An interventional study of Multimodal lifestyle intervention in MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla. Recruiting at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-23.
Sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Not applicable, Interventional, and Treatment
Overall design: The study will include one intervention based on Mediterranean diet plus structured lifestyle intervention (150 min/week of moderate-intensity or 75 min/week of high-intensity exercise) for a total of 16 weeks. Following a screening period of up to 12 months, eligible participants will be included in a single cohort.
Study details include:
The UNMASK trial is a multicenter (Spain, Italy and Turkey), prospective, open-label lifestyle intervention based on tailored caloric restriction and monitored exercise. UNMASK aims to prove that the amelioration of MASLD at systemic and hepatic levels will be parallel to the improvement in our selected biomarkers. Given the known challenges with diagnosis and staging of MASH when using histopathological assessments of liver biopsies, the study will evaluate various blood-based non-invasive biomarkers. Non-invasive tests will be performed to asses endpoints. UNMASK includes a single arm in which patients undergo lifestyle changes, chiefly through the prescription of Mediterranean diet and physical exercise.
1,270 studies on the registry are indexed under Fibrosis; 276 are open to participants now.
This study's planned enrollment of 450 is above the median of 63 across 840 interventional studies indexed under Fibrosis.
Browse Fibrosis studies →Fundación Pública Andaluza para la gestión de la Investigación en Sevilla is the lead sponsor of 120 studies on the registry; 26 are open to participants now.
Compared within Fibrosis, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mediterranean diet (MD) rich in olive oil, nuts and coffee, combined with structured exercise through a lifestyle intervention (LSI)
Behavioral: Multimodal lifestyle intervention
Mediterranean diet plus structured lifestyle intervention (150 min/week of moderate-intensity or 75 min/week of high-intensity exercise) for a total of 16 weeks.
Number of Participants Achieving a Steatosis Response
Defined as a 30% decrease in MRI-Proton Density Fat Fraction (PDFF) and CAP assessed by Transient Elastography
Time frame: From baseline to month 16
Number of Participants Achieving Fibrosis Regression
\>20% reduction in liver stiffness measured by MRE.
Time frame: From baseline to month 16
Change From Baseline in Metabolic Dysfunction-Associated Steatohepatitis Resolution Index Score
Change from baseline to Month 16 in the Metabolic Dysfunction-Associated Steatohepatitis Resolution Index (MASH Resolution Index; MASH-RI), a composite non-invasive score developed to estimate resolution of steatohepatitis. The MASH-RI is calculated as: 0.520-0.003×baseline ALT (U/L)-0.024×(latest ALT (U/L)-baseline ALT (U/L))-0.048×baseline MRI-PDFF-2.571×(\[latest MRI-PDFF-baseline MRI-PDFF\]/baseline MRI-PDFF)-0.039×baseline AST (U/L). A MASH-RI ≥-0.67 rules in MASH resolution, and a MASH-RI of ≤-2.67 rules out a resolution.
Time frame: From baseline to month 16
% Change in Weight
Weight measured in kilograms
Time frame: From baseline to month 16
% Change in Waist Circumference
Waist Circumference measured in centimeters
Time frame: From baseline to month 16
Change in Patient Reported Physical Activity
Assessment of patient reported physical activity using the International Physical Activity Questionnaire (IPAQ). IPAQ classifies individuals into five categories based on their total Metabolic Equivalent of Task (MET) minutes per week. Low physical activity: Less than 600 MET-minutes/week; moderate physical activity: Between 600 and 3,000 MET-minutes/week; or high physical activity: More than 3,000 MET-minute/week
Time frame: From baseline to month 16
Change in Patient Reported Diet Habits by MEDAS Questionnaire
Assessment of patient reported diet habits using the MEDAS questionnaire, a 14-item questionnaire of Mediterranean Diet adherence. Score lower than 9 means low adherence to Mediterranean Diet, and score equal or higher that 9 means good adherence to Mediterranean Diet.
Time frame: From baseline to month 16
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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