Clinical trial NCT05076058: Effects of Tablets of Silybum Marianum, Pueraria Lobate and Salvia Miltiorrhiza on Fatty Liver
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fatty Liver Disease
Keywords: fatty liver
silybum marianum
Pueraria lobate
salvia miltiorrhiza
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-10-13
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

1. 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.
2. 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.


Eligibility criteria: Inclusion Criteria:

* Age: 18-65 years
* BMI: 24-30 kg/m2
* Fatty liver, assessed by ultrasound or MR
* Had normal diet and normal daily life.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from baseline proton density fat fraction of liver at 6 months
timeFrame: 0 and 6 months
measure: Change from baseline liver fibrosis biomarker (Type pro-collagen III N terminal peptide) at 6 months
timeFrame: 0 and 6 months
measure: Change from baseline liver fibrosis biomarker (hyaluronic acid) at 6 months
timeFrame: 0 and 6 months
measure: Change from baseline liver fibrosis biomarker (laminin) at 6 months
timeFrame: 0 and 6 months
measure: Change from baseline liver fibrosis biomarker (collagen type IV) at 6 months
timeFrame: 0 and 6 months
measure: Change from baseline liver fibrosis biomarker (glycocholic acid) at 6 months
timeFrame: 0 and 6 months
measure: Change from baseline NAFLD fibrosis score at 6 months
timeFrame: 0 and 6 months
Secondary outcomes:
measure: Change from baseline liver function biomarker (AST) at 6 months
timeFrame: 0 and 6 months
measure: Change from baseline liver function biomarker (ALT) at 6 months
timeFrame: 0 and 6 months
measure: Change from baseline liver function biomarker (GGT) at 6 months
timeFrame: 0 and 6 months
measure: Change from baseline liver function biomarker (total protein) at 6 months
timeFrame: 0 and 6 months
measure: Change from baseline liver function biomarker (ALP) at 6 months
timeFrame: 0 and 6 months
measure: Change from baseline liver function biomarker (bile acids) at 6 months
timeFrame: 0 and 6 months
measure: Change from baseline fasting blood lipid (TG) at 6 months
timeFrame: 0 and 6 months
measure: Change from baseline fasting blood lipid (TC) at 6 months
timeFrame: 0 and 6 months
measure: Change from baseline fasting blood lipid (HDL-C) at 6 months
timeFrame: 0 and 6 months
measure: Change from baseline fasting blood lipid (LDL-C) at 6 months
timeFrame: 0 and 6 months
measure: Change from baseline fasting blood glucose at 6 months
timeFrame: 0 and 6 months
measure: Change from baseline fasting blood insulin at 6 months
timeFrame: 0 and 6 months
measure: Change from baseline systolic blood pressure at 6 months
timeFrame: 0 and 6 months
measure: Change from baseline diastolic blood pressure at 6 months
timeFrame: 0 and 6 months
measure: Change from baseline Inflammatory factor (hsCRP ) at 6 months
timeFrame: 0 and 6 months
measure: Change from baseline Inflammatory factor (IL-6) at 6 months
timeFrame: 0 and 6 months
measure: Change from baseline oxidative stress (SOD) at 6 months
timeFrame: 0 and 6 months
measure: Change from baseline oxidative stress (MDA) at 6 months
timeFrame: 0 and 6 months
measure: Change from baseline fat mass at 6 months
timeFrame: 0 and 6 months
measure: Change from baseline percentage fat mass at 6 months
timeFrame: 0 and 6 months
Other outcomes:
measure: Change from baseline body weight at 6 months
timeFrame: 0 and 6 months
measure: Change from baseline body height at 6 months
timeFrame: 0 and 6 months
measure: Change from baseline waist circumference at 6 months
timeFrame: 0 and 6 months
measure: Change from baseline hip circumference at 6 months
timeFrame: 0 and 6 months
measure: Change from baseline anxiety score at 6 months
timeFrame: 0 and 6 months
measure: Number of treated events related to supplements between baseline to 6 months
timeFrame: 0 and 6 months
measure: Percentage of the interventional supplements consumed between baseline to 6 months
timeFrame: at 6 months
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University
state: Guangdong
Study officials:
References: