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

NCT ID: NCT07073326

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2026-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

HYPOTRAIN

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

Group Type: EXPERIMENTAL

HYPOTRAIN

Intervention Type: 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%

NORMOTRAIN

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

Group Type: SHAM_COMPARATOR

NORMOTRAIN

Intervention Type: 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%

Interventions

HYPOTRAIN

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%

Intervention Type: OTHER

NORMOTRAIN

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%

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Trieste

OTHER

Sponsor Role: lead

Responsible Party

Alex Buoite Stella

PhD, Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: BACKGROUND

PMID: 35563600 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29923910 (View on PubMed)

Other Identifiers

DSM_FisioMedSport_Hypoxic25

Identifier Type: -

Identifier Source: org_study_id