Effectiveness of Hyperbaric Oxygen Therapy in Adults
- Conditions
- Healthy
- Interventions
- Device: Hyperbaric Oxygen Therapy - HBOT
- Registration Number
- NCT06284603
- Lead Sponsor
- Poznan University of Physical Education
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 80
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study Group 1: HBOT 3/week Hyperbaric Oxygen Therapy - HBOT The protocol comprises 10 Hyperbaric Oxygen Treatments (HBOT), 3 sessions per week. Study Group 2: HBOT 6/week Hyperbaric Oxygen Therapy - HBOT The protocol comprises 10 Hyperbaric Oxygen Treatments (HBOT), 6 sessions per week.
- Primary Outcome Measures
Name Time Method Volume of oxygen and carbon dioxide 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.
Heart rate 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.
Vascular circulation measures 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 Outcome Measures
Name Time Method endothelial nitric oxide synthase (eNOS) baseline and the next morning after the last HBOT intervention; up to 24 days. eNOS activity is measured using immunoenzymatic methods
Oxidative stress indicators 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
F2-Isoprostanes (F2-IsoP) 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
Nicotinamide (NAD) metabolites 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)
Indicators of intestinal inflammation (fecal calprotectin, claudin, occludin, zonulin, sIgA) 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).
Inflammatory cytokine profile 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
Brain-derived neurotrophic factor concentration (BDNF) baseline and the next morning after the last HBOT intervention; up to 24 days. BDNF concentration is measured using immunoenzymatic methods
Body composition (body mass, fat mass, lean body mass, muscle mass) 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).
Gut microbiome and metabolome 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)
Hypoxia inducible factor-1 (HIF-1alfa) baseline and the next morning after the last HBOT intervention; up to 24 days. Concentration of HIF-1alfa is measured using immunoenzymatic methods
Vascular endothelial growth factor (VEGF) baseline and after the intervention; up to 24 days. Concentration of VEGF is measured using immunoenzymatic methods
Trial Locations
- Locations (1)
Poznan University of Physical Education
🇵🇱Poznan, Wielkopolska, Poland