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UNMASK: UNveiling the Pathobiology of Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) for the Discovery of Novel Therapeutics and biomarKers
Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Summary
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.
Official title: UNMASK Study Protocol V2.0
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
450
Start Date
2026-01-20
Completion Date
2027-02
Last Updated
2026-06-16
Healthy Volunteers
No
Interventions
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.
Locations (3)
Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Internal Medicine and Liver Transplantation Unit
Roma, Italy
Hospital Universitario Virgen del Rocío de Sevilla
Seville, Spain
Hacettepe University
Ankara, Turkey (Türkiye)