MASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseaseHYPOMASLDNCT07073326
Effects of Normobaric Hypoxic Training in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
A study testing HYPOTRAIN and NORMOTRAIN in people with MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease and Normobaric Hypoxia, run by University of Trieste at 1 site in Italy.
Trial summary
Altitude training has been suggested to be of potential support to improve some chronic clinical conditions, especially metabolic conditions. Normobaric hypoxia represents a promising system to simulate altitude training, and its efficacy and safety have been suggested in different conditions, including diabetes… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Normobaric Hypoxia
- What is being tested?
- HYPOTRAIN and NORMOTRAIN
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2025to 5 Aug 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed with MASLD from at the least 3 years
- BMI > 26 kg/m2
- Being sedentary
Who cannot join
- Cardiovascular, respiratory, renal complications
- Hypertension
- COPD
- Previous history of acute mountain sickness or altitude-associated symptoms
- Females only: pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
Italy1 site
University of Trieste - Exercise Physiology and Kinesiology Lab
Trieste, Trieste, 34100
About this study
Official title: Effects of Normobaric Hypoxia Aerobic Training in People With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Altitude training has been suggested to be of potential support to improve some chronic clinical conditions, especially metabolic conditions. Normobaric hypoxia represents a promising system to simulate altitude training, and its efficacy and safety have been suggested in different conditions, including diabetes, obesity and hypertension. Metabolic dysfunction-associated steatotic liver disease (MASLD) can characterized by metabolic alterations (including altered body composition, lipid and glycemic profile, etc.), and might benefit from aerobic training performed in simulated altitude training (i.e., normobaric hypoxia). Mild altitude training will be proposed (equal to about 2'500 m, 15% FiO2) and compared to a sham normobaric normoxia condition, during a 6-week 3 times per week 50-min aerobic training (walking) at 60-65% of maximum heart rate (HRmax). Cardiorespiratory fitness, body composition, and metabolic profile will be investigated.
- Being tested
- HYPOTRAIN, NORMOTRAIN
- Keywords
- Hypoxia, Altitude, Exercise, Liver, Metabolism, Fat
- Medical subject headings
- Hypoxia, Motor Activity, Platelet Glycoprotein IV Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HYPOTRAINOther
6 weeks of 3 times per week, 50 min aerobic training (walking on a treadmill at 60-65% HRmax) while wearing a mask and air is delivered between 15 and 16 FiO2%
NORMOTRAINOther
6 weeks of 3 times per week, 50 min aerobic training (walking on a treadmill at 60-65% HRmax) while wearing a mask and air is delivered between at normal (around 21) FiO2%
| Study group | Role | What they receive |
|---|---|---|
| HYPOTRAIN | Experimental | This arm will perform the normobaric hypoxic aerobic training (HYPOTRAIN) Receives: Other: HYPOTRAIN |
| NORMOTRAIN | Sham comparator | This arm will perform the normobaric normoxia aerobic training (NORMOTRAIN) Receives: Other: NORMOTRAIN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass (kg)
Evaluation of changes in body mass measured on a scale
Measured: At the beginning of the study and after 8 weeks of training
Fat mass (%)
Evaluation of changes in fat mass, as percentage of body mass, assessed with bioimpedence (BIA)
Measured: At the beginning of the study and after 8 weeks of training
Secondary outcomes (10)
Maximum oxygen uptake (mL/kg*min)
Maximum oxygen uptake (VO2 max) assessed during a cardiopulmonary exercise test (CPET)
Measured: At the beginning of the study and potentially after 8 weeks of training
Liver markers
Markers of liver health including ultrasound evaluation
Measured: At the beginning of the study and after 8 weeks of training
Ventilatory threshold (mL/kg*min)
Metabolic intensity at which the ventilatory threshold occurs, as measured during the cardiopulmonary exercise test (CPET)
Measured: At the beginning of the study and potentially after 8 weeks of training
Triglyceride (mg/dL)
Blood triglyceride concentration
Measured: At the beginning of the study and after 8 weeks of training
Total cholesterol (mg/dL)
Blood total cholesterol concentration
Measured: At the beginning of the study and after 8 weeks of training
High-density lipoprotein (mg/dL)
Blood high-density lipoprotein concentration
Measured: At the beginning of the study and after 8 weeks of training
Low-density lipoprotein (mg/dL)
Blood low-density lipoprotein concentration
Measured: At the beginning of the study and after 8 weeks of training
C-reactive protein (mg/dL)
Blood c-reactive protein concentration
Measured: At the beginning of the study and after 8 weeks of training
Glycemia (mg/dL)
Blood glucose concentration
Measured: At the beginning of the study and after 8 weeks of training
Insulinemia (mg/dL)
Blood insulin concentration
Measured: At the beginning of the study and after 8 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start1 Sep 2025
- Primary completion13 Jul 2026
- Study completion5 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Trieste
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alex Buoite Stella, University of Trieste
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073326
- Sponsor's protocol ID
- DSM_FisioMedSport_Hypoxic25
- Acronym
- HYPOMASLD
- Status last verified
- Aug 2026
- First submitted
- 1 Jun 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Luo Y, Chen Q, Zou J, Fan J, Li Y, Luo Z. Chronic Intermittent Hypoxia Exposure Alternative to Exercise Alleviates High-Fat-Diet-Induced Obesity and Fatty Liver. Int J Mol Sci. 2022 May 6;23(9):5209. doi: 10.3390/ijms23095209.
PubMed 35563600DE Groote E, Britto FA, Bullock L, Francois M, DE Buck C, Nielens H, Deldicque L. Hypoxic Training Improves Normoxic Glucose Tolerance in Adolescents with Obesity. Med Sci Sports Exerc. 2018 Nov;50(11):2200-2208. doi: 10.1249/MSS.0000000000001694.
PubMed 29923910
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Normobaric Hypoxia Aerobic Training in People With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
- ClinicalTrials.gov ID
- NCT07073326
- Acronym / sponsor ID
- HYPOMASLD / DSM_FisioMedSport_Hypoxic25
- Keywords
- Hypoxia, Altitude, Exercise, Liver, Metabolism, Fat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of TriesteUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 13 Jul 2026 (actual)
- Study completion
- 5 Aug 2026 (actual)
- First posted
- 18 Jul 2025 (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.
Altitude training has been suggested to be of potential support to improve some chronic clinical conditions, especially metabolic conditions. Normobaric hypoxia represents a promising system to simulate altitude training, and its efficacy and safety have been suggested in different conditions, including diabetes, obesity and hypertension. Metabolic dysfunction-associated steatotic liver disease (MASLD) can characterized by metabolic alterations (including altered body composition, lipid and glycemic profile, etc.), and might benefit from aerobic training performed in simulated altitude training (i.e., normobaric hypoxia). Mild altitude training will be proposed (equal to about 2'500 m, 15% FiO2) and compared to a sham normobaric normoxia condition, during a 6-week 3 times per week 50-min aerobic training (walking) at 60-65% of maximum heart rate (HRmax). Cardiorespiratory fitness, body composition, and metabolic profile will be investigated.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HYPOTRAIN | Experimental | Other: HYPOTRAINThis arm will perform the normobaric hypoxic aerobic training (HYPOTRAIN) |
| NORMOTRAIN | Sham comparator | Other: NORMOTRAINThis arm will perform the normobaric normoxia aerobic training (NORMOTRAIN) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being diagnosed with MASLD from at the least 3 years
- BMI > 26 kg/m2
- Being sedentary
Key exclusion criteria (5 listed)
- Cardiovascular, respiratory, renal complications
- Hypertension
- COPD
- Previous history of acute mountain sickness or altitude-associated symptoms
- Females only: pregnancy or breastfeeding
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 |
|---|---|---|
| HYPOTRAIN6 weeks of 3 times per week, 50 min aerobic training (walking on a treadmill at 60-65% HRmax) while wearing a mask and air is delivered between 15 and 16 FiO2% | Other | HYPOTRAIN |
| NORMOTRAIN6 weeks of 3 times per week, 50 min aerobic training (walking on a treadmill at 60-65% HRmax) while wearing a mask and air is delivered between at normal (around 21) FiO2% | Other | NORMOTRAIN |
Primary outcome
Body mass (kg)
Time frame: At the beginning of the study and after 8 weeks of training
Evaluation of changes in body mass measured on a scale
Fat mass (%)
Time frame: At the beginning of the study and after 8 weeks of training
Evaluation of changes in fat mass, as percentage of body mass, assessed with bioimpedence (BIA)
10 secondary outcomes
Maximum oxygen uptake (mL/kg*min)
Time frame: At the beginning of the study and potentially after 8 weeks of training
Liver markers
Time frame: At the beginning of the study and after 8 weeks of training
Ventilatory threshold (mL/kg*min)
Time frame: At the beginning of the study and potentially after 8 weeks of training
Triglyceride (mg/dL)
Time frame: At the beginning of the study and after 8 weeks of training
Total cholesterol (mg/dL)
Time frame: At the beginning of the study and after 8 weeks of training
High-density lipoprotein (mg/dL)
Time frame: At the beginning of the study and after 8 weeks of training
Low-density lipoprotein (mg/dL)
Time frame: At the beginning of the study and after 8 weeks of training
C-reactive protein (mg/dL)
Time frame: At the beginning of the study and after 8 weeks of training
Glycemia (mg/dL)
Time frame: At the beginning of the study and after 8 weeks of training
Insulinemia (mg/dL)
Time frame: At the beginning of the study and after 8 weeks of training
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 17 Aug 2026.
- Background: PubMed 35563600Luo Y, Chen Q, Zou J, Fan J, Li Y, Luo Z. Chronic Intermittent Hypoxia Exposure Alternative to Exercise Alleviates High-Fat-Diet-Induced Obesity and Fatty Liver. Int J Mol Sci. 2022 May 6;23(9):5209. doi: 10.3390/ijms23095209.
- Background: PubMed 29923910DE Groote E, Britto FA, Bullock L, Francois M, DE Buck C, Nielens H, Deldicque L. Hypoxic Training Improves Normoxic Glucose Tolerance in Adolescents with Obesity. Med Sci Sports Exerc. 2018 Nov;50(11):2200-2208. doi: 10.1249/MSS.0000000000001694.
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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 HYPOTRAIN and NORMOTRAIN in people with MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease and Normobaric Hypoxia, run by University of Trieste at 1 site in Italy.
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 3 inclusion and 5 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 17 Aug 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 Italy. 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. Some participants in this study may receive a placebo. 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?
Body mass (kg) (time frame: At the beginning of the study and after 8 weeks of training). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07073326, which also lists 2 linked publications.
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 17 Aug 2026.