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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03121885
Other study ID # MetaboDyn
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2017
Est. completion date November 1, 2018

Study information

Verified date July 2017
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date November 1, 2018
Est. primary completion date July 20, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
30-minute movement activity
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.
Other:
Hypoxia
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.

Locations

Country Name City State
Germany Charité University Experimental & Clinical Research Center Berlin

Sponsors (2)

Lead Sponsor Collaborator
Benjamin Gollasch Max Delbrück Center for Molecular Medicine in the Helmholtz Association (MDC) Berlin

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 months
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