MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Normobaric Hypoxia
Conditions
Keywords
Hypoxia, Altitude, Exercise, Liver, Metabolism, Fat
Brief 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, 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.
Interventions
OTHERHYPOTRAIN
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%
OTHERNORMOTRAIN
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%
Sponsors
University of Trieste
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body mass (kg) | At the beginning of the study and after 8 weeks of training | Evaluation of changes in body mass measured on a scale |
| Fat mass (%) | 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
| Measure | Time frame | Description |
|---|---|---|
| Maximum oxygen uptake (mL/kg*min) | 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) |
| Liver markers | At the beginning of the study and after 8 weeks of training | Markers of liver health including ultrasound evaluation |
| Ventilatory threshold (mL/kg*min) | 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) |
| Triglyceride (mg/dL) | At the beginning of the study and after 8 weeks of training | Blood triglyceride concentration |
| Total cholesterol (mg/dL) | At the beginning of the study and after 8 weeks of training | Blood total cholesterol concentration |
| High-density lipoprotein (mg/dL) | At the beginning of the study and after 8 weeks of training | Blood high-density lipoprotein concentration |
| Low-density lipoprotein (mg/dL) | At the beginning of the study and after 8 weeks of training | Blood low-density lipoprotein concentration |
| C-reactive protein (mg/dL) | At the beginning of the study and after 8 weeks of training | Blood c-reactive protein concentration |
| Glycemia (mg/dL) | At the beginning of the study and after 8 weeks of training | Blood glucose concentration |
| Insulinemia (mg/dL) | At the beginning of the study and after 8 weeks of training | Blood insulin concentration |
Countries
Italy
Outcome results
None listed