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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02577692
Recruitment Status : Unknown
Verified March 2018 by Michael Dolch, Klinikum der Universitaet Muenchen, Grosshadern.
Recruitment status was:  Active, not recruiting
First Posted : October 16, 2015
Last Update Posted : March 8, 2018
Sponsor:
Collaborators:
Airbus Defence and Space
DLR German Aerospace Center
Information provided by (Responsible Party):
Michael Dolch, Klinikum der Universitaet Muenchen, Grosshadern

Tracking Information
First Submitted Date  ICMJE October 13, 2015
First Posted Date  ICMJE October 16, 2015
Last Update Posted Date March 8, 2018
Study Start Date  ICMJE May 2016
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2015)
Change in blood oxidative stress biomarkers [ Time Frame: 1, 4, and 24 hour ]
Measurement of oxidative stress biomarkers in blood e.g. ethane, malondialdehyde, pentane, propionaldheyde, total oxidative and antioxidative capacity, glutathione
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inspired Oxygen on Oxidative Stress and Breath Volatile Organic Compound Composition in Healthy Volunteers
Official Title  ICMJE Impact of Inspired Oxygen on Oxidative Stress and Breath Volatile Organic Compound Composition in Healthy Volunteers: A Randomized Controlled Cross-over Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Oxidative Stress
Intervention  ICMJE
  • Other: Oxygen
    breathing oxygen
  • Other: Ambient
    breathing ambient air
Study Arms  ICMJE
  • Experimental: Oxygen
    Day 1: breathing of 100% oxygen; Day 2: ambient air breathing
    Interventions:
    • Other: Oxygen
    • Other: Ambient
  • Experimental: Ambient
    Day 1: breathing of 100% oxygen; Day 2: ambient air breathing
    Interventions:
    • Other: Oxygen
    • Other: Ambient
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: October 15, 2015)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02577692
Other Study ID Numbers  ICMJE eN-2015-1.0
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Dolch, Klinikum der Universitaet Muenchen, Grosshadern
Study Sponsor  ICMJE Klinikum der Universitaet Muenchen, Grosshadern
Collaborators  ICMJE
  • Airbus Defence and Space
  • DLR German Aerospace Center
Investigators  ICMJE
Principal Investigator: Michael E Dolch, MD Klinikum der Universitaet Muenchen - Campus Grosshadern
PRS Account Klinikum der Universitaet Muenchen, Grosshadern
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP