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

NCT06204731 | Recruiting

• 1 other identifier: SKN/SP/570048/2023
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypoxia, Altitude

Keywords

inflammation; oxidative stress; intestinal damage; muscle damage; mitochondrial metabolism; normobaric hypoxia; training

Outcome Measures

Primary Outcomes (4)

• 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.

• 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

• 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.

• 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.

Study Arms (4)

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%).

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)

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%).

Other: Exercise and environmental conditions

Interventions

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.

LHTL (live high - train low); LLTH (live low - train high); LLTL (live low - train low)

Eligibility Criteria

• Age: 19 Years - 29 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University School of Physical Education, Krakow, Poland: lead
• Ministry of Education and Science,Poland: collaborator

Study Sites (1)

University School of Physical Education in Cracow

Krakow, 31-571, Poland

RECRUITING

MeSH Terms

Conditions

Altitude Sickness; Inflammation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Anna Radoń, MSc

CONTACT

+45126831142; anna.radon@awf.krakow.pl

Anna Kałuża, MSc

CONTACT

anna.kaluza@doctoral.awf.krakow.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: January 12, 2024
• Study Start: February 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 12, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)