Simulated altitude (normobaric hypoxia) walking program for MASLD
Effects of Normobaric Hypoxia Aerobic Training in People With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
This trial will test whether walking exercise performed in a simulated high-altitude (lower-oxygen) environment helps people with MASLD improve fitness, body composition, and metabolic markers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | University of Trieste Academic / other |
| Locations | 1 site (Trieste, Trieste) |
| Trial ID | NCT07073326 on ClinicalTrials.gov |
What this trial studies
Adults with long-standing MASLD will be assigned to an 8-week aerobic walking program performed either in a simulated altitude environment (≈2,500 m, 15% FiO2) or in a sham normoxia condition. Sessions last about 1 hour at 60–65% of maximum heart rate, two or three times per week. The protocol will compare changes in cardiorespiratory fitness, body composition, and metabolic profile between the two conditions. Safety and tolerability of mild normobaric hypoxia will also be monitored throughout the intervention.
Who should consider this trial
Good fit: Ideal candidates are sedentary adults with MASLD diagnosed for at least three years and a BMI over 26 kg/m2 who do not have the listed exclusion conditions.
Not a fit: Patients with cardiovascular, respiratory, renal disease, hypertension, COPD, a history of altitude sickness, or who are pregnant or breastfeeding are excluded and likely would not benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could lead to improved fitness, better body composition, and healthier metabolic measures that may help manage MASLD.
How similar studies have performed: Normobaric hypoxia interventions have shown promise in conditions like diabetes, obesity, and hypertension, but applying this approach specifically to MASLD is relatively novel with limited direct evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Trieste, Trieste
- University of Trieste - Exercise Physiology and Kinesiology Lab — Trieste, Trieste, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.