ClinicalTrials.gg
CompletedNCT07551869Updated Apr 30, 2026

Oxygen as a Metabolic Modulator: Divergent Physiological Adaptations to Hypoxic and Hyperoxic Tabata Training.

An interventional study of FIO2 modulation during HIIT protocol on assault bike in Hyperoxia / High FiO₂ Exposure, Interval Training and HIIT, sponsored by Haute Ecole Bruxelles-Brabant. Completed at 1 site in Belgium. Open to male participants aged 19 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-30.

Sponsored by Haute Ecole Bruxelles-Brabant · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 3 years 2 months after the study started (first participant enrolled Jan 2023, registered Apr 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
19 Years to 35 Years
Sex
Male
01

Study summary

The purpose of this study is to examine how breathing air with different oxygen concentrations (higher or lower than normal) during high-intensity interval training affects:

  • Aerobic capacity (VO₂max)
  • Ventilatory thresholds
  • Blood lactate levels
  • Perceived exertion This research aims to better understand how oxygen availability influences physiological adaptations to exercise.

If you agree to participate, you will undergo the following:

Baseline testing:

  • Cardiopulmonary exercise test (cycling until exhaustion)
  • Measurement of oxygen consumption, heart rate, and ventilatory thresholds
  • Blood lactate measurement (finger prick)

Training intervention (3 weeks):

  • 3 sessions per week (total of 9 sessions)
  • High-intensity interval training (Tabata protocol: 8 × 20 seconds effort / 10 seconds rest)
  • Exercise performed on an air-resistance cycle ergometer

During training, you will breathe either:

  • Hyperoxic air (high oxygen concentration) or
  • Hypoxic air (low oxygen concentration) You will be randomly assigned to one of these conditions.

Post-intervention testing:

  • Same assessments as baseline

The risks associated with this study are similar to those encountered during high-intensity exercise:

  • Fatigue
  • Muscle soreness
  • Shortness of breath
  • Temporary discomfort from finger-prick blood sampling

Breathing altered oxygen concentrations (hypoxia or hyperoxia) may induce:

  • Mild dizziness
  • Increased breathing effort (hypoxia)
  • Sensations of ease or altered effort perception (hyperoxia) All sessions are supervised by trained personnel, and safety monitoring is ensured throughout the study

You may benefit from:

  • Improved physical fitness
  • Detailed physiological assessment (VO₂max, thresholds) However, no direct health benefit is guaranteed. Your participation is entirely voluntary.
  • You may withdraw at any time
  • You do not need to provide a reason
  • Withdrawal will not affect your academic or professional standing

All collected data will be:

  • Anonymized
  • Stored securely
  • Used only for research purposes Your identity will not be disclosed in any publication. Data will be handled in accordance with applicable data protection regulations (GDPR).

You have the right to:

  • Access your data
  • Request correction or deletion where applicable
02

Conditions studied

  • Hyperoxia / High FiO₂ Exposure
  • Interval Training
  • HIIT
  • High Intensity Interval Training
  • VO2max
  • Hypoxia

Keywords

  • Human
  • HIIT
  • High Intensity Interval Training
  • Assault-Bike
  • VO2max
  • Tabata training
  • Hypoxia
  • Hyperoxia
03

In context

Hyperoxia

115 studies on the registry are indexed under Hyperoxia; 13 are open to participants now.

This study's enrollment of 23 is below the median of 48 across 82 interventional studies indexed under Hyperoxia.

Browse Hyperoxia studies →

Lead sponsor

Haute Ecole Bruxelles-Brabant is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 35 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • recreationally active
  • male
  • 18-35 years old

Exclusion criteria

Exclusion Criteria:

  • engaged in professional or elite-level sports training
  • cardiovascular, pulmonary, metabolic, or neurological disease
  • taking medications known to influence cardiovascular or metabolic responses to exercise To minimize potential confounding factors, participants were instructed to refrain from strenuous physical activity, alcohol consumption, caffeine intake, and smoking for at least 24 hours before each testing session, in accordance with standard exercise testing procedures recommended in exercise physiology guidelines
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    Hyperoxia group

    inspired oxygen fraction (FiO₂) = 0.60 during Tabatha protocol

    Other: FIO2 modulation during HIIT protocol on assault bike

  • Experimental
    Hypoxia group

    inspired oxygen fraction (FiO₂) = 0.16 during Tabatha protocol

    Other: FIO2 modulation during HIIT protocol on assault bike

Interventions

  • OtherFIO2 modulation during HIIT protocol on assault bike

    Normobaric hyperoxic breathing during high-intensity interval training (FiO2 0.60) and hypoxic (FiO2 0.16)

06

What researchers measure

Primary outcomes

  1. maximal oxygen uptake (VO₂max)

    VO2max represents the maximal rate at which an individual can consume oxygen during incremental exercise. It is measured during a graded exercise test (e.g., treadmill or cycle ergometer) using indirect calorimetry. It reflects aerobic capacity and cardiovascular fitness. Higher values indicate better aerobic performance and endurance capacity.

    Time frame: From enrollment to the end of protocol at 3 weeks

Secondary outcomes

  1. the first and second ventilatory thresholds (VT1, VT2)

    VT1 (first ventilatory threshold) corresponds to the exercise intensity at which ventilation begins to increase disproportionately relative to oxygen uptake, indicating the onset of lactate accumulation. VT2 (second ventilatory threshold) marks a further disproportionate increase in ventilation due to metabolic acidosis. These thresholds are determined from gas exchange analysis during exercise testing and reflect submaximal aerobic and anaerobic transition points.

    Time frame: from enrollment to the end of the protocol at 3 weeks

  2. peak blood lactate

    Peak blood lactate is the highest concentration of lactate measured in the blood during or immediately after maximal exercise. It is assessed via capillary or venous blood sampling. This measure reflects the degree of anaerobic metabolism and glycolytic contribution during high-intensity effort.

    Time frame: from enrollment to the end of protocol at 3 weeks

  3. session rating of perceived exertion (RPE).

    RPE is a subjective measure of exercise intensity based on an individual's perception of effort, typically assessed using standardized scales such as the Borg scale (6-20 or 0-10). It integrates physiological and psychological responses to exercise and is useful for monitoring training load and tolerance.

    Time frame: from enrollment to the end of the protocol at 3 weeks

07

Study locations

1 site
  • Haute Ecole Bruxelles Brabant - HE2B
    Brussels, Brussels Capital 1040, Belgium
08

References and documents

Publications

  • Balestra C, Lambrechts K, Mrakic-Sposta S, Vezzoli A, Levenez M, Germonpre P, Virgili F, Bosco G, Lafere P. Hypoxic and Hyperoxic Breathing as a Complement to Low-Intensity Physical Exercise Programs: A Proof-of-Principle Study. Int J Mol Sci. 2021 Sep 4;22(17):9600. doi: 10.3390/ijms22179600. PubMed 34502508 ↗
  • Balestra C, Mrakic-Sposta S, Virgili F. Oxygen Variations-Insights into Hypoxia, Hyperoxia and Hyperbaric Hyperoxia-Is the Dose the Clue? Int J Mol Sci. 2023 Aug 30;24(17):13472. doi: 10.3390/ijms241713472. PubMed 37686277 ↗
  • Balestra C, Kot J. Oxygen: A Stimulus, Not "Only" a Drug. Medicina (Kaunas). 2021 Oct 25;57(11):1161. doi: 10.3390/medicina57111161. PubMed 34833379 ↗

Individual participant data

Plan to share: No — Data are collected for this study only. The experiments opens new questions and so new data collection

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07551869
Lead sponsor
Haute Ecole Bruxelles-Brabant
Responsible party
Costantino Balestra (Director of the Integrative Physiology Laboratory , Professor, PhD, Haute Ecole Bruxelles-Brabant) — Principal investigator
First posted
Apr 27, 2026
Start date
Jan 10, 2023
Primary completion
Jun 10, 2023
Completion
Dec 15, 2025
Last update
Apr 30, 2026

Study contacts

Clément Levêque, PhD
study director · HE2B

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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