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

NCT03121885 | Completed

• 1 other identifier: MetaboDyn
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Energy Metabolism; Hypoxia; Metabolism and Nutrition Disorder

Outcome Measures

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.

  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

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• approval and written, informed consent
• healthy adults of varying fitness levels (age \>18 years to 75 years)

You may not qualify if:

• 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

Sponsors & Collaborators

• Benjamin Gollasch: lead
• Max Delbrück Center for Molecular Medicine in the Helmholtz Association (MDC) Berlin: collaborator

Study Sites (1)

Charité University Experimental & Clinical Research Center

Berlin, 13125, Germany

Location

MeSH Terms

Conditions

Hypoxia; Nutrition Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. med. Benjamin Gollasch

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: April 20, 2017
• Study Start: January 1, 2017
• Primary Completion: July 20, 2017
• Study Completion: November 1, 2018
• Last Updated: January 30, 2019

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)