Role of a Wheat-based Diet in NASH (NASH-ATI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Effect of ATI-free Nutrition on hepatic inflammation
研究概览
简要总结
Effects of Wheat-based diet vs. ATI-free diet on NASH
详细描述
40 patients with the diagnosis of a non-alcoholic- steatohepatitis (NASH) will be recruited at the University Hospitals of Mainz and Frankfurt. Patients are assessed with regards to their diet using standardized questionnaire and nutritionists.
Patients will be randomized into two parallel groups. The first group will continue a wheat-based Nutrition, while the second Group will receive dietary counselling to achieve an ATI-free nutrition, trying to reduce the daily ATI consumption.
The clinical trial will run over 16 weeks including 4 visits at the study center. Study visits include physical examinations, blood-based parameters, cytokines and urine samples, as well for the analysis of the intestinal microbiome by using stool samples. In addition the patients have to complete dietary and health-related quality of life (HRQL) questionnaires. Visits are planned at baseline, W4, W8 and W16.
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)
盲法说明
randomization
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
- •histologically proven NASH in the past 36 months with increased ALT: males: >60, females: >42 U/ml
- •no body weight modification about >10% in the past 24 weeks
- •no new drugs treating parts of the metabolic syndrome in the past 12 weeks
- •for patients with Diabetes: HbA1c value <8,6%
- •the ability to understand the aim and the possible individual consequences of this Trial
- •signed and dated consent before the Trial starts
排除标准
- •unstable coronary heart disease, stroke in the past 6 months
- •different liver diseases
- •proceeded fibrosis (Fibroscan >9,6 kPA) or histological cirrhosis
- •hepatocellular carcinoma or not curative treated carcinomas
- •alcohol consumption >10g/day (females), >20g/day (males)
- •gravidity
- •drugs causing secondary NASH (e.g. Tamoxifen, corticosteroids)
- •immunological or inflammatory diseases (e.g. systemic Lupus erythematodes)
- •warfarin therapy
- •implementation of another Special diet
结局指标
主要结局
Effect of ATI-free Nutrition on hepatic inflammation
时间窗: 16 weeks
Reduction of Alanine-Aminotransferase (ALT; U/ml) compared to baseline
次要结局
- Quality of Life using the chronic liver disease questionnaire (CLDQ)(16 weeks)
研究者
Jörn M. Schattenberg
Director Metabolic Liver Disease Program
Johannes Gutenberg University Mainz