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

NCT07652151 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2026-06-23

No results posted yet for this study

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.

Conditions

  • MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)

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.

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    collaborator OTHER

  • Hacettepe University

    collaborator OTHER

  • Consorcio Centro de Investigación Biomédica en Red (CIBER)

    collaborator OTHER_GOV

  • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-20
Primary Completion
2026-11-30
Completion
2027-02-28

Countries

  • Italy
  • Spain
  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07652151 on ClinicalTrials.gov