Efficacy of Isocaloric Mediterranean Diet and Low-fat Diet in Overweight/Obese MASLD Subjects With Respect to PNPLA3 Single Nucleotide Polymorphism: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Decrease in CAP (db/m)
研究概览
简要总结
The study is designed as a 12-week randomized controlled dietary intervention in individuals who had been diagnosed with NAFLD in the last 6 months and whose body mass index is above 25 at the time of participation in the pre-screening. The study sample is determined as 150 subjects and randomization will be done by stratification according to PNPLA3 genotype. At baseline, hepatic steatosis and fibrosis will be measured with Fibroscan, body composition will be analyzed, and transaminases and sugar and lipid metabolism indicators will be examined. The study will be conducted in parallel groups, with each group receiving equal amounts and intensity of Mediterranean diet or low-fat diet therapy. At the end of the 12-week intervention, baseline measurements will be repeated and the efficacy of the Mediterranean Diet and Low-fat diet therapies will be compared, as well as the effect of PNPLA3 mutation on intrahepatic response will be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to understand and sign informed consent
- •BMI> 25 kg/m2
- •Between 18-80 years
- •previous clinical diagnosis of MASLD by abdominal USG, MRI, FibroScan® or liver biopsy
排除标准
- •Excessive alcohol use (more than 20 g/day for women and 30g/day for men= >2 units alcohol/day for women and >3 units for men)
- •Other liver diseases: Hepatitis B virus, Hepatitis C virus, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis, Wilson's disease, Alpha 1 antitrypsin deficiency
- •Secondary causes for steatosis: disorders of lipid metabolism, HCV Genotype 3, total parental nutrition, severe surgical weight loss, medications (amiodarone, tamoxifen, methotrexate, corticosteroids and HAART)
- •Celiac disease
- •pregnancy and breastfeeding
结局指标
主要结局
Decrease in CAP (db/m)
时间窗: 12 weeks
The primary objective of this study is to determine the percentage decrease in hepatic steatosis at the end of week 12, measured by FibroScan® with CAP
Decrease in Liver Stiffness (kPa)
时间窗: 12 weeks
The primary objective of this study is to determine the percentage decrease in hepatic fibrosis at the end of week 12, measured by FibroScan® with E
次要结局
未报告次要终点