An interventional study of Time Restricted Eating and Usual care only in MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), sponsored by Nantes University Hospital. Recruiting at 9 sites in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Nantes University Hospital · Not applicable, Interventional, and Treatment
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).
Obesity is a growing health problem. The increase in obesity is driving the growing prevalence of metabolic dysfunction-associated steatotic liver disease (MASLD, formerly called non-alcoholic fatty liver disease or NAFLD).
Chronobiology has revealed new risk factors for metabolic disease including MASLD. Proof-of-concept studies showed that time-restricted eating (TRE), a dietary intervention that involves longer fasting periods (typically > 12 h per day) without caloric restriction, reprograms metabolism favorably. The state of the art now justifies clinical trials on clinical populations.
The aim of this randomized, parallel group, controlled study is to test the efficacy of Time Restricted Eating (TRE) implemented with dietary coaching and a dedicated mobile application compared to usual care. The primary endpoint is the evolution of liver fat content quantified by Magnetic Resonance Imaging (MRI).
Patients presenting all inclusion criteria without non-inclusion ciriteria will be included and a Magnetic Resonnance Imaging of the liver will be programmed. Randomization will be performed within 3 months post inclusion after MRI results are obtained. Only patients showing Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) > or equal to 8% will be randomized. Other patients will be withdrawn from study before randomization.
After randomization, both groups will benefit from the standard of care for obesity management and metabolic assessment. Both groups will benefit from dietary counselling to achieve a balanced diet (no calorie restriction) and increase physical activity as recommended. This counselling will be performed by weekly phone calls of a centralized dietetician during a period of 12 weeks. Both groups of patients will use a mobile application to daily register time of first food intake and of time of last food intake (through time-stamped photos of first and last feedings). This will allow to know length of the patient's eating period per 24 hours.
Difference between the 2 groups of patients is only that, in the experimental arm (TRE), patients will additionnaly be instructed to reduce time of daily food intake to a window of 8 hours per day or less and thus increase daily fasting to at least 16 hours. This coaching will be performed during the weekly phone calls of a centralized dietetician.
333 studies on the registry are indexed under Intermittent Fasting; 99 are open to participants now.
This study's planned enrollment of 72 is above the median of 50 across 320 interventional studies indexed under Intermittent Fasting.
Browse Intermittent Fasting studies →Nantes University Hospital is the lead sponsor of 839 studies on the registry; 195 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Magnetic Resonance Imaging (MRI) not possible due to patient's anthropometric characteristics. Any of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Behavioral: Time Restricted Eating
Only usual care: usual dietary counselling to achieve a balanced diet (no calorie restriction) and increase physicial activity as recommended (current guidelines).
Behavioral: Usual care only
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).
Usual care: dietary counselling to achieve a balanced diet (no calorie restriction) and increase physicial activity as recommended (current guidelines).
Liver fat content quantified by Magnetic Resonance Imaging Proton Density Fat Fraction
Liver fat content quantified Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) before randomization and then at 12 weeks post randomization
Time frame: 12 weeks post randomization
Average lenght of the eating period per 24 hours
Average lenght of the eating period per 24 hours as assessed byt he self-declared times of first and last food intake every day of the 12 weeks intervention. (Daily registration of time of first food intake and of time of last food intake will be performed by all patients on the dedicated mobile application through time-stamped photos of first and last feedings)
Time frame: 12 weeks post randomization
Liver steatosis and Stiffness as assessed by the Fibroscan
Liver steatosis ans stiffness evaluated by Fibroscan Controlled Attenuation Parameter before randomization and then at 12 weeks post randomization
Time frame: 12 weeks post randomization
Hepatic outcomes evaluated through aspartates aminotransferases (ASAT) blood level before randomization and at 12 weeks post randomization.
Level of aspartate aminotransferases (ASAT) in blood before randomization and at 12 weeks post randomization.
Time frame: 12 weeks post randomization
Physical activity level measured by accelerometry with a watch accelerometer
Physical activity measured by accelerometry with a watch accelerometer during 7 days before randomization, then during 7 days of the sixth and twelfth weeks after randomization.
Time frame: 12 weeks post randomization
Anthropometric outcomes assessed by body weight.
Patient weight assessed before randomization, then at 6 and 12 weeks post randomization
Time frame: 12 weeks post randomization
Anthropometric outcomes assessed by impedancemetry
Anthropometric oucome : body fat assessed by impedancemetry before randomization, then at 6 and 12 weeks post randomization
Time frame: 12 weeks pour randomization
Anthropometric outcomes assessed by Magnetic Resonance Imaging of the liver
Percentage of visceral and sub-cutaneaous fat, percentage of muscle fat and muscular surface assessed by Magnetic Resonance Imaging before randomization and at 12 weeks post randomization.
Time frame: 12 weeks post randomization
Blood pressure
Blood pressure measured before randomization, then at 6 and 12 weeks post randomization
Time frame: 12 weeks post randomization
Metabolic outcomes related to energy balance evaluated through glycated hemoglobin (HbA1c) blood level before randomization and at 12 weeks post randomization.
Level of HbA1c in blood before randomization and at 12 weeks post randomization.
Time frame: 12 weeks post randomization
Metabolic outcomes related to energy balance or insulin signaling/resistance assessed through indirect calorimetry
Metabolic outcome : resting energy expenditure as assessed by indirect calorimetry at assessed by indirect calorimetry before randomization then at 12 weeks post randomization.
Time frame: 12 weeks post randomization
Depression assessed using the PHQ-9 questionnaire
Depression assessed using the PHQ-9 (Patient Health Questionnaire-9) before randomization , then at 12 weeks post randomization
Time frame: 12 weeks post randomization
Anxiety assessed using the GAD-7 questionnaire
Anxiety assessed using the Generalized Anxiety Disorder questionnaire (GAD-7) before randomization, then at 12 weeks post randomization
Time frame: 12 weeks post randomization
Quality of sleep using Pittsburgh sleep quality index
Quality of sleep using Pittsburgh sleep quality index before randomization, then at 12 weeks post randomization
Time frame: 12 weeks post randomization
Quality of life assessed by EQ-5D questionnaire
Quality of life assessed by the Euro Quality of Life-5 Dimensions (EQ-5D) questionnaire before randomization, then at 12 weeks post randomization.
Time frame: 12 weeks post randomization
Chronotype as assessed by Micro Munich ChronoType Questionnaire
Chronotype as assessed by Micro Munich ChronoType Questionnaire before randomization, then at 12 weeks post randomization
Time frame: 12 weeks post randomization
Appetite as assessed by FCQ-T-r questionnaire
Appetite as assessed by Food Craving Questionnaire-Trait-reduced (FCQ-T-r) before randomization, then at 12 weeks post randomization
Time frame: 12 weeks post randomization
Caloric intake
Total caloric intake and macronutrient repartition as assessed by registration on the dedicated mobile application of photos of patient's intakes during 3 days before randomization, then during 3 days of the sixth and twelfth weeks after randomization
Time frame: 12 weeks post randomization
Occurrence of the following adverse events: headache, nausea, diarrhea, constipation, dizziness, fatigue and irritability
Occurrence of the following adverse events: headache, nausea, diarrhea, constipation, dizziness, fatigue and irritability up to 12 weeks post randomization
Time frame: 12 weeks post randomization
Hepatic outcomes evaluated through alanine aminotransferase (ALAT) blood level before randomization and at 12 weeks post randomization.
Level of alanine aminotransferase (ALAT) in blood before randomization and at 12 weeks post randomization.
Time frame: 12 weeks post randomization
Hepatic outcomes evaluated through gamma glutamyl-transpeptidase (gamma-GT) blood level before randomization and at 12 weeks post randomization.
Level of gamma glutamyl-transpeptidase (gamma-GT) in blood before randomization and at 12 weeks post randomization.
Time frame: 12 weeks post randomization
Hepatic outcomes evaluated through alcaline phosphatases (ALP) blood level before randomization and at 12 weeks post randomization.
Level of alcaline phosphatases (ALP) in blood before randomization and at 12 weeks post randomization.
Time frame: 12 weeks post randomization
Hepatic outcomes evaluated through bilirubin blood level before randomization and at 12 weeks post randomization.
Level of bilirubin in blood before randomization and at 12 weeks post randomization.
Time frame: 12 weeks post randomization
Hepatic outcomes evaluated through blood parameter transferrin saturation coefficient before randomization and at 12 weeks post randomization.
Level of transferrin saturation coefficient before randomization and at 12 weeks post randomization.
Time frame: 12 weeks post randomization
Hepatic outcomes evaluated through ferritin blood level before randomization and at 12 weeks post randomization.
Level of ferritin in blood before randomization and at 12 weeks post randomization.
Time frame: 12 weeks post randomization
Hepatic outcomes evaluated through blood parameter prothrombin ratio before randomization and at 12 weeks post randomization.
Level of prothrombin ratio before randomization and at 12 weeks post randomization.
Time frame: 12 weeks post randomization
Hepatic outcomes evaluated through iron blood level before randomization and at 12 weeks post randomization.
Level of iron in blood before randomization and at 12 weeks post randomization.
Time frame: 12 weeks post randomization
Hepatic outcomes evaluated through protein C-reactive (CRP) blood level before randomization and at 12 weeks post randomization.
Level of protein C-reactive (CRP) in blood before randomization and at 12 weeks post randomization.
Time frame: 12 weeks post randomization
Anthropometric outcomes assessed by waist circumference.
Patient waist circumference assessed before randomization, then at 6 and 12 weeks post randomization.
Time frame: 12 weeks post randomization
Anthropometric outcomes assessed by hip circumference.
Patient hip circumference assessed before randomization, then at 6 and 12 weeks post randomization.
Time frame: 12 weeks post randomization
Metabolic outcomes related to energy balance evaluated through total cholesterol blood level before randomization and at 12 weeks post randomization.
Level of total cholesterol in blood before randomization and at 12 weeks post randomization.
Time frame: 12 weeks post randomization
Metabolic outcomes related to energy balance evaluated through LDL-cholesterol blood level before randomization and at 12 weeks post randomization.
Level of LDL-cholesterol in blood before randomization and at 12 weeks post randomization.
Time frame: 12 weeks post randomization
Metabolic outcomes related to energy balance evaluated through HDL-cholesterol blood level before randomization and at 12 weeks post randomization.
Level of HDL-cholesterol in blood lbefore randomization and at 12 weeks post randomization.
Time frame: 12 weeks post randomization
Metabolic outcomes related to energy balance evaluated through triglycerids blood level before randomization and at 12 weeks post randomization.
Level of triglycerids in blood before randomization and at 12 weeks post randomization.
Time frame: 12 weeks post randomization
Metabolic outcomes related to energy balance or insulin signaling/resistance assessed through glucose continuous monitoring
Continous monitroing of glucose in blood during 7 days before randomization and during 7 days of the sixth and of the twelfth weeks after randomization
Time frame: 12 weeks post randomization
Metabolic outcomes related to energy balance or insulin signaling/resistance assessed through determination of HOMA-IR
Homesotasis Model Assessment of Insulin Resistance (HOMA-IR) calculated from basal (fasting) glucose and insulin before randomization then at 12 weeks post randomization
Time frame: 12 weeks post randomization
Metabolic outcomes related to energy balance or insulin signaling/resistance assessed through determination of HOMA-beta
Homesotasis Model Assessment for Beta-cell function (HOMA-beta) calculated from basal (fasting) glucose and insulin before randomization then at 12 weeks post randomization
Time frame: 12 weeks post randomization
Plan to share: Undecided
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Started Jun 2026 (actual). Primary completion is estimated for Jun 2029, 36 months after the start.
Of 257 non-industry interventional studies with no phase under Intermittent Fasting, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 34. This study's planned 36 months is above that.
Counting every sponsor, half of 263 studies reached it within 17 months; a quarter within 8 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
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