Effectiveness of Hyperbaric Oxygen Therapy in Adults

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06284603
• Other study ID #: AWF_LA_HBOT
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: December 20, 2023

Study information

• Verified date: September 2023
• Source: Poznan University of Physical Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 20, 2023
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• Hyperbaric Oxygen Therapy - HBOT
Each session includes exposure of 60 minutes to 100% oxygen at 2.5 atmosphere absolute (ATA), with 5-minute air breaks every 20 minutes

Locations

Country	Name	City	State
Poland	Poznan University of Physical Education	Poznan	Wielkopolska

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Physical Education

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline and the next morning after the last HBOT intervention; up to 24 days.
Primary	Heart rate	Cardiopulmonary exercise test (CPET) is conducted while an incremental running test on the treadmill using a heart rate monitor.	baseline and the next morning after the last HBOT intervention; up to 24 days.
Primary	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)	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	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).	baseline and the next morning after the last HBOT intervention; up to 24 days.
Secondary	Inflammatory cytokine profile	tumor necrosis factor (TNFalfa) and interleukins (IL-1beta, IL-6, IL-10) is measured using immunoenzymatic methods	baseline and the next morning after the last HBOT intervention; up to 24 days.
Secondary	Oxidative stress indicators	The activity of superoxide dismutase (SOD); catalase (CAT); glutathione peroxidase (GPx) is measured using spectrophotometric and immunoenzymatic methods	baseline and the next morning after the last HBOT intervention; up to 24 days.
Secondary	F2-Isoprostanes (F2-IsoP)	The measurement of F2-Isoprostanes (F2-IsoP) is performed using the spectrophotometric and immunoenzymatic methods	baseline and the next morning after the last HBOT intervention; up to 24 days.
Secondary	Brain-derived neurotrophic factor concentration (BDNF)	BDNF concentration is measured using immunoenzymatic methods	baseline and the next morning after the last HBOT intervention; up to 24 days.
Secondary	Nicotinamide (NAD) metabolites	NAD metabolites are measured using a combination of high-performance liquid chromatography-mass spectrometer methods (HPLC-MS)	baseline and the next morning after the last HBOT intervention; up to 24 days.
Secondary	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)	baseline and the next morning after the last HBOT intervention; up to 24 days.
Secondary	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).	baseline and the next morning after the last HBOT intervention; up to 24 days.
Secondary	endothelial nitric oxide synthase (eNOS)	eNOS activity is measured using immunoenzymatic methods	baseline and the next morning after the last HBOT intervention; up to 24 days.
Secondary	Vascular endothelial growth factor (VEGF)	Concentration of VEGF is measured using immunoenzymatic methods	baseline and after the intervention; up to 24 days.
Secondary	Hypoxia inducible factor-1 (HIF-1alfa)	Concentration of HIF-1alfa is measured using immunoenzymatic methods	baseline and the next morning after the last HBOT intervention; up to 24 days.