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NCT02577692 Clinical Trial

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

Oxidative Stress Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02577692
Other study ID # eN-2015-1.0
Secondary ID
Status Active, not recruiting
Phase N/A
First received October 13, 2015
Last updated March 6, 2018
Start date May 2016
Est. completion date November 2019

Study information
Verified date March 2018
Source Klinikum der Universitaet Muenchen, Grosshadern
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 20
Est. completion date November 2019
Est. primary completion date November 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 25 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Oxygen
breathing oxygen
• Ambient
breathing ambient air

Locations
Country Name City State
Germany Department of Aneshtesiology, University Hospital of Munich Muenchen

Sponsors (3)
Lead Sponsor Collaborator
Klinikum der Universitaet Muenchen, Grosshadern Airbus Defence and Space, DLR German Aerospace Center

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in exhaled breath oxidative stress biomarker Measurement of oxidative stress biomarkers in breath e.g. acetaldehyde, ethan, malondialdheyde, propionaldehyde, pentane 1, 4, and 24 hour
Secondary 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 1, 4, and 24 hour
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