Inspired Oxygen on Oxidative Stress and Breath Volatile Organic Compound Composition in Healthy Volunteers

NCT02577692 — Not applicable, Unknown, 20 participants, Klinikum der Universitaet Muenchen, Grosshadern

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Impact of Inspired Oxygen on Oxidative Stress and Breath Volatile Organic Compound Composition in Healthy Volunteers: A Randomized Controlled Cross-over Trial

Registry	NCT02577692
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: none, basic science
Enrollment	20 (Actual)
Sponsor	Klinikum der Universitaet Muenchen, Grosshadern (Other); collaborators: Airbus Defence and Space, DLR German Aerospace Center
Conditions	Oxidative Stress
Interventions	Oxygen, Ambient (Other)
Dates	start 2016-05-01, primary completion 2019-11-01 (estimated), completion 2019-11-01 (estimated), first posted 2015-10-16, last updated 2018-03-08
Locations	1 site in Germany

-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. 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.

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+Arms and interventions

Arm	Type	Interventions	Description
Oxygen	Experimental	Other: Oxygen; Other: Ambient	Day 1: breathing of 100% oxygen; Day 2: ambient air breathing
Ambient	Experimental	Other: Oxygen; Other: Ambient	Day 1: breathing of 100% oxygen; Day 2: ambient air breathing

Oxygen (Other): breathing oxygen
Ambient (Other): breathing ambient air

+Outcome measures

Primary outcomes

Change in exhaled breath oxidative stress biomarker [1, 4, and 24 hour]: Measurement of oxidative stress biomarkers in breath e.g. acetaldehyde, ethan, malondialdheyde, propionaldehyde, pentane

Secondary outcomes

Change in blood oxidative stress biomarkers [1, 4, and 24 hour]: Measurement of oxidative stress biomarkers in blood e.g. ethane, malondialdehyde, pentane, propionaldheyde, total oxidative and antioxidative capacity, glutathione

+Eligibility

Sex: Male, ages: 25 Years to 65 Years, accepts healthy volunteers

Inclusion Criteria:

* healthy male volunteers who have given an oral and written informed consent

Exclusion Criteria:

* smoker or ex-smoker
* any pulmonary disease
* any heart disease
* any chemotherapy in the past
* any kind of daily medication

+Locations (1)

Facility	City	Country	Status
Department of Aneshtesiology, University Hospital of Munich	München	Germany

+Investigators

Michael E Dolch, MD, Principal investigator, Klinikum der Universitaet Muenchen - Campus Grosshadern