Effects of Tablets of Silybum Marianum, Pueraria Lobate and Salvia Miltiorrhiza on the Progression of Fatty Liver in Adults: a Double-blinded Randomized Placebo-controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Change from baseline proton density fat fraction of liver at 6 months
研究概览
简要总结
Objectives: To examine the effects of tablets of silybum marianum, Pueraria lobate and salvia miltiorrhiza on the progression of fatty liver in patients with fatty liver.
Design: a double-blinded randomized placebo-controlled clinical trial.
Setting: community residents, Guangzhou city, South China.
Participants: a total 118 men and women (18-65 years), with BMI range of 24-30 kg/m2, and with fatty liver screened by ultrasound or MR at baseline.
Arms and Interventions: 118 participants were randomly allocated into two arms using a block randomization method. Experimental Arm: tablet of silybum marianum, Pueraria lobate and salvia miltiorrhiza, 3 tablets (1g each) twice a day for 6 months; Placebo Arm: placebo tablets, 3 tablets (1g each) twice a day for 6 months.
Outcome Measures: determined at baseline and at 6 months post treatment
- Primary Outcome Measures: 1) proton density fat fraction of liver assessed by MR; 2) serum liver fibrosis biomarkers: type procollagen III N terminal peptide, hyaluronic acid, laminin, collagen type IV, and glycocholic acid; 3) NAFLD fibrosis score.
- Secondary Outcome Measures: 1) serum liver function biomarkers: AST, ALT, GGT, ALP, total protein, and bile acids; 2) fasting blood lipids: total triglycerides, total cholesterol, HDL cholesterol and LDL cholesterol; 3) fasting serum glucose and insulin; 4) serum inflammatory factors (hsCRP and IL-6); 5) oxidative stress: SOD and MDA; and 6) body measurements and body fat mass.
Data Analyses: Mean changes in the above outcome measures from baseline to 6 months will be compared between the two arms.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Placebo with the same appearance, taste, smell, and packing box to the experimental supplement was used. 118 serial numbers matched to each one participant, and corresponding to study arms (named as 1 or 2 on the tablet box), were used to replace the original label of supplement or placebo after randomization. The code of serial number corresponding to the group code (1 or 2) of tablets was kept by the PI, and will not be disclosed until the completion of all data collection. The group code corresponding to the two types of tablets was/will be kept by the producer till the completion of data analysis.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-65 years
- •BMI: 24-30 kg/m2
- •Fatty liver, assessed by ultrasound or MR
- •Had normal diet and normal daily life.
排除标准
- •Hospital confirmed diseases of heart, liver (viral hepatitis, drug-induced liver injury, cirrhosis), kidney, brain, hematopoietic system，diabetes, immune system, and cancer；
- •Taking medicine or supplements known to affect fatty liver, body fat;
- •Body weight had changed more than 10% within the past 3 months;
- •Physical or mental disabled to participate the trial;
- •Compliance of tablet consumption is/was less than 80% in run-in period;
- •Pregnant or lactating women, or intended pregnancy during the trial period;
- •Be allergic to the proposed supplements；
- •Attended or plan to attend other trial(s);
- •Be unwell to sign the informed consent form, or have other conditions that be not suitable to attend the trial considered by the investigators.
结局指标
主要结局
Change from baseline proton density fat fraction of liver at 6 months
时间窗: 0 and 6 months
Proton density fat fraction of liver: measured using magnetic resonance (MR)
Change from baseline liver fibrosis biomarker (hyaluronic acid) at 6 months
时间窗: 0 and 6 months
Liver fibrosis biomarker 2: hyaluronic acid
Change from baseline liver fibrosis biomarker (laminin) at 6 months
时间窗: 0 and 6 months
Liver fibrosis biomarker 3: laminin
Change from baseline liver fibrosis biomarker (Type pro-collagen III N terminal peptide) at 6 months
时间窗: 0 and 6 months
Liver fibrosis biomarker 1: Type pro-collagen III N terminal peptide
Change from baseline liver fibrosis biomarker (collagen type IV) at 6 months
时间窗: 0 and 6 months
Liver fibrosis biomarker 4: Collagen type IV
Change from baseline liver fibrosis biomarker (glycocholic acid) at 6 months
时间窗: 0 and 6 months
Liver fibrosis biomarker 5: Glycocholic acid
Change from baseline NAFLD fibrosis score at 6 months
时间窗: 0 and 6 months
NAFLD fibrosis score: = -1.675 + 0.037 Age (yrs) + 0.094 BMI (kg/m2) + 1.13 impaired fasting glucose (IFG)/diabetes (yes = 1, no = 0) + 0.99 AST/ALT ratio - 0.013Platelet (\*10E9/L) - 0.66 Albumin (g/dl)
次要结局
- Change from baseline fasting blood lipid (TC) at 6 months(0 and 6 months)
- Change from baseline liver function biomarker (ALP) at 6 months(0 and 6 months)
- Change from baseline liver function biomarker (total protein) at 6 months(0 and 6 months)
- Change from baseline liver function biomarker (ALT) at 6 months(0 and 6 months)
- Change from baseline fasting blood insulin at 6 months(0 and 6 months)
- Change from baseline diastolic blood pressure at 6 months(0 and 6 months)
- Change from baseline liver function biomarker (AST) at 6 months(0 and 6 months)
- Change from baseline liver function biomarker (GGT) at 6 months(0 and 6 months)
- Change from baseline liver function biomarker (bile acids) at 6 months(0 and 6 months)
- Change from baseline fasting blood lipid (TG) at 6 months(0 and 6 months)
- Change from baseline fasting blood lipid (HDL-C) at 6 months(0 and 6 months)
- Change from baseline fasting blood lipid (LDL-C) at 6 months(0 and 6 months)
- Change from baseline systolic blood pressure at 6 months(0 and 6 months)
- Change from baseline percentage fat mass at 6 months(0 and 6 months)
- Change from baseline fasting blood glucose at 6 months(0 and 6 months)
- Change from baseline Inflammatory factor (hsCRP ) at 6 months(0 and 6 months)
- Change from baseline Inflammatory factor (IL-6) at 6 months(0 and 6 months)
- Change from baseline oxidative stress (SOD) at 6 months(0 and 6 months)
- Change from baseline oxidative stress (MDA) at 6 months(0 and 6 months)
- Change from baseline fat mass at 6 months(0 and 6 months)
研究者
Yu-ming Chen
Professor
Sun Yat-sen University