HealthyNCT06284603
Effectiveness of Hyperbaric Oxygen Therapy in Adults
A study testing Hyperbaric Oxygen Therapy - HBOT in people with Healthy, run by Poznan University of Physical Education at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Hyperbaric Oxygen Therapy - HBOT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2022to 20 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Poznan University of Physical Education
Poznan, Wielkopolska, 61-871
About this study
Official title: 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:
Read more
- 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?
- Does the body's response to 10 treatments of hyperbaric oxygen therapy differ depending on the frequency of treatments?
- 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.
- Conditions
- Healthy
- Being tested
- Hyperbaric Oxygen Therapy - HBOT
- Keywords
- physical performance, vascular circulation, gut microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen Therapy - HBOTDevice
Each session includes exposure of 60 minutes to 100% oxygen at 2.5 atmosphere absolute (ATA), with 5-minute air breaks every 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| Study Group 1: HBOT 3/week | Active comparator | The protocol comprises 10 Hyperbaric Oxygen Treatments (HBOT), 3 sessions per week. Receives: Device: Hyperbaric Oxygen Therapy - HBOT |
| Study Group 2: HBOT 6/week | Active comparator | The protocol comprises 10 Hyperbaric Oxygen Treatments (HBOT), 6 sessions per week. Receives: Device: Hyperbaric Oxygen Therapy - HBOT |
| Control Group | No intervention | No changes to a daily routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Measured: 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 (11)
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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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
Measured: 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
Measured: baseline and after the intervention; up to 24 days.
Hypoxia inducible factor-1 (HIF-1alfa)
Concentration of HIF-1alfa is measured using immunoenzymatic methods
Measured: baseline and the next morning after the last HBOT intervention; up to 24 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start1 Mar 2022
- Primary completion20 Dec 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two study groups (dependent on frequency of HBOT treatments) and control group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara Pospieszna, PhD., Principal investigator, Department of Athletics, Strength and Conditioning, Poznan Univ of Physical Ed, Poznan, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284603
- Sponsor's protocol ID
- AWF_LA_HBOT
- Status last verified
- Sep 2023
- First submitted
- 24 Jan 2024
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Hyperbaric Oxygen Therapy on Physical Capacity, Health, and Gut Microbiota in Healthy Male Adults
- ClinicalTrials.gov ID
- NCT06284603
- Acronym / sponsor ID
- AWF_LA_HBOT
- Conditions
- Healthy
- Keywords
- physical performance, vascular circulation, gut microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- Does the body's response to 10 treatments of hyperbaric oxygen therapy differ depending on the frequency of treatments?
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Two study groups (dependent on frequency of HBOT treatments) and control group
| Arm | Type | Receives |
|---|---|---|
| Study Group 1: HBOT 3/week | Active comparator | Device: Hyperbaric Oxygen Therapy - HBOTThe protocol comprises 10 Hyperbaric Oxygen Treatments (HBOT), 3 sessions per week. |
| Study Group 2: HBOT 6/week | Active comparator | Device: Hyperbaric Oxygen Therapy - HBOTThe protocol comprises 10 Hyperbaric Oxygen Treatments (HBOT), 6 sessions per week. |
| Control Group | No intervention | –No changes to a daily routine. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric Oxygen Therapy - HBOTEach session includes exposure of 60 minutes to 100% oxygen at 2.5 atmosphere absolute (ATA), with 5-minute air breaks every 20 minutes | Device | Study Group 1: HBOT 3/week, Study Group 2: HBOT 6/week |
Primary outcome
Volume of oxygen and carbon dioxide
Time frame: 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
Time frame: 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
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.
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)
11 secondary outcomes
Body composition (body mass, fat mass, lean body mass, muscle mass)
Time frame: baseline and the next morning after the last HBOT intervention; up to 24 days.
Inflammatory cytokine profile
Time frame: baseline and the next morning after the last HBOT intervention; up to 24 days.
Oxidative stress indicators
Time frame: baseline and the next morning after the last HBOT intervention; up to 24 days.
F2-Isoprostanes (F2-IsoP)
Time frame: baseline and the next morning after the last HBOT intervention; up to 24 days.
Brain-derived neurotrophic factor concentration (BDNF)
Time frame: baseline and the next morning after the last HBOT intervention; up to 24 days.
Nicotinamide (NAD) metabolites
Time frame: baseline and the next morning after the last HBOT intervention; up to 24 days.
Gut microbiome and metabolome
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)
Time frame: baseline and the next morning after the last HBOT intervention; up to 24 days.
endothelial nitric oxide synthase (eNOS)
Time frame: baseline and the next morning after the last HBOT intervention; up to 24 days.
Vascular endothelial growth factor (VEGF)
Time frame: baseline and after the intervention; up to 24 days.
Hypoxia inducible factor-1 (HIF-1alfa)
Time frame: baseline and the next morning after the last HBOT intervention; up to 24 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Pospieszna, PhD. principal investigator
Department of Athletics, Strength and Conditioning, Poznan Univ of Physical Ed, Poznan, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric Oxygen Therapy - HBOT in people with Healthy, run by Poznan University of Physical Education at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of oxygen and carbon dioxide (time frame: baseline and the next morning after the last HBOT intervention; up to 24 days.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.