Time-restricted Feeding in MASLD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversität des Saarlandes
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
time-restricted feeding in a 5:2 regimen
BehavioralParticipants 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).
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: 5:2 fastingExperimental treatment 1 intervention
Group B: control groupNo intervention 0 interventions
Trial outcomes
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
Time frame
from enrollment to the end of treatment at 12 weeksSecondary outcomes
1
Improvement in liver stiffness measurment (LSM)
Liver stiffness measurement (LSM) is a non-invasive technique used to assess hepatic fibrosis. It is most commonly performed using transient elastography (FibroScan®), which measures the velocity of a shear wave generated by a mechanical pulse through the liver tissue. The faster the wave propagates, the stiffer the liver, reflecting the degree of fibrosis. Results are expressed in kilopascals (kPa). In patients with metabolic dysfunction-associated steatotic liver disease (MASLD), LSM provides valuable information on fibrosis stage and risk of progression to advanced liver disease, including cirrhosis.
Time frame
from enrollment to the end of treatment at 12 weeks2
Improvement in CLDQ-NAFLD/NASH for liver-specific quality of life
The CLDQ (Chronic Liver Disease Questionnaire) is a validated questionnaire for assessing quality of life in patients with chronic liver disease. An improvement in quality of life is defined as a significant improvement in the score on the liver-specific quality of life scale compared to the baseline value.
Time frame
from enrollment to the end of treatment at 12 weeks3
Change in insulin sensitivity (HOMA-IR)
Insulin sensitivity is assessed using HOMA-IR (Homeostasis Model Assessment of Insulin Resistance), an index that describes the body's resistance to insulin. An improvement is defined as a significant reduction in the HOMA-IR value compared to the baseline value.
Time frame
from enrollment to the end of treatment at 12 weeks4
Changes in the gut microbiome
Changes in the gut microbiome (diversity and composition of the microbial population) are investigated using microbiological analyses (e.g. 16S rRNA sequencing). A change is defined as a significant shift in the composition or diversity of the microbiome compared to the baseline value.
Time frame
from enrollment to the end of treatment at 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Universität des Saarlandes
Lead sponsor
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
Source ClinicalTrials.gov