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Clinical Trials/NCT02577692
NCT02577692
Unknown
Not Applicable

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

Klinikum der Universitaet Muenchen, Grosshadern1 site in 1 country20 target enrollmentMay 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Oxidative Stress
Sponsor
Klinikum der Universitaet Muenchen, Grosshadern
Enrollment
20
Locations
1
Primary Endpoint
Change in exhaled breath oxidative stress biomarker
Last Updated
8 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
May 2016
End Date
November 2019
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Male

Investigators

Sponsor
Klinikum der Universitaet Muenchen, Grosshadern
Responsible Party
Principal Investigator
Principal Investigator

Michael Dolch

Dr. med.

Klinikum der Universitaet Muenchen, Grosshadern

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Change in blood oxidative stress biomarkers(1, 4, and 24 hour)

Study Sites (1)

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