Health Effects of Biodiesel Exhaust Exposure

NCT01883466 | Completed

• 1 other identifier: UMU-12-14031
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Urban air pollution is a major contributor to greenhouse gases and has been shown to increase cardiovascular mortality and morbidity. This century has seen a rebirth of biofuel marketing and research, with biodiesel emerging as one of the strongest contenders within international markets. The pursuit of alternative renewable fuels is incredibly complex and has powered research in agriculture, biotechnology, production, transportation, feedstocks, ecology and biomass manufacturing. In spite of this, health effects have been an almost completely overlooked aspect. The purpose of this study is to investigate whether 100% biodiesel exhaust exposure in healthy volunteers leads to cardiovascular and inflammatory responses. Further investigations into the chemical composition of biodiesel exhaust will also be performed.

Conditions

Vascular Endothelium

Keywords

Air Pollution; Biodiesel exhaust; Diesel exhaust; Vascular function; Fibrinolysis; Acute 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 and -independent vasodilators (bradykinin \& acetylcholine and sodium nitroprusside \& verapamil respectively). Tissue plasminogen activator and plasminogen activator inhibitor-1 were analysed in blood samples taken after bradykinin infusions in order to assess fibrinolytic function. These composite outcome measures will together indicate vascular vasomotor function.

  4-6 hours after exposure

Secondary Outcomes (2)

• Respiratory function tests

  Baseline, 6 and 24 hours after exposure

• Effects of exposure on metabolomic markers in plasma

  Baseline and 2, 4 & 24 hours after exposure

Study Arms (2)

Diesel exhaust exposure

EXPERIMENTAL

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

Other: Forearm venous occlusion plethysmography study

Biodiesel exhaust exposure

EXPERIMENTAL

1 hour exposure to dilute biodiesel exhaust (generated at same running conditions as diesel exhaust) during intermittent exercise

Other: Forearm venous occlusion plethysmography study

Interventions

Forearm venous occlusion plethysmography study OTHER

Measurement of forearm blood flow during unilateral intrabrachial infusion of four vasodilator drugs in incremental doses separated with 20-min washout periods. Bradykinin (endothelial-dependent vasodilator that releases t-PA) was infused at 100, 300 and 1000 pmol/min; acetylcholine (endothelial independent vasodilator that does not release t-PA) was infused at 5, 10 and 20 mcg/min; sodium nitroprusside (endothelial independent vasodilator that does not release t-PA) was infused at 2, 4 and 8 mcg/min and verapamil (endothelial independent and NO independent vasodilator that does not release t-PA) was infused at 10, 30 and 100 mcg/min. Bradykinin, acetylcholine and sodium nitroprusside were given in random order and verapamil was administered last due to its long acting effects.

Biodiesel exhaust exposure; Diesel exhaust exposure

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non-smoking, healthy male subjects. All subjects undergo a general health examination and are required to have normal clinical examination, ECG, blood tests and lung function.

You may not qualify if:

• Diabetes Mellitus
• Cardiovascular disease
• Asthma
• Respiratory infection within 2 weeks of the study
• Antioxidant- and/or vitamin supplementation within 1 week prior to, as well as during the course of the study. (incl vitamin C, Acetylcysteine)
• Smokers or regular snus usage

Sponsors & Collaborators

• Umeå University: lead
• University of Edinburgh: collaborator

Study Sites (1)

Umeå University Hospital

Umeå, 90185, 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, 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: SPONSOR

Study Record Dates

• First Submitted: April 30, 2013
• First Posted: June 21, 2013
• Study Start: September 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: April 1, 2013
• Last Updated: June 21, 2013

Record last verified: 2013-06

Locations

SE (1)