Time-restricted Feeding in MASLD

NCT07530809 | Recruiting

• 1 other identifier: 100/25
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Metabolic Associated-dysfunction Steatotic Liver Disease (MASLD)

Keywords

time-restricted feeding; intermittend fasting; 5:2 fasting; steatotic liver disease; MASLD; liver health; dietary intervention; nutrition; lifestyle intervention

Outcome Measures

Primary Outcomes (1)

• Reduction of controlled attenuation parameter (CAP)

  The Controlled Attenuation Parameter (CAP) is a non-invasive ultrasound-based measure obtained during transient elastography (FibroScan®). CAP quantifies the attenuation of ultrasound signals as they pass through the liver, which correlates with the degree of hepatic steatosis. It is expressed in decibels per meter (dB/m). In patients with metabolic dysfunction-associated steatotic liver disease (MASLD), CAP is widely used to assess and grade liver fat content. Higher CAP values reflect greater hepatic fat accumulation. An improvement is defined as a reduction in CAP value of at least 20 dB/m compared to the baseline value

  from enrollment to the end of treatment at 12 weeks

Secondary Outcomes (13)

• Improvement in liver stiffness measurment (LSM)

  from enrollment to the end of treatment at 12 weeks

• Improvement in CLDQ-NAFLD/NASH for liver-specific quality of life

  from enrollment to the end of treatment at 12 weeks

• Change in insulin sensitivity (HOMA-IR)

  from enrollment to the end of treatment at 12 weeks

• Changes in the gut microbiome

  from enrollment to the end of treatment at 12 weeks

• Reduction of skin AGE

  from enrollment to the end of treatment at 12 weeks

Study Arms (2)

5:2 fasting

EXPERIMENTAL

Participants in this arm are advised to follow a 5:2 intermittent fasting regimen. On two non-consecutive days per week, their energy intake is restricted to a maximum of one-quarter of their individual requirements (approximately 500-600 kcal). On these fasting days, participants are encouraged to consume only breakfast and then fast until the following morning. On the remaining five days, they are advised to follow a healthy, balanced diet in line with the recommendations of the German Nutrition Society (DGE), without specific (caloric) restrictions.

Behavioral: time-restricted feeding in a 5:2 regimen

control group

NO INTERVENTION

The control group follows a balanced diet without fasting, based on the DGE guidelines.

Interventions

time-restricted feeding in a 5:2 regimen BEHAVIORAL

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).

5:2 fasting

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universität des Saarlandes: lead
• M3 Research Center, Dr. Suchira Gallage: collaborator
• Center for Molecular Signaling, Prof. Dr. Daniela Yildiz: collaborator
• Department of Internal Medicine I, University Medical Centre Mainz, Prof. Dr. Peter R. Galle und PD Dr. Christian Labenz: collaborator

Study Sites (1)

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

Homburg, Saarland, 66424, Germany

RECRUITING

MeSH Terms

Conditions

Intermittent Fasting

Interventions

Clinical Protocols

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Jörn M Schattenberg, Prof. Dr.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ute M Stern

CONTACT

+ 49 6841 16 15863; ute.stern@uni-saarland.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.-Prof. Dr.

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: April 15, 2026
• Study Start: October 15, 2025
• Primary Completion (Estimated): May 15, 2029
• Study Completion (Estimated): May 15, 2029
• Last Updated: April 15, 2026

Record last verified: 2026-03

Locations

DE (1)