Hepaxa Management of Non-Alcoholic Fatty Liver Disease (NAFLD): A Real-world Pilot Study Observing Effects of Nutritional Management With Hepaxa in Subjects With Liver Steatosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The change in liver fat content (hepatic steatosis) from baseline to end of study
研究概览
简要总结
This study measures the steatosis in patients With fatty livers as determined by CAP score from a fibroscan assessment. The study attempts to determine the effect of using the Medical Food Hepaxa in a Clinical setting Close to real-world use.
详细描述
Subjects With fatty liver are given Hepaxa for 6 months. Fibroscan CAP measurements are taken at 3 monthly intervals. Subjects consent to Collection of data from approximately 6 months prior to use of Hepaxa. Patients unresponsive to life style recommendations given as standard practice will be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women, ≥18 years of age.
- •Suspicion of NAFLD
- •Able to understand and cooperate with study procedures, and have signed a written informed consent prior to any study procedures.
- •CAP score at -6 months and at inclusion of >268
- •A fibroscan elastography score <9 Kpa (Advanced Fibrosis)
排除标准
- •Other causes of liver inflammation including Hepatitis A, B or C, HIV, confirmed or suspected cirrhosis, Wilson's disease, autoimmune hepatitis, hemochromatosis, alcoholic steatohepatitis, pancreatitis, or prescription medications known to cause liver damage, or known to be hepatotoxic.
- •Significant weight loss (> 5% body weight) or rapid weight loss (>1.6 kg/week), within six months of screening.
- •Individuals taking prescription or supplemental omega-3 fatty acids.
- •Has a condition the Investigator believes would interfere with the evaluation of the subject, or may put the subject at undue risk during the course of the study, including potentially abnormal lab results, due to a traumatic event.
研究组 & 干预措施
Hepaxa
Subjects will receive Hepaxa according to standard use (4 capsules daily over a 6 month period)
干预措施: Hepaxa (Dietary Supplement)
结局指标
主要结局
The change in liver fat content (hepatic steatosis) from baseline to end of study
时间窗: 6 months
Liver fat will be measured using the "Controlled Attenuation Parameter" from the ultrasound based Fibroscan machine
次要结局
- Change in liver function test: aspartate aminotransferase (AST) from baseline (IU/L) to end of study(6 months)
- Change in the liver function test: alanine aminotransferase (ALT) from baseline (IU/L) to end of study(6 months)
- Change in the liver function test: gamma glutamyltransferase (GGT) from baseline (IU/L) to end of study(6 months)
- Change in Level of plasma triglycerides from baseline to end of study(6 months)
- Change in weight from baseline to end of study(6 months)