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: * Study duration will be up to 36 months including the screening period. * Intervention will be up to 16 weeks. * Visit frequency will be every 4 weeks for the interventional period and every 12 weeks during follow-up.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
450
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.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Internal Medicine and Liver Transplantation Unit
Roma, Italy
NOT_YET_RECRUITINGHospital Universitario Virgen del Rocío de Sevilla
Seville, Spain
RECRUITINGHacettepe University
Ankara, Turkey (Türkiye)
NOT_YET_RECRUITINGNumber 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
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