NAFLD: Independent Effects of Western Dietary Pattern Profile and Sedentary Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 主要终点
- Decrease of fatty liver appearance by ultrasound
研究概览
简要总结
Investigators perform a counseling intervention study (6 months) in adult subjects with evidence of Fatty Liver by Ultrasound, graded 0-3 according to the Bright Liver Score (BLS); exclusion criteria are diabetes, renal insufficiency (glomerular filtration rate < 90 ml/min), cancer, heart failure > II NYHA ( New York Heart Association) Class), chronic virus hepatitis, and cirrhosis. Insulin resistance was assessed as homeostasis model assessment-insulin resistance (HOMA-IR) . Suggestions and advice on individual "healthy" food purchase, storage, and cooking were given. Reliable feedback and evidence of patients' adherence were obtained by scheduled dietician's interviews. Investigators will challenge the predictive effects of the Adherence to Mediterranean Diet, of Western dietary profile score and of increased physical activity at 6 months in a body mass index changes-balanced model to detect independent effects, if any, of the studied variable on NAFLD persistence, amelioration or disappearance. Threshold and odds of Mediterranean and Western dietary profile score will be calculated by contingency tables and receiver operator characteristic curve (ROC) analysis..
详细描述
Dietary and physical exercise counseling.
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
- 21 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of fatty liver
排除标准
- •type I or type II diabetes,
- •no alcohol, cancer, malnutrition, severe obesity, renal insufficiency, viral hepatitis, other chronic disease
结局指标
主要结局
Decrease of fatty liver appearance by ultrasound
时间窗: 6 months
次要结局
未报告次要终点
研究者
Guglielmo Trovato, MD, PhD
Dirigente Medico
Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
