Obesity & OverweightHYPOXHIITNCT07814599
Metabolic and Nutritional Responses to Acute High-intensity Interval Exercise Performed Under Hypoxic vs. Normoxic Conditions at Matched External Workload in Adults With Overweight and Obesity.
A study testing HIIE - Normoxia and HIIE - Hypoxia in people with Obesity & Overweight and Energy Expenditure, run by Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques at 1 site in France.
Trial summary
Obesity management involves lifestyle and dietary measures that include appropriate nutrition and increased physical activity (PA). Among the various PA options available, HIIT (High-Intensity Interval Training) workouts are now recognized as fun and effective programs for promoting fat loss. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Obesity & Overweight, Energy Expenditure, Substrate Oxidation
- What is being tested?
- HIIE - Normoxia and HIIE - Hypoxia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2024to 1 Sep 2026
- Phase
- Interventional
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- overweight or obesity (BMI between 25 kg/m2 and 35 kg/m2)
Who cannot join
- medical contraindications to intense physical activity
- taking ß-blocker
- diabete
- women taking hormonal replacement therapy
Trial locations and contacts
1 site in 1 country.
France1 site
CREPS Auvergne Rhône-Alpes / Vichy
Bellerive-sur-Allier, Allier, 03321
About this study
Official title: Comparison of HIIT Exercise Under Hypoxic and Normoxic Conditions in Adults With Overweight or Obesity: Impact on Oxygen Consumption, Carbohydrate and Lipid Substrate Utilization, and Appetite During Recovery.
Obesity management involves lifestyle and dietary measures that include appropriate nutrition and increased physical activity (PA). Among the various PA options available, HIIT (High-Intensity Interval Training) workouts are now recognized as fun and effective programs for promoting fat loss. To date, in overweight or obese individuals, only two studies mention the benefits of HIIT performed under hypoxia for modulating body composition, and more specifically, reducing the amount of adipose tissue. These studies hypothesize an increased energy expenditure under hypoxia associated with a transient loss of appetite. In order, to further investigate the adaptations following HIIT under hypoxia versus normoxia, we propose to compare, in acute conditions, two HIIT sessions (simulated hypoxia-normobaric vs. normoxia) in overweight or obese subjects. The objective of this assessment is to compare, during exercise and recovery (+2h), oxygen consumption, corresponding energy expenditure, and carbohydrate and lipid utilization in hypoxic versus normoxic conditions. Given the potential influence of hypoxia on appetite, spontaneous food intake and energy expenditure post-24h will also be measured. Finally, since pleasure and perceived exertion are key parameters in adherence to an adapted physical activity (APA) program, these two concepts will also be evaluated through the subjects' experiences.
Read the detailed description
Obesity management involves lifestyle and dietary measures that include appropriate nutrition and increased physical activity (PA). Among the various PA options available, High-intensity interval training (HIIT) is now recognized as a well-tolerated, safe, and effective exercise modality for improving body composition. In 2016, our pioneering study demonstrated that HIIT is more effective than moderate-intensity continuous training (MICT) in inducing abdominal fat loss in postmenopausal women. A subsequent meta-analysis, conducted by our team in 2018 and encompassing 39 articles involving 617 participants, confirmed the significant effects of HIIT on reducing total and abdominal fat mass in overweight or obese individuals More recently, our work has shown significant results from HIIT + resistance training or HIIT cycling vs. running on improving body composition, and more specifically on reducing abdominal and visceral fat mass, in overweight or obese subjects.
With a focus on performance, HIIT has been combined with simulated hypoxia to maximize training adaptations, particularly to improve cardiovascular, respiratory, circulatory, hematological, and metabolic capacities at the muscular level. Live Low Train High (LLTH) allows athletes to maintain normoxia while being exposed to acute periods of hypoxia during training via hypoxic chambers (simulated altitude). More recently, research has explored the effects of HIIT under hypoxic conditions in patients with metabolic disorders and/or physical deconditioning, focusing primarily on cardiovascular and ventilatory adaptations. To date, in overweight or obese individuals, only three studies investigated the benefit of HIIT under simulated hypoxia for modulating body composition, and more specifically for reducing total or abdominal fat. These studies generally hypothesize a higher energy expenditure during hypoxia, associated with a transient loss of appetite that may be linked to hormonal disturbances, central nervous system adaptability, or metabolic flexibility altering hunger and satiety signals.
In parallel with these hypotheses, hypoxia stimulates HIF-1 production, thus promoting a shift from oxidative metabolism to glycolysis. At the same external mechanical load, the increased use of carbohydrates via glycolysis, combined with increased cardiovascular stress, should promote, during the recovery phase, greater oxygen consumption and lipid oxidation following a hypoxic session. To date, no study has yet evaluated these hypotheses by comparing these parameters following two acute HIIT sessions performed under normoxia or hypoxia.
The aim is to compare the influence of these two sessions on oxygen consumption, the corresponding energy expenditure, and carbohydrate and lipid utilization during recovery (+2h). Given the potential influence of hypoxia on appetite, food intake and spontaneous energy expenditure post-24h will also be measured. Finally, since enjoyment and perceived exertion are crucial parameters for adherence to an adapted physical activity (APA) program, these two concepts will also be assessed through the participants' experiences.
The authors propose the following hypotheses:
Main hypothesis:
- Lipid oxidation (g/min) during recovery (+2h) will be higher post-hypoxic session. Secondary hypotheses:
- Oxygen consumption and energy expenditure will be increased during post-hypoxic session recovery.
4/ Energy intake from the post-exercise meal may be lower post-hypoxic condition.
5/ The effort will be perceived as slightly more difficult in hypoxia due to increased cardiovascular demand.
- Being tested
- HIIE - Normoxia, HIIE - Hypoxia
- Keywords
- high intensity interval exercise, hypoxia, substrate oxidation, appetite, energy intake
- Medical subject headings
- Obesity, Overweight, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIIE - NormoxiaOther
Cycling HIIE in Normoxia: 60 x [8 seconds at a power equivalent to 80-85% of HRmax followed by 12 seconds of active recovery at a power equivalent to 40% of HRmax]
HIIE - HypoxiaOther
Cycling HIIE in Hypoxia (FiO2: 15%): 60 x [8 seconds at a power equivalent to 80-85% of HRmax followed by 12 seconds of active recovery at a power equivalent to 40% of HRmax]
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Exercise - Normoxia | Experimental | HIIE in normoxia Receives: Other: HIIE - Normoxia |
| High Intensity Interval Exercise - Hypoxia | Experimental | HIIE in hypoxia Receives: Other: HIIE - Hypoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid oxidation after the exercise session (nromoxia and hypoxia).
Determination of lipid and carbohydrate oxidation after the exercise (HIIE normoxia and hypoxia). Lipid aoxidation is measured from oxygen and carbon dioxide consumption (Metamax 3D Cortex).
Measured: Measurement during two hours after the end of the exercise
Secondary outcomes (3)
Oxygen consumption during the recovery period
Determination of oxygen consumption 2 hours after the exercise session (HIIE normoxia and hypoxia). Determination from Metamax (3D Cortex).
Measured: Two hours after the end of the exercise
Energy intakes 24 hours after the exercise
Evaluation of energy intakes after the exercise session (HIIE normoxia and HIIE hypoxia) during 24 hours (from questionnaires)
Measured: 24 hours post exercise
Appetite
Feelings of appetite are measured using a visual appetite scale immediately before and after exercise (+0 min, +60 min, and +120 min).
Measured: Before exercise and after exercise (+0 min, +60 min, and +120 min).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start1 Nov 2024
- Primary completion1 Sep 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
- Sponsor type
- University, hospital or other
- Collaborators
- CREPS Vichy Auvergne
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814599
- Sponsor's protocol ID
- IRB00012476-2024-23-09-342
- Acronym
- HYPOXHIIT
- Status last verified
- Sep 2026
- First submitted
- 5 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of HIIT Exercise Under Hypoxic and Normoxic Conditions in Adults With Overweight or Obesity: Impact on Oxygen Consumption, Carbohydrate and Lipid Substrate Utilization, and Appetite During Recovery.
- ClinicalTrials.gov ID
- NCT07814599
- Acronym / sponsor ID
- HYPOXHIIT / IRB00012476-2024-23-09-342
- Keywords
- high intensity interval exercise, hypoxia, substrate oxidation, appetite, energy intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et PathologiquesUniversity, hospital or other
- Collaborators
- CREPS Vichy Auvergne
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 11 Sep 2026 (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.
Obesity management involves lifestyle and dietary measures that include appropriate nutrition and increased physical activity (PA). Among the various PA options available, HIIT (High-Intensity Interval Training) workouts are now recognized as fun and effective programs for promoting fat loss. To date, in overweight or obese individuals, only two studies mention the benefits of HIIT performed under hypoxia for modulating body composition, and more specifically, reducing the amount of adipose tissue. These studies hypothesize an increased energy expenditure under hypoxia associated with a transient loss of appetite. In order, to further investigate the adaptations following HIIT under hypoxia versus normoxia, we propose to compare, in acute conditions, two HIIT sessions (simulated hypoxia-normobaric vs. normoxia) in overweight or obese subjects. The objective of this assessment is to compare, during exercise and recovery (+2h), oxygen consumption, corresponding energy expenditure, and carbohydrate and lipid utilization in hypoxic versus normoxic conditions. Given the potential influence of hypoxia on appetite, spontaneous food intake and energy expenditure post-24h will also be measured. Finally, since pleasure and perceived exertion are key parameters in adherence to an adapted physical activity (APA) program, these two concepts will also be evaluated through the subjects' experiences.
Detailed description
Obesity management involves lifestyle and dietary measures that include appropriate nutrition and increased physical activity (PA). Among the various PA options available, High-intensity interval training (HIIT) is now recognized as a well-tolerated, safe, and effective exercise modality for improving body composition. In 2016, our pioneering study demonstrated that HIIT is more effective than moderate-intensity continuous training (MICT) in inducing abdominal fat loss in postmenopausal women. A subsequent meta-analysis, conducted by our team in 2018 and encompassing 39 articles involving 617 participants, confirmed the significant effects of HIIT on reducing total and abdominal fat mass in overweight or obese individuals More recently, our work has shown significant results from HIIT + resistance training or HIIT cycling vs. running on improving body composition, and more specifically on reducing abdominal and visceral fat mass, in overweight or obese subjects.
With a focus on performance, HIIT has been combined with simulated hypoxia to maximize training adaptations, particularly to improve cardiovascular, respiratory, circulatory, hematological, and metabolic capacities at the muscular level. Live Low Train High (LLTH) allows athletes to maintain normoxia while being exposed to acute periods of hypoxia during training via hypoxic chambers (simulated altitude). More recently, research has explored the effects of HIIT under hypoxic conditions in patients with metabolic disorders and/or physical deconditioning, focusing primarily on cardiovascular and ventilatory adaptations. To date, in overweight or obese individuals, only three studies investigated the benefit of HIIT under simulated hypoxia for modulating body composition, and more specifically for reducing total or abdominal fat. These studies generally hypothesize a higher energy expenditure during hypoxia, associated with a transient loss of appetite that may be linked to hormonal disturbances, central nervous system adaptability, or metabolic flexibility altering hunger and satiety signals.
In parallel with these hypotheses, hypoxia stimulates HIF-1 production, thus promoting a shift from oxidative metabolism to glycolysis. At the same external mechanical load, the increased use of carbohydrates via glycolysis, combined with increased cardiovascular stress, should promote, during the recovery phase, greater oxygen consumption and lipid oxidation following a hypoxic session. To date, no study has yet evaluated these hypotheses by comparing these parameters following two acute HIIT sessions performed under normoxia or hypoxia.
The aim is to compare the influence of these two sessions on oxygen consumption, the corresponding energy expenditure, and carbohydrate and lipid utilization during recovery (+2h). Given the potential influence of hypoxia on appetite, food intake and spontaneous energy expenditure post-24h will also be measured. Finally, since enjoyment and perceived exertion are crucial parameters for adherence to an adapted physical activity (APA) program, these two concepts will also be assessed through the participants' experiences.
The authors propose the following hypotheses:
Main hypothesis:
- Lipid oxidation (g/min) during recovery (+2h) will be higher post-hypoxic session. Secondary hypotheses:
- Oxygen consumption and energy expenditure will be increased during post-hypoxic session recovery.
4/ Energy intake from the post-exercise meal may be lower post-hypoxic condition.
5/ The effort will be perceived as slightly more difficult in hypoxia due to increased cardiovascular demand.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Exercise - Normoxia | Experimental | Other: HIIE - NormoxiaHIIE in normoxia |
| High Intensity Interval Exercise - Hypoxia | Experimental | Other: HIIE - HypoxiaHIIE in hypoxia |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- overweight or obesity (BMI between 25 kg/m2 and 35 kg/m2)
Key exclusion criteria (4 listed)
- medical contraindications to intense physical activity
- taking ß-blocker
- diabete
- women taking hormonal replacement therapy
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 |
|---|---|---|
| HIIE - NormoxiaCycling HIIE in Normoxia: 60 x [8 seconds at a power equivalent to 80-85% of HRmax followed by 12 seconds of active recovery at a power equivalent to 40% of HRmax] | Other | High Intensity Interval Exercise - Normoxia |
| HIIE - HypoxiaCycling HIIE in Hypoxia (FiO2: 15%): 60 x [8 seconds at a power equivalent to 80-85% of HRmax followed by 12 seconds of active recovery at a power equivalent to 40% of HRmax] | Other | High Intensity Interval Exercise - Hypoxia |
Primary outcome
Lipid oxidation after the exercise session (nromoxia and hypoxia).
Time frame: Measurement during two hours after the end of the exercise
Determination of lipid and carbohydrate oxidation after the exercise (HIIE normoxia and hypoxia). Lipid aoxidation is measured from oxygen and carbon dioxide consumption (Metamax 3D Cortex).
3 secondary outcomes
Oxygen consumption during the recovery period
Time frame: Two hours after the end of the exercise
Energy intakes 24 hours after the exercise
Time frame: 24 hours post exercise
Appetite
Time frame: Before exercise and after exercise (+0 min, +60 min, and +120 min).
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 11 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIE - Normoxia and HIIE - Hypoxia in people with Obesity & Overweight and Energy Expenditure, run by Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques at 1 site in France.
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 1 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 11 Sep 2026. 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 France. 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.
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?
Lipid oxidation after the exercise session (nromoxia and hypoxia). (time frame: Measurement during two hours after the end of the exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2026.