The Impact of Time-restricted Feeding on Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Reduction of controlled attenuation parameter (CAP)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
5:2 fasting
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.
干预措施: time-restricted feeding in a 5:2 regimen (Behavioral)
control group
The control group follows a balanced diet without fasting, based on the DGE guidelines.
结局指标
主要结局
Reduction of controlled attenuation parameter (CAP)
时间窗: from enrollment to the end of treatment at 12 weeks
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
次要结局
- 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)
- Number of participants with selected genetic variants at baseline(baseline)
- Change in proportion fo circulating immune cell subsets(from enrollment to the end of treatment at 12 weeks)
- Change in fasting plasma glucose(From enrollment to end of treatment at 12 weeks)
- Change in LDL cholesterol(From enrollment to end of treatment at 12 weeks.)
- Change in HDL cholesterol(From enrollment to end of treatment at 12 weeks.)
- Change in triglycerides(From enrollment to end of treatment at 12 weeks.)
- Change in blood pressure(From enrollment to end of treatment at 12 weeks.)
- Change in serum cytokine and chemokine levels(From enrollment to end of treatment at 12 weeks)
研究者
Jörn Markus Schattenberg
Univ.-Prof. Dr.
Universität des Saarlandes