NCT03485716

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 2, 2018

Completed
Last Updated

April 2, 2018

Status Verified

March 1, 2018

Enrollment Period

8 months

First QC Date

March 19, 2018

Last Update Submit

March 30, 2018

Conditions

Keywords

metabolismmetabolomephysical activityhypoxia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

running under hypoxia - first

EXPERIMENTAL

running under hypoxia (first day) and normoxia (second day)

Other: running on a treadmill under normoxia or hypoxia

running under normoxia - first

ACTIVE COMPARATOR

running under normoxia (first day) and hypoxia (second day)

Other: running on a treadmill under normoxia or hypoxia

Interventions

* 30 min running (60% VO2max) on a treadmill under hypoxia (O2: 14%) * 30 min running (60% VO2max) on a treadmill under normoxia (O2: 20%)

running under hypoxia - firstrunning under normoxia - first

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy volunteers
  • written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite University Medicine, ECRC

Berlin, 13125, Germany

Location

MeSH Terms

Conditions

Motor ActivityHypoxia

Condition Hierarchy (Ancestors)

BehaviorSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Boschmann, Dr.

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Michael Boschmann

Study Record Dates

First Submitted

March 19, 2018

First Posted

April 2, 2018

Study Start

August 1, 2016

Primary Completion

March 31, 2017

Study Completion

December 31, 2017

Last Updated

April 2, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations