Enriched Oxygen Mixtures in Athletes

NCT04366427 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2021-04-30

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04366427 on ClinicalTrials.gov