Enriched Oxygen Mixtures in Athletes
NCT04366427 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2021-04-30
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.
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:
1. HBO can reduce oxidative stress and induce stem cell mobilization in healthy professional athletes;
2. hyperoxic mixtures can reduce oxidative stress and induce stem cells mobilization in healthy professional athletes;
3. 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.
Conditions
- Oxidative Stress
- Stem Cell Research
Interventions
- COMBINATION_PRODUCT
-
L-HBO
as previously described.
- COMBINATION_PRODUCT
-
HBO
as previously described.
- COMBINATION_PRODUCT
-
30% O2
as previously described
- COMBINATION_PRODUCT
-
50% O2
as previously described
Sponsors & Collaborators
-
Performa di Crocicchia Srl
collaborator UNKNOWN -
University of Padova
lead OTHER
Principal Investigators
-
Gerardo Bosco, MD, PhD · University of Padova
-
Matteo Paganini, MD · University of Padova
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 35 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-09-15
- Primary Completion
- 2020-11-15
- Completion
- 2020-12-31
Countries
- Italy
Study Locations
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