Clinical trial NCT06284603: Effectiveness of Hyperbaric Oxygen Therapy in Adults
Official title: The Effects of Hyperbaric Oxygen Therapy on Physical Capacity, Health, and Gut Microbiota in Healthy Male Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: physical performance
vascular circulation
gut microbiota
Lead sponsor: Poznan University of Physical Education
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two study groups (dependent on frequency of HBOT treatments) and control group
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Volume of oxygen and carbon dioxide
timeFrame: baseline and the next morning after the last HBOT intervention; up to 24 days.
measure: Heart rate
timeFrame: baseline and the next morning after the last HBOT intervention; up to 24 days.
measure: Vascular circulation measures
timeFrame: 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:
measure: Body composition (body mass, fat mass, lean body mass, muscle mass)
timeFrame: baseline and the next morning after the last HBOT intervention; up to 24 days.
measure: Inflammatory cytokine profile
timeFrame: baseline and the next morning after the last HBOT intervention; up to 24 days.
measure: Oxidative stress indicators
timeFrame: baseline and the next morning after the last HBOT intervention; up to 24 days.
measure: F2-Isoprostanes (F2-IsoP)
timeFrame: baseline and the next morning after the last HBOT intervention; up to 24 days.
measure: Brain-derived neurotrophic factor concentration (BDNF)
timeFrame: baseline and the next morning after the last HBOT intervention; up to 24 days.
measure: Nicotinamide (NAD) metabolites
timeFrame: baseline and the next morning after the last HBOT intervention; up to 24 days.
measure: Gut microbiome and metabolome
timeFrame: baseline and the next morning after the last HBOT intervention; up to 24 days.
measure: Indicators of intestinal inflammation (fecal calprotectin, claudin, occludin, zonulin, sIgA)
timeFrame: baseline and the next morning after the last HBOT intervention; up to 24 days.
measure: endothelial nitric oxide synthase (eNOS)
timeFrame: baseline and the next morning after the last HBOT intervention; up to 24 days.
measure: Vascular endothelial growth factor (VEGF)
timeFrame: baseline and after the intervention; up to 24 days.
measure: Hypoxia inducible factor-1 (HIF-1alfa)
timeFrame: baseline and the next morning after the last HBOT intervention; up to 24 days.
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Poznan University of Physical Education
state: Wielkopolska
Study officials:
affiliation: Department of Athletics, Strength and Conditioning, Poznan Univ of Physical Ed, Poznan, Poland
name: Barbara Pospieszna, PhD.
role: PRINCIPAL_INVESTIGATOR
References: