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| Name | Class |
|---|---|
| M3 Research Center, Dr. Suchira Gallage | UNKNOWN |
| Center for Molecular Signaling, Prof. Dr. Daniela Yildiz | UNKNOWN |
| Department of Internal Medicine I, University Medical Centre Mainz, Prof. Dr. Peter R. Galle und PD Dr. Christian Labenz |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| control group | No Intervention | The control group follows a balanced diet without fasting, based on the DGE guidelines. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ute M Stern | Contact | + 49 6841 16 15863 | ute.stern@uni-saarland.de |
| Name | Affiliation | Role |
|---|---|---|
| Jörn M Schattenberg, Prof. Dr. | Department of Internal Medicine II, Saarland University Medical Center, Saarland University, Homburg, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine II, Saarland University Medical Center, Saarland University, | Recruiting | Homburg | Saarland | 66424 | Germany |
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| ID | Term |
|---|---|
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D002985 | Clinical Protocols |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D016020 | Epidemiologic Study Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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|
| from enrollment to the end of treatment at 12 weeks |
| 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. | from enrollment to the end of treatment at 12 weeks |
| 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. | from enrollment to the end of treatment at 12 weeks |
| 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. | from enrollment to the end of treatment at 12 weeks |
| Reduction of skin AGE | Skin AGE (Advanced Glycation End-products) is measured as a biomarker for oxidative stress and skin ageing. A reduction in Skin AGE is defined as a significant decrease in the AGE value compared to the baseline value. | from enrollment to the end of treatment at 12 weeks |
| Number of participants with selected genetic variants at baseline | Genotyping will be performed at baseline for the following variants: MBOAT7, TM6SF2, PNPLA3, HSD17B13, and MTARC1. The outcome is defined as the number and proportion of participants carrying each genetic variant. | baseline |
| Change in proportion fo circulating immune cell subsets | Immunophenotyping will be performed to quantify circulating immune cell subsets, including Th1, Th17, regulatory T cells (Treg), CD4+ T cells, CD8+ T cells, CD16+ cells, naïve and IgA+ B cells, natural killer cells, neutrophils, and M1 and M2 macrophages. The outcome is defined as the mean change in the proportion (%) of each immune cell subset from baseline to Week 12. | from enrollment to the end of treatment at 12 weeks |
| Change in fasting plasma glucose | Fasting plasma glucose will be measured in mg/dL. The outcome is defined as the mean change from baseline to week 12 | From enrollment to end of treatment at 12 weeks |
| Change in LDL cholesterol | low-density lipoprotein (LDL) cholesterol will be measured in mg/dL. The outcome is defined as the mean change from baseline to week 12. | From enrollment to end of treatment at 12 weeks. |
| Change in HDL cholesterol | High-density lipoprotein (HDL) cholesterol will be measured in mg/dL. The outcome is defined as the mean change from baseline to week 12. | From enrollment to end of treatment at 12 weeks. |
| Change in triglycerides | Triglyceride levels will be measured in mg/dL. The outcome is defined as the mean change from baseline to week 12. | From enrollment to end of treatment at 12 weeks. |
| Change in blood pressure | Systolic and diastolic blood pressure will be measured in mmHg. The outcome is defined as the mean change from baseline to week 12. | From enrollment to end of treatment at 12 weeks. |
| Change in serum cytokine and chemokine levels | Serum levels of cytokines and chemokines, including IL-6, IL-6 receptor, IL-8, CCL2, TNF-α, and IFN-γ, will be measured. The outcome is defined as the mean change in concentration (pg/mL) from baseline to Week 12. | From enrollment to end of treatment at 12 weeks |
| D017530 | Health Care Quality, Access, and Evaluation |