Oxidative StressPhase 2OXY-SPORTNCT04366427
Enriched Oxygen Mixtures in Athletes
A Phase 2 study testing L-HBO, HBO and 30% O2 in people with Oxidative Stress and Stem Cell Research, run by University of Padova at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress, Stem Cell Research
- What is being tested?
- L-HBO, HBO and 30% O2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteItaly
- Study dates
- 15 Sep 2020to 31 Dec 2020
- Phase
- Phase 2
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- professional athletes
- performing at least 3 training sessions/week
Who cannot join
- previous pneumothorax
- problems with compensation maneuvers
- known epilepsy
- active smoker
Trial locations and contacts
1 site in 1 country.
Italy1 site
Human Physiology Institute, Department of Biomedical Sciences, University of Padova
Padova, Veneto, 35135
About this study
Official title: Effects of Enriched Oxygen Mixtures and Exercise on Oxidative Stress and Stem Cells Proliferation in Athletes.
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.
Read more
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:
- HBO can reduce oxidative stress and induce stem cell mobilization in healthy professional athletes;
- hyperoxic mixtures can reduce oxidative stress and induce stem cells mobilization in healthy professional athletes;
- HBO at low pressures (L-HBO at 1.45 ATA) is at least comparable to conventional HBO (at 2.5 ATA) in reducing oxidative stress and increasing stem cell mobilization.
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.
Read the detailed description
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:
- Arm 1(control): no intervention.
- Arm 2 (L-HBO): treated with oxygen at 1.45 ATA for 60 min (inclusive of compression and decompression times, and an air break of 3 minutes breathing air);
- Arm 3 (HBO): treated with oxygen at 2.5 ATA for 60 min (inclusive of compression and decompression times, and an air break of 3 minutes breathing air).
- Arm 4 (30% O2): breathing an air mixture with 30% of oxygen at atmospheric pressure (1 ATA).
- Arm 5 (50% O2): breathing an air mixture with 50% of oxygen at atmospheric pressure (1 ATA).
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:
- a standardized panel including Complete Blood Count (CBC), creatinine, Blood Urea Nitrogen (BUN), C reactive protein, and VES will be performed at T0, T1, and T2.
- oxidative stress markers will be analyzed on blood, urine, and saliva samples. On blood samples (T0; T1; T2), the Authors will measure IL-1 beta, IL-6, TNF-alfa, reactive oxygen species and total antioxidant capacity (by paramagnetic resonance), total (tot) and reduced (red) aminothiols (by fluorescence spectroscopy), 3-nitrotyrosine (3-NT) (by competitive immunoassay).
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).
- stem cells will be analyzed on blood samples (at T0, T1, T2) (by flow cytometry).
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.
- Conditions
- Oxidative Stress, Stem Cell Research
- Being tested
- L-HBO, HBO, 30% O2, 50% O2
- Keywords
- Hyperbaric Oxigenation, Sport Medicine, Training, Recovery, Oxidative Stress, Stem Cell Research
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-HBOCombination product
Also called Low Pressure Oxygenation
as previously described.
HBOCombination product
Also called Standard Pressure Oxygenation
as previously described.
30% O2Combination product
Also called 30% O2 mixture
as previously described
50% O2Combination product
Also called 50% O2 mixture
as previously described
| Study group | Role | What they receive |
|---|---|---|
| Low-pressure hyperbaric oxygenation (L-HBO) | Experimental | 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). Receives: Combination Product: L-HBO |
| Standard-pressure hyperbaric oxygenation (HBO) | Experimental | 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). Receives: Combination Product: HBO |
| Control | No intervention | Control group of athletes, no intervention. |
| 30% O2 | Experimental | 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). Receives: Combination Product: 30% O2 |
| 50% O2 | Experimental | 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). Receives: Combination Product: 50% O2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Reactive oxygen species production
Reactive oxygen species production (μmol min-1) (by paramagnetic resonance)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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)
Measured: 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) (%)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start15 Sep 2020
- Primary completion15 Nov 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Oxidative StressStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Five arms: one control without treatment; one at low pressure (1.45 ATA); one at standard pressure (2.5 ATA); one at atmospheric pressure (1 ATA) breathing air mixture with 30% O2; one at atmospheric pressure (1 ATA) breathing air mixture with 50% O2;
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Collaborators
- Performa di Crocicchia Srl
- Responsible party
- Principal investigator, Gerardo Bosco, University of Padova
- Investigators
- Gerardo Bosco, MD, PhD, Principal investigator, University of PadovaMatteo Paganini, MD, Study director, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366427
- Sponsor's protocol ID
- HEC-DSB/04-19
- Acronym
- OXY-SPORT
- Status last verified
- Apr 2021
- First submitted
- 4 Mar 2020
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: First, data will be shared with the funding partner and disseminated through publications and meetings, and then made available upon request.
Publications
Pedoto A, Nandi J, Yang ZJ, Wang J, Bosco G, Oler A, Hakim TS, Camporesi EM. Beneficial effect of hyperbaric oxygen pretreatment on lipopolysaccharide-induced shock in rats. Clin Exp Pharmacol Physiol. 2003 Jul;30(7):482-8. doi: 10.1046/j.1440-1681.2003.03865.x.
PubMed 12823263Bosco G, Yang ZJ, Nandi J, Wang J, Chen C, Camporesi EM. Effects of hyperbaric oxygen on glucose, lactate, glycerol and anti-oxidant enzymes in the skeletal muscle of rats during ischaemia and reperfusion. Clin Exp Pharmacol Physiol. 2007 Jan-Feb;34(1-2):70-6. doi: 10.1111/j.1440-1681.2007.04548.x.
PubMed 17201738Yang ZJ, Xie Y, Bosco GM, Chen C, Camporesi EM. Hyperbaric oxygenation alleviates MCAO-induced brain injury and reduces hydroxyl radical formation and glutamate release. Eur J Appl Physiol. 2010 Feb;108(3):513-22. doi: 10.1007/s00421-009-1229-9. Epub 2009 Oct 23.
PubMed 19851780Bosco G, Yang ZJ, Di Tano G, Camporesi EM, Faralli F, Savini F, Landolfi A, Doria C, Fano G. Effect of in-water oxygen prebreathing at different depths on decompression-induced bubble formation and platelet activation. J Appl Physiol (1985). 2010 May;108(5):1077-83. doi: 10.1152/japplphysiol.01058.2009. Epub 2010 Feb 25.
PubMed 20185629Morabito C, Bosco G, Pilla R, Corona C, Mancinelli R, Yang Z, Camporesi EM, Fano G, Mariggio MA. Effect of pre-breathing oxygen at different depth on oxidative status and calcium concentration in lymphocytes of scuba divers. Acta Physiol (Oxf). 2011 May;202(1):69-78. doi: 10.1111/j.1748-1716.2010.02247.x. Epub 2011 Mar 1.
PubMed 21199400Nasole E, Nicoletti C, Yang ZJ, Girelli A, Rubini A, Giuffreda F, Di Tano A, Camporesi E, Bosco G. Effects of alpha lipoic acid and its R+ enantiomer supplemented to hyperbaric oxygen therapy on interleukin-6, TNF-alpha and EGF production in chronic leg wound healing. J Enzyme Inhib Med Chem. 2014 Apr;29(2):297-302. doi: 10.3109/14756366.2012.759951. Epub 2013 Jan 30.
PubMed 23360079Camporesi EM, Bosco G. Mechanisms of action of hyperbaric oxygen therapy. Undersea Hyperb Med. 2014 May-Jun;41(3):247-52.
PubMed 24984320Bosco G, Vezzani G, Mrakic Sposta S, Rizzato A, Enten G, Abou-Samra A, Malacrida S, Quartesan S, Vezzoli A, Camporesi E. Hyperbaric oxygen therapy ameliorates osteonecrosis in patients by modulating inflammation and oxidative stress. J Enzyme Inhib Med Chem. 2018 Dec;33(1):1501-1505. doi: 10.1080/14756366.2018.1485149.
PubMed 30274530Moskowitz A, Andersen LW, Huang DT, Berg KM, Grossestreuer AV, Marik PE, Sherwin RL, Hou PC, Becker LB, Cocchi MN, Doshi P, Gong J, Sen A, Donnino MW. Ascorbic acid, corticosteroids, and thiamine in sepsis: a review of the biologic rationale and the present state of clinical evaluation. Crit Care. 2018 Oct 29;22(1):283. doi: 10.1186/s13054-018-2217-4.
PubMed 30373647Fisher-Wellman K, Bloomer RJ. Acute exercise and oxidative stress: a 30 year history. Dyn Med. 2009 Jan 13;8:1. doi: 10.1186/1476-5918-8-1.
PubMed 19144121Menzies P, Menzies C, McIntyre L, Paterson P, Wilson J, Kemi OJ. Blood lactate clearance during active recovery after an intense running bout depends on the intensity of the active recovery. J Sports Sci. 2010 Jul;28(9):975-82. doi: 10.1080/02640414.2010.481721.
PubMed 20544484Van Hooren B, Peake JM. Do We Need a Cool-Down After Exercise? A Narrative Review of the Psychophysiological Effects and the Effects on Performance, Injuries and the Long-Term Adaptive Response. Sports Med. 2018 Jul;48(7):1575-1595. doi: 10.1007/s40279-018-0916-2.
PubMed 29663142
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Enriched Oxygen Mixtures and Exercise on Oxidative Stress and Stem Cells Proliferation in Athletes.
- ClinicalTrials.gov ID
- NCT04366427
- Acronym / sponsor ID
- OXY-SPORT / HEC-DSB/04-19
- Conditions
- Oxidative Stress, Stem Cell Research
- Keywords
- Hyperbaric Oxigenation, Sport Medicine, Training, Recovery, Oxidative Stress, Stem Cell Research
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Collaborators
- Performa di Crocicchia Srl
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 15 Nov 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 28 Apr 2020 (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.
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:
- HBO can reduce oxidative stress and induce stem cell mobilization in healthy professional athletes;
- hyperoxic mixtures can reduce oxidative stress and induce stem cells mobilization in healthy professional athletes;
- HBO at low pressures (L-HBO at 1.45 ATA) is at least comparable to conventional HBO (at 2.5 ATA) in reducing oxidative stress and increasing stem cell mobilization.
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.
Detailed description
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:
- Arm 1(control): no intervention.
- Arm 2 (L-HBO): treated with oxygen at 1.45 ATA for 60 min (inclusive of compression and decompression times, and an air break of 3 minutes breathing air);
- Arm 3 (HBO): treated with oxygen at 2.5 ATA for 60 min (inclusive of compression and decompression times, and an air break of 3 minutes breathing air).
- Arm 4 (30% O2): breathing an air mixture with 30% of oxygen at atmospheric pressure (1 ATA).
- Arm 5 (50% O2): breathing an air mixture with 50% of oxygen at atmospheric pressure (1 ATA).
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:
- a standardized panel including Complete Blood Count (CBC), creatinine, Blood Urea Nitrogen (BUN), C reactive protein, and VES will be performed at T0, T1, and T2.
- oxidative stress markers will be analyzed on blood, urine, and saliva samples. On blood samples (T0; T1; T2), the Authors will measure IL-1 beta, IL-6, TNF-alfa, reactive oxygen species and total antioxidant capacity (by paramagnetic resonance), total (tot) and reduced (red) aminothiols (by fluorescence spectroscopy), 3-nitrotyrosine (3-NT) (by competitive immunoassay).
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).
- stem cells will be analyzed on blood samples (at T0, T1, T2) (by flow cytometry).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
- Model description
- Five arms: one control without treatment; one at low pressure (1.45 ATA); one at standard pressure (2.5 ATA); one at atmospheric pressure (1 ATA) breathing air mixture with 30% O2; one at atmospheric pressure (1 ATA) breathing air mixture with 50% O2;
| Arm | Type | Receives |
|---|---|---|
| Low-pressure hyperbaric oxygenation (L-HBO) | Experimental | Combination Product: L-HBOLow-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). |
| Standard-pressure hyperbaric oxygenation (HBO) | Experimental | Combination Product: HBOStandard 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). |
| Control | No intervention | –Control group of athletes, no intervention. |
| 30% O2 | Experimental | Combination Product: 30% O2Administration 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). |
| 50% O2 | Experimental | Combination Product: 50% O2Administration 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). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- professional athletes
- performing at least 3 training sessions/week
Key exclusion criteria (4 listed)
- previous pneumothorax
- problems with compensation maneuvers
- known epilepsy
- active smoker
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 |
|---|---|---|
| L-HBOAlso: Low Pressure Oxygenationas previously described. | Combination product | Low-pressure hyperbaric oxygenation (L-HBO) |
| HBOAlso: Standard Pressure Oxygenationas previously described. | Combination product | Standard-pressure hyperbaric oxygenation (HBO) |
| 30% O2Also: 30% O2 mixtureas previously described | Combination product | 30% O2 |
| 50% O2Also: 50% O2 mixtureas previously described | Combination product | 50% O2 |
Primary outcome
Change in Reactive oxygen species production
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)
Reactive oxygen species production (μmol min-1) (by paramagnetic resonance)
Change in Total antioxidant capacity
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)
Total antioxidant capacity (by paramagnetic resonance) (mM)
Change in Cortisol levels
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)
Cortisol (by competitive immunoassay) (ng/ml)
Change in nitrite and nitrate (NO2/NO3) concentration
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)
nitrite and nitrate (NO2/NO3) concentration (by colorimetry based on the Griess reaction) (μM)
Change in inducible Nitric Oxide Synthase (iNOS)
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)
inducible Nitric Oxide Synthase (by ELISA commercially available kit) (IU mL-1)
Change in aminothiols levels
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)
total (tot) and reduced (red) aminothiols (by fluorescence spectroscopy) (μmol L-1)
Change in Cytokines levels
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)
IL-1 beta, IL-6, TNF-alfa (pg ml-1)
Change in lipid peroxidation markers
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)
On urine samples, we will assess lipid peroxidation by measuring 8-isoprostane and 8-OH-deoxyguanosine concentration (by competitive immunoassay) - (pg mg-1 creatinine)
Change in Renal damage markers
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)
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).
Change in 3-nitrotyrosine levels
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)
3-nitrotyrosine (3-NT) (by competitive immunoassay)( nM·L-1)
Change in Stem cells mobilization
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)
Stem cells (by flow cytometry) (%)
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 30 Apr 2021.
- Background: PubMed 12823263Pedoto A, Nandi J, Yang ZJ, Wang J, Bosco G, Oler A, Hakim TS, Camporesi EM. Beneficial effect of hyperbaric oxygen pretreatment on lipopolysaccharide-induced shock in rats. Clin Exp Pharmacol Physiol. 2003 Jul;30(7):482-8. doi: 10.1046/j.1440-1681.2003.03865.x.
- Background: PubMed 17201738Bosco G, Yang ZJ, Nandi J, Wang J, Chen C, Camporesi EM. Effects of hyperbaric oxygen on glucose, lactate, glycerol and anti-oxidant enzymes in the skeletal muscle of rats during ischaemia and reperfusion. Clin Exp Pharmacol Physiol. 2007 Jan-Feb;34(1-2):70-6. doi: 10.1111/j.1440-1681.2007.04548.x.
- Background: PubMed 19851780Yang ZJ, Xie Y, Bosco GM, Chen C, Camporesi EM. Hyperbaric oxygenation alleviates MCAO-induced brain injury and reduces hydroxyl radical formation and glutamate release. Eur J Appl Physiol. 2010 Feb;108(3):513-22. doi: 10.1007/s00421-009-1229-9. Epub 2009 Oct 23.
- Background: PubMed 20185629Bosco G, Yang ZJ, Di Tano G, Camporesi EM, Faralli F, Savini F, Landolfi A, Doria C, Fano G. Effect of in-water oxygen prebreathing at different depths on decompression-induced bubble formation and platelet activation. J Appl Physiol (1985). 2010 May;108(5):1077-83. doi: 10.1152/japplphysiol.01058.2009. Epub 2010 Feb 25.
- Background: PubMed 21199400Morabito C, Bosco G, Pilla R, Corona C, Mancinelli R, Yang Z, Camporesi EM, Fano G, Mariggio MA. Effect of pre-breathing oxygen at different depth on oxidative status and calcium concentration in lymphocytes of scuba divers. Acta Physiol (Oxf). 2011 May;202(1):69-78. doi: 10.1111/j.1748-1716.2010.02247.x. Epub 2011 Mar 1.
- Background: PubMed 23360079Nasole E, Nicoletti C, Yang ZJ, Girelli A, Rubini A, Giuffreda F, Di Tano A, Camporesi E, Bosco G. Effects of alpha lipoic acid and its R+ enantiomer supplemented to hyperbaric oxygen therapy on interleukin-6, TNF-alpha and EGF production in chronic leg wound healing. J Enzyme Inhib Med Chem. 2014 Apr;29(2):297-302. doi: 10.3109/14756366.2012.759951. Epub 2013 Jan 30.
- Background: PubMed 24984320Camporesi EM, Bosco G. Mechanisms of action of hyperbaric oxygen therapy. Undersea Hyperb Med. 2014 May-Jun;41(3):247-52.
- Background: PubMed 30274530Bosco G, Vezzani G, Mrakic Sposta S, Rizzato A, Enten G, Abou-Samra A, Malacrida S, Quartesan S, Vezzoli A, Camporesi E. Hyperbaric oxygen therapy ameliorates osteonecrosis in patients by modulating inflammation and oxidative stress. J Enzyme Inhib Med Chem. 2018 Dec;33(1):1501-1505. doi: 10.1080/14756366.2018.1485149.
- Background: PubMed 30373647Moskowitz A, Andersen LW, Huang DT, Berg KM, Grossestreuer AV, Marik PE, Sherwin RL, Hou PC, Becker LB, Cocchi MN, Doshi P, Gong J, Sen A, Donnino MW. Ascorbic acid, corticosteroids, and thiamine in sepsis: a review of the biologic rationale and the present state of clinical evaluation. Crit Care. 2018 Oct 29;22(1):283. doi: 10.1186/s13054-018-2217-4.
- Background: PubMed 19144121Fisher-Wellman K, Bloomer RJ. Acute exercise and oxidative stress: a 30 year history. Dyn Med. 2009 Jan 13;8:1. doi: 10.1186/1476-5918-8-1.
- Background: PubMed 20544484Menzies P, Menzies C, McIntyre L, Paterson P, Wilson J, Kemi OJ. Blood lactate clearance during active recovery after an intense running bout depends on the intensity of the active recovery. J Sports Sci. 2010 Jul;28(9):975-82. doi: 10.1080/02640414.2010.481721.
- Background: PubMed 29663142Van Hooren B, Peake JM. Do We Need a Cool-Down After Exercise? A Narrative Review of the Psychophysiological Effects and the Effects on Performance, Injuries and the Long-Term Adaptive Response. Sports Med. 2018 Jul;48(7):1575-1595. doi: 10.1007/s40279-018-0916-2.
- Individual participant dataSharing planned: 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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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.
Gerardo Bosco, MD, PhD principal investigator
University of Padova
Matteo Paganini, MD study director
University of Padova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing L-HBO, HBO and 30% O2 in people with Oxidative Stress and Stem Cell Research, run by University of Padova at 1 site in Italy.
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 2 inclusion and 4 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 30 Apr 2021. 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 Italy. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in Reactive oxygen species production (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)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04366427, which also lists 12 linked publications.
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 30 Apr 2021.