Efficacy of 12-week Daytime Restricted Eating on Hepatic Steatosis of Obesity (NCT07378072) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy of 12-week Daytime Restricted Eating on Hepatic Steatosis of Obesity
France72 participantsStarted 2026-02
Plain-language 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).
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 anthropom…
What they're measuring
1
Liver fat content quantified by Magnetic Resonance Imaging Proton Density Fat Fraction