Impact of Artificial Intelligence Algorithm-driven Versus Standard Lifestyle Intervention in Non-Alcoholic Fatty Liver Disease - A Multicenter, Randomized, Open-label, Controlled Trial (S@VE-LIVER)

March 23, 2026 updated by: University Hospital, Toulouse

Now considered as a major public health challenge, non-alcoholic fatty liver disease (NAFLD) is rapidly rising as a major cause of end-stage liver disease. NAFLD encompasses a spectrum of conditions, ranging from steatosis, defined by excessive liver fat deposition, to Non-Alcoholic Steato-Hepatitis (NASH), an inflammatory and fibrotic stage which promotes severe complications such as cirrhosis and hepatocellular carcinoma.

Although several drugs are currently under clinical development to limit inflammation and fibrosis processes, clinical evidence and previous studies support the role of lifestyle intervention (dietary modifications and exercise) as a cornerstone for NAFLD management. Indeed, insulin resistance is a key pathogenic trigger of the disease and patients with NAFLD are frequently obese and/or have type 2 diabetes. Therefore, lifestyle intervention should be implemented as early as possible in the disease course, from the first evidence of steatosis.

Designing lifestyle interventions with good efficacy and sustainability for patients with NAFLD, and with acceptable medico-economic costs, is thus urgently needed. However, the optimal way to implement such lifestyle modification programs remains unclear. Technological innovations in health-monitoring devices recently made it possible to propose disruptive lifestyle interventions, but the value of such strategies has not been addressed in NAFLD so far.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

216

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard lifestyle intervention
Personalized dietary and physical activity advices will be provided at baseline (investigator, dietitian, educator for adapted physical activities) and reinforced/adjusted at on-site visits V1 (investigator and dietitian) and V2 (investigator and dietitian). To standardize on-site lifestyle interventions in all centers and in both arms, health professional training and monitoring will be ensured by a coordinating dietitian and a coordinating educator for adapted physical activities from the project coordinating team.
Other: Fibroscan CAP/VTE

A FibroScan CAP is a specific ultrasound technology that allows for the assessment of liver stiffness and lipid alterations by measuring:

  • Liver elasticity, defined by the speed at which sound waves propagate. This correlates well with the degree of liver fibrosis.
  • The attenuation of ultrasound waves in the liver. This correlates with steatosis.
Other: Randomization
In order to ensure the comparability of both arms (connected versus standard lifestyle intervention) in terms of major confounding factors, the 1:1 randomization procedure is planned to be stratified by centre, gender and history of diabetes.
Radiation: MRI-PDFF
Proton density fat fraction magnetic resonance imaging (PDFF MRI) of liver tissue is a non-invasive and quantitative biomarker, derived from magnetic resonance imaging, that allows for the assessment of liver fat content.
Behavioral: Diet and physical activity personalized advice

If the participant is randomized in the control group, a final interview with the investigator validates the lifestyle modification advice given.

If the participant is randomized in the connected intervention group, she/he receives training in the use of the telemonitoring device and her/his characteristics are entered into the software so that she/he can benefit from personalized advice concerning his diet and physical activity.

Behavioral: Evaluation of nutritional intakes
This is a survey on patients' food intake (meals, snacks, drinks). For 3 days, they will have to indicate the exact nature of the product consumed, its quantity, the cooking method, the fat used and its quantity, as well as the time and place of consumption.
Behavioral: Evaluation of nutritional knowledge questionnaire
This is a questionnaire about knowledge in nutrition and physical activity, consisting of 19 multiple-choice questions
Behavioral: Evaluation of physical activity level (GPAQ)
This questionnaire asks about the time the patient spends on different physical activities during the week. It is divided into four sections: "activities at work," "traveling from one place to another," "leisure activities," and "sedentary behavior." The patient must answer a total of 16 questions.
Behavioral: Quality of life (EQ 5D 5L)
This is a quality of life questionnaire consisting of 5 questions covering the following areas: mobility, independence, daily activities, pain/discomfort, and anxiety/depression. In addition, this questionnaire also includes a scale from 0 (worst imaginable health condition) to 100 (best imaginable health condition) on which the respondent can indicate their health status.
Experimental: Connected lifestyle intervention

Patients will benefit from personalized dietary and physical activity advices in face-to-face meetings at baseline (medical investigator, dietitian and educator for adapted physical activities), 6 months (medical investigator and dietitian) and 12 months (medical investigator and dietitian) associated with a 12-month connected lifestyle intervention program at home: nutritional and physical activity monitoring, weekly artificial intelligence-driven advices and monthly interactions with health professionals through secure messaging.

Patients randomized in the connected intervention group will be given connected tools and will be trained in the use of lifestyle educational/advice software applications (available via study-supplied tablet,smartphone or computer).
Other: Fibroscan CAP/VTE

A FibroScan CAP is a specific ultrasound technology that allows for the assessment of liver stiffness and lipid alterations by measuring:

  • Liver elasticity, defined by the speed at which sound waves propagate. This correlates well with the degree of liver fibrosis.
  • The attenuation of ultrasound waves in the liver. This correlates with steatosis.
Other: Randomization
In order to ensure the comparability of both arms (connected versus standard lifestyle intervention) in terms of major confounding factors, the 1:1 randomization procedure is planned to be stratified by centre, gender and history of diabetes.
Radiation: MRI-PDFF
Proton density fat fraction magnetic resonance imaging (PDFF MRI) of liver tissue is a non-invasive and quantitative biomarker, derived from magnetic resonance imaging, that allows for the assessment of liver fat content.
Behavioral: Diet and physical activity personalized advice

If the participant is randomized in the control group, a final interview with the investigator validates the lifestyle modification advice given.

If the participant is randomized in the connected intervention group, she/he receives training in the use of the telemonitoring device and her/his characteristics are entered into the software so that she/he can benefit from personalized advice concerning his diet and physical activity.

Behavioral: Evaluation of nutritional intakes
This is a survey on patients' food intake (meals, snacks, drinks). For 3 days, they will have to indicate the exact nature of the product consumed, its quantity, the cooking method, the fat used and its quantity, as well as the time and place of consumption.
Behavioral: Evaluation of nutritional knowledge questionnaire
This is a questionnaire about knowledge in nutrition and physical activity, consisting of 19 multiple-choice questions
Behavioral: Evaluation of physical activity level (GPAQ)
This questionnaire asks about the time the patient spends on different physical activities during the week. It is divided into four sections: "activities at work," "traveling from one place to another," "leisure activities," and "sedentary behavior." The patient must answer a total of 16 questions.
Behavioral: Quality of life (EQ 5D 5L)
This is a quality of life questionnaire consisting of 5 questions covering the following areas: mobility, independence, daily activities, pain/discomfort, and anxiety/depression. In addition, this questionnaire also includes a scale from 0 (worst imaginable health condition) to 100 (best imaginable health condition) on which the respondent can indicate their health status.
Behavioral: Number and time of connections

This document details the connection data that will be collected during the study: - Educational software and S@VE LIVER application: connection dates, duration of use, number of uses

  • Sensor: dates and number of uses for each sensor, synchronization dates
  • Technical alerts: date and number of alerts received per patient during monitoring
Behavioral: Satisfaction questionnaire

This is a patient satisfaction questionnaire regarding:

  • the training received at the beginning of the protocol
  • the ease of use of the device's components
  • the device's functionality
  • the device's usefulness
  • meal logging
  • the recipe section
  • the connected scale
  • the activity tracker
  • all the software The patient can write comments in each section

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with a relative decline of at least 30% in liver fat
Time Frame: 12 months
Percentage of participants with a relative decline of at least 30% in liver fat content measured by MRI-PDFF (Proton Density Fat Fraction) from baseline to 12 months, i.e. at the end of the intervention period.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of fat content
Time Frame: 12 months
Percentage of liver fat content measured by PDF MRI
12 months
Determination of fat content
Time Frame: 24 months
Liver fat percentage measured by Fibroscan CAP
24 months
Determination of the fibrosis score
Time Frame: 24 months
Percentage of fibrosis score measured by Fibroscan® Vibration-controlled Transient Elastography (VTE)
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/21/0335
  • 2023-A02422-43 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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