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

Klinikum der Universitaet Muenchen, Grosshadern

Status: Unknown

Conditions: Oxidative Stress

Treatments: Other: Oxygen; Other: Ambient

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02577692

eN-2015-1.0

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Male

Ages: 25 to 65 years old

Volunteers: 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Oxygen

Experimental group

Description:

Day 1: breathing of 100% oxygen; Day 2: ambient air breathing

Treatment:

Other: Oxygen

Other: Ambient

Ambient

Experimental group

Description:

Day 1: breathing of 100% oxygen; Day 2: ambient air breathing

Treatment:

Other: Oxygen

Other: Ambient