5:2 intermittent fasting for MASLD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.