Effectiveness of Hyperbaric Oxygen Therapy in Adults

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: Hyperbaric Oxygen Therapy - HBOT

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Wielkopolska
    • Poznan, Wielkopolska, Poland, 61-871
      • Poznań University of Physical Education

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Study Group 1: HBOT 3/week; The protocol comprises 10 Hyperbaric Oxygen Treatments (HBOT), 3 sessions per week.	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
Active Comparator: Study Group 2: HBOT 6/week; The protocol comprises 10 Hyperbaric Oxygen Treatments (HBOT), 6 sessions per week.	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
No Intervention: Control Group; No changes to a daily routine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.
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.
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.
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.
Vascular endothelial growth factor (VEGF)	Concentration of VEGF is measured using immunoenzymatic methods	baseline and after the intervention; up to 24 days.
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.

Collaborators and Investigators

• Sponsor: Poznan University of Physical Education
• Investigators: Principal Investigator: Barbara Pospieszna, PhD., Department of Athletics, Strength and Conditioning, Poznan Univ of Physical Ed, Poznan, Poland

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): December 20, 2023
• Study Completion (Actual): December 20, 2023

Study Registration Dates

• First Submitted: January 24, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Estimated): February 29, 2024

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: physical performance; gut microbiota; vascular circulation
• Other Study ID Numbers: AWF_LA_HBOT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No