NCT07652151Recruiting
UNMASK: Unveiling the Pathobiology of Metabolic Dysfunction-Associated Steatotic Liver Disease for the Discovery of Novel Therapeutics and Biomarkers
UNMASK: Unveiling the Pathobiology of Metabolic Dysfunction-Associated Steatotic Liver Disease for the Discovery of Novel Therapeutics and Biomarkers - Study Protocol Version 2.0
Source: ClinicalTrials.gov · Last updated 23 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 450 (estimated)
- First submitted
- 11 Jun 2026
- Start date
- 20 Jan 2026
- Primary completion date
- Nov 2026
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Diseases
- Obesity, Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07652151
What you commit to
- Study type: Interventional
- Planned participants: 450
- From 20 Jan 2026 to the primary completion date, Nov 2026
- 3 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 illness
- 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
Other
- 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.
Who the study is looking for
- 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%. ,
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Virgen del Rocío de Sevilla Coordinator of this site? Confirm its status | Seville | Spain | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Internal Medicine and Liver Transplantation Unit Coordinator of this site? Confirm its status | Roma | Italy | Not yet recruiting |
| Hacettepe University Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.