Effects of Normobaric Hypoxic Training in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) (HYPOMASLD)

April 27, 2026 updated by: Alex Buoite Stella, University of Trieste

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 an 8-week 3 or 2 times per week 1-h aerobic training (walking) at 60-65% of maximum heart rate (HRmax). Cardiorespiratory fitness, body composition, and metabolic profile will be investigated.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Trieste
      • Trieste, Trieste, Italy, 34100
        • Recruiting
        • University of Trieste - Exercise Physiology and Kinesiology Lab
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being diagnosed with MASLD from at the least 3 years
  • BMI > 26 kg/m2
  • Being sedentary

Exclusion Criteria:

  • Cardiovascular, respiratory, renal complications
  • Hypertension
  • COPD
  • Previous history of acute mountain sickness or altitude-associated symptoms
  • Females only: pregnancy or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HYPOTRAIN
This arm will perform the normobaric hypoxic aerobic training (HYPOTRAIN)
Other: HYPOTRAIN
8 weeks of 2/3 times per week, 1-h aerobic training (walking on a treadmill at 60-65% HRmax) while wearing a mask and air is delivered between 15 and 16 FiO2%
Sham Comparator: NORMOTRAIN
This arm will perform the normobaric normoxia aerobic training (NORMOTRAIN)
Other: NORMOTRAIN
8 weeks of 2/3 times per week, 1-h aerobic training (walking on a treadmill at 60-65% HRmax) while wearing a mask and air is delivered between at normal (around 21) FiO2%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At the beginning of the study and after 8 weeks of training
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)
At the beginning of the study and after 8 weeks of training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum oxygen uptake (mL/kg*min)
Time Frame: At the beginning of the study and potentially after 8 weeks of training
Maximum oxygen uptake (VO2 max) assessed during a cardiopulmonary exercise test (CPET)
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
Markers of liver health including ultrasound evaluation
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
Metabolic intensity at which the ventilatory threshold occurs, as measured during the cardiopulmonary exercise test (CPET)
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
Blood triglyceride concentration
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
Blood total cholesterol concentration
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
Blood high-density lipoprotein concentration
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
Blood low-density lipoprotein concentration
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
Blood c-reactive protein concentration
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
Blood glucose concentration
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
Blood insulin concentration
At the beginning of the study and after 8 weeks of training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Trieste

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

June 1, 2025

First Submitted That Met QC Criteria

July 9, 2025

First Posted (Actual)

July 18, 2025

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSM_FisioMedSport_Hypoxic25

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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