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

January 3, 2024 updated by: University School of Physical Education, Krakow, Poland

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
      • Krakow, Poland, 31-571
        • Recruiting
        • University School of Physical Education in Cracow
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
The control group will not undergo the training program.
Experimental: LHTL (live high - train low)
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
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.
Experimental: LLTH (live low - train high)

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
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.
Experimental: LLTL (live low - train low)
Training performed and stay and sleep in normoxic conditions (223m) and thermoneutral conditions (21°C) and constant humidity (40%).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
7 days before training and 7-10 days after the training. Training will last 4 weeks.
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)
7 days before training and 7-10 days after the training. Training will last 4 weeks
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).
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
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]
7 days before training and 7-10 days after the training. Training will last 4 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University School of Physical Education, Krakow, Poland

Collaborators

Ministry of Education and Science,Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 11, 2023

First Submitted That Met QC Criteria

January 3, 2024

First Posted (Actual)

January 12, 2024

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SKN/SP/570048/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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