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Tests treatment safety and results for MASLD (Metabolic Dysfunction-Associated Steatotic Liver...
Official title Efficacy of 12-week Daytime Restricted Eating on Hepatic Steatosis of Obesity
ClinicalTrials.gov ID: NCT07378072
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- 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
You likely can't join if
- 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)
See the full eligibility 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)
- 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 anthropometric characteristics. Any of the following:
- abdominal and/or thoracic circumference with arms greater than 200 cm
- Sagittal diameter (or abdominal height, i.e. the distance between the dorsum and the apex of the abdomen, which was measured in the supine position at the midpoint between the iliac crest and the last rib) over 70 cm
- body weight over 160 kg
- MRI not possible due to the following (an MRI safety screening form will have to be filled for inclusion): presence of a pacemaker or cardiac defibrillator or cardiovascular catheter or neurostimulator or an implantable...
- History of severe eating disorders: Binge Eating Disorder, Bulimia Nervosa; Night eating syndrome
- Minors
- Adults under guardianship, trusteeship or under safeguard of justice
- Other clinical trial participation that could interfere with the study
- Pregnant women or women trying to be pregnant
- Nursing mothers
- Any treatment triggering hepatic steatosis
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Bordeaux, France
- Dijon, France
- Lyon, France
- Marseille, France
- Montpellier, France
- Nantes, France
- Paris, France
- Rennes, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Bordeaux, France; Dijon, France; Lyon, France; Marseille, France; Montpellier, France and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.