AzTrials
AzTrials

Non Alcoholic Fatty Liver DiseaseS@VE-LIVERNCT07497750

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

A study testing Fibroscan CAP/VTE, Randomization and MRI-PDFF in people with Non Alcoholic Fatty Liver Disease, run by University Hospital, Toulouse at 9 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Alcoholic Fatty Liver Disease
What is being tested?
Fibroscan CAP/VTE, Randomization and MRI-PDFF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
9 sitesFrance
Study dates
1 Jun 2026to 31 Dec 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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);
Show all 9Show fewer
  • 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

Who cannot join

  • 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;
Show all 19Show fewer
  • 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

Trial locations and contacts

9 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Pierre GOURDY, MD contact

5 61 32 37 40 ext. +33

gourdy.p@chu-toulouse.fr

9 sites in 1 country

France9 sites

  • CHU Angers

    Angers, 49933

    Jérôme BOURSIER, MD, JeBoursier@chu-angers.fr

  • APHP Hôpital Beaujon

    Clichy, 92110

    Laurent CASTERA, MD, laurent.castera@aphp.fr

  • CHU Dijon Hôpital Le Bocage

    Dijon, 21000

    Jean-Michel PETIT, MD, jean-michel.petit@chu-dijon.fr

  • CHU Lyon

    Lyon, 69310

    Cyrielle CAUSSY, MD, cyrielle.caussy@chu-lyon.fr

  • CHU Nantes

    Nantes, 44093

    Bertrand CARIOU, MD, bertrand.cariou@univ-nantes.fr

  • APHP Cochin

    Paris, 75014

    Lucia PARLATI, MD, lucia.parlati@aphp.fr

  • CHU Bordeaux

    Pessac, 33600

    Victor DE LEDINGHEN, MD, victor.deledinghen@chu-bordeaux.fr

  • CHU Toulouse Rangueil

    Toulouse, 31059

    Pierre GOURDY, MD, 5 61 32 37 40 ext. +33, gourdy.p@chu-toulouse.fr

    Christophe BUREAU, MD

  • Clinique Pasteur Toulouse

    Toulouse, 31300

    Maeva GUILLAUME, MD, mguillaume@clinique-pasteur.com

Other trials in France

About this study

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.

Being tested
Fibroscan CAP/VTE, Randomization, MRI-PDFF, Diet and physical activity personalized advice, Evaluation of nutritional intakes
Keywords
artificial intelligence, Non-Alcoholic Fatty Liver Disease
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fibroscan CAP/VTEOther

    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.

  • RandomizationOther

    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.

  • MRI-PDFFRadiation

    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.

  • Diet and physical activity personalized adviceBehavioural

    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.

  • Evaluation of nutritional intakesBehavioural

    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.

  • Evaluation of nutritional knowledge questionnaireBehavioural

    This is a questionnaire about knowledge in nutrition and physical activity, consisting of 19 multiple-choice questions

  • Evaluation of physical activity level (GPAQ)Behavioural

    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.

  • Quality of life (EQ 5D 5L)Behavioural

    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.

  • Number and time of connectionsBehavioural

    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

  • Satisfaction questionnaireBehavioural

    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
Study groups in NCT07497750
Study groupRoleWhat they receive
Standard lifestyle interventionActive comparatorPersonalized 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.
Receives: Other: Fibroscan CAP/VTE; Other: Randomization; Radiation: MRI-PDFF; Behavioral: Diet and physical activity personalized advice; Behavioral: Evaluation of nutritional intakes; Behavioral: Evaluation of nutritional knowledge questionnaire; Behavioral: Evaluation of physical activity level (GPAQ); Behavioral: Quality of life (EQ 5D 5L)
Connected lifestyle interventionExperimentalPatients 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).
Receives: Other: Fibroscan CAP/VTE; Other: Randomization; Radiation: MRI-PDFF; Behavioral: Diet and physical activity personalized advice; Behavioral: Evaluation of nutritional intakes; Behavioral: Evaluation of nutritional knowledge questionnaire; Behavioral: Evaluation of physical activity level (GPAQ); Behavioral: Quality of life (EQ 5D 5L); Behavioral: Number and time of connections; Behavioral: Satisfaction questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants with a relative decline of at least 30% in liver fat

    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.

    Measured: 12 months

Secondary outcomes (3)

  1. Determination of fat content

    Percentage of liver fat content measured by PDF MRI

    Measured: 12 months

  2. Determination of fat content

    Liver fat percentage measured by Fibroscan CAP

    Measured: 24 months

  3. Determination of the fibrosis score

    Percentage of fibrosis score measured by Fibroscan® Vibration-controlled Transient Elastography (VTE)

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Controlled trial in parallel groups: home connected device including artificial intelligence algorithms versus standard lifestyle intervention
Masking
None (open label)
Enrolment
216 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07497750
Sponsor's protocol ID
RC31/21/0335
Other IDs
2023-A02422-43
Acronym
S@VE-LIVER
Status last verified
Mar 2026
First submitted
23 Mar 2026
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Fibroscan CAP/VTE, Randomization and MRI-PDFF in people with Non Alcoholic Fatty Liver Disease, run by University Hospital, Toulouse at 9 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pierre GOURDY, MD (5 61 32 37 40 ext. +33, gourdy.p@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants with a relative decline of at least 30% in liver fat (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07497750.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in