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

University of Trieste

Status: Not yet enrolling

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

Treatments: Other: HYPOTRAIN; Other: NORMOTRAIN

Study type: Interventional

Funder types: Other

Identifiers

NCT07073326

DSM_FisioMedSport_Hypoxic25

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

HYPOTRAIN

Experimental group

Description:

This arm will perform the normobaric hypoxic aerobic training (HYPOTRAIN)

Treatment:

Other: HYPOTRAIN

NORMOTRAIN

Sham Comparator group

Description:

This arm will perform the normobaric normoxia aerobic training (NORMOTRAIN)

Treatment:

Other: NORMOTRAIN