An interventional study of Hyperbaric Oxygen Therapy - HBOT in Healthy, sponsored by Poznan University of Physical Education. Completed at 1 site in Poland. Open to male participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-29.
Sponsored by Poznan University of Physical Education · Not applicable, Interventional, and Treatment
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:
Participants are exposed to hyperoxia under hyperbaric conditions or form a control group with no treatment.
Poznan University of Physical Education is the lead sponsor of 90 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The protocol comprises 10 Hyperbaric Oxygen Treatments (HBOT), 3 sessions per week.
Device: Hyperbaric Oxygen Therapy - HBOT
The protocol comprises 10 Hyperbaric Oxygen Treatments (HBOT), 6 sessions per week.
Device: Hyperbaric Oxygen Therapy - HBOT
No changes to a daily routine.
Each session includes exposure of 60 minutes to 100% oxygen at 2.5 atmosphere absolute (ATA), with 5-minute air breaks every 20 minutes
Volume of oxygen and carbon dioxide
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.
Time frame: baseline and the next morning after the last HBOT intervention; up to 24 days.
Heart rate
Cardiopulmonary exercise test (CPET) is conducted while an incremental running test on the treadmill using a heart rate monitor.
Time frame: baseline and the next morning after the last HBOT intervention; up to 24 days.
Vascular circulation measures
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)
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.
Body composition (body mass, fat mass, lean body mass, muscle mass)
Body composition is tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA).
Time frame: baseline and the next morning after the last HBOT intervention; up to 24 days.
Inflammatory cytokine profile
tumor necrosis factor (TNFalfa) and interleukins (IL-1beta, IL-6, IL-10) is measured using immunoenzymatic methods
Time frame: baseline and the next morning after the last HBOT intervention; up to 24 days.
Oxidative stress indicators
The activity of superoxide dismutase (SOD); catalase (CAT); glutathione peroxidase (GPx) is measured using spectrophotometric and immunoenzymatic methods
Time frame: baseline and the next morning after the last HBOT intervention; up to 24 days.
F2-Isoprostanes (F2-IsoP)
The measurement of F2-Isoprostanes (F2-IsoP) is performed using the spectrophotometric and immunoenzymatic methods
Time frame: baseline and the next morning after the last HBOT intervention; up to 24 days.
Brain-derived neurotrophic factor concentration (BDNF)
BDNF concentration is measured using immunoenzymatic methods
Time frame: baseline and the next morning after the last HBOT intervention; up to 24 days.
Nicotinamide (NAD) metabolites
NAD metabolites are measured using a combination of high-performance liquid chromatography-mass spectrometer methods (HPLC-MS)
Time frame: baseline and the next morning after the last HBOT intervention; up to 24 days.
Gut microbiome and metabolome
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)
Time frame: baseline and the next morning after the last HBOT intervention; up to 24 days.
Indicators of intestinal inflammation (fecal calprotectin, claudin, occludin, zonulin, sIgA)
Indicators of intestinal inflammation are measured using Western blot analysis and real-time Polymerase Chain Reaction (RT-PCR).
Time frame: baseline and the next morning after the last HBOT intervention; up to 24 days.
endothelial nitric oxide synthase (eNOS)
eNOS activity is measured using immunoenzymatic methods
Time frame: baseline and the next morning after the last HBOT intervention; up to 24 days.
Vascular endothelial growth factor (VEGF)
Concentration of VEGF is measured using immunoenzymatic methods
Time frame: baseline and after the intervention; up to 24 days.
Hypoxia inducible factor-1 (HIF-1alfa)
Concentration of HIF-1alfa is measured using immunoenzymatic methods
Time frame: baseline and the next morning after the last HBOT intervention; up to 24 days.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Poznan University of Physical Education