PhD Umeå University
University of Edinburgh
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP