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NCT Number: NCT07073326

Effects of Normobaric Hypoxic Training in 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.

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Key information

Conditions

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease Behavior Hypoxia Motor Activity Normobaric Hypoxia Pathological Conditions, Signs and Symptoms Platelet Glycoprotein IV Deficiency Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Trieste - Exercise Physiology and Kinesiology Lab

Trieste, 34100, Italy

Location status: Recruiting

Location contact

Alex Buoite Stella, PhD

CONTACT

[email protected]

0039 0403996582

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HYPOTRAIN

Other

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%

NORMOTRAIN

Other

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%

Primary outcomes

  1. 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

  2. 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)

Secondary outcomes

  1. 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)

  2. Liver markers

    Time frame: At the beginning of the study and after 8 weeks of training

    Markers of liver health including ultrasound evaluation

  3. 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)

  4. Triglyceride (mg/dL)

    Time frame: At the beginning of the study and after 8 weeks of training

    Blood triglyceride concentration

  5. Total cholesterol (mg/dL)

    Time frame: At the beginning of the study and after 8 weeks of training

    Blood total cholesterol concentration

  6. High-density lipoprotein (mg/dL)

    Time frame: At the beginning of the study and after 8 weeks of training

    Blood high-density lipoprotein concentration

  7. Low-density lipoprotein (mg/dL)

    Time frame: At the beginning of the study and after 8 weeks of training

    Blood low-density lipoprotein concentration

  8. C-reactive protein (mg/dL)

    Time frame: At the beginning of the study and after 8 weeks of training

    Blood c-reactive protein concentration

  9. Glycemia (mg/dL)

    Time frame: At the beginning of the study and after 8 weeks of training

    Blood glucose concentration

  10. Insulinemia (mg/dL)

    Time frame: At the beginning of the study and after 8 weeks of training

    Blood insulin concentration

Sponsors and collaborators

Lead sponsor

University of Trieste

Other

Registry information

Official study title

Effects of Normobaric Hypoxia Aerobic Training in People With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

Acronym: HYPOMASLD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 18, 2025
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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