Biodiesel Exhaust, Acute Vascular and Endothelial Responses

NCT01337882 | Completed

• 1 other identifier: BEAVER
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Air Pollution; Diesel exhaust; Biodiesel exhaust; Vascular function; Fibrinolysis; Acute vascular and endothelial responses

Outcome Measures

Primary Outcomes (1)

• Vascular vasomotor and fibrinolytic function

  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.

  4-6 hours after exposure

Secondary Outcomes (3)

• Respiratory function tests

  6 hours after exposure

• Inflammatory markers

  Baseline and up to 24 hours after exposure

• Central arterial stiffness

  Baseline and post exposure

Study Arms (2)

Diesel exhaust exposure

EXPERIMENTAL

1 hour exposure to dilute diesel exhaust (approximate PM10 concentration 300 mcg/m3) during intermittent exercise

Other: Forearm venous occlusion plethysmography study

Biodiesel exhaust exposure

EXPERIMENTAL

1 hour exposure to dilute biodiesel exhaust (approximate PM10 concentration 300 mcg/m3) during intermittent exercise

Other: Forearm venous occlusion plethysmography study

Interventions

Forearm venous occlusion plethysmography study OTHER

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.

Biodiesel exhaust exposure; Diesel exhaust exposure

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Edinburgh: lead
• Umeå University: collaborator

Study Sites (1)

Umeå University Hospital

Umeå, 901 85, Sweden

Location

Related Publications (1)

• Unosson J, Kabele M, Boman C, Nystrom R, Sadiktsis I, Westerholm R, Mudway IS, Purdie E, Raftis J, Miller MR, Mills NL, Newby DE, Blomberg A, Sandstrom T, Bosson JA. Acute cardiovascular effects of controlled exposure to dilute Petrodiesel and biodiesel exhaust in healthy volunteers: a crossover study. Part Fibre Toxicol. 2021 Jun 14;18(1):22. doi: 10.1186/s12989-021-00412-3.

  PMID: 34127003 DERIVED

Study Officials

• Jenny A Bosson Damewood, MD PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Lecturer and Specialty Registrar in Cardiology

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: April 19, 2011
• Study Start: April 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: November 1, 2011
• Last Updated: December 1, 2011

Record last verified: 2011-11

Locations

SE (1)