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

January 29, 2019 updated by: Benjamin Gollasch

MetaboDyn- Liquid-liquid Extraction of Single Drops of Whole Capillary Blood as a Reliable Method of Measuring Metabolic Effects of Exercise: A Pilot Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13125
        • Charité University Experimental & Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benjamin Gollasch

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

July 20, 2017

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

March 31, 2017

First Submitted That Met QC Criteria

April 15, 2017

First Posted (Actual)

April 20, 2017

Study Record Updates

Last Update Posted (Actual)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MetaboDyn

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Liquid-liquid extraction of single drops of whole capillary blood with collaborator partner MDC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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