Healthy Men and WomenNCT03485716
Metabolic Dynamics During Physical Activity
A study testing running on a treadmill under normoxia or hypoxia in people with Healthy Men and Women, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Men and Women
- What is being tested?
- running on a treadmill under normoxia or hypoxia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2016to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers
- written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy Men and Women
- Being tested
- running on a treadmill under normoxia or hypoxia
- Keywords
- metabolism, metabolome, physical activity, hypoxia
- Medical subject headings
- Motor Activity, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
running on a treadmill under normoxia or hypoxiaOther
- 30 min running (60% VO2max) on a treadmill under hypoxia (O2: 14%)
- 30 min running (60% VO2max) on a treadmill under normoxia (O2: 20%)
| Study group | Role | What they receive |
|---|---|---|
| running under hypoxia - first | Experimental | running under hypoxia (first day) and normoxia (second day) Receives: Other: running on a treadmill under normoxia or hypoxia |
| running under normoxia - first | Active comparator | running under normoxia (first day) and hypoxia (second day) Receives: Other: running on a treadmill under normoxia or hypoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in capillary lactate/pyruvate Ratio (dimension-free)
marker for the ratio between anaerobic / aerobic glycolysis
Measured: t = 0 min (before exercise); t = 10, 20 and 30 min during exercise; t = 50 and 60 min during recovery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start1 Aug 2016
- Primary completion31 Mar 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Men and WomenStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Boschmann, Charite University, Berlin, Germany
- Investigators
- Michael Boschmann, Dr., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485716
- Sponsor's protocol ID
- Hypoxitrain 2
- Status last verified
- Mar 2018
- First submitted
- 19 Mar 2018
- Last updated
- 2 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Dynamics During Physical Activity Under Normobaric Normoxia or Moderate Hypoxia - a Pilot Study
- ClinicalTrials.gov ID
- NCT03485716
- Acronym / sponsor ID
- Hypoxitrain 2
- Conditions
- Healthy Men and Women
- Keywords
- metabolism, metabolome, physical activity, hypoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 2 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| running under hypoxia - first | Experimental | Other: running on a treadmill under normoxia or hypoxiarunning under hypoxia (first day) and normoxia (second day) |
| running under normoxia - first | Active comparator | Other: running on a treadmill under normoxia or hypoxiarunning under normoxia (first day) and hypoxia (second day) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy volunteers
- written informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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%) | Other | running under hypoxia - first, running under normoxia - first |
Primary outcome
Change in capillary lactate/pyruvate Ratio (dimension-free)
Time frame: t = 0 min (before exercise); t = 10, 20 and 30 min during exercise; t = 50 and 60 min during recovery
marker for the ratio between anaerobic / aerobic glycolysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Boschmann, Dr. principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing running on a treadmill under normoxia or hypoxia in people with Healthy Men and Women, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in capillary lactate/pyruvate Ratio (dimension-free) (time frame: t = 0 min (before exercise); t = 10, 20 and 30 min during exercise; t = 50 and 60 min during recovery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2018.