RecruitingNot ApplicableNCT07652151

UNMASK: UNveiling the Pathobiology of Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) for the Discovery of Novel Therapeutics and biomarKers

UNMASK Study Protocol V2.0

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Enrollment

450 participants

Start Date

Jan 20, 2026

Study Type

INTERVENTIONAL

Conditions

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Multimodal lifestyle intervention for people with masld - metabolic dysfunction-associated steatotic liver disease. The study is currently recruiting participants at 3 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALMultimodal 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.