Oxidative StressNCT02577692
Inspired Oxygen on Oxidative Stress and Breath Volatile Organic Compound Composition in Healthy Volunteers
A study testing Oxygen and Ambient in people with Oxidative Stress, run by Klinikum der Universitaet Muenchen, Grosshadern at 1 site in Germany.
Trial summary
High inspiratory oxygen fractions are known to induce oxidative stress and lipid peroxidation. The degrading products of oxidative stress induced lipid peroxidation are in part volatile and appear in breath where they can be measured non-invasively. Read more about this study
- Who is it for?
- Ages 25 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress
- What is being tested?
- Oxygen and Ambient
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- May 2016to Nov 2019
- 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 25 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy male volunteers who have given an oral and written informed consent
Who cannot join
- smoker or ex-smoker
- any pulmonary disease
- any heart disease
- any chemotherapy in the past
- any kind of daily medication
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Aneshtesiology, University Hospital of Munich
München
About this study
Official title: Impact of Inspired Oxygen on Oxidative Stress and Breath Volatile Organic Compound Composition in Healthy Volunteers: A Randomized Controlled Cross-over Trial
High inspiratory oxygen fractions are known to induce oxidative stress and lipid peroxidation. The degrading products of oxidative stress induced lipid peroxidation are in part volatile and appear in breath where they can be measured non-invasively. However, there is lack of knowledge on the correlation of blood and breath biomarkers of oxidative stress.
This study aims to investigate the effects of a high inspiratory oxygen fraction on oxidative stress in healthy volunteers. The primary outcome is the appearance of exhaled breath biomarkers of oxidative stress by electrochemical sensors and ion mobility mass spectrometry. Secondary outcomes are changes in oxidative stress biomarkers in blood and their relationship to breath biomarkers.
- Conditions
- Oxidative Stress
- Being tested
- Oxygen, Ambient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygenOther
breathing oxygen
AmbientOther
breathing ambient air
| Study group | Role | What they receive |
|---|---|---|
| Oxygen | Experimental | Day 1: breathing of 100% oxygen; Day 2: ambient air breathing Receives: Other: Oxygen; Other: Ambient |
| Ambient | Experimental | Day 1: breathing of 100% oxygen; Day 2: ambient air breathing Receives: Other: Oxygen; Other: Ambient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in exhaled breath oxidative stress biomarker
Measurement of oxidative stress biomarkers in breath e.g. acetaldehyde, ethan, malondialdheyde, propionaldehyde, pentane
Measured: 1, 4, and 24 hour
Secondary outcomes (1)
Change in blood oxidative stress biomarkers
Measurement of oxidative stress biomarkers in blood e.g. ethane, malondialdehyde, pentane, propionaldheyde, total oxidative and antioxidative capacity, glutathione
Measured: 1, 4, and 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startMay 2016
- Primary completionNov 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinikum der Universitaet Muenchen, Grosshadern
- Sponsor type
- University, hospital or other
- Collaborators
- Airbus Defence and Space, DLR German Aerospace Center
- Responsible party
- Principal investigator, Michael Dolch, Klinikum der Universitaet Muenchen, Grosshadern
- Investigators
- Michael E Dolch, MD, Principal investigator, Klinikum der Universitaet Muenchen - Campus Grosshadern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577692
- Sponsor's protocol ID
- eN-2015-1.0
- Status last verified
- Mar 2018
- First submitted
- 13 Oct 2015
- Last updated
- 8 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Inspired Oxygen on Oxidative Stress and Breath Volatile Organic Compound Composition in Healthy Volunteers: A Randomized Controlled Cross-over Trial
- ClinicalTrials.gov ID
- NCT02577692
- Acronym / sponsor ID
- eN-2015-1.0
- Conditions
- Oxidative Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Klinikum der Universitaet Muenchen, GrosshadernUniversity, hospital or other
- Collaborators
- Airbus Defence and Space, DLR German Aerospace Center
- Study start
- May 2016
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 16 Oct 2015 (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.
High inspiratory oxygen fractions are known to induce oxidative stress and lipid peroxidation. The degrading products of oxidative stress induced lipid peroxidation are in part volatile and appear in breath where they can be measured non-invasively. However, there is lack of knowledge on the correlation of blood and breath biomarkers of oxidative stress.
This study aims to investigate the effects of a high inspiratory oxygen fraction on oxidative stress in healthy volunteers. The primary outcome is the appearance of exhaled breath biomarkers of oxidative stress by electrochemical sensors and ion mobility mass spectrometry. Secondary outcomes are changes in oxidative stress biomarkers in blood and their relationship to breath biomarkers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxygen | Experimental | Other: Oxygen, Other: AmbientDay 1: breathing of 100% oxygen; Day 2: ambient air breathing |
| Ambient | Experimental | Other: Oxygen, Other: AmbientDay 1: breathing of 100% oxygen; Day 2: ambient air breathing |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy male volunteers who have given an oral and written informed consent
Key exclusion criteria (5 listed)
- smoker or ex-smoker
- any pulmonary disease
- any heart disease
- any chemotherapy in the past
- any kind of daily medication
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 |
|---|---|---|
| Oxygenbreathing oxygen | Other | Ambient, Oxygen |
| Ambientbreathing ambient air | Other | Ambient, Oxygen |
Primary outcome
Change in exhaled breath oxidative stress biomarker
Time frame: 1, 4, and 24 hour
Measurement of oxidative stress biomarkers in breath e.g. acetaldehyde, ethan, malondialdheyde, propionaldehyde, pentane
1 secondary outcome
Change in blood oxidative stress biomarkers
Time frame: 1, 4, and 24 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2018.
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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.
Michael E Dolch, MD principal investigator
Klinikum der Universitaet Muenchen - Campus Grosshadern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen and Ambient in people with Oxidative Stress, run by Klinikum der Universitaet Muenchen, Grosshadern at 1 site in Germany.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Mar 2018. 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 Germany. 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?
Results are not available in the source record.
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?
Change in exhaled breath oxidative stress biomarker (time frame: 1, 4, and 24 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Mar 2018.