About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Being diagnosed with MASLD from at the least 3 years
BMI > 26 kg/m2
Being sedentary
Disqualifiers
Cardiovascular, respiratory, renal complications
Hypertension
COPD
Previous history of acute mountain sickness or altitude-associated symptoms
Trial design
Parallel
Treatments tested in this trial
HYPOTRAIN
Other intervention8 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 intervention8 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%
Treatment groups
Trial outcomes
Primary outcomes
Body mass (kg)
Evaluation of changes in body mass measured on a scale
Fat mass (%)
Evaluation of changes in fat mass, as percentage of body mass, assessed with bioimpedence (BIA)
Secondary outcomes
Maximum oxygen uptake (mL/kg*min)
Maximum oxygen uptake (VO2 max) assessed during a cardiopulmonary exercise test (CPET)
Liver markers
Markers of liver health including ultrasound evaluation
Ventilatory threshold (mL/kg*min)
Metabolic intensity at which the ventilatory threshold occurs, as measured during the cardiopulmonary exercise test (CPET)
Triglyceride (mg/dL)
Blood triglyceride concentration
Sponsors and contacts
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