HealthyBEAVERNCT01337882
Biodiesel Exhaust, Acute Vascular and Endothelial Responses
A study testing Forearm venous occlusion plethysmography study in people with Healthy, run by University of Edinburgh at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Forearm venous occlusion plethysmography study
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2011to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Forearm venous occlusion plethysmography study
- Keywords
- Air Pollution, Diesel exhaust, Biodiesel exhaust, Vascular function, Fibrinolysis, Acute vascular and endothelial responses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forearm venous occlusion plethysmography studyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Diesel exhaust exposure | Experimental | 1 hour exposure to dilute diesel exhaust (approximate PM10 concentration 300 mcg/m3) during intermittent exercise Receives: 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 Receives: Other: Forearm venous occlusion plethysmography study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4-6 hours after exposure
Secondary outcomes (3)
Respiratory function tests
Basic spirometry will be performed at baseline and 6 hours after each exposure
Measured: 6 hours after exposure
Inflammatory markers
Blood samples will be taken and stored as plasma and serum for measurement of inflammatory mediators
Measured: Baseline and up to 24 hours after exposure
Central arterial stiffness
Central arterial stiffness (PWV and PWA) will be measured at baseline and immediately after the exposure
Measured: Baseline and post exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionJul 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Umeå University
- Responsible party
- Principal investigator, Jeremy Langrish, University of Edinburgh
- Investigators
- Jenny A Bosson Damewood, MD PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337882
- Sponsor's protocol ID
- BEAVER
- Acronym
- BEAVER
- Status last verified
- Nov 2011
- First submitted
- 15 Apr 2011
- Last updated
- 1 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34127003
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhalation of Dilute Biodiesel Exhaust: Acute Vascular and Endothelial Responses
- ClinicalTrials.gov ID
- NCT01337882
- Acronym / sponsor ID
- BEAVER / BEAVER
- Conditions
- Healthy
- Keywords
- Air Pollution, Diesel exhaust, Biodiesel exhaust, Vascular function, Fibrinolysis, Acute vascular and endothelial responses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- Umeå University
- Study start
- Apr 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 19 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diesel exhaust exposure | Experimental | Other: Forearm venous occlusion plethysmography study1 hour exposure to dilute diesel exhaust (approximate PM10 concentration 300 mcg/m3) during intermittent exercise |
| Biodiesel exhaust exposure | Experimental | Other: Forearm venous occlusion plethysmography study1 hour exposure to dilute biodiesel exhaust (approximate PM10 concentration 300 mcg/m3) during intermittent exercise |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 20 healthy, non-smoking subjects, age 20-55 year old, both genders.
- Normal clinical examination Normal EKG Normal routine blood tests Normal lung function
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Forearm venous occlusion plethysmography studyForearm 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. | Other | Biodiesel exhaust exposure, Diesel exhaust exposure |
Primary outcome
Vascular vasomotor and fibrinolytic function
Time frame: 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.
3 secondary outcomes
Respiratory function tests
Time frame: 6 hours after exposure
Inflammatory markers
Time frame: Baseline and up to 24 hours after exposure
Central arterial stiffness
Time frame: Baseline and post exposure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2011.
- Derived from this study: PubMed 34127003Unosson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenny A Bosson Damewood, MD PhD principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forearm venous occlusion plethysmography study in people with Healthy, run by University of Edinburgh at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular vasomotor and fibrinolytic function (time frame: 4-6 hours after exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01337882, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2011.