Efficacy of Nutritional Therapy With High Methionine Content in the Treatment of Non-alcoholic Fatty Liver: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- NAFLD reversal
研究概览
简要总结
To assess the effect of a methionine metabolism-based dietary strategy in patients with non-alcoholic fatty liver disease in order to reduce complications while improving the quality of life for patients.
详细描述
A randomized controlled clinical trial with parallel design was performed, a ratio of at least one patient in the control group for each subject in the experimental group.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Balanced groups are produced on the computer-generated random numbers based on the sex of the study subjects, that is, men and women were proportionally assigned in both groups. An investigator from outside the allocation of exposure generated the random numbers in four blocks: 1) men assigned to the experimental group, 2) women assigned to the experimental group, 3) men assigned to the control group and 4) women assigned to the control group. A second investigator, blindly assigned subjects to experimental and control group. Although concealment of allocation to interest groups could be confirmed, masking of difficulties was not possible once the follow-up began.
入排标准
- 年龄范围
- 20 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Non-alcoholic Fatty Liver Disease by biochemical parameters used by the SteatoTest and Fatty Liver Index (IHG), greater than 60 points on the scale and confirmed by liver ultrasound
排除标准
- •Previous diagnosis of cirrhosis, hepatocarcinoma, Wilson's disease, viral hepatitis B and C and neoplasms of any origin
结局指标
主要结局
NAFLD reversal
时间窗: Three months
Change in FLI to a level less than 60 points at the end of the dietary intervention. FLI was the result of the algorithm based on waist circumference, body mass index, serum GGT level and triglycerides. Bedogni, et al developed this fatty liver prediction model. The total possible score ranges from 1 to 100 points, where a score greater than or equal to 60 is considered to be NAFLD probable, and a level below 30 points is considered normal
次要结局
- The Short Form (36) Health Survey (SF-36).(Three months)
研究者
María Cristina León
Investigator
Universidad Veracruzana