Effectiveness of Hyperbaric Oxygen Therapy in Adults

Poznan University of Physical Education80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Eligibility

Sex: MALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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.

Effectiveness of Hyperbaric Oxygen Therapy in Adults

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes