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Exercise and diet combo takes on fatty liver inflammation

NCT ID NCT06186869

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether adding aerobic or high-intensity interval exercise to a low-glycemic Mediterranean diet can lower inflammation better than diet alone. Researchers will enroll 90 adults aged 18-65 with obesity and non-alcoholic fatty liver disease. Participants will be split into three groups: diet only, diet plus moderate aerobic exercise, or diet plus HIIT, and their inflammatory markers will be measured.

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 either moderate aerobic exercise or high-intensity interval training (HIIT)
What this could lead to
If it works, this could show that combining exercise with a Mediterranean diet is better than diet alone for reducing inflammation and improving health in people with obesity and fatty liver disease.
What could go wrong
This is a small, early-stage study (90 people) and results may not apply to everyone. The benefits seen might be modest, and participants must stick to the programs for results.

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 90 people

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

Started

Oct 2023

Expected to finish

Dec 2026

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 to 65 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 characterise metabolic syndrome * Age range 18-65 years, both sexes * Diagnosis of hepatic steatosis, formulated on the basis of recognised criteria (fibroscan (CAP (controlled attenuation parameter) \> 238 dB/m)). Exclusion Criteria: * Normal and underweight subjects * Presence of any pathology that may influence the presence of steatosis apart from pathologies that are inclusion criteria, neurological and psychiatric pathologies, gastrointestinal, oncological and cardiovascular diseases * Pregnancy or breastfeeding * Subjects with osteoarticular pathologies that may prevent regular exercise * Inability to quantify the degree of NAFLD by Fibroscan * Person not in possession of a medical certificate of fitness for non-competitive physical activity.

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Conditions

The condition(s) this trial relates to.

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.

NAFLD Obesity

How to take part

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

  1. The places running it

    1 site. 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

  • IRCCS De Bellis

    RECRUITING

    Castellana Grotte, Bari, 70013, Italy

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