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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.

Key facts

Who runs it
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Where
Ankara, TürkiyeSee the siteAlso in 2 other countries, 2 sites
Trial code
Registry title
UNMASK: Unveiling the Pathobiology of Metabolic Dysfunction-Associated Steatotic Liver Disease for the Discovery of Novel Therapeutics and Biomarkers
Status
Recruiting
People taking part
450 people, planned
Started
20 Jan 2026
Expected to end
Feb 2027
Type of study
Interventional
Treatments tested
  • Multimodal lifestyle intervention
Record updated
23 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with fatty liver disease linked to metabolic problems. They follow a Mediterranean diet and an exercise plan for 16 weeks.

Age
Over 18 years old
Sex
All sexes can join
Disease stage
Fatty liver disease (MASLD) shown by scans: Fibroscan liver stiffness ≥ 8, CAP ≥ 248 db/m and MRI PDFF ≥ 5%. Also metabolic problems such as type 2 diabetes, central obesity, BMI ≥ 25 kg/m2, high blood pressure or abnormal blood fats.
Earlier treatment
No diet counselling or weight loss higher than 10% in the prior 6 months. No nutritional interventions, weight-loss medicines or weight loss higher than 5% in the last year.
Biomarker or test result
Fibroscan liver stiffness ≥ 8, CAP ≥ 248 db/m and MRI PDFF ≥ 5%.

Main reasons for not taking part

  • Heavy alcohol use (30 g/day or more in men, 20 g/day or more in women)
  • Other liver disease, such as viral or autoimmune hepatitis, HIV or drug-induced fatty liver
  • Cirrhosis, severe liver disease, or being on a transplant waiting list
  • Pregnancy or parenteral nutrition
  • No personal smartphone running Android 7.0 or iOS 14.0 or later

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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%. ,

Who cannot take part

  • 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

Where in Türkiye

Also in 2 other countries, 2 sites

  • Hacettepe UniversityAnkara, TürkiyeContact: Yasemin BalabanNot yet recruiting

About the trial

What the trial wants to find out

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

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.

The group in the trial

  • Multimodal lifestyle interventionTreatment being tested

    Mediterranean diet (MD) rich in olive oil, nuts and coffee, combined with structured exercise through a lifestyle intervention (LSI)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Diet and exercise program for people with fatty liver disease linked to metabolismGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Record updated
23 June 2026