Metabolic Dynamics During Physical Activity

Metabolic Dynamics During Physical Activity Under Normobaric Normoxia or Moderate Hypoxia - a Pilot Study

The aim of this study is to systematically Analyse the metabolome in capillary blood of healthy men and women at rest and during defined standardized physical activity under normobaric normoxia or hypoxia with a specific focus on metabolites and metabolic pattern related to energy metabolism. The metabolome analyses in capillary blood could give us also or more detailed insight into erythrocyte metabolic physiology because it is known for a longer time that the primary metabolism of the erythrocyte reflects its Oxygen Saturation via the glycolytic metabolites / intermediates pattern.

Study Overview

• Status: Completed
• Conditions: Healthy Men and Women
• Intervention / Treatment: Other: running on a treadmill under normoxia or hypoxia

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13125
    • Charite University Medicine, ECRC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• healthy volunteers
• written informed consent

Exclusion Criteria:

• known cardio-vascular, lung, metabolic, endocrine, hematologic, kidney or neurologic diseases
• pregnancy, lactating period
• unability to understand study content and aims and to give written informed consent

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: running under hypoxia - first; running under hypoxia (first day) and normoxia (second day)	Other: running on a treadmill under normoxia or hypoxia; 30 min running (60% VO2max) on a treadmill under hypoxia (O2: 14%); 30 min running (60% VO2max) on a treadmill under normoxia (O2: 20%)
Active Comparator: running under normoxia - first; running under normoxia (first day) and hypoxia (second day)	Other: running on a treadmill under normoxia or hypoxia; 30 min running (60% VO2max) on a treadmill under hypoxia (O2: 14%); 30 min running (60% VO2max) on a treadmill under normoxia (O2: 20%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in capillary lactate/pyruvate Ratio (dimension-free)	marker for the ratio between anaerobic / aerobic glycolysis	t = 0 min (before exercise); t = 10, 20 and 30 min during exercise; t = 50 and 60 min during recovery

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Michael Boschmann, Dr., Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): March 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: March 19, 2018
• First Submitted That Met QC Criteria: March 30, 2018
• First Posted (Actual): April 2, 2018

Study Record Updates

• Last Update Posted (Actual): April 2, 2018
• Last Update Submitted That Met QC Criteria: March 30, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: physical activity; hypoxia; metabolism; metabolome
• Other Study ID Numbers: Hypoxitrain 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No