Time-restricted Feeding in MASLD
Key facts
- Where
- Homburg, GermanySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07530809, who can take part
Where in Germany
- Department of Internal Medicine II, Saarland University Medical Center, Saarland University,Homburg, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universität des Saarlandes
- Trial code
- NCT07530809
- Record updated
- 15 April 2026
- Original description
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.Read full original descriptionShow less
The Impact of Time-restricted Feeding on Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)
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.
Inclusion: 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; Ability to understand the study and the individual consequences of participating in the study; Signed and dated consent form before the start of any study activity.
Exclusion: Statins and/or other lipid-lowering drugs, if these have not been taken in a stable dose for at least 4 weeks; 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); Immunological or inflammatory diseases (e.g. systemic lupus erythematosus); Uncontrolled type 2 diabetes defined as HbA1c value > 9.0% or insulin-dependent type 2 diabetes; Hepatocellular carcinoma or non-curatively treated carcinomas; Alcohol consumption >20 g (women) and >30 g (men) per day; Body weight changes of > 5% in the last 6 months; Pregnancy; Following a restrictive, special diet; Patients who have undergone organ transplants; Lack of or absence of capacity to give consent.