MASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseaseEXALIVERNCT07467512
Exercise for an Aging Liver (EXALIVER)
A study testing Exercise in people with MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease and MASH - Metabolic Dysfunction-Associated Steatohepatitis, run by Consorcio Centro de Investigación Biomédica en Red (CIBER) at 1 site in Spain.
Trial summary
The goal of this clinical trial is to learn how physical exercise affects liver health in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) or at-risk metabolic dysfunction-associated steatohepatitis (MASH); comparing responses between middle-aged adults (40-60 years old) and older adults… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, MASH - Metabolic Dysfunction-Associated Steatohepatitis, Liver Fibrosis/NASH
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Middle-aged adults (40 to 60 years old) and older adults (aged 70 years or older)
- People diagnosed with Metabolic Disfunction-Associated Steatotic Liver Disease (MASLD); defined as the presence of hepatic steatosis (≥5% fat content) in conjunction with at least one cardiometabolic risk factor (overweight or obesity, dysglycaemia or Type II diabetes, elevated plasma triglycerides, reduced HDL-cholesterol or high blood preassure) with no other discernable cause.
- People diagnosed with at-risk Metabolic Disfunction-Associated SteatoHepatitis (MASH) according to the following criteria: I) a positive liver biopsy (NAS score ≥ 4 points (with at least one point in each of the components of the score: steatosis, lobular inflammation and ballooning, AND significant (F2) or advanced (F3) fibrosis), or II) a FAST score >0.65.
Who cannot join
- Descompensated cirrhosis or end-stage liver disease.
- Other causes of liver disease, such as alcohol abuse or drug-induced, virus-related, or hereditary disease.
- History of a major adverse cardiovascular event, clinically significant kidney, endocrine, or neurological disease, bariatric surgery, HIV/AIDS, known inflammatory and/or rheumatologic disease, cancer, or other medical condition in which exercise is absolute contraindicated.
- Recent or planned major surgery, as well as anticancer therapies.
- Participating in a weight loss, a weight-management program or a supervised exercise program (more than 30 minutes three times per week, or 45 minutes twice a week, moderate/vigorous intensity).
- Body weight instability. Participants must have maintained the body weight registered at screening visit (tolerance: 5%) for more than 3 months.
Show all 12Show fewer
- Regular use of medication or compounds that may affect study outcomes based on research staff criteria.
- Pregnancy and lactation or planned pregnancy (within the study period).
- Frequent travel over time zones during the study period.
- Fear of needles and claustrophobia to magnetic resonance imaging (MRI).
- Low physical function (ie, ambulation dependency)
- Being unable to understand and to accept the instructions or the study objectives and protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, 28007
Carlos Rodriguez Lopez, PhD, +34915868835, crlopez@salud.madrid.org
About this study
Official title: Evaluation of the Impact of Physical Exercise on Metabolic Dysfunction-associated Steatotic Liver Disease in the Elderly
The goal of this clinical trial is to learn how physical exercise affects liver health in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) or at-risk metabolic dysfunction-associated steatohepatitis (MASH); comparing responses between middle-aged adults (40-60 years old) and older adults (70 years and older) of any sex, as well as between participants with low-risk MASLD and high-risk MASH. The main question it aims to answer is:
Could an exercise program reduce liver fat, inflammation and fibrosis, regardless of age and disease severity?
Read more
Researchers will compare 4 different groups:
- older adults with at risk MASH who will exercise B) middle-aged people with at risk MASH who will exercise C) middle-aged people with low-risk MASLD who will exercise D) middle-aged people with low-risk MASLD who will not exercise, receiving usual care.
Participants in the exercise groups will take part in a supervised 12-week exercise program that includes both strength and aerobic training, completed twice a week.
All participants, including those receiving usual care, will have health asssessments before and after the 12-week period to measure changes in liver health.
- Conditions
- MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, MASH - Metabolic Dysfunction-Associated Steatohepatitis, Liver Fibrosis/NASH
- Being tested
- Exercise, Usual Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
The exercise intervention will include 2 days/week of supervised moderate-high intensity resistance training (rating perceived exertion >7, circuit-training, upper and lower body exercises involving major muscle groups) and high-intensity interval training (4 sets of 4-minute intervals at >85% peak heat rate with 4-minute of active recovery at 50-65% peak heat rate, uphill treadmill walking). Moreover, participants will receive an individualized moderate-intensity goal-setting aerobic (walking) program to achieve a minimum of 135 minutes per week.
Usual CareBehavioural
Participants will receive standard recommendations on healthy lifestyle based on Mediterranean dietary pattern and physical activity recommendations for weight loss and health promotion.
| Study group | Role | What they receive |
|---|---|---|
| Older adults with at risk MASH who exercise | Experimental | Older adults with Metabolic Dysfunction-Associated SteatoHepatitis aged 70 years or older who will complete the supervised 12-week exercise program. Receives: Behavioral: Exercise |
| Middle-age adults with at risk MASH who exercise | Experimental | Middle-aged adults (40 to 60 years old) with at-risk metabolic dysfunction-associated SteatoHepatitis (MASH) who will complete a supervised 12-week exercise program Receives: Behavioral: Exercise |
| Middle-age adults with MASLD who exercise | Experimental | Middle-aged adults (40 to 60 years old) with metabolic dysfunction-associated steatotic liver disease (MASLD) who will complete a supervised 12-week exercise program.
This study arm will not recruit new participants. Instead, participants will be selected from a concluded clinical trial (NCT05897073; Study Arm: Experimental - Supervised Exercise Intervention), in which they completed the same exercise program and the same study outcome assessments of the present trial. These participants will be matched by sex, age and potential confounders to the individuals enrolled in the "Middle-aged adults with at-risk MASH who exercise" arm of the present study. Receives: Behavioral: Exercise |
| Middle-age adults with MASLD receiving usual care | Active comparator | Middle-aged adults (40 to 60 years old) with metabolic dysfunction-associated steatotic liver disease (MASLD) who receive usual care.
This study arm will not recruit new participants. Instead, participants will be selected from a concluded clinical trial (NCT05897073, Study Arm: No Intervention: Usual-care control group), in which they received usual care and the same study outcome assessments of the present trial. These participants will be matched by sex, age and potential confounders to the individuals enrolled in the "Middle-aged adults with at-risk MASH who exercise" arm of the present study. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hepatic fat content
Hepatic fat content will be determined by Proton Density Fat Fraction (PDFF) assessed by Magnetic Resonance Imaging (MRI)
Measured: Change from baseline to 12 weeks
Change in liver inflammation and fibrosis
Iron-corrected T1 (cT1) will be determined though MRI to reflect liver tissue water content, correlating with histological features of fibroinflammation (ballooning, fibrosis, and NAS)
Measured: Change from baseline to 12 weeks
Change in liver stiffness
Determined by vibration-controlled Transient Elastography (Fibroscan ®, VCTE). This is an ultrasound-based technique widely used in clinical practice to diagnose and monitor fibrosis progression. Liver stifness measurement increases with liver fibrosis.
Measured: Change from baseline to 12 weeks.
Secondary outcomes (41)
Change in Enhanced Liver Fibrosis (ELF) Score
Fasting blood samples will be used to assess the Enhanced Liver Fibrosis (ELF) serum biomarker. The ELF score reflects the risk of advanced liver fibrosis, with higher values indicating higher risk.
Measured: Change from baseline to 12 weeks
Change in Pro-C3 serum levels
Fasting blood samples will be used to asses Pro-C3 serum levels, a biomarker of liver fibrosis. Higher PRO-C3 levels indicate ongoing fibrotic activity
Measured: Change from baseline to 12 weeks
Change in NIS4 serum biomarker of liver fibrosis
Fasting blood samples will be used to asses NIS4, a blood-based diagnostic tool designed to identify patients with at-risk MASH. It generates a composite score stratifying patients by risk.
Measured: Change from baseline to 12 weeks
Change in Metabolomics Advanced Steatohepatitis Fibrosis Score (MASEF)
Fasting blood samples will be used to asses Metabolomics Advanced Steatohepatitis Fibrosis Score (MASEF) in serum samples. Is a proprietary algorithm that generates a numeric score that reflects the likelihood of a patient having at-risk MASH.
Measured: Change from baseline to 12 weeks
Change in visceral adipose tissue
Visceral adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)
Measured: Change from baseline to 12 weeks
Change in pancreatic fat content
Pancreatic fat content will be assessed by Magnetic Resonance Imaging (MRI)
Measured: Change from baseline to 12 weeks
Change in abdominal subcutaneous adipose tissue
Abdominal subcutaneous adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)
Measured: Change from baseline to 12 weeks
Change in abdominal intermuscular fat content
Abdominal intermuscular fat content will be assessed by Magnetic Resonance Imaging (MRI)
Measured: Change from baseline to 12 weeks
Change in abdominal intramuscular fat content
Abdominal intramuscular fat content will be assessed by Magnetic Resonance Imaging (MRI)
Measured: Change from baseline to 12 weeks
Change in abdominal skeletal muscle tissue
Abdominal skeletal muscle tissue will be assessed by Magnetic Resonance Imaging (MRI)
Measured: Change from baseline to 12 weeks
Change in values of fasting glucose
Fasting blood samples will be used to assess glucose
Measured: Change from baseline to 12 weeks
Change in values of HbA1c
Fasting blood samples will be used to assess HbA1c. Higher fasting HbA1C values indicates poorer glucemic control.
Measured: Change from baseline to 12 weeks
Change in values of fasting insulin
Fasting blood samples will be used to assess insulin
Measured: Change from baseline to 12 weeks
Change in levels of mean glucose (Continuous Glucose Monitoring)
24-hour, diurnal and nocturnal mean glucose over 14 days will be assessed by Continuous Glucose Monitoring during 2 weeks
Measured: Change from baseline to 12 weeks.
Change in fasting lipid profile
Fasting blood samples will be used to assess levels of triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol an total cholesterol.
Measured: Change from baseline to 12 weeks
Change in alkaline phosphatase
Fasting blood samples will be used to assess serum alkaline phosphatase using standard clinical chemistry methods.
Measured: Baseline to 12 weeks
Change in alanine aminotransferase (ALT)
Fasting blood samples will be used to assess serum alanine aminotransferase (ALT) using standard clinical chemistry methods.
Measured: Baseline to 12 weeks
Change in gamma-glutamyl transferase (GGT)
Fasting blood samples will be used to assess serum gamma-glutamyl transferase (GGT) using standard clinical chemistry methods.
Measured: Baseline to 12 weeks
Change in total bilirubin
Fasting blood samples will be used to assess total serum bilirubin using standard clinical chemistry methods.
Measured: Baseline to 12 weeks
Change in creatinine
Fasting blood samples will be used to assess serum creatinine using standard clinical chemistry methods.
Measured: Baseline to 12 weeks
Change in estimated glomerular filtration rate (eGFR)
eGFR will be calculated from serum creatinine using a standard equation (e.g., CKD-EPI 2021), as implemented by the study laboratory.
Measured: Baseline to 12 weeks
Change in values of C-reactive protein
Fasting blood samples will be used to assess levels of C-reactive protein. Higher values indicate inflammation in the body.
Measured: Change from baseline to 12 weeks
Change in values of interleukin 6
Fasting blood samples will be used to assess levels of interleukin 6. Higher basal levels often indicating greater inflammation or metabolic stress.
Measured: Change from baseline to 12 weeks]
Change in blood pressure
Systolic and Diastolic blood pressure will be assessed by blood pressure monitor
Measured: Change from baseline to 12 weeks
Change in waist, hip and neck circumference
Circumference will be assessed by measuring tape following the procedures outlined by the International Society for the Advancement of Kinanthropometry
Measured: Change from baseline to 12 weeks.
Change in body weight
Body weight will be measured by a digital scale
Measured: Change from baseline to 12 weeks
Change in moderate-to-vigorous physical activity (MVPA)
Moderate-to-vigorous physical activity (minutes per day) will be estimated from wrist-worn accelerometry recorded over a 2-week monitoring period.
Measured: Baseline to 12 weeks
Change in light physical activity
Light physical activity (minutes per day) will be estimated from wrist-worn accelerometry recorded over a 2-week monitoring period.
Measured: Baseline to 12 weeks
Change in sedentary time
Sedentary time (minutes per day) will be estimated from wrist-worn accelerometry recorded over a 2-week monitoring period.
Measured: Baseline to 12 weeks
Change in total activity counts
Total activity counts per day will be estimated from wrist-worn accelerometry recorded over a 2-week monitoring period.
Measured: Baseline to 12 weeks
Change in Subjective sleep quality
Subjective sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI). Minimum value is 0 (never) and maximum value is 3 (3 or more times per week). Higher values mean a worse outcome.
Measured: Baseline to 12 weeks
Change in total sleep time
Total sleep time (minutes per night) will be estimated from wrist-worn accelerometry recorded over a 2-week monitoring period.
Measured: Baseline to 12 weeks
Change in Cardiorespiratory Fitness
Cardiorespiratory fitness measured by maximum treadmill test
Measured: Change from baseline to 12 weeks
Change in Lower-body muscular performance
Lower body muscular performance measured by chair stand test.
Measured: Change from baseline to 12 weeks
Change in Upper muscular strength
Upper body muscular strength measured by hand grip strength test.
Measured: Change from baseline to 12 weeks
Change in Quality of life
Quality of life will be assessed by the Rand Short Form 36 (SF-36). This questionnaire provides an score ranged from 0 to 100. Higher values mean better quality of life.
Measured: Changes from baseline to 12-weeks
Change EuroQol Visual Analogue Scale (EQ-VAS) score
The EQ-VAS is a vertical 0-100 scale used in the EuroQol EQ-5D instrument to measure a patient's self-rated, current overall health. It ranges from 0 (worst imaginable health) to 100 (best imaginable health), allowing patients to quantify their perceived health status.
Measured: Changes from baseline to 12-weeks
Change in mid-thigh subcutaneous adipose tissue area
Mid-thigh subcutaneous adipose tissue area will be quantified from segmented magnetic resonance imaging (MRI) slices.
Measured: Baseline to 12 weeks
Change in mid-thigh intramuscular fat content
Mid-thigh intramuscular fat content will be quantified from segmented magnetic resonance imaging (MRI) slices.
Measured: Baseline to 12 weeks
Change in mid-thigh intermuscular fat content
Mid-thigh intermuscular fat content will be quantified from segmented magnetic resonance imaging (MRI) slices.
Measured: Baseline to 12 weeks
Change in mid-thigh skeletal muscle cross-sectional area
Mid-thigh skeletal muscle cross-sectional area will be quantified from segmented magnetic resonance imaging (MRI) slices.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Mar 2026
- Primary completionJun 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Sponsor type
- Other government
- Collaborators
- Hospital General Universitario Gregorio Marañon, Universidad de Granada, Universidad Politecnica de Madrid, Universidad Complutense de Madrid, Instituto Mixto Universitario Deporte y Salud
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467512
- Sponsor's protocol ID
- AG24_13
- Acronym
- EXALIVER
- Status last verified
- Oct 2026
- First submitted
- 3 Feb 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Physical Exercise on Metabolic Dysfunction-associated Steatotic Liver Disease in the Elderly
- ClinicalTrials.gov ID
- NCT07467512
- Acronym / sponsor ID
- EXALIVER / AG24_13
- Conditions
- MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, MASH - Metabolic Dysfunction-Associated Steatohepatitis, Liver Fibrosis/NASH
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Consorcio Centro de Investigación Biomédica en Red (CIBER)Other government
- Collaborators
- Hospital General Universitario Gregorio Marañon, Universidad de Granada, Universidad Politecnica de Madrid, Universidad Complutense de Madrid, Instituto Mixto Universitario Deporte y Salud
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn how physical exercise affects liver health in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) or at-risk metabolic dysfunction-associated steatohepatitis (MASH); comparing responses between middle-aged adults (40-60 years old) and older adults (70 years and older) of any sex, as well as between participants with low-risk MASLD and high-risk MASH. The main question it aims to answer is:
Could an exercise program reduce liver fat, inflammation and fibrosis, regardless of age and disease severity?
Researchers will compare 4 different groups:
- older adults with at risk MASH who will exercise B) middle-aged people with at risk MASH who will exercise C) middle-aged people with low-risk MASLD who will exercise D) middle-aged people with low-risk MASLD who will not exercise, receiving usual care.
Participants in the exercise groups will take part in a supervised 12-week exercise program that includes both strength and aerobic training, completed twice a week.
All participants, including those receiving usual care, will have health asssessments before and after the 12-week period to measure changes in liver health.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Older adults with at risk MASH who exercise | Experimental | Behavioral: ExerciseOlder adults with Metabolic Dysfunction-Associated SteatoHepatitis aged 70 years or older who will complete the supervised 12-week exercise program. |
| Middle-age adults with at risk MASH who exercise | Experimental | Behavioral: ExerciseMiddle-aged adults (40 to 60 years old) with at-risk metabolic dysfunction-associated SteatoHepatitis (MASH) who will complete a supervised 12-week exercise program |
| Middle-age adults with MASLD who exercise | Experimental | Behavioral: ExerciseMiddle-aged adults (40 to 60 years old) with metabolic dysfunction-associated steatotic liver disease (MASLD) who will complete a supervised 12-week exercise program. This study arm will not recruit new participants. Instead, participants will be selected from a concluded clinical trial (NCT05897073; Study Arm: Experimental - Supervised Exercise Intervention), in which they completed the same exercise program and the same study outcome assessments of the present trial. These participants will be matched by sex, age and potential confounders to the individuals enrolled in the "Middle-aged adults with at-risk MASH who exercise" arm of the present study. |
| Middle-age adults with MASLD receiving usual care | Active comparator | Behavioral: Usual CareMiddle-aged adults (40 to 60 years old) with metabolic dysfunction-associated steatotic liver disease (MASLD) who receive usual care. This study arm will not recruit new participants. Instead, participants will be selected from a concluded clinical trial (NCT05897073, Study Arm: No Intervention: Usual-care control group), in which they received usual care and the same study outcome assessments of the present trial. These participants will be matched by sex, age and potential confounders to the individuals enrolled in the "Middle-aged adults with at-risk MASH who exercise" arm of the present study. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Middle-aged adults (40 to 60 years old) and older adults (aged 70 years or older)
- People diagnosed with Metabolic Disfunction-Associated Steatotic Liver Disease (MASLD); defined as the presence of hepatic steatosis (≥5% fat content) in conjunction with at least one cardiometabolic risk factor (overweight or obesity, dysglycaemia or Type II diabetes, elevated plasma triglycerides, reduced HDL-cholesterol or high blood preassure) with no other discernable cause.
- People diagnosed with at-risk Metabolic Disfunction-Associated SteatoHepatitis (MASH) according to the following criteria: I) a positive liver biopsy (NAS score ≥ 4 points (with at least one point in each of the components of the score: steatosis, lobular inflammation and ballooning, AND significant (F2) or advanced (F3) fibrosis), or II) a FAST score >0.65.
Key exclusion criteria (12 listed)
- Descompensated cirrhosis or end-stage liver disease.
- Other causes of liver disease, such as alcohol abuse or drug-induced, virus-related, or hereditary disease.
- History of a major adverse cardiovascular event, clinically significant kidney, endocrine, or neurological disease, bariatric surgery, HIV/AIDS, known inflammatory and/or rheumatologic disease, cancer, or other medical condition in which exercise is absolute contraindicated.
- Recent or planned major surgery, as well as anticancer therapies.
- Participating in a weight loss, a weight-management program or a supervised exercise program (more than 30 minutes three times per week, or 45 minutes twice a week, moderate/vigorous intensity).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseThe exercise intervention will include 2 days/week of supervised moderate-high intensity resistance training (rating perceived exertion >7, circuit-training, upper and lower body exercises involving major muscle groups) and high-intensity interval training (4 sets of 4-minute intervals at >85% peak heat rate with 4-minute of active recovery at 50-65% peak heat rate, uphill treadmill walking). Moreover, participants will receive an individualized moderate-intensity goal-setting aerobic (walking) program to achieve a minimum of 135 minutes per week. | Behavioural | Middle-age adults with MASLD who exercise, Middle-age adults with at risk MASH who exercise, Older adults with at risk MASH who exercise |
| Usual CareParticipants will receive standard recommendations on healthy lifestyle based on Mediterranean dietary pattern and physical activity recommendations for weight loss and health promotion. | Behavioural | Middle-age adults with MASLD receiving usual care |
Primary outcome
Change in hepatic fat content
Time frame: Change from baseline to 12 weeks
Hepatic fat content will be determined by Proton Density Fat Fraction (PDFF) assessed by Magnetic Resonance Imaging (MRI)
Change in liver inflammation and fibrosis
Time frame: Change from baseline to 12 weeks
Iron-corrected T1 (cT1) will be determined though MRI to reflect liver tissue water content, correlating with histological features of fibroinflammation (ballooning, fibrosis, and NAS)
Change in liver stiffness
Time frame: Change from baseline to 12 weeks.
Determined by vibration-controlled Transient Elastography (Fibroscan ®, VCTE). This is an ultrasound-based technique widely used in clinical practice to diagnose and monitor fibrosis progression. Liver stifness measurement increases with liver fibrosis.
41 secondary outcomes
Change in Enhanced Liver Fibrosis (ELF) Score
Time frame: Change from baseline to 12 weeks
Change in Pro-C3 serum levels
Time frame: Change from baseline to 12 weeks
Change in NIS4 serum biomarker of liver fibrosis
Time frame: Change from baseline to 12 weeks
Change in Metabolomics Advanced Steatohepatitis Fibrosis Score (MASEF)
Time frame: Change from baseline to 12 weeks
Change in visceral adipose tissue
Time frame: Change from baseline to 12 weeks
Change in pancreatic fat content
Time frame: Change from baseline to 12 weeks
Change in abdominal subcutaneous adipose tissue
Time frame: Change from baseline to 12 weeks
Change in abdominal intermuscular fat content
Time frame: Change from baseline to 12 weeks
Change in abdominal intramuscular fat content
Time frame: Change from baseline to 12 weeks
Change in abdominal skeletal muscle tissue
Time frame: Change from baseline to 12 weeks
Change in values of fasting glucose
Time frame: Change from baseline to 12 weeks
Change in values of HbA1c
Time frame: Change from baseline to 12 weeks
Change in values of fasting insulin
Time frame: Change from baseline to 12 weeks
Change in levels of mean glucose (Continuous Glucose Monitoring)
Time frame: Change from baseline to 12 weeks.
Change in fasting lipid profile
Time frame: Change from baseline to 12 weeks
Change in alkaline phosphatase
Time frame: Baseline to 12 weeks
Change in alanine aminotransferase (ALT)
Time frame: Baseline to 12 weeks
Change in gamma-glutamyl transferase (GGT)
Time frame: Baseline to 12 weeks
Change in total bilirubin
Time frame: Baseline to 12 weeks
Change in creatinine
Time frame: Baseline to 12 weeks
Change in estimated glomerular filtration rate (eGFR)
Time frame: Baseline to 12 weeks
Change in values of C-reactive protein
Time frame: Change from baseline to 12 weeks
Change in values of interleukin 6
Time frame: Change from baseline to 12 weeks]
Change in blood pressure
Time frame: Change from baseline to 12 weeks
Change in waist, hip and neck circumference
Time frame: Change from baseline to 12 weeks.
Change in body weight
Time frame: Change from baseline to 12 weeks
Change in moderate-to-vigorous physical activity (MVPA)
Time frame: Baseline to 12 weeks
Change in light physical activity
Time frame: Baseline to 12 weeks
Change in sedentary time
Time frame: Baseline to 12 weeks
Change in total activity counts
Time frame: Baseline to 12 weeks
Change in Subjective sleep quality
Time frame: Baseline to 12 weeks
Change in total sleep time
Time frame: Baseline to 12 weeks
Change in Cardiorespiratory Fitness
Time frame: Change from baseline to 12 weeks
Change in Lower-body muscular performance
Time frame: Change from baseline to 12 weeks
Change in Upper muscular strength
Time frame: Change from baseline to 12 weeks
Change in Quality of life
Time frame: Changes from baseline to 12-weeks
Change EuroQol Visual Analogue Scale (EQ-VAS) score
Time frame: Changes from baseline to 12-weeks
Change in mid-thigh subcutaneous adipose tissue area
Time frame: Baseline to 12 weeks
Change in mid-thigh intramuscular fat content
Time frame: Baseline to 12 weeks
Change in mid-thigh intermuscular fat content
Time frame: Baseline to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease and MASH - Metabolic Dysfunction-Associated Steatohepatitis, run by Consorcio Centro de Investigación Biomédica en Red (CIBER) at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jose Serra-Rexach, PhD (+34915868835, joseantonio.serra@salud.madrid.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hepatic fat content (time frame: Change from baseline to 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.