See if a Mediterranean-style lifestyle program helps MASLD patients improve liver health
Official title: UNMASK: Unveiling the Pathobiology of Metabolic Dysfunction-Associated Steatotic Liver Disease for the Discovery of Novel Therapeutics and Biomarkers - Study Protocol Version 2.0
Run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · NCT07652151 · Data updated 2026-11-12
This trial tests a Mediterranean diet plus personalized exercise plan in adults with MASLD to see if it improves liver and systemic markers.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 450 (estimated) |
| Sponsor | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla Academic / other |
| Locations | 3 sites (Roma and 2 other locations) |
| Status | Recruiting |
| Started | January 20, 2026 |
| Main results expected | November 2026 |
| Study ends | February 2027 |
| Registry record updated | June 23, 2026 |
| Trial ID | NCT07652151 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 with MASLD and metabolic risk factors who have not recently undergone substantial weight loss or diet counseling, and who meet liver biomarker and imaging criteria.
✕Probably not a fit
Individuals who do not respond to lifestyle changes or who have contraindicating conditions may not experience measurable liver-related benefits.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, single-arm study testing a tailored caloric-restricted Mediterranean diet and structured exercise over 16 weeks, with follow-up up to 36 months. Participants have MASLD with metabolic risk factors and liver stiffness, CAP, and MRI-PDFF criteria. The study relies on non-invasive biomarkers to monitor liver status and systemic changes, with visits every 4 weeks during the intervention and every 12 weeks afterward. The goal is to determine if lifestyle changes can parallel improvements in hepatic and systemic biomarkers. No control group is described; outcomes focus on feasibility and biomarker trends.
Why it matters
Potential benefit: If successful, participants may see improvements in liver health and metabolic markers, potentially slowing MASLD progression.
How similar studies have gone: Previous lifestyle interventions in MAFLD/MASLD have shown biomarker and hepatic improvements in many cohorts, though results vary and this exact design is novel in its biomarker-focused approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Significant alcohol intake (≥30 g/day in men and ≥20 g/day in women) * Other causes of liver disease (evidence of viral or autoimmune hepatitis, HIV, drug-induced fatty liver or other metabolic liver diseases) * Use of recreational drugs * Decompensated acute or chronic liver disease * Cirrhosis or transplant waitlist * Pregnancy or parenteral nutrition * No nutritional interventions, medications for weight loss or weight loss higher than 5% within the last year * 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.
Where it's running
-
Hospital Universitario Virgen del Rocío de Sevilla
Seville, Spain Recruiting -
Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Internal Medicine and Liver Transplantation Unit
Roma, Italy Not yet recruiting -
Hacettepe University
Ankara, Turkey (Türkiye) Not yet recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Exercise for an Aging Liver
This study tests whether a supervised 12-week exercise program can reduce liver fat, inflammation, and fibrosis in adults with MASLD or at-risk MASH, comparing younger and older adults and different disease severities.
-
Spleen stiffness measurement to detect advanced liver fibrosis
This study will test whether measuring spleen stiffness with a 100‑Hz probe can help detect advanced fibrosis and portal hypertension in adults with MASLD and compensated advanced chronic liver disease.
-
Extra virgin olive oil for liver and metabolic health in MASLD
This trial will test whether taking extra virgin olive oil every day helps adults with MASLD and overweight reduce liver fat and improve blood sugar and cholesterol.
-
Pulsendo for Type 2 Diabetes and fatty liver disease in adults
This study tests the pulsENDO procedure in adults with type 2 diabetes who still have high blood sugar despite meds, to see if it helps their diabetes and fatty liver disease.
-
Time-restricted eating for fatty liver disease in obesity
This study tests whether an 8-hour daily eating window can reduce liver fat in adults with obesity and MASLD, using coaching and a phone app alongside standard care.
-
Gut microbiota–derived amino acid metabolites in MASLD/MASH
This study tests whether gut microbiota–produced amino acid metabolites are linked to MASLD/MASH in adults by collecting stool, blood, and urine samples and analyzing dietary factors.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.