CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
L-HBO +3 morecombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04366427
NCT04366427Phase 2Completed

Effects of Enriched Oxygen Mixtures and Exercise on Oxidative Stress and Stem Cells Proliferation in Athletes.

University of Padova·interventional·Posted Apr 28, 2020·Updated Apr 30, 2021

In Brief

A Phase 2 clinical trial evaluating L-HBO, HBO, and 2 other interventions for Oxidative Stress and Stem Cell Research. Completed, enrolled 42 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedApr 28, 2020
Enrollment StartSep 15, 2020
Primary CompletionNov 15, 2020
Study CompletionDec 31, 2020
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 6.2 years ago

Interventions

L-HBOcombination

as previously described.

HBOcombination

as previously described.

30% O2combination

as previously described

50% O2combination

as previously described