Time-restricted Feeding in MASLD

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversität des Saarlandes

About this trial

The recommended treatment for metabolic dysfunction-associated steatotic liver disease (MASLD) currently focuses on lifestyle changes, including dietary adjustments and increased physical activity. Intermittent fasting is a specific dietary approach in which food intake is restricted for certain periods. Recent scientific evidence suggests that intermittent fasting can positively influence body weight, insulin resistance, and markers of inflammation.

This study will examine whether restricting energy intake to approximately 600 kcal on two days per week has beneficial effects on MASLD. The nutritional framework is based on the guidelines of the German Nutrition Society (DGE) for a healthy diet (10 rules for healthy eating). Following a two-week introduction to these DGE recommendations, participants will be randomly assigned to one of two treatment groups.

In the intervention group, participants follow a 5:2 intermittent fasting regimen, eating without restrictions on five days per week and limiting intake to about one-quarter of their usual daily energy (≈600 kcal) on two non-consecutive days. In the control group, participants follow a healthy diet according to DGE guidelines without restrictions on timing or energy intake.

Eligibility criteria

Qualifiers

18 and 75 years

Body mass index (BMI) > 25 kg/m²

MASLD grade 3 with CAP ≥ 280 dB/m, excluding liver damage

Liver stiffness < 13 kPa

Disqualifiers

Hepatocellular carcinoma or non-curatively treated carcinomas

Alcohol consumption >20 g (women) and >30 g (men) per day

Other liver diseases (HBV, HCV, HDV, HEV, HIV), autoimmune diseases or chronic cholestatic liver disease, hereditary haemochromatosis, Wilson's disease, α-1-antitrypsin deficiency

Medications that cause liver disease or secondary NAFLD (e.g. tamoxifen, systemic corticosteroids, methotrexate, tetracyclines, oestrogens, valproic acid)

Trial design

Treatments tested in this trial

  • time-restricted feeding in a 5:2 regimen

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Universität des Saarlandes

Lead sponsor

M3 Research Center, Dr. Suchira Gallage

Collaborator

Center for Molecular Signaling, Prof. Dr. Daniela Yildiz

Collaborator

Department of Internal Medicine I, University Medical Centre Mainz, Prof. Dr. Peter R. Galle und PD Dr. Christian Labenz

Collaborator