Time-restricted eating for fatty liver disease in obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, parallel-group study compares time-restricted eating with usual care in adults with obesity and MASLD. Participants start with MRI to measure liver fat, and only those with MRI-PDFF of 8% or higher are randomized. The intervention uses a daily eating window of up to 8 hours, supported by dietary coaching and a dedicated mobile app, while the control receives standard obesity management. Primary outcome is change in liver fat content measured by MRI. All participants receive usual obesity and metabolic care throughout the trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Body mass index (BMI) between 30.0 and 49.9 kg/m2
* Age between 18 and 65 years (limits included)
* Sedentary (light-intensity physical activity less than 1 hour per week) or moderately active (moderate exercise 1 to 2 hours per week). Self-declared criteria.
* Weight stable for at least 3 months prior to the beginning of the study (gain or loss \<4 kg). Self-declared criteria.
* Able to give written informed consent
* Self-reported eating interval \> 12 hours per day
* Subject who owns a smartphone with access to the internet, and agrees to use it in the study
* Affiliation with French social security system or beneficiary from such system
* Fibroscan® Controlled Attenuation Parameter (CAP) \> 300 dB/ms
* Hepatitis B and C serologies negative (or showing past-infection or protective immunization)

Exclusion Criteria:

* Alcohol intake \> 20 g/day
* Night-shift workers or rotating shift workers
* Smoking
* Patient with diabetes if HbA1c not at target (\<7%) and/or using a non-authorized medication)
* Chronic liver disease other than MASLD
* Severe hepatic disease (cirrhosis, hepatocellular carcinoma)
* Severe cardiac disease (Chronic heart failure classified as being in New York Heart Association (NYHA) Class III or IV)
* Severe Kidney disease with CKD-EPI\<30 mL/min/1,73m2
* Initiation of hormonal treatment during the study period
* Medications affecting weight or energy balance
* Magnetic Resonance Imaging (MRI) not possible due to patient's anthropometric characteristics. Any of the following:

  * abdominal and/or thoracic circumference with arms greater than 200 cm
  * Sagittal diameter (or abdominal height, i.e. the distance between the dorsum and the apex of the abdomen, which was measured in the supine position at the midpoint between the iliac crest and the last rib) over 70 cm
  * body weight over 160 kg
* MRI not possible due to the following (an MRI safety screening form will have to be filled for inclusion): presence of a pacemaker or cardiac defibrillator or cardiovascular catheter or neurostimulator or an implantable electronic pump for automated drug injection or an electronically-controlled implantable chamber. Ocular metallic foreign bodies
* History of severe eating disorders: Binge Eating Disorder, Bulimia Nervosa; Night eating syndrome
* Minors
* Adults under guardianship, trusteeship or under safeguard of justice
* Other clinical trial participation that could interfere with the study
* Pregnant women or women trying to be pregnant
* Nursing mothers
* Any treatment triggering hepatic steatosis

Where it's running

• CHU Nantes
  Nantes, France Recruiting
• CHU Angers
  Angers, France Not yet recruiting
• CHU Bordeaux
  Bordeaux, France Not yet recruiting
• CHU Dijon-Bourgogne
  Dijon, France Not yet recruiting
• CHU Lyon
  Lyon, France Not yet recruiting
• CHU Marseille
  Marseille, France Not yet recruiting

Study contacts

• Study coordinator: David JACOBI, MD
• Email: david.jacobi@chu-nantes.fr
• Phone: 02 53 48 27 01

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.