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Recruiting NCT07530809

Time-restricted Feeding in MASLD

No phase Interventional Metabolic Associated-dysfunction Steatotic Liver Disease (MASLD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: time-restricted feeding in a 5:2 regimen.
Who it may be relevant to
Registry conditions: Metabolic Associated-dysfunction Steatotic Liver Disease (MASLD). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Behavioral time-restricted feeding in a 5:2 regimen
    Participants in the intervention group follow a 5:2 intermittent fasting regimen, consisting of two non-consecutive days per week with a reduced energy intake of approximately 600 kcal, while on the remaining five days they adhere to a balanced diet in accordance with the recommendations of the German Nutrition Society (DGE).

Primary outcome measures

  • Reduction of controlled attenuation parameter (CAP) [Time frame: from enrollment to the end of treatment at 12 weeks]
Secondary outcome measures (12)
  • Improvement in liver stiffness measurment (LSM) [Time frame: from enrollment to the end of treatment at 12 weeks]
  • Improvement in CLDQ-NAFLD/NASH for liver-specific quality of life [Time frame: from enrollment to the end of treatment at 12 weeks]
  • Change in insulin sensitivity (HOMA-IR) [Time frame: from enrollment to the end of treatment at 12 weeks]
  • Changes in the gut microbiome [Time frame: from enrollment to the end of treatment at 12 weeks]
  • Reduction of skin AGE [Time frame: from enrollment to the end of treatment at 12 weeks]
  • Number of participants with selected genetic variants at baseline [Time frame: baseline]
  • Change in proportion fo circulating immune cell subsets [Time frame: from enrollment to the end of treatment at 12 weeks]
  • Change in fasting plasma glucose [Time frame: From enrollment to end of treatment at 12 weeks]
  • Change in LDL cholesterol [Time frame: From enrollment to end of treatment at 12 weeks.]
  • Change in HDL cholesterol [Time frame: From enrollment to end of treatment at 12 weeks.]
  • Change in triglycerides [Time frame: From enrollment to end of treatment at 12 weeks.]
  • Change in blood pressure [Time frame: From enrollment to end of treatment at 12 weeks.]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Germany · 1 center
  • Department of Internal Medicine II, Saarland University Medical Center, Saarland Universit — Homburg

Identifiers

NCT: NCT07530809 · 100/25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗