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Efficacy of 12-week Daytime Restricted Eating on Hepatic Steatosis of Obesity: Randomized, Open-label, Parallel Group, Controlled Superiority Trial _ CHRONOSTEATOSIS
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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
• Hepatitis B and C serologies negative (or showing past-infection or protective immunization)
Locations
Other Locations
France
CHU Angers
NOT_YET_RECRUITING
Angers
CHU Bordeaux
NOT_YET_RECRUITING
Bordeaux
CHU Dijon-Bourgogne
NOT_YET_RECRUITING
Dijon
CHU Lyon
NOT_YET_RECRUITING
Lyon
CHU Marseille
NOT_YET_RECRUITING
Marseille
CHU Montpellier
NOT_YET_RECRUITING
Montpellier
CHU Nantes
RECRUITING
Nantes
Hôpital Européen Georges Pompidou
NOT_YET_RECRUITING
Paris
CHU Rennes
NOT_YET_RECRUITING
Rennes
Contact Information
Primary
David JACOBI, MD
david.jacobi@chu-nantes.fr
02 53 48 27 01
Time Frame
Start Date:2026-06-17
Estimated Completion Date:2029-06
Participants
Target number of participants:72
Treatments
Experimental: 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).
Active_comparator: Usual care only
Only usual care: usual dietary counselling to achieve a balanced diet (no calorie restriction) and increase physicial activity as recommended (current guidelines).