A Phase 2 interventional study of L-HBO and HBO in Oxidative Stress and Stem Cell Research, sponsored by University of Padova. Completed at 1 site in Italy. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-30.
Sponsored by University of Padova · Phase 2, Interventional, and Treatment
Currently, Hyperbaric Oxigen (HBO) is a widely used treatment for several conditions. There are 14 indications for HBO, officially recognized by the Undersea and Hyperbaric Medical Society (UHMS), but research is discovering other interesting applications.
HBO plays an important role in enhancing antioxidant defense mechanisms by increasing radical oxygen species (ROS) and nitric oxide species (NOS). This controlled oxidative stress has been shown to stop the vicious circle of inflammation - damage - hypoxia already seen in several diseases. Increased neoangiogenesis has been demonstrated at pressures of 2 atmospheres absolute (ATA), while effects helping ischemic tissues need pressures between 2.5 and 2.8 ATA to develop. Also, stem cell proliferation and mobilization have been demonstrated after HBO treatments.
During sports activities, metabolism generates waste products - mostly CO2, lactic acid, but also ROS. HBO could be useful in modulating antioxidant mechanisms and increasing stem cell mobilization, thus helping cells in the recovery after training and sportive competitions.
The authors hypothesize that:
The Authors will include healthy athletes. These will be randomly assigned to a control group, a L-HBO group, a HBO group, a 30% O2 group, or a 50% O2 group.
The Authors will assess oxidative stress changes and stem cells proliferation before and after 20 L-HBO/HBO/30% O2 mix/50% O2 mix treatments, and after 2 months after the end of treatments.
Subjects will be recruited through public announcements in local gyms and gathered to explain the protocol. Those willing to participate will sign a written informed consent and recruited. To be included, all the subjects will undergo a general medical screening to allow hyperbaric treatments. This will include weight, height, non-invasive arterial blood pressure, and heart rate measurements.
After inclusion, subjects will be randomly assigned to three arms using an electronic number generator by personnel not directly involved in the experiment:
Subjects included in Arm 2, 3, 4, 5 will undergo a total of 20 treatments. They will follow a personalized diet proportional to their energetic expenditure.
The Authors will identify 3 time-points in the protocol:
TIME 0 (T0): immediately after inclusion, before any treatment or experiment; TIME 1 (T1): at the end of HBO treatments; TIME 2 (T2): 2 months after the end of HBO treatments.
The following exams will be performed on the included subjects:
On urine samples (T0; T1; T2), the Authors will assess lipid peroxidation by measuring 8-isoprostane concentration (by competitive immunoassay), nitrite and nitrate (NO2/NO3) concentration (by colorimetry based on the Griess reaction), inducible Nitric Oxide Synthase (by ELISA commercially available kit), creatinine, neopterine, and uric acid concentrations, 8-oh-2-deoxyguanosine (by competitive immunoassay).
On saliva samples (T0; T1; T2) the Authors will measure reactive oxygen species and total antioxidant capacity (by paramagnetic resonance), and cortisol (by competitive immunoassay).
Blood samples (approximately 6-12 ml) will be drawn from the veins of the forearms (preferentially on the non-dominant limb); plasma and erythrocytes will be separated by centrifuge at 1000×g for 10 min at 4°C. Urine samples will be collected by voluntary voiding in sterile containers. 1 mL of saliva will be obtained by Salivette devices (Sarstedt, Nümbrecht, Germany). The subjects will be instructed to refrain from drinking, eating, smoking, brushing their teeth, and using mouthwash in the 30 min before salivary collection.
All samples will be stored in multiple aliquots at - 80 °C until assayed and thawed only once before analysis.
With this setting, blinding of patients and investigators will be impossible due to different structural characteristics. However, outcome assessors will be blinded to patients' allocation.
University of Padova is the lead sponsor of 210 studies on the registry; 42 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Low-pressure hyperbaric oxygen administration at 1.45 ATA for 60 minutes, inclusive of compression and decompression times, and a 3-minute air pause at the midtime. For a total of 20 sessions (3-4 per week).
Combination Product: L-HBO
Standard pressure hyperbaric oxygen administration at 2.5 ATA for 60 minutes, inclusive of compression and decompression times, and a 3-minute air pause at the midtime. For a total of 20 non-consecutive sessions (3-4 per week).
Combination Product: HBO
Control group of athletes, no intervention.
Administration of air mixture with 30% O2, subjects breathing this mixture for 60 minutes for a total of 20 non-consecutive sessions (3-4 per week).
Combination Product: 30% O2
Administration of air mixture with 50% O2, subjects breathing this mixture for 60 minutes for a total of 20 non-consecutive sessions (3-4 per week).
Combination Product: 50% O2
as previously described.
Also known as: Low Pressure Oxygenation
as previously described.
Also known as: Standard Pressure Oxygenation
as previously described
Also known as: 30% O2 mixture
as previously described
Also known as: 50% O2 mixture
Change in Reactive oxygen species production
Reactive oxygen species production (μmol min-1) (by paramagnetic resonance)
Time frame: On blood and saliva: at baseline (T0), at the completion of treatments (Time 1: 5 weeks after the baseline) and 2 months after the end of treatments (Time 2)
Change in Total antioxidant capacity
Total antioxidant capacity (by paramagnetic resonance) (mM)
Time frame: On blood and saliva: at baseline (T0), at the completion of treatments (Time 1: 5 weeks after the baseline) and 2 months after the end of treatments (Time 2)
Change in Cortisol levels
Cortisol (by competitive immunoassay) (ng/ml)
Time frame: On saliva: at baseline (T0), at the completion of treatments (Time 1: 5 weeks after the baseline) and 2 months after the end of treatments (Time 2)
Change in nitrite and nitrate (NO2/NO3) concentration
nitrite and nitrate (NO2/NO3) concentration (by colorimetry based on the Griess reaction) (μM)
Time frame: On urine: at baseline (T0), at the completion of treatments (Time 1: 5 weeks after the baseline) and 2 months after the end of treatments (Time 2)
Change in inducible Nitric Oxide Synthase (iNOS)
inducible Nitric Oxide Synthase (by ELISA commercially available kit) (IU mL-1)
Time frame: On urine: at baseline (T0), at the completion of treatments (Time 1: 5 weeks after the baseline) and 2 months after the end of treatments (Time 2)
Change in aminothiols levels
total (tot) and reduced (red) aminothiols (by fluorescence spectroscopy) (μmol L-1)
Time frame: On blood: Change from Baseline (T0) aminothiols concentration after the exercise test (Time 1: the day after baseline measurements), and at the completion of treatments after a second exercise test (Time 3: 5 weeks after the baseline)
Change in Cytokines levels
IL-1 beta, IL-6, TNF-alfa (pg ml-1)
Time frame: On blood: at baseline (T0), at the completion of treatments (Time 1: 5 weeks after the baseline) and 2 months after the end of treatments (Time 2)
Change in lipid peroxidation markers
On urine samples, we will assess lipid peroxidation by measuring 8-isoprostane and 8-OH-deoxyguanosine concentration (by competitive immunoassay) - (pg mg-1 creatinine)
Time frame: On urine: at baseline (T0), at the completion of treatments (Time 1: 5 weeks after the baseline) and 2 months after the end of treatments (Time 2)
Change in Renal damage markers
On urine samples, we will assess renal damage by measuring creatinine (g-L-1), neopterin (μmol·mol-1 creatinine), and uric acid levels (mg/dl).
Time frame: On urine: at baseline (T0), at the completion of treatments (Time 1: 5 weeks after the baseline) and 2 months after the end of treatments (Time 2)
Change in 3-nitrotyrosine levels
3-nitrotyrosine (3-NT) (by competitive immunoassay)( nM·L-1)
Time frame: On urine: at baseline (T0), at the completion of treatments (Time 1: 5 weeks after the baseline) and 2 months after the end of treatments (Time 2)
Change in Stem cells mobilization
Stem cells (by flow cytometry) (%)
Time frame: On blood: at baseline (T0), at the completion of treatments (Time 1: 5 weeks after the baseline) and 2 months after the end of treatments (Time 2)
Plan to share: No — First, data will be shared with the funding partner and disseminated through publications and meetings, and then made available upon request.
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