Comparison Between 14/10 Intermittent Fasting and the Southern Italian Mediterranean Diet in the Variation of NAFLD Score, Inflammatory Indices and Intestinal Microbiota
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- The effect of intervention on CAP value
研究概览
简要总结
This study aims to evaluate the effects of Intermittent Fasting (IF) 14/10 compared with the Low Glycemic Index Mediterranean Diet on NAFLD.
详细描述
Interventional, randomized, controlled 2-arm clinical trial
The two study arms are:
- Low-Glycemic Index Mediterranean Diet (Control Arm).
- IF 14/10 (Experimental Arm) with 14 hours of overnight fasting and 10 hours of feeding with Low Glycemic Index Mediterranean Diet.
The study involves the enrollment of 60 subjects (30 in each arm) with NAFLD, medium/severe grade diagnosed by Fibroscan, randomly assigned using randomization tables to one of the two study arms.
The duration of the nutritional intervention is 4 months. During the study duration period, patients will undergo 3 visits.
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
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medium/severe NAFLD (CAP>268)
- •BMI between 25 and 35
排除标准
- •diabetes treated with insulin,
- •fatty liver disease linked to alcohol consumption,
- •chronic inflammatory intestinal and oncological diseases,
- •visceral obesity which does not allow good resolution of Fibroscan images,
- •subjects in serious medical conditions that may compromise participation in the trial,
- •people following a special diet or unable to follow a diet for religious or other reasons.
- •Pregnancy and breastfeeding
结局指标
主要结局
The effect of intervention on CAP value
时间窗: at Baseline and after 4 months
To evaluate the change in hepatic steatosis score after 4 months of a low glycemic index Mediterranean diet and 14/10 intermittent fasting with a low glycemic index Mediterranean diet. The cut off to indicate the presence of steatosis is CAP\>268. A decrease in the CAP value indicates an improvement in the pathology
次要结局
- The effect of the intervention on the Body Composition detected with DEXA(at Baseline and after 4 months)
- The effect of the intervention on the Body Composition detected with bioimpedance analysis(at Baseline and after 4 months)
研究者
Dr. Rosa Reddavide - MSc
Principal Investigator, Biologyst
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis