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AI diet coach takes on fatty liver: 216-Person trial launches

NCT ID NCT07497750

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether an artificial intelligence (AI) program that gives personalized diet and exercise advice can help people with non-alcoholic fatty liver disease (NAFLD) reduce liver fat more than standard lifestyle counseling. About 216 adults with NAFLD and overweight will be randomly assigned to either the AI-driven program or usual care for 12 months. The main goal is to see if more people in the AI group achieve at least a 30% drop in liver fat measured by MRI.

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 216 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

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: * Male or female aged 18 years or older; * Body mass index (BMI) between 25.0 and 45.0 kg/m² (including limit values); * Stable body weight for at least 3 months prior to inclusion (weight gain or loss \< 3%); * Medical history supporting the diagnosis of Non-alcoholic Fatty Liver Disease diagnosis (including available biology, imaging and/or histology data from the medical file); * Presence of significant liver steatosis attested by Fibroscan® Controlled Attenuation Parameter (CAP) value \> 300 dB/m; * Absence of severe fibrosis attested by Fibroscan Vibration controlled Transient Elastography (VTE) value \< 8.5 kPa (corresponding to stage F0-F2); * Availability of a WIFI internet connection at patient home * Able to provide written informed consent and agree to comply with the study protocol; * Covered by a French National Health Insurance plan Exclusion criteria: * History of liver disease other than NAFLD; * History of cirrhosis and/or liver cancer; * History of alcohol abuse and/or significant consumption in the past six months; * AST or ALT \> 5 times the upper limit of normal; * History of diabetes mellitus with another etiological diagnosis than type 2 diabetes; * Type 2 diabetes with HbA1c ≥ 8% and/or requiring insulin therapy; * Type 2 diabetes with significant change in oral antidiabetic therapy in the last 3 months; * Type 2 diabetes with significant change in GLP-1RA therapy in the last 6 months; * History of bariatric surgery or bariatric surgery planned during the study period; * Use of medications affecting weight or energy intake/expenditure in the last 3 months, including weight loss medications, corticosteroids, antipsychotic drugs or other medications according to investigator's opinion; * History of hypothyroidism with abnormal TSH value and/or adjustment of hormonal therapy in the last 3 months; * Severe chronic renal failure (eGFR\<30 ml/min/1.73 m2); * Severe cardiovascular disease, heart failure or any other medical condition not compatible with participation in the study according to investigator's opinion; * History of malignant tumor, unless considered to be in remission for 5 years or more; * Pregnant women or women planning to become pregnant; * Contra-indication to MRI examination or condition not allowing MRI to be carried out; * Persons participating in another research including a period of exclusion still in course * Patients who are unwilling or unable to give informed consent * Persons placed under judicial protection

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    9 sites. 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

  • APHP Cochin

    Paris, 75014, France

  • APHP Hôpital Beaujon

    Clichy, 92110, France

  • CHU Angers

    Angers, 49933, France

  • CHU Bordeaux

    Pessac, 33600, France

  • CHU Dijon Hôpital Le Bocage

    Dijon, 21000, France

  • CHU Lyon

    Lyon, 69310, France

  • CHU Nantes

    Nantes, 44093, France

  • CHU Toulouse Rangueil

    Toulouse, 31059, France

  • Clinique Pasteur Toulouse

    Toulouse, 31300, France

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