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RECRUITING
NCT07652151
NA

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

View on ClinicalTrials.gov

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

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.

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)