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

Sponsor

Benjamin Gollasch (Other)

Overall Status

Completed

CT.gov ID

NCT03121885

Collaborator

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

Enrollment

Location

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Energy Metabolism Hypoxia Metabolism and Nutrition Disorder	Behavioral: 30-minute movement activity Other: Hypoxia	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Basic Science

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.

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Jul 20, 2017

Actual Study Completion Date :

Nov 1, 2018

Outcome Measures

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. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charité University Experimental & Clinical Research Center	Berlin		Germany	13125

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Benjamin Gollasch, Dr. med. Benjamin Gollasch, Charite University, Berlin, Germany

ClinicalTrials.gov Identifier:

NCT03121885

Other Study ID Numbers:

MetaboDyn

First Posted:

Apr 20, 2017

Last Update Posted:

Jan 30, 2019

Last Verified:

Jul 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Nutrition Disorders

Hypoxia

Study Results

No Results Posted as of Jan 30, 2019