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NCT Number: NCT06204731

The Impact of Physical Training Under Normobaric Hypoxia on Oxidative Stress Level, Inflammatory State, Intestinal Damage, and Mitochondrial Metabolism in Young 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.

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Key information

Conditions

Hypoxia, Altitude Altitude Sickness Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases

Age range

19 year–29 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University School of Physical Education in Cracow

Krakow, 31-571, Poland

Location status: Recruiting

Location contact

Anna Radon, Msc

CONTACT

[email protected]

48 12 6831142

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • changes in diet during the experiment, smoking and abuse of alcohol and/or other stimulants.

Treatment and study plan

Exercise and environmental conditions

Other

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.

Primary outcomes

  1. 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)

  2. 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)

  3. 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).

  4. 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]

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Kałuża, MSc

CONTACT

[email protected]

Anna Radoń, MSc

CONTACT

[email protected]

+45126831142

Sponsors and collaborators

Lead sponsor

University School of Physical Education, Krakow, Poland

Other

Collaborators

  • Ministry of Education and Science,Poland

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 12, 2024
Registry last updated
Jan 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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