NCT07378072

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

Efficacy of 12-week Daytime Restricted Eating on Hepatic Steatosis of Obesity: Randomized, Open-label, Parallel Group, Controlled Superiority Trial _ CHRONOSTEATOSIS

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Obesity is a growing health problem. The increase in obesity is driving the growing prevalence of metabolic dysfunction-associated steatotic liver disease (MASLD, formerly called non-alcoholic fatty liver disease or NAFLD). Chronobiology has revealed new risk factors for metabolic disease including MASLD. Proof-of-concept studies showed that time-restricted eating (TRE), a dietary intervention that involves longer fasting periods (typically \> 12 h per day) without caloric restriction, reprograms metabolism favorably. The state of the art now justifies clinical trials on clinical populations. The aim of this randomized, parallel group, controlled study is to test the efficacy of Time Restricted Eating (TRE) implemented with dietary coaching and a dedicated mobile application compared to usual care. The primary endpoint is the evolution of liver fat content quantified by Magnetic Resonance Imaging (MRI). Patients presenting all inclusion criteria without non-inclusion ciriteria will be included and a Magnetic Resonnance Imaging of the liver will be programmed. Randomization will be performed within 3 months post inclusion after MRI results are obtained. Only patients showing Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) \> or equal to 8% will be randomized. Other patients will be withdrawn from study before randomization. After randomization, both groups will benefit from the standard of care for obesity management and metabolic assessment. Both groups will benefit from dietary counselling to achieve a balanced diet (no calorie restriction) and increase physical activity as recommended. This counselling will be performed by weekly phone calls of a centralized dietetician during a period of 12 weeks. Both groups of patients will use a mobile application to daily register time of first food intake and of time of last food intake (through time-stamped photos of first and last feedings). This will allow to know length of the patient's eating period per 24 hours. Difference between the 2 groups of patients is only that, in the experimental arm (TRE), patients will additionnaly be instructed to reduce time of daily food intake to a window of 8 hours per day or less and thus increase daily fasting to at least 16 hours. This coaching will be performed during the weekly phone calls of a centralized dietetician.

Conditions

• MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)

Interventions

Type	Name	Description
BEHAVIORAL	Time Restricted Eating	Coaching of the patient by a dietetician for reduction of time of daily food intake to a window of 8 hours per day or less and thus increase of daily fasting to at least 16 hours, in addition to usual dietary counselling to achieve a balanced diet (no calorie restriction) and increase physicial activity as recommended (current guidelines).
BEHAVIORAL	Usual care only	Usual care: dietary counselling to achieve a balanced diet (no calorie restriction) and increase physicial activity as recommended (current guidelines).

Timeline

• Start date: 2026-02-01
• Primary completion: 2030-05-01
• Completion: 2030-08-01
• First posted: 2026-01-30
• Last updated: 2026-01-30

Locations

9 sites across 1 country: France