Efficacy of 12-week Daytime Restricted Eating on Hepatic Steatosis of Obesity (NCT07378072) | Clinical Trial Compass
RecruitingNot Applicable
Efficacy of 12-week Daytime Restricted Eating on Hepatic Steatosis of Obesity
France72 participantsStarted 2026-06-17
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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Liver fat content quantified by Magnetic Resonance Imaging Proton Density Fat Fraction