NCT07530809Recruiting

Time-restricted Feeding in MASLD

The Impact of Time-restricted Feeding on Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)

Source: ClinicalTrials.gov · Last updated 15 Apr 2026

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Study type: Interventional
Enrollment: 120 (estimated)
First submitted: 24 Mar 2026
Start date: 15 Oct 2025
Primary completion date: 15 May 2029
Lead sponsor: Universität des Saarlandes
Diseases: Fatty liver disease (MASLD/MASH)
NCT number: NCT07530809

What you commit to

Study type: Interventional
Planned participants: 120
From 15 Oct 2025 to the primary completion date, 15 May 2029
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Statins and/or other lipid-lowering drugs, if these have not been taken in a stable dose for at least 4 weeks

Other illness

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)

Lab values

Uncontrolled type 2 diabetes defined as HbA1c value \> 9.0% or insulin-dependent type 2 diabetes

Other

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

Who the study is looking for

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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Department of Internal Medicine II, Saarland University Medical Center, Saarland University, Coordinator of this site? Confirm its status	Homburg	Germany	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.