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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of Trieste

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Being diagnosed with MASLD from at the least 3 years

BMI > 26 kg/m2

Being sedentary

Disqualifiers

Cardiovascular, respiratory, renal complications

Hypertension

COPD

Previous history of acute mountain sickness or altitude-associated symptoms

Trial design

Design model

Parallel

Treatments tested in this trial

  • HYPOTRAIN

    Other intervention

    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

    Other intervention

    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%

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: HYPOTRAINExperimental treatment 1 intervention
Group B: NORMOTRAINSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Body mass (kg)

Evaluation of changes in body mass measured on a scale

Time frame
At the beginning of the study and after 8 weeks of training
2

Fat mass (%)

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

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

Secondary outcomes

1

Maximum oxygen uptake (mL/kg*min)

Maximum oxygen uptake (VO2 max) assessed during a cardiopulmonary exercise test (CPET)

Time frame
At the beginning of the study and potentially after 8 weeks of training
2

Liver markers

Markers of liver health including ultrasound evaluation

Time frame
At the beginning of the study and after 8 weeks of training
3

Ventilatory threshold (mL/kg*min)

Metabolic intensity at which the ventilatory threshold occurs, as measured during the cardiopulmonary exercise test (CPET)

Time frame
At the beginning of the study and potentially after 8 weeks of training
4

Triglyceride (mg/dL)

Blood triglyceride concentration

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

Other outcomes

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