Clinical Trial

Time-restricted Feeding in MASLD

Study acronym: MASLD-Interval
Recruiting
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Summary
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.
Trial Details
NCT Number NCT07530809
Lead Sponsor Universität des Saarlandes
Collaborators: M3 Research Center, Dr. Suchira Gallage, Center for Molecular Signaling, Prof. Dr. Daniela Yildiz, Department of Internal Medicine I, University Medical Centre Mainz, Prof. Dr. Peter R. Galle und PD Dr. Christian Labenz
Conditions Metabolic Associated-dysfunction Steatotic Liver Disease (MASLD)
Enrollment 120 participants
Start Date 2025-10-15
Primary Completion 2029-05-15 (estimated)
Study Completion 2029-05-15 (estimated)
Updated on ClinicalTrials.gov 2026-04-15