MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)CHRONOSTEATOSINCT07378072
Efficacy of 12-week Daytime Restricted Eating on Hepatic Steatosis of Obesity
A study testing Time Restricted Eating in people with MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), run by Nantes University Hospital at 9 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
- What is being tested?
- Time Restricted Eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 9 sitesFrance
- Study dates
- 17 Jun 2026to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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)
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- 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 electronic pump for automated drug injection or an electronically-controlled implantable chamber. Ocular metallic foreign bodies
- 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
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
France9 sites, 9 recruiting
- Not yet recruiting
CHU Angers
Angers, 49993
Agnes SALLE, MD, 02 41 35 44 99 ext. +33, AgSalle@chu-angers.fr
Agnes SALLE, MD
- Not yet recruiting
CHU Bordeaux
Bordeaux, 33404
Blandine GATTA-CHERIFI, MD, 05 57 65 64 33 ext. +33, blandine.gatta-cherifi@chu-bordeaux.fr
Blandine GATTA-CHERIFI, MD
- Not yet recruiting
CHU Dijon-Bourgogne
Dijon, 21000
Marie-Claude BRINDISI, MD, 03 80 29 34 53 ext. +33, marie-claude.brindisi@chu-dijon.fr
Marie-Claude BRINDISI, MD
- Not yet recruiting
CHU Lyon
Lyon, 69495
Cyrielle CAUSSY, MD, 04 78 86 44 48 ext. +33, cyrielle.caussy@chu-lyon.fr
Cyrielle CAUSSY, MD
- Not yet recruiting
CHU Marseille
Marseille, 13000
Bénédicte GABORIT, MD, 04 91 96 87 23 ext. +33, benedicte.gaborit@ap-hm.fr
Bénédicte GABORIT, MD
- Not yet recruiting
CHU Montpellier
Montpellier, 34000
Antoine AVIGNON, MD, 04 67 33 63 48 ext. +33, a-avignon@chu-montpellier.fr
Antoine AVIGNON, MD
- Recruiting
CHU Nantes
Nantes, 44093
David JACOBI, MD, 02 53 48 27 01 ext. +33, david.jacobi@chu-nantes.fr
David JACOBI
- Not yet recruiting
Hôpital Européen Georges Pompidou
Paris, 75015
Claire CARETTE, MD, 01 56 09 59 68 ext. +33, claire.carette@aphp.fr
Claire CARETTE, MD
- Not yet recruiting
CHU Rennes
Rennes, 35000
Ronan THIBAULT, MD, 02 99 26 71 42 ext. +33, ronan.thibault@chu-rennes.fr
Ronan THIBAULT, MD
About this study
Official title: Efficacy of 12-week Daytime Restricted Eating on Hepatic Steatosis of Obesity: Randomized, Open-label, Parallel Group, Controlled Superiority Trial _ CHRONOSTEATOSIS
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).
Read the detailed description
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.
- Being tested
- Time Restricted Eating, Usual care only
- Keywords
- Time-restricted eating, Obesity, MASLD, circadian rhythms
- Medical subject headings
- Intermittent Fasting, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time Restricted EatingBehavioural
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 onlyBehavioural
Usual care: dietary counselling to achieve a balanced diet (no calorie restriction) and increase physicial activity as recommended (current guidelines).
| Study group | Role | What they receive |
|---|---|---|
| Time Restricted Eating | Experimental | 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). Receives: Behavioral: Time Restricted Eating |
| Usual care only | Active comparator | Only usual care: usual dietary counselling to achieve a balanced diet (no calorie restriction) and increase physicial activity as recommended (current guidelines). Receives: Behavioral: Usual care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks post randomization
Secondary outcomes (36)
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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 12 weeks post randomization
Anthropometric outcomes assessed by body weight.
Patient weight assessed before randomization, then at 6 and 12 weeks post randomization
Measured: 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
Measured: 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.
Measured: 12 weeks post randomization
Blood pressure
Blood pressure measured before randomization, then at 6 and 12 weeks post randomization
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks post randomization
Anthropometric outcomes assessed by waist circumference.
Patient waist circumference assessed before randomization, then at 6 and 12 weeks post randomization.
Measured: 12 weeks post randomization
Anthropometric outcomes assessed by hip circumference.
Patient hip circumference assessed before randomization, then at 6 and 12 weeks post randomization.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 12 weeks post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start17 Jun 2026
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)Studies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378072
- Sponsor's protocol ID
- RC21_0569
- Acronym
- CHRONOSTEATOSI
- Status last verified
- Jun 2026
- First submitted
- 11 Dec 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of 12-week Daytime Restricted Eating on Hepatic Steatosis of Obesity: Randomized, Open-label, Parallel Group, Controlled Superiority Trial _ CHRONOSTEATOSIS
- ClinicalTrials.gov ID
- NCT07378072
- Acronym / sponsor ID
- CHRONOSTEATOSI / RC21_0569
- Keywords
- Time-restricted eating, Obesity, MASLD, circadian rhythms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 17 Jun 2026 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time Restricted Eating | Experimental | Behavioral: Time Restricted EatingCoaching 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 only | Active comparator | Behavioral: Usual care onlyOnly usual care: usual dietary counselling to achieve a balanced diet (no calorie restriction) and increase physicial activity as recommended (current guidelines). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time Restricted EatingCoaching 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). | Behavioural | Time Restricted Eating |
| Usual care onlyUsual care: dietary counselling to achieve a balanced diet (no calorie restriction) and increase physicial activity as recommended (current guidelines). | Behavioural | Usual care only |
Primary outcome
Liver fat content quantified by Magnetic Resonance Imaging Proton Density Fat Fraction
Time frame: 12 weeks post randomization
Liver fat content quantified Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) before randomization and then at 12 weeks post randomization
36 secondary outcomes
Average lenght of the eating period per 24 hours
Time frame: 12 weeks post randomization
Liver steatosis and Stiffness as assessed by the Fibroscan
Time frame: 12 weeks post randomization
Hepatic outcomes evaluated through aspartates aminotransferases (ASAT) blood level before randomization and at 12 weeks post randomization.
Time frame: 12 weeks post randomization
Physical activity level measured by accelerometry with a watch accelerometer
Time frame: 12 weeks post randomization
Anthropometric outcomes assessed by body weight.
Time frame: 12 weeks post randomization
Anthropometric outcomes assessed by impedancemetry
Time frame: 12 weeks pour randomization
Anthropometric outcomes assessed by Magnetic Resonance Imaging of the liver
Time frame: 12 weeks post randomization
Blood pressure
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.
Time frame: 12 weeks post randomization
Metabolic outcomes related to energy balance or insulin signaling/resistance assessed through indirect calorimetry
Time frame: 12 weeks post randomization
Depression assessed using the PHQ-9 questionnaire
Time frame: 12 weeks post randomization
Anxiety assessed using the GAD-7 questionnaire
Time frame: 12 weeks post randomization
Quality of sleep using Pittsburgh sleep quality index
Time frame: 12 weeks post randomization
Quality of life assessed by EQ-5D questionnaire
Time frame: 12 weeks post randomization
Chronotype as assessed by Micro Munich ChronoType Questionnaire
Time frame: 12 weeks post randomization
Appetite as assessed by FCQ-T-r questionnaire
Time frame: 12 weeks post randomization
Caloric intake
Time frame: 12 weeks post randomization
Occurrence of the following adverse events: headache, nausea, diarrhea, constipation, dizziness, fatigue and irritability
Time frame: 12 weeks post randomization
Hepatic outcomes evaluated through alanine aminotransferase (ALAT) blood level 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.
Time frame: 12 weeks post randomization
Hepatic outcomes evaluated through alcaline phosphatases (ALP) blood level 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.
Time frame: 12 weeks post randomization
Hepatic outcomes evaluated through blood parameter 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.
Time frame: 12 weeks post randomization
Hepatic outcomes evaluated through blood parameter 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.
Time frame: 12 weeks post randomization
Hepatic outcomes evaluated through protein C-reactive (CRP) blood level before randomization and at 12 weeks post randomization.
Time frame: 12 weeks post randomization
Anthropometric outcomes assessed by waist circumference.
Time frame: 12 weeks post randomization
Anthropometric outcomes assessed by hip circumference.
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.
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.
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.
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.
Time frame: 12 weeks post randomization
Metabolic outcomes related to energy balance or insulin signaling/resistance assessed through glucose continuous monitoring
Time frame: 12 weeks post randomization
Metabolic outcomes related to energy balance or insulin signaling/resistance assessed through determination of HOMA-IR
Time frame: 12 weeks post randomization
Metabolic outcomes related to energy balance or insulin signaling/resistance assessed through determination of HOMA-beta
Time frame: 12 weeks post randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time Restricted Eating in people with MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), run by Nantes University Hospital at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David JACOBI, MD (02 53 48 27 01 ext. +33, david.jacobi@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver fat content quantified by Magnetic Resonance Imaging Proton Density Fat Fraction (time frame: 12 weeks post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.