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Lifestyle overhaul tested as fatty liver fix

NCT ID NCT07652151

Disease control Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

The UNMASK study is testing whether a 16-week program of Mediterranean diet and regular exercise can reduce liver fat and scarring in people with metabolic fatty liver disease (MASLD). Researchers will enroll 450 adults and track changes in liver health using scans and blood tests. The goal is to see if lifestyle changes alone can improve this common condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mediterranean diet plus structured exercise (150 min/week moderate or 75 min/week high-intensity)
What this could lead to
If successful, this could show that a simple lifestyle program can reduce liver fat and scarring in people with fatty liver disease, pointing toward a non-drug treatment option.
What could go wrong
This is an early-stage observational study with no control group, so results may not prove cause and effect. The lifestyle changes are intensive and may be hard for many to maintain long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 450 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Fibrosis metabolic dysfunction-associated steatotic liver disease Obesity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Masld (metabolic dysfunction-associated steatotic liver disease)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Internal Medicine and Liver Transplantation Unit

    NOT_YET_RECRUITING

    Roma, Italy

  • Hacettepe University

    NOT_YET_RECRUITING

    Ankara, Turkey (Türkiye)

  • Hospital Universitario Virgen del Rocío de Sevilla

    RECRUITING

    Seville, Spain

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