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

Hypoxia, Altitude Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06204731
• Other study ID #: SKN/SP/570048/2023
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: December 2026

Study information

• Verified date: December 2023
• Source: University School of Physical Education, Krakow, Poland
• Contact: Anna Radon, MSc
• Phone: +45126831142
• Email: anna.radon[@]awf.krakow.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 29 Years

Eligibility

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.

Related Conditions & MeSH terms

• Altitude Sickness
• Hypoxia
• Hypoxia, Altitude

Intervention

Other:
• Exercise and environmental conditions
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.

Locations

Country	Name	City	State
Poland	University School of Physical Education in Cracow	Krakow

Sponsors (2)

Lead Sponsor	Collaborator
University School of Physical Education, Krakow, Poland	Ministry of Education and Science,Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of aerobic capacity (endurance)	Measurement of maximal oxygen uptake and determination of ventilatory thresholds (ergospirometry)	7 days before training and 7-10 days after the training. Training will last 4 weeks.
Primary	Measurement of anaerobic capacity	Measurement of maximal anaerobic power (Wingate Anaerobic Test)	7 days before training and 7-10 days after the training. Training will last 4 weeks
Primary	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).	7 days before training and 7- 10 days after the training. The training will last 4 weeks and will consist of 12 workouts.
Primary	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]	7 days before training and 7-10 days after the training. Training will last 4 weeks.