5:2 intermittent fasting for MASLD
The Impact of Time-restricted Feeding on Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)
This trial will test whether eating normally five days and limiting intake to about 600 calories on two days each week helps adults with MASLD.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Universität des Saarlandes Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Homburg, Saarland) |
| Trial ID | NCT07530809 on ClinicalTrials.gov |
What this trial studies
After a two-week introduction to the German Nutrition Society (DGE) healthy-eating recommendations, eligible participants are randomly assigned to either a 5:2 intermittent fasting group or a comparison group following the DGE framework without fasting. The 5:2 regimen limits energy intake to roughly 600 kcal on two nonconsecutive days per week while allowing unrestricted eating on the other five days. Outcomes of interest include changes in body weight, insulin resistance, markers of inflammation, and liver fat measured by CAP, with regular clinical visits at the study center. The study enrolls adults with MASLD grade 3 and elevated CAP but excludes patients with other liver diseases, recent large weight changes, or high alcohol intake.
Who should consider this trial
Good fit: Adults aged 18–75 with BMI >25 kg/m² and confirmed MASLD (CAP ≥280 dB/m and liver stiffness <13 kPa) who can give informed consent and maintain stable medications are ideal candidates.
Not a fit: People with other liver diseases, untreated cancers, recent >5% weight change, high daily alcohol intake, or those on unstable or liver-damaging medications are unlikely to benefit from this protocol and are excluded.
Why it matters
Potential benefit: If successful, this approach could reduce liver fat and improve weight and metabolic markers with an intermittent, easier-to-follow eating pattern.
How similar studies have performed: Previous trials of intermittent fasting and 5:2 regimens have shown improvements in body weight and insulin sensitivity, but evidence specifically targeting MASLD is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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) * Body weight changes of \> 5% in the last 6 months * Statins and/or other lipid-lowering drugs, if these have not been taken in a stable dose for at least 4 weeks * Uncontrolled type 2 diabetes defined as HbA1c value \> 9.0% or insulin-dependent type 2 diabetes * Pregnancy * Immunological or inflammatory diseases (e.g. systemic lupus erythematosus) * Following a restrictive, special diet * Patients who have undergone organ transplants * Lack of or absence of capacity to give consent
Where this trial is running
Homburg, Saarland
- Department of Internal Medicine II, Saarland University Medical Center, Saarland University, — Homburg, Saarland, Germany (Recruiting)
Study contacts
- Principal investigator: Jörn M Schattenberg, Prof. Dr. — Department of Internal Medicine II, Saarland University Medical Center, Saarland University, Homburg, Germany
- Study coordinator: Ute M Stern
- Email: ute.stern@uni-saarland.de
- Phone: + 49 6841 16 15863
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.