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

Not Applicable

Not yet recruiting

• Conditions: MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease; Normobaric Hypoxia

• Registration Number: NCT07073326
• Lead Sponsor: University of Trieste

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-01
• Status Verified: 2025-07
• Study Start: 2025-07-01
• Study First Submitted QC: 2025-07-09
• Last Update Submitted: 2025-07-09
• Study First Posted: 2025-07-18
• Last Update Posted: 2025-07-18
• Primary Completion: 2026-05
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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