UNMASK: Unveiling the Pathobiology of Metabolic Dysfunction-Associated Steatotic Liver Disease for the Discovery of Novel Therapeutics and Biomarkers

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.

NCT Number	NCT07652151
Lead Sponsor	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla Collaborators: Instituto de Salud Carlos III, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Hacettepe University, Consorcio Centro de Investigación Biomédica en Red (CIBER)
Conditions	MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
Enrollment	450 participants
Start Date	2026-01-20
Primary Completion	2026-11 (estimated)
Study Completion	2027-02 (estimated)
Updated on ClinicalTrials.gov	2026-06-23