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Metabolic Dynamics During Physical Activity

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: NCT03485716
Recruitment Status : Completed
First Posted : April 2, 2018
Last Update Posted : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Boschmann, Charite University, Berlin, Germany

Study Description
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Brief Summary:
The aim of this study is to systematically Analyse the metabolome in capillary blood of healthy men and women at rest and during defined standardized physical activity under normobaric normoxia or hypoxia with a specific focus on metabolites and metabolic pattern related to energy metabolism. The metabolome analyses in capillary blood could give us also or more detailed insight into erythrocyte metabolic physiology because it is known for a longer time that the primary metabolism of the erythrocyte reflects its Oxygen Saturation via the glycolytic metabolites / intermediates pattern.

Condition or disease Intervention/treatment Phase
Healthy Men and Women Other: running on a treadmill under normoxia or hypoxia Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Metabolic Dynamics During Physical Activity Under Normobaric Normoxia or Moderate Hypoxia - a Pilot Study
Actual Study Start Date : August 1, 2016
Actual Primary Completion Date : March 31, 2017
Actual Study Completion Date : December 31, 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: running under hypoxia - first
running under hypoxia (first day) and normoxia (second day)
 Other: running on a treadmill under normoxia or hypoxia
  • 30 min running (60% VO2max) on a treadmill under hypoxia (O2: 14%)
  • 30 min running (60% VO2max) on a treadmill under normoxia (O2: 20%)
Active Comparator: running under normoxia - first
running under normoxia (first day) and hypoxia (second day)
 Other: running on a treadmill under normoxia or hypoxia
  • 30 min running (60% VO2max) on a treadmill under hypoxia (O2: 14%)
  • 30 min running (60% VO2max) on a treadmill under normoxia (O2: 20%)


Outcome Measures
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Primary Outcome Measures :
  1. Change in capillary lactate/pyruvate Ratio (dimension-free) [ Time Frame: t = 0 min (before exercise); t = 10, 20 and 30 min during exercise; t = 50 and 60 min during recovery ]
    marker for the ratio between anaerobic / aerobic glycolysis


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteers
  • written informed consent

Exclusion Criteria:

  • known cardio-vascular, lung, metabolic, endocrine, hematologic, kidney or neurologic diseases
  • pregnancy, lactating period
  • unability to understand study content and aims and to give written informed consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03485716


Locations
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Germany
Charite University Medicine, ECRC
Berlin, Germany, 13125
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Michael Boschmann, Dr. Charite University, Berlin, Germany
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Michael Boschmann, Dr. Michael Boschmann, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03485716    
Other Study ID Numbers: Hypoxitrain 2
First Posted: April 2, 2018    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Boschmann, Charite University, Berlin, Germany:
metabolism
metabolome
physical activity
hypoxia