Back to resultsHuman Metabolic Dynamics at Rest and During Aerobic Exercise Under Normobaric Normoxic and Moderate Hypoxic Conditions
Primary Purpose
Energy Metabolism, Hypoxia, Metabolism and Nutrition Disorder
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
30-minute movement activity
Hypoxia
Sponsored by
About this trial
This is an interventional basic science trial for Energy Metabolism
Eligibility Criteria
Inclusion criteria:
- approval and written, informed consent
- healthy adults of varying fitness levels (age >18 years to 75 years)
Exclusion criteria:
- chronic illness requiring any medication
- pregnancy
- limitations regarding functioning in the hypoxic chamber
- inability to follow simple instructions
- relevant or severe abnormalities in medical history, physical examination, ECG routine laboratory parameters from blood and urine
Sites / Locations
- Charité University Experimental & Clinical Research Center
Outcomes
Primary Outcome Measures
Coefficient of variation of relative quantities of metabolites and physiological parameters related to its dynamic during exercise under normoxic and hypoxic conditions, using GC-MS.
A drop of capillary blood (20 µl) will be collected from the hyperemic earlobe for metabolomic analysis at the times t = 0 min (before starting), 10 min, 20 min and 30 min during the activity, and t = 50 and 60 min taken in the recovery phase. The oxygen saturation and heart rate will be determined at the same time points by pulse oximetry and heart rate monitoring, as well as blood gas analyses and subjective self-perception of energy availability on a quantitative scale throughout exercise.
Secondary Outcome Measures
Full Information
NCT ID
NCT03121885
First Posted
March 31, 2017
Last Updated
January 29, 2019
Sponsor
Benjamin Gollasch
Collaborators
Max Delbrück Center for Molecular Medicine in the Helmholtz Association (MDC) Berlin
1. Study Identification
Unique Protocol Identification Number
NCT03121885
Brief Title
Human Metabolic Dynamics at Rest and During Aerobic Exercise Under Normobaric Normoxic and Moderate Hypoxic Conditions
Official Title
MetaboDyn- Liquid-liquid Extraction of Single Drops of Whole Capillary Blood as a Reliable Method of Measuring Metabolic Effects of Exercise: A Pilot Study.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
July 20, 2017 (Actual)
Study Completion Date
November 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Benjamin Gollasch
Collaborators
Max Delbrück Center for Molecular Medicine in the Helmholtz Association (MDC) Berlin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim is to define in detail metabolic pathways at rest and during aerobic exercise in normal and healthy men and women under normobaric normoxic and moderate hypoxic conditions, using metabolomics technologies based on minimally invasive sampling relying on gas chromatography and mass spectrometry.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Energy Metabolism, Hypoxia, Metabolism and Nutrition Disorder
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
30-minute movement activity
Intervention Description
The subjects arrive in the CRU after a 12 hours overnight fast to perform a 30-minute movement activity with individually adapted exercise intensity on the treadmill.
Intervention Type
Other
Intervention Name(s)
Hypoxia
Intervention Description
The 30-minute movement activity on the treadmill will be completed by each subject once under normobaric normoxic and once under normobaric hypoxic conditions (equivalent to approximately 3000 meters above sea level) in a randomized episode.
Primary Outcome Measure Information:
Title
Coefficient of variation of relative quantities of metabolites and physiological parameters related to its dynamic during exercise under normoxic and hypoxic conditions, using GC-MS.
Description
A drop of capillary blood (20 µl) will be collected from the hyperemic earlobe for metabolomic analysis at the times t = 0 min (before starting), 10 min, 20 min and 30 min during the activity, and t = 50 and 60 min taken in the recovery phase. The oxygen saturation and heart rate will be determined at the same time points by pulse oximetry and heart rate monitoring, as well as blood gas analyses and subjective self-perception of energy availability on a quantitative scale throughout exercise.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
approval and written, informed consent
healthy adults of varying fitness levels (age >18 years to 75 years)
Exclusion criteria:
chronic illness requiring any medication
pregnancy
limitations regarding functioning in the hypoxic chamber
inability to follow simple instructions
relevant or severe abnormalities in medical history, physical examination, ECG routine laboratory parameters from blood and urine
Facility Information:
Facility Name
Charité University Experimental & Clinical Research Center
City
Berlin
ZIP/Postal Code
13125
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Liquid-liquid extraction of single drops of whole capillary blood with collaborator partner MDC
Learn more about this trial
Human Metabolic Dynamics at Rest and During Aerobic Exercise Under Normobaric Normoxic and Moderate Hypoxic Conditions
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