Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT07530809

Time-restricted Feeding in MASLD

Led by Universität des Saarlandes · Updated on 2026-04-15

120

Participants Needed

1

Research Sites

186 weeks

Total Duration

On this page

Sponsors

U

Universität des Saarlandes

Lead Sponsor

M

M3 Research Center, Dr. Suchira Gallage

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Time-restricted Feeding in MASLD

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants aged 18 to 75 years
  • Body mass index (BMI) greater than 25 kg/m²
  • MASLD grade 3 with controlled attenuation parameter (CAP) of at least 280 dB/m, without liver damage
  • Liver stiffness less than 13 kPa
  • Ability to understand the study and its consequences
  • Signed and dated consent form before starting study activities
Not Eligible

You will not qualify if you...

  • Presence of hepatocellular carcinoma or untreated carcinomas
  • Alcohol intake over 20 g per day for women or over 30 g per day for men
  • Other liver diseases such as HBV, HCV, HDV, HEV, HIV, autoimmune or chronic cholestatic liver disease, hereditary haemochromatosis, Wilson's disease, or alpha-1-antitrypsin deficiency
  • Use of medications causing liver disease or secondary NAFLD (e.g., tamoxifen, corticosteroids, methotrexate, tetracyclines, estrogens, valproic acid)
  • Body weight changes over 5% in the past 6 months
  • Use of statins or lipid-lowering drugs not stable for at least 4 weeks
  • Uncontrolled type 2 diabetes (HbA1c over 9.0%) or insulin-dependent type 2 diabetes
  • Pregnancy
  • Immunological or inflammatory diseases like systemic lupus erythematosus
  • Following a restrictive or special diet
  • History of organ transplant
  • Lack of capacity to give consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department of Internal Medicine II, Saarland University Medical Center, Saarland University,

Homburg, Saarland, Germany, 66424

Actively Recruiting

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Research Team

U

Ute M Stern

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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