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Efficacy of 12-week Daytime Restricted Eating on Hepatic Steatosis of Obesity

ConditionMASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNantes University Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Time Restricted Eating

    Behavioral

    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 only

    Behavioral

    Usual care: dietary counselling to achieve a balanced diet (no calorie restriction) and increase physicial activity as recommended (current guidelines).

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Time Restricted EatingExperimental treatment 1 intervention
Group B: Usual care onlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nantes University Hospital

Lead sponsor

Source ClinicalTrials.gov
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