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Completed

NCT Number: NCT06284603

Effectiveness of Hyperbaric Oxygen Therapy in Adults

The goal of this controlled, experimental study is to learn about the effects of 10 sessions of hyperbaric oxygen therapy on physical performance, vascular circulation, biochemical parameters, and composition of the intestinal microbiota in young healthy men depending on the frequency of single treatments.

The main questions it aims to answer are:

1. Do 10 treatments of hyperbaric oxygen therapy induce significant changes in physical performance levels, vascular circulation, and concentrations of biochemical parameters in young, healthy men? 2. Does the body's response to 10 treatments of hyperbaric oxygen therapy differ depending on the frequency of treatments? 3. Does a series of hyperbaric oxygen therapy treatments induce significant changes in the composition of the intestinal microbiota, metabolome, and functional status of the intestines?

Participants are exposed to hyperoxia under hyperbaric conditions or form a control group with no treatment.

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Key information

Conditions

Healthy

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Poznan University of Physical Education

Poznan, Wielkopolska, 61-871, Poland

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 18-35;
  • Healthy, physically active men;
  • Subject who is knowingly willing to participate in the study;
  • Subject able to read, understand and sign an informed consent to participate.

Exclusion criteria

  • Inability to attend scheduled visits and/or follow study protocol;
  • Use of HBOT prior to study inclusion;
  • Severe or unstable physical impairment or severe cognitive deficits at study entry;
  • Pressure-sensitive chest diseases (including moderate or severe asthma) or pressure-sensitive ear or sinus diseases;
  • Active smoking;
  • Having suffered an injury within 3 months up to the date of the study;
  • Taking pre- and/or probiotics in the last 3 months before the study;
  • Inpatient hospital or emergency room stay in the last 4 weeks prior to study entry;
  • Travel to tropical countries during the last 4 weeks prior to the study;
  • Taking antibiotics, steroids and steroid-anabolic agents during the last 4 weeks before the study

Treatment and study plan

Hyperbaric Oxygen Therapy - HBOT

Device

Each session includes exposure of 60 minutes to 100% oxygen at 2.5 atmosphere absolute (ATA), with 5-minute air breaks every 20 minutes

Primary outcomes

  1. Volume of oxygen and carbon dioxide

    Time frame: baseline and the next morning after the last HBOT intervention; up to 24 days.

    A cardiopulmonary exercise test (CPET) is conducted while an incremental running test on the treadmill using a portable breath-by-breath ergospirometer; VO2 and VCO2 are measured constantly.

  2. Heart rate

    Time frame: baseline and the next morning after the last HBOT intervention; up to 24 days.

    Cardiopulmonary exercise test (CPET) is conducted while an incremental running test on the treadmill using a heart rate monitor.

  3. Vascular circulation measures

    Time frame: baseline (before and immediately after CPET), before and after 5th treatment, and the next morning after the last HBOT intervention (before and immediately after CPET); up to 24 days.

    Nicotinamide adenine dinucleotide (NADH) content changes in the skin area are measured during transient ischemia and reperfusion with the use of the Flow Mediated Skin Fluorescence (FMSF) using The AngioExpert device (AngioExpert, Poland)

Secondary outcomes

  1. Body composition (body mass, fat mass, lean body mass, muscle mass)

    Time frame: baseline and the next morning after the last HBOT intervention; up to 24 days.

    Body composition is tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA).

  2. Inflammatory cytokine profile

    Time frame: baseline and the next morning after the last HBOT intervention; up to 24 days.

    tumor necrosis factor (TNFalfa) and interleukins (IL-1beta, IL-6, IL-10) is measured using immunoenzymatic methods

  3. Oxidative stress indicators

    Time frame: baseline and the next morning after the last HBOT intervention; up to 24 days.

    The activity of superoxide dismutase (SOD); catalase (CAT); glutathione peroxidase (GPx) is measured using spectrophotometric and immunoenzymatic methods

  4. F2-Isoprostanes (F2-IsoP)

    Time frame: baseline and the next morning after the last HBOT intervention; up to 24 days.

    The measurement of F2-Isoprostanes (F2-IsoP) is performed using the spectrophotometric and immunoenzymatic methods

  5. Brain-derived neurotrophic factor concentration (BDNF)

    Time frame: baseline and the next morning after the last HBOT intervention; up to 24 days.

    BDNF concentration is measured using immunoenzymatic methods

  6. Nicotinamide (NAD) metabolites

    Time frame: baseline and the next morning after the last HBOT intervention; up to 24 days.

    NAD metabolites are measured using a combination of high-performance liquid chromatography-mass spectrometer methods (HPLC-MS)

  7. Gut microbiome and metabolome

    Time frame: baseline and the next morning after the last HBOT intervention; up to 24 days.

    Metabolites produced by bacteria such as short-chain fatty acids (SCFA), tryptophan catabolites, and non-targeted metabolomes are measured using Ultra High Pressure Liquid Chromatography (UHPLC)

  8. Indicators of intestinal inflammation (fecal calprotectin, claudin, occludin, zonulin, sIgA)

    Time frame: baseline and the next morning after the last HBOT intervention; up to 24 days.

    Indicators of intestinal inflammation are measured using Western blot analysis and real-time Polymerase Chain Reaction (RT-PCR).

  9. endothelial nitric oxide synthase (eNOS)

    Time frame: baseline and the next morning after the last HBOT intervention; up to 24 days.

    eNOS activity is measured using immunoenzymatic methods

  10. Vascular endothelial growth factor (VEGF)

    Time frame: baseline and after the intervention; up to 24 days.

    Concentration of VEGF is measured using immunoenzymatic methods

  11. Hypoxia inducible factor-1 (HIF-1alfa)

    Time frame: baseline and the next morning after the last HBOT intervention; up to 24 days.

    Concentration of HIF-1alfa is measured using immunoenzymatic methods

Sponsors and collaborators

Lead sponsor

Poznan University of Physical Education

Other

Registry information

Official study title

The Effects of Hyperbaric Oxygen Therapy on Physical Capacity, Health, and Gut Microbiota in Healthy Male Adults

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 29, 2024
Registry last updated
Feb 29, 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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