Effects of Tablets of Silybum Marianum, Pueraria Lobate and Salvia Miltiorrhiza on Fatty Liver

Fatty Liver Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05076058
• Other study ID #: K19-51000-043
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: September 2021
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 118
• Est. completion date: June 30, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Fatty Liver Disease
• Liver Diseases

Intervention

Dietary Supplement:
• Tablet of silybum marianum, Pueraria lobate and salvia miltiorrhiza
Brand names: BY-HEALTH; Main contents (per 100g): silibinin 2g, salvianolic acid B 0.72g,Puerarin 0.68g

Other:
• Placebo tablet
Brand names: BY-HEALTH; Main contents : starch

Locations

Country	Name	City	State
China	Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline body weight at 6 months	Body measurement 1: Body weight (in kg)	0 and 6 months
Other	Change from baseline body height at 6 months	Body measurement 2: Body height (in cm)	0 and 6 months
Other	Change from baseline waist circumference at 6 months	Body measurement 3: Waist circumference (in cm)	0 and 6 months
Other	Change from baseline hip circumference at 6 months	Body measurement 4: hip circumference (in cm)	0 and 6 months
Other	Change from baseline anxiety score at 6 months	Anxiety Score: assessed by a Self Rating Anxiety Scale (SAS).the minimum and maximum values: 25-100 points. Higher scores mean worse outcome.	0 and 6 months
Other	Number of treated events related to supplements between baseline to 6 months	Adverse/side effects: Assessed by using questionnaire of medical history, medication use, symptoms.	0 and 6 months
Other	Percentage of the interventional supplements consumed between baseline to 6 months	Compliance assessment: Assessed by counting the number of remaining supplemental tablets at 6 months	at 6 months
Primary	Change from baseline proton density fat fraction of liver at 6 months	Proton density fat fraction of liver: measured using magnetic resonance (MR)	0 and 6 months
Primary	Change from baseline liver fibrosis biomarker (Type pro-collagen III N terminal peptide) at 6 months	Liver fibrosis biomarker 1: Type pro-collagen III N terminal peptide	0 and 6 months
Primary	Change from baseline liver fibrosis biomarker (hyaluronic acid) at 6 months	Liver fibrosis biomarker 2: hyaluronic acid	0 and 6 months
Primary	Change from baseline liver fibrosis biomarker (laminin) at 6 months	Liver fibrosis biomarker 3: laminin	0 and 6 months
Primary	Change from baseline liver fibrosis biomarker (collagen type IV) at 6 months	Liver fibrosis biomarker 4: Collagen type IV	0 and 6 months
Primary	Change from baseline liver fibrosis biomarker (glycocholic acid) at 6 months	Liver fibrosis biomarker 5: Glycocholic acid	0 and 6 months
Primary	Change from baseline NAFLD fibrosis score at 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)	0 and 6 months
Secondary	Change from baseline liver function biomarker (AST) at 6 months	Liver function biomarkers 1: AST	0 and 6 months
Secondary	Change from baseline liver function biomarker (ALT) at 6 months	Liver function biomarkers 2: serum ALT	0 and 6 months
Secondary	Change from baseline liver function biomarker (GGT) at 6 months	Liver function biomarkers 3: serum gamma-glutamyl transpeptidase (GGT)	0 and 6 months
Secondary	Change from baseline liver function biomarker (total protein) at 6 months	Liver function biomarkers 4: serum total protein	0 and 6 months
Secondary	Change from baseline liver function biomarker (ALP) at 6 months	Liver function biomarkers 5: serum alkaline phosphatase (ALP)	0 and 6 months
Secondary	Change from baseline liver function biomarker (bile acids) at 6 months	Liver function biomarkers 6: serum bile acids	0 and 6 months
Secondary	Change from baseline fasting blood lipid (TG) at 6 months	Fasting blood lipid 1: serum triglycerides	0 and 6 months
Secondary	Change from baseline fasting blood lipid (TC) at 6 months	Fasting blood lipid 2: serum total cholesterol	0 and 6 months
Secondary	Change from baseline fasting blood lipid (HDL-C) at 6 months	Fasting blood lipid 3: serum high-density lipoprotein cholesterol (HDL-C)	0 and 6 months
Secondary	Change from baseline fasting blood lipid (LDL-C) at 6 months	Fasting blood lipid 4: serum low-density lipoprotein cholesterol (LDL-C)	0 and 6 months
Secondary	Change from baseline fasting blood glucose at 6 months	Fasting blood glucose: serum glucose	0 and 6 months
Secondary	Change from baseline fasting blood insulin at 6 months	Fasting blood insulin: serum insulin	0 and 6 months
Secondary	Change from baseline systolic blood pressure at 6 months	Blood pressure: systolic blood pressure	0 and 6 months
Secondary	Change from baseline diastolic blood pressure at 6 months	Blood pressure: diastolic blood pressure	0 and 6 months
Secondary	Change from baseline Inflammatory factor (hsCRP ) at 6 months	Inflammatory factor 1: serum high sensitivity C reactive protein (hsCRP)	0 and 6 months
Secondary	Change from baseline Inflammatory factor (IL-6) at 6 months	Inflammatory factor 2: serum IL-6	0 and 6 months
Secondary	Change from baseline oxidative stress (SOD) at 6 months	Oxidative stress biomarker 1: serum SOD	0 and 6 months
Secondary	Change from baseline oxidative stress (MDA) at 6 months	Oxidative stress biomarker 2: serum malondialdehyde (MDA)	0 and 6 months
Secondary	Change from baseline fat mass at 6 months	Fat mass (FM): FM (kg) at total body and sub-regions determined by a dual energy x-ray absorptiometry (DXA)	0 and 6 months
Secondary	Change from baseline percentage fat mass at 6 months	Percentage Fat mass (%FM): %FM (%) at total body and sub-regions determined by DXA	0 and 6 months