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

NCT07073326 | Recruiting

• 1 other identifier: DSM_FisioMedSport_Hypoxic25
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Hypoxia; Altitude; Exercise; Liver; Metabolism; Fat

Outcome Measures

Primary Outcomes (2)

• Body mass (kg)

  Evaluation of changes in body mass measured on a scale

  At the beginning of the study and after 8 weeks of training

• Fat mass (%)

  Evaluation of changes in fat mass, as percentage of body mass, assessed with bioimpedence (BIA)

  At the beginning of the study and after 8 weeks of training

Secondary Outcomes (10)

• Maximum oxygen uptake (mL/kg*min)

  At the beginning of the study and potentially after 8 weeks of training

• Liver markers

  At the beginning of the study and after 8 weeks of training

• Ventilatory threshold (mL/kg*min)

  At the beginning of the study and potentially after 8 weeks of training

• Triglyceride (mg/dL)

  At the beginning of the study and after 8 weeks of training

• Total cholesterol (mg/dL)

  At the beginning of the study and after 8 weeks of training

Study Arms (2)

HYPOTRAIN

EXPERIMENTAL

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

Other: HYPOTRAIN

NORMOTRAIN

SHAM COMPARATOR

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

Other: NORMOTRAIN

Interventions

HYPOTRAIN OTHER

8 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%

HYPOTRAIN

NORMOTRAIN OTHER

8 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%

NORMOTRAIN

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Being diagnosed with MASLD from at the least 3 years
• BMI \> 26 kg/m2
• Being sedentary

You may not qualify if:

• Cardiovascular, respiratory, renal complications
• Hypertension
• COPD
• Previous history of acute mountain sickness or altitude-associated symptoms
• Females only: pregnancy or breastfeeding

Sponsors & Collaborators

• University of Trieste: lead

Study Sites (1)

University of Trieste - Exercise Physiology and Kinesiology Lab

Trieste, Trieste, 34100, Italy

RECRUITING

Related Publications (2)

• Luo Y, Chen Q, Zou J, Fan J, Li Y, Luo Z. Chronic Intermittent Hypoxia Exposure Alternative to Exercise Alleviates High-Fat-Diet-Induced Obesity and Fatty Liver. Int J Mol Sci. 2022 May 6;23(9):5209. doi: 10.3390/ijms23095209.

  PMID: 35563600 BACKGROUND

• DE Groote E, Britto FA, Bullock L, Francois M, DE Buck C, Nielens H, Deldicque L. Hypoxic Training Improves Normoxic Glucose Tolerance in Adolescents with Obesity. Med Sci Sports Exerc. 2018 Nov;50(11):2200-2208. doi: 10.1249/MSS.0000000000001694.

  PMID: 29923910 BACKGROUND

MeSH Terms

Conditions

Hypoxia; Motor Activity; Platelet Glycoprotein IV Deficiency

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Assistant Professor

Study Record Dates

• First Submitted: June 1, 2025
• First Posted: July 18, 2025
• Study Start: September 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

IT (1)