Hypoxia, AltitudeNCT06204731
The Impact of Physical Training Under Normobaric Hypoxia on Oxidative Stress Level, Inflammatory State, Intestinal Damage, and Mitochondrial Metabolism in Young Males
A study testing Exercise and environmental conditions in people with Hypoxia, Altitude, run by University School of Physical Education, Krakow, Poland at 1 site in Poland.
Trial summary
Cognitive assessment of the influence of a 4-week proprietary training program under normobaric hypoxia conditions on the levels of inflammatory markers, disturbances in prooxidant-antioxidant balance, degree of intestinal damage, and mitochondrial energy production rate in young sedentary males. Read more about this study
- Who is it for?
- Ages 19 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypoxia, Altitude
- What is being tested?
- Exercise and environmental conditions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 1 Feb 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 29 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- no known metabolic diseases, no contraindications to physical exercise and no history of high altitude sickness stated in interview. A medical examination (including ECG, blood and urine tests) is required.
Who cannot join
- changes in diet during the experiment, smoking and abuse of alcohol and/or other stimulants.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anna Kałuża, MSc contact
Poland1 site, 1 recruiting
- Recruiting
University School of Physical Education in Cracow
Krakow, 31-571
Anna Radon, Msc, 48 12 6831142, anna.radon@awf.krakow.pl
About this study
Official title: The Influence of Physical Training in Normobaric Hypoxia on Prooxidant-Antioxidant Imbalance, Inflammatory Marker Levels, Intestinal Damage Degree, and Mitochondrial Energy Release Rate in Young Non-trained Males
- Cognitive assessment of the influence of a 4-week proprietary training program under normobaric hypoxia conditions on the levels of inflammatory markers, disturbances in prooxidant-antioxidant balance, degree of intestinal damage, and mitochondrial energy production rate in young sedentary males.
- Applied objective: Development of practical training guidelines utilizing training in normobaric hypoxia conditions to enhance mechanisms related to oxygen transport, adaptive changes within the immune system, body's antioxidant capacity, gut permeability, substrate utilization efficiency, and mitochondrial function for coaches and athletes.
- Conditions
- Hypoxia, Altitude
- Being tested
- Exercise and environmental conditions
- Keywords
- inflammation, oxidative stress, intestinal damage, muscle damage, mitochondrial metabolism, normobaric hypoxia, training
- Medical subject headings
- Altitude Sickness, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and environmental conditionsOther
Participants will engage in interval training and will reside and sleep at different altitudes for a period of 4 weeks. Aerobic and anaerobic capacity tests and an eccentric exercise test will be performed before and after the training intervention. Before and after the training program, somatic measurements will also be taken. Before and after the first and last workout, blood will be drawn for biochemical analysis.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group will not undergo the training program. |
| LHTL (live high - train low) | Experimental | Training performed under normoxic conditions (223m), stay and sleep in normobaric hypoxic conditions (3000m) and thermoneutral conditions (21°C) and constant humidity (40%). Receives: Other: Exercise and environmental conditions |
| LLTH (live low - train high) | Experimental | Training performed under normobaric hypoxia conditions (3000m), stay and sleep in normoxic conditions (223m) and thermoneutral conditions (21°C) and constant humidity (40%).
will stay and sleep in normoxic (223m), and train in normobaric hypoxia (3000m) Receives: Other: Exercise and environmental conditions |
| LLTL (live low - train low) | Experimental | Training performed and stay and sleep in normoxic conditions (223m) and thermoneutral conditions (21°C) and constant humidity (40%). Receives: Other: Exercise and environmental conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of aerobic capacity (endurance)
Measurement of maximal oxygen uptake and determination of ventilatory thresholds (ergospirometry)
Measured: 7 days before training and 7-10 days after the training. Training will last 4 weeks.
Measurement of anaerobic capacity
Measurement of maximal anaerobic power (Wingate Anaerobic Test)
Measured: 7 days before training and 7-10 days after the training. Training will last 4 weeks
Blood analysis
Indicators of prooxidant-antioxidant imbalance, markers of inflammatory status, markers of muscle damage, markers of intestinal damage, HIF (hypoxia-inducible factor), EPO (erythropoietin), markers of mitochondrial metabolism, morphology (including reticulocytes).
Measured: 7 days before training and 7- 10 days after the training. The training will last 4 weeks and will consist of 12 workouts.
Somatic indices
Body composition analysis ( body height [m], body mass [kg], Quetelet II Index [kg/m^2], lean body mass [kg], fat mass [kg], fat percentage [%] and total water content [kg]
Measured: 7 days before training and 7-10 days after the training. Training will last 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start1 Feb 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxia, AltitudeStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University School of Physical Education, Krakow, Poland
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Education and Science,Poland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204731
- Sponsor's protocol ID
- SKN/SP/570048/2023
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 12 Jan 2024
- 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 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Physical Training in Normobaric Hypoxia on Prooxidant-Antioxidant Imbalance, Inflammatory Marker Levels, Intestinal Damage Degree, and Mitochondrial Energy Release Rate in Young Non-trained Males
- ClinicalTrials.gov ID
- NCT06204731
- Acronym / sponsor ID
- SKN/SP/570048/2023
- Conditions
- Hypoxia, Altitude
- Keywords
- inflammation, oxidative stress, intestinal damage, muscle damage, mitochondrial metabolism, normobaric hypoxia, training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University School of Physical Education, Krakow, PolandUniversity, hospital or other
- Collaborators
- Ministry of Education and Science,Poland
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Jan 2024 (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.
- Cognitive assessment of the influence of a 4-week proprietary training program under normobaric hypoxia conditions on the levels of inflammatory markers, disturbances in prooxidant-antioxidant balance, degree of intestinal damage, and mitochondrial energy production rate in young sedentary males.
- Applied objective: Development of practical training guidelines utilizing training in normobaric hypoxia conditions to enhance mechanisms related to oxygen transport, adaptive changes within the immune system, body's antioxidant capacity, gut permeability, substrate utilization efficiency, and mitochondrial function for coaches and athletes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group will not undergo the training program. |
| LHTL (live high - train low) | Experimental | Other: Exercise and environmental conditionsTraining performed under normoxic conditions (223m), stay and sleep in normobaric hypoxic conditions (3000m) and thermoneutral conditions (21°C) and constant humidity (40%). |
| LLTH (live low - train high) | Experimental | Other: Exercise and environmental conditionsTraining performed under normobaric hypoxia conditions (3000m), stay and sleep in normoxic conditions (223m) and thermoneutral conditions (21°C) and constant humidity (40%). will stay and sleep in normoxic (223m), and train in normobaric hypoxia (3000m) |
| LLTL (live low - train low) | Experimental | Other: Exercise and environmental conditionsTraining performed and stay and sleep in normoxic conditions (223m) and thermoneutral conditions (21°C) and constant humidity (40%). |
Who may qualify
- Ages
- 19 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- no known metabolic diseases, no contraindications to physical exercise and no history of high altitude sickness stated in interview. A medical examination (including ECG, blood and urine tests) is required.
Key exclusion criteria (1 listed)
- changes in diet during the experiment, smoking and abuse of alcohol and/or other stimulants.
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 |
|---|---|---|
| Exercise and environmental conditionsParticipants will engage in interval training and will reside and sleep at different altitudes for a period of 4 weeks. Aerobic and anaerobic capacity tests and an eccentric exercise test will be performed before and after the training intervention. Before and after the training program, somatic measurements will also be taken. Before and after the first and last workout, blood will be drawn for biochemical analysis. | Other | LHTL (live high - train low), LLTH (live low - train high), LLTL (live low - train low) |
Primary outcome
Measurement of aerobic capacity (endurance)
Time frame: 7 days before training and 7-10 days after the training. Training will last 4 weeks.
Measurement of maximal oxygen uptake and determination of ventilatory thresholds (ergospirometry)
Measurement of anaerobic capacity
Time frame: 7 days before training and 7-10 days after the training. Training will last 4 weeks
Measurement of maximal anaerobic power (Wingate Anaerobic Test)
Blood analysis
Time frame: 7 days before training and 7- 10 days after the training. The training will last 4 weeks and will consist of 12 workouts.
Indicators of prooxidant-antioxidant imbalance, markers of inflammatory status, markers of muscle damage, markers of intestinal damage, HIF (hypoxia-inducible factor), EPO (erythropoietin), markers of mitochondrial metabolism, morphology (including reticulocytes).
Somatic indices
Time frame: 7 days before training and 7-10 days after the training. Training will last 4 weeks.
Body composition analysis ( body height [m], body mass [kg], Quetelet II Index [kg/m^2], lean body mass [kg], fat mass [kg], fat percentage [%] and total water content [kg]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- 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.
Anna Kałuża, MSc contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and environmental conditions in people with Hypoxia, Altitude, run by University School of Physical Education, Krakow, Poland at 1 site in Poland.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 12 Jan 2024. 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Radoń, MSc (+45126831142, anna.radon@awf.krakow.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of aerobic capacity (endurance) (time frame: 7 days before training and 7-10 days after the training. Training will last 4 weeks.). The study lists 4 primary outcomes in all. 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 12 Jan 2024.