Efficacy of Phosphatidylcholine in NAFLD
关键词
抽象
描述
As a result of increasing rates of obesity Non Alcoholic Fatty Liver (NAFLD) is the most common liver disorder affecting 17-46% of adults and parallels the prevalence of Metabolic Syndrome (MetS) and its components which also increases the risk of more advanced disease both in adults and in children.
Its pathogenesis is complex and multifactorial, mainly involving genetic, environmental and metabolic factors. New concepts are constantly appearing in the literature, promising new diagnostic and therapeutic tools. Further studies are needed to better characterize not only NAFLD development but overall NAFLD progression, in order to better identify NAFLD patients at higher risk of metabolic, cardiovascular and neoplastic complications. Pharmacological treatments aimed primarily at improving liver disease should generally be limited to those with biopsy-proven Nonalcoholic steatohepatitis (NASH) and liver fibrosis. Not much therapeutic options for NAFLD are accepted until today besides correction of obesity with hypocaloric diets and physical exercise and controlling hyperglycemia with diet, insulin, or oral hypoglycemic agents. Weight loss generally reduces hepatic steatosis.Essential phospholipid (EPL) as a nutritional supplement is one of the drugs under discussion with significant positive effects as antioxidative, antifibrotic effects and high biocompatibility on NAFLD.
日期
| 最后验证: | 05/31/2020 |
| 首次提交: | 05/09/2020 |
| 提交的预估入学人数: | 05/27/2020 |
| 首次发布: | 06/01/2020 |
| 上次提交的更新: | 05/31/2020 |
| 最近更新发布: | 06/03/2020 |
| 实际学习开始日期: | 01/01/2016 |
| 预计主要完成日期: | 01/02/2019 |
| 预计完成日期: | 06/30/2019 |
状况或疾病
干预/治疗
Dietary Supplement: Intervention Group
Behavioral: Lifestyle modification
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Intervention Group 50 Participants with NAFLD that receive lifestyle modification by Clinical Pharmacist plus Phosphatidylcholine two soft capsules 3 times daily(2.1 g per day) for 6 month | Dietary Supplement: Intervention Group 2.1 g Phosphatidylcholine daily in addition to lifestyle modification |
| Active Comparator: Control Group 50 Participants with NAFLD that receive only lifestyle modification by Clinical Pharmacist |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Patients were included in the study when the following criteria to were fulfilled : Inclusion Criteria: - fatty liver upon Ultrasonography (US) /Computed Tomography (CT) /Magnetic Resonance Imaging (MRI) with either incidental increased Alanine Aminotransferase (ALT) - the presence of risk factors related to NAFLD + increased ALT - symptomatic liver disease +/- hepatomegaly, +/- increased ALT - homeostasis model assessment-insulin resistance HOMA IR score > 3 - presence of liver steatosis or stiffness measured by transient elastography - eligible patients had at least one of the following metabolic comorbidities: hypertension, Type 2 Diabetes Mellitus, overweight/obesity (BMI>27 kg/m2) serum cholesterol of > 200 mg/d Patients were excluded from the study if showing evidence : Exclusion Criteria: - if showing evidence of alcoholic or chronic liver disease - Hepatocellular Carcinoma, autoimmune hepatitis - end stage liver disease - treatment with other hepatoprotectants - other concomitant EPL within 30 days of study initiation - pregnancy or lactation |
结果
主要结果指标
1. change from baseline Body Mass Index (BMI) at 3 and 6 month [baseline, at 3 and 6 month]
2. change from baseline liver stiffness at 3 and 6 month [baseline , at 3 and 6 month]
3. change from baseline Lipid Profile [baseline , at 3 and 6 month]
4. change from baseline Oxidative stress markers [baseline , at 3 and 6 month]
5. change from baseline NAFLD score at 3 and 6 month [baseline , at 3 and 6 month]
6. change from baseline homeostasis model assessment Insulin resistance HOMA IR scores at 3 and 6 month [baseline , at 3 and 6 month]
次要成果指标
1. change from baseline Complete Blood Picture at 3 and 6 month [baseline , at 3 and 6 month]
