Open-label, Non-Pharmacological, Intervention Cohort Study Without Control Arm, in Patients With Non Alcoholic Fatty Liver Disease and in Healthy Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Weight loss
研究概览
简要总结
The study is an open-label intervention non pharmacological Cohort Study without control arm in patients with Non Alcoholic Fatty Liver Disease (NAFLD) and in healthy subjects.
The intervention in patients with NAFLD is educational, providing personalized suggestions to improve diet and physical activity; the intervention in healthy subjects is educational, providing general suggestions to improve diet and physical activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presence of Fatty Liver at ultrasonography
排除标准
- •Pregnancy;
- •Breast Feeding
- •Cirrhosis or End Stage Liver Disease
- •Fatty Liver due to Hepatic Diseases other than Non Alcoholic Fatty Liver disease
- •Concomitant severe clinical condition
研究组 & 干预措施
Mediterranean Style
Educational intervention with personalized suggestions to improve diet and physical activity
干预措施: Mediterranean Style (Behavioral)
结局指标
主要结局
Weight loss
时间窗: 12 months
A reduction of at least 3 Kg
Body Mass Index (BMI) decrease
时间窗: 12 months
A dicresae of at least 1Kg/m2
Waist Circumference (WC) decrease
时间窗: 12 months
A decrease of at least 1.5 cm
次要结局
- Blood cholesterol level decrease(12 months)
- Blood triglycerides level dicrease(12 months)
- Blood sugar level decrease(12 months)
研究者
Chiara Ricci
Associate Professor
Università degli Studi di Brescia