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OpenTrials
Completed

NCT Number: NCT03121885

Human Metabolic Dynamics at Rest and During Aerobic Exercise Under Normobaric Normoxic and Moderate Hypoxic Conditions

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.

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Key information

Conditions

Energy Metabolism Hypoxia Metabolism and Nutrition Disorder Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité University Experimental & Clinical Research Center

Berlin, 13125, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

30-minute movement activity

Behavioral

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.

Hypoxia

Other

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 outcomes

  1. 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.

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Benjamin Gollasch

Other

Collaborators

  • Max Delbrück Center for Molecular Medicine in the Helmholtz Association (MDC) Berlin

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Apr 20, 2017
Registry last updated
Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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