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

Not Applicable

• Conditions: Oxidative Stress
• Interventions: Other: Oxygen; Other: Ambient

• Registration Number: NCT02577692
• Lead Sponsor: Klinikum der Universitaet Muenchen, Grosshadern

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-13
• Study First Submitted QC: 2015-10-15
• Study First Posted: 2015-10-16
• Study Start: 2016-05
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-06
• Last Update Posted: 2018-03-08
• Primary Completion: 2019-11
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ambient	Oxygen	Day 1: breathing of 100% oxygen; Day 2: ambient air breathing
Ambient	Ambient	Day 1: breathing of 100% oxygen; Day 2: ambient air breathing
Oxygen	Ambient	Day 1: breathing of 100% oxygen; Day 2: ambient air breathing
Oxygen	Oxygen	Day 1: breathing of 100% oxygen; Day 2: ambient air breathing

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Aneshtesiology, University Hospital of Munich; 🇩🇪 Muenchen, Germany