AI diet coach takes on fatty liver: 216-Person trial launches
NCT ID NCT07497750
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 216 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
9 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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APHP Cochin
Paris, 75014, France
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APHP Hôpital Beaujon
Clichy, 92110, France
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CHU Angers
Angers, 49933, France
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CHU Bordeaux
Pessac, 33600, France
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CHU Dijon Hôpital Le Bocage
Dijon, 21000, France
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CHU Lyon
Lyon, 69310, France
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CHU Nantes
Nantes, 44093, France
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CHU Toulouse Rangueil
Toulouse, 31059, France
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Clinique Pasteur Toulouse
Toulouse, 31300, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can one workout a week melt liver fat?
- Ten-Year liver study asks: what makes fatty liver disease progress?
- Can a liver drug also protect the heart? study tests ursodeoxycholic acid in fatty liver disease
- Ketogenic diet vs mediterranean diet: which better reshapes metabolism?
- Can a simple scan reveal hidden liver damage in diabetes patients?