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Can a tailored mediterranean diet and exercise reverse fatty liver?

NCT ID NCT06275906

Disease control Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested two versions of a low-calorie Mediterranean diet, each with different carb and fat levels, combined with moderate aerobic exercise in 36 adults with obesity and fatty liver disease (NAFLD). The goal was to see if one diet plan worked better than the other at reducing liver fat, improving gut health, and lowering metabolic risks after 3 months. Participants were aged 18-60 with a BMI of 30 or higher or abdominal obesity.

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

36 people

The number who actually took part.

Started

Mar 2024

Finished

Apr 2026

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 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * BMI ≥ 30 Kg/m2 or an abdominal circumference (waist) \> 94 cm in men and \> 80 cm in women (IDF criteria for the definition of abdominal obesity) with or without the characteristics that characterize metabolic syndrome * Age range between 18 and 60 years, both sexes * Diagnosis of hepatic steatosis, formulated on the basis of recognized criteria (fibroscan \[CAP (controlled attenuation parameter) \> 238 dB/m\], FLI). Exclusion Criteria: * Normal weight and underweight subjects * Presence of any pathology that could influence the presence of steatosis apart from the pathologies that represent inclusion criteria * Treatment with any device, pharmacological or otherwise, which can influence hepatic metabolism and, therefore, the presence of steatosis * Pregnancy or breastfeeding * Subjects with osteo-articular pathologies that may prevent regular physical exercise

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Conditions

The condition(s) this trial relates to.

irritable bowel syndrome metabolic dysfunction-associated steatotic liver disease Motor Activity Obesity obesity disorder

As listed by the trial registrant

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

IBS NAFLD Obesity

Contacts and locations

Locations

  • Irccs Saverio de Bellis

    Castellana Grotte, BARI, 70013, Italy

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