Mediterranean Diet Versus Paleolithic Diet for the Treatment of Non Alcohlic Fatty
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in the severity of the fatty liver measured by ultrasound and elastography.
研究概览
简要总结
Non- alcoholic fatty liver disease (NAFLD) is one of metabolic syndrome manifestation, and has become the leading cause for cirrhosis and the need for liver transplantation.
The Mediterranean diet showed in many trials its benefit in the treatment of the metabolic syndrome and NAFLD. The Paleolithic Diet includes meat, fish, fruits, vegetables, nuts and seeds and avoidance of processed food and most of carbohydrates. In some studies this diet seemed to decrease triglycerides levels and improve insulin resistance.
The aim of this study is to evaluate the influance of the paleolithic diat for the treatment of NAFLD, as shown in the Mediterranean Diet.
详细描述
Recruitment of 60 patients with the diagnosis NAFLD from clinics in Rabin Medical center, aged 18-65.
Two study groups- Mediterranean Diet and Paleolithic Diet The dietitian will assign randomly for the study groups, and will assess diet adherence within 6 weeks of the trial and in its end- after 3 months.
blood test for liver enzymes, lipids, crp, mda and HbA1C, will be taken at recruitment and after 3 months.
Ultrasound and elastography will be tested at recruitment and after 3 months, to evaluate the degree of the fatty liver, by a the same doctor who is blind to the study groups.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •pregnancy
- •Chronic kidney disease
- •post transplant
结局指标
主要结局
Changes in the severity of the fatty liver measured by ultrasound and elastography.
时间窗: 3 months
Changes in fatty liver severity score according to ultrasound wave intensity analysis- light ; moderate ; severe.
次要结局
- Changes in HbA1C(3 months)
- Changes in Triglycerides levels(3 months)
研究者
AMIR SHLOMAI
Head of internal medicine department
Rabin Medical Center