Impact of Time-restricted Feeding on Hepatic Steatosis in NAFLD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Evaluation of the impact of TRF on liver steatosis by CAP (dB/m)
研究概览
简要总结
This is a randomised controlled study of patients with Non-Alcoholic Fatty Liver Disease (NAFLD).
Patients will be trained according to the 10 rules of a healthy nutrition according to the German Association for Nutrition (DGE).
One arm will undergo Time-Restricted Feeding (TRF) for 12 weeks. The control arm is not subject to any time restrictions concerning eating.
It will be investigated whether TRF improves insulin sensitivity, impacts on metabolic inflammation and reduces liver steatosis.
详细描述
Patients are recruited in the Liver Outpatient Clinic of the University Medical Center of Mainz.
About 100 patients will be enrolled in this pilot study. Inclusions criteria are exclusions of known causes of liver injury, Body Mass Index (BMI) > 25 kg/m^2, severe steatosis according to CAP ≥ 300 dB/m and absence of advanced fibrosis according to liver stiffness < 13 kPa.
Following the written consent, all patients will be trained to undertake a 2-week lead-in period of DGE.
Beginning in week 3 (Visit 2), an interventional group and a control group are generated through randomisation. The interventional group is instructed to follow TRF, whereas the control group is not subject to any time restrictions. Both arms will be accompanied for a duration of 12 weeks.TRF diet is based on temporal food consumption between 8:00 a.m. and 16:00 p.m., thus a 16 hour lasting period. After 10 weeks from the completion of the experimental phase (wash-out period), there will be the "end of follow up" visit.
The whole duration of the study is 24 weeks (2 weeks lead-in, 12 weeks intervention and 10 weeks post-intervention investigation).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
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
- •Patients with steady medication during the last 3 months. A diabetes mellitus must not be decompensated (HbA1c <6.5%). Patients with advanced fibrosis - defined about the non-invasive Fibroscan-procedure (Fibroscan >13 kPa) - will not be included.
- •Complete inclusion criteria:
- •Age between 18 and 75 years
- •Body Mass Index (BMI) > 25 kg/m2
- •Grade 3 steatosis evaluated by with CAP ≥ 300 dB/m and exclusion of known causes of liver steatosis
- •Liver elastography < 13 kPa
- •Capability to understand the study and the individual consequences of participation
- •Signed and dated declaration of agreement in the forefront of the study
排除标准
- •Liver cirrhosis
- •Hepatocellular carcinoma or non-curative treated carcinoma
- •Alcohol consumption >20g (female) und >30 g (male)/day
- •Other causes of chronic liver disease (HBV, HCV, HDV, HEV, HIV), autoimmune diseases or chronic cholestatic liver disease, hereditary haemochromatosis, Wilson disease, α-1-Antitrypsin deficiency
- •Medications which cause liver disease or secondary NAFLD (e. g. Tamoxifen, systemic Corticosteroids, Methotrexate, Tetracycline, Estrogens, Valproic acid)
- •Changes in body weight > 5% in the last 6 months
- •Statins and/ or other fat-reducer medications if not taken in steady dosage during at least 4 weeks
- •Uncontrolled diabetes type 2 defined as HbA1c value > 9.0% or insulin depending type 2 diabetes
- •Immunologic or inflammatory disease (e. h. systemic lupus erythematodes)
- •Patients after organ transplantations
- •Missing or lacking consent capability
结局指标
主要结局
Evaluation of the impact of TRF on liver steatosis by CAP (dB/m)
时间窗: 12 weeks
The primary outcome of interest is a change in CAP value of a least 20 db/m with TRF
次要结局
- Evaluation of changes in insulin sensitivity(12 weeks)
- Changes in FIB-4 as indirect non-invasive tools of liver fibrosis(12 weeks)
- Evaluation of changes in liver-specific quality of life(12 weeks)
- Changes in liver fibrosis by liver stiffness (kPa) under TRF(12 weeks)
- Evaluation of changes in direct non-invasive tool of liver fibrosis ELF(12 weeks)
- Evaluation of changes in direct marker of liver fibrogenesis PRO-C3 (ng/ml)(12 weeks)
- Evaluation of changes in the gut microbiota(12 weeks)
- Evaluation of changes in markers of oxidative stress (AGEs)(12 weeks)
- Changes in spleen volume by spleen stiffness under TRF(12 weeks)
研究者
Jörn M. Schattenberg
Prof. Dr. Jörn M. Schattenberg
Johannes Gutenberg University Mainz