NCT03738358已完成不适用
A 12-week, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Study to Evaluate the Efficacy and Safety of Trehalose in Patients With Fatty Liver Disease
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 主要终点
- Change in liver fat content scanned by CT
研究概览
简要总结
This clinical study will be conducted to evaluate the efficacy and safety of trehalose in patients with fatty liver disease. After 12-week intake, subjects will be checked up fat content in liver using CT scan.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 19-year-old and 79-year-old
- •Weight (≥50kg)
- •Is diagnosed as fatty liver on ultrasonography within 24 weeks from screening day
- •Has willingness and ability to participate whole clinical study period
- •Willing to give informed consent form
排除标准
- •Patient with alcoholic fatty liver
- •Patient with inflammatory bowel disease
- •Is required treatment for like liver, kidney, digestive system, circulatory system, respiratory system, endocrine system(except diabetes), musculoskeletal, neuropsychiatry, or hemato-oncology etc., which is able to effect on clinical study
- •Has any medical history with virus or toxic hepatitis
- •Has any medical history of gastrointestinal surgery (except simple appendectomy & repair of hernia)
- •Has medical history of malignant tumor (except non-melanoma skin cancer) within the last 5 years from the screening day
- •Took any drugs (UDCA, silymarin, omega-3, fenofibrate etc.) which is decided as unsuitable drug for combined-dose by investigator
- •Over 4 times of maximum reference range of ALT or AST
- •Average drinking quantity per week > alcohol 140 g
- •Pregnant or nursing women
- •Is currently participating into another clinical study
- •Being made a decision from investigator as unsuitable to participate this study
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Other)
Trehalose
Experimental
干预措施: Trehalose (Dietary Supplement)
结局指标
主要结局
Change in liver fat content scanned by CT
时间窗: Screening (baseline) and 12 weeks
Trehalose group and placebo comparator group are scanned by CT to compare the difference of liver fat content
次要结局
- Change in visceral fat and subcutaneous fat levels(0 week and 12 weeks)
- Change in ALT and AST(0 (baseline) and 12 weeks)
- Change in total cholesterol, LDL, HDL, triglyceride (TG) and free fatty acid(0 (baseline), 6 and 12 weeks)
- Change in BMI(0 (baseline), 6 and 12 weeks)
- Adverse event (AE)(0 week, 6 weeks, and 12 weeks)
- Change in homeostatic model assessment-insulin resistance (HOMA-IR)(Screening (baseline) and 12 weeks)
研究者
Jung-Ryul Kim
Professor
Samsung Medical Center
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