Diet and exercise program for people with fatty liver disease linked to metabolism
Tests a Mediterranean diet plus exercise program in adults with metabolic-related fatty liver disease.
Plain-language title generated from the registry record
Registry title: UNMASK: Unveiling the Pathobiology of Metabolic Dysfunction-Associated Steatotic Liver Disease for the Discovery of Novel Therapeutics and Biomarkers
Key facts
- Where
- Roma, ItalySee the site
Where in Italy
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Internal Medicine and Liver Transplantation UnitRoma, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Trial code
- NCT07652151
- Record updated
- 23 June 2026
- Original description
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.Read full original descriptionShow less
UNMASK: Unveiling the Pathobiology of Metabolic Dysfunction-Associated Steatotic Liver Disease for the Discovery of Novel Therapeutics and Biomarkers - Study Protocol Version 2.0
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.
Inclusion: Metabolic disarrangements following ATPIII criteria (i.e. comorbidities such as Type 2 diabetes, central obesity, BMI≥>25 kg/m2, hypertension, dyslipidaemia; Written informed consent; No dietetical counsellor/weight loss higher than 10% within the prior 6 months; Age over 18 years old; Liver stiffness measurement by Fibroscan ≥ 8, CAP ≥ 248 db/m and MRI PDFF ≥ 5%. ,.
Exclusion: Use of recreational drugs; Cirrhosis or transplant waitlist; No nutritional interventions, medications for weight loss or weight loss higher than 5% within the last year; Other causes of liver disease (evidence of viral or autoimmune hepatitis, HIV, drug-induced fatty liver or other metabolic liver diseases); Decompensated acute or chronic liver disease; Significant alcohol intake (≥30 g/day in men and ≥20 g/day in women); Pregnancy or parenteral nutrition; Presence of other comorbidities that would impact lifestyle intervention (i. e. prosthesis); Absence of a personal smartphone with a compatible operating system capable of supporting the Amazfit Bip 6 accelerometer app's functionalities: Android 7.0 or iOS 14.0, or later.