NCT07378072 Efficacy of 12-week Daytime Restricted Eating on Hepatic Steatosis of Obesity

Eligibility & Interventions

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This trial targets 72 participants in total. It began in 2026-06-17 with a primary completion date of 2029-06.

Brief Summary

The objective of this study is to demonstrate that an \< or equal to 8-hour time-restricted eating (i.e., fasting for at least 16 hours every day), not focusing on reducing caloric intake, reduces intra-hepatic fat in patients with obesity and Metabolic dysfunction-Associated Steatotic liver Disease (MASLD).

Eligibility Criteria

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

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