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

Primary Purpose

Oxidative Stress

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Oxygen
Ambient
Sponsored by
Klinikum der Universitaet Muenchen, Grosshadern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Oxidative Stress

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)MaleAccepts 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

Sites / Locations

  • Department of Aneshtesiology, University Hospital of Munich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Oxygen

Ambient

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in exhaled breath oxidative stress biomarker
Measurement of oxidative stress biomarkers in breath e.g. acetaldehyde, ethan, malondialdheyde, propionaldehyde, pentane

Secondary Outcome Measures

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

Full Information

First Posted
October 13, 2015
Last Updated
March 6, 2018
Sponsor
Klinikum der Universitaet Muenchen, Grosshadern
Collaborators
Airbus Defence and Space, DLR German Aerospace Center
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1. Study Identification

Unique Protocol Identification Number
NCT02577692
Brief Title
Inspired Oxygen on Oxidative Stress and Breath Volatile Organic Compound Composition in Healthy Volunteers
Official Title
Impact of Inspired Oxygen on Oxidative Stress and Breath Volatile Organic Compound Composition in Healthy Volunteers: A Randomized Controlled Cross-over Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Klinikum der Universitaet Muenchen, Grosshadern
Collaborators
Airbus Defence and Space, DLR German Aerospace Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxidative Stress

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxygen
Arm Type
Experimental
Arm Description
Day 1: breathing of 100% oxygen; Day 2: ambient air breathing
Arm Title
Ambient
Arm Type
Experimental
Arm Description
Day 1: breathing of 100% oxygen; Day 2: ambient air breathing
Intervention Type
Other
Intervention Name(s)
Oxygen
Intervention Description
breathing oxygen
Intervention Type
Other
Intervention Name(s)
Ambient
Intervention Description
breathing ambient air
Primary Outcome Measure Information:
Title
Change in exhaled breath oxidative stress biomarker
Description
Measurement of oxidative stress biomarkers in breath e.g. acetaldehyde, ethan, malondialdheyde, propionaldehyde, pentane
Time Frame
1, 4, and 24 hour
Secondary Outcome Measure Information:
Title
Change in blood oxidative stress biomarkers
Description
Measurement of oxidative stress biomarkers in blood e.g. ethane, malondialdehyde, pentane, propionaldheyde, total oxidative and antioxidative capacity, glutathione
Time Frame
1, 4, and 24 hour

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael E Dolch, MD
Organizational Affiliation
Klinikum der Universitaet Muenchen - Campus Grosshadern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Aneshtesiology, University Hospital of Munich
City
Muenchen
Country
Germany

12. IPD Sharing Statement

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

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