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NCT07378072
Efficacy of 12-week Daytime Restricted Eating on Hepatic Steatosis of Obesity
Conditions: MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 72
Sponsor: Nantes University Hospital
Location: CHU Angers Angers
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 \ 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 (\
Source: ClinicalTrials.gov (NCT07378072). StuddyBuddy aggregates publicly available trial information.