Nonalcoholic Fatty Liver Disease
Conditions
Keywords
Nonalcoholic fatty liver disease, Silymarin, Inflammation, Lipid metabolism
Brief summary
Non-alcoholic fatty liver disease (NAFLD) has become the most prevalent liver disorder in China. The aim of this project is to evaluate the effects of compound silymarin on biomarkers of lipid metabolism and inflammation in the patients with NAFLD.
Detailed description
Non-alcoholic fatty liver disease (NAFLD) has become the most prevalent liver disorder in China but still has no exact therapy for this disease instead of improving our diet and enhancing physical activity. Silymarin is a mixture of flavonoids extracted from seeds of Silybum marianum or milk thistle, and its major active compound is silibinin. Because of its antioxidant, anti-inflammatory and antifibrotic power, silymarin has important biological effects in NAFLD. Furthermore, some traditional liver protective Chinese medicines are also helpful in controlling the progression of NAFLD, such as pueraria, schisandra and salvia miltiorrhiza. At present, there are few reports on the combination of silymarin and these traditional Chinese medicines in the treatment of NAFLD. This study aims to test the effect of compound silymarin on laboratory markers and clinical evolution of patients with NAFLD.
Interventions
DIETARY_SUPPLEMENTSilibinin extract, mixed power of pueraria, schisandra and salvia miltiorrhiza
Take 4 tablets with warm water twice a day
DIETARY_SUPPLEMENTSilibinin extract
Take 4 tablets with warm water twice a day
DIETARY_SUPPLEMENTPlacebo
Take 4 tablets with warm water twice a day
Sponsors
Affiliated Hospital of Guangdong Medical University
Guangzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subject's BMI is ≥ 22.0 kg/m2 and \< 33.0 kg/m2; * Subject is diagnosed with NAFLD according to the Chinese Non-alcoholic fatty liver disease prevention guide 2018; * A mildly elevated of ALT level (≥ 30 U/L for male, ≥ 19 U/L for female) or an AST/ALT ratio \< 1.0; * Must be able to swallow tablets.
Exclusion criteria
* ≥ 30 grams of alcohol/day for male and ≥ 20 grams of alcohol/day for female; * Patients with certain hepatic diseases such as gallstones, hepatitis C, autoimmune hepatitis, and hepatolenticular degeneration which can lead to fatty liver disease; * Be taking medicines or supplements that would influence the liver function, lipid metabolism; * Patients with total parenteral nutrition, inflammatory bowel disease, celiac disease, hypothyroidism, Cushing syndrome, Mauriac syndrome, etc; * Patients with hereditary diseases, coronary heart disease, mental disorder, cancer, cirrhosis and renal disease; * Body weight change are more than 10% in previous 3 months; * Patients who have participated in or are participating in other clinical trials within 3 months of their first administration of the study product; * Subjects are allergic to the ingredients in the test or control samples; * Woman who is pregnant or breastfeeding; * Subjects cannot meet the requirements of compliance in the pre-experiment period; * Subjects who fail to sign the informed consent forms.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liver enzymes | Change from baseline ALT and AST at 12 weeks | Serum activities of alanine transaminase (ALT) and aspartate transaminase (AST) |
| Lipid profile | Change from baseline lipid profile at 12 weeks | Serum levels of total cholesterol (TC), triglyceride (TG), high density lipoprotein-cholesterol (HDL-C) and low density lipoprotein-cholesterol (LDL-C) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| T-Lymphocytes' composition | Change from baseline T-Lymphocytes' composition at 12 weeks | Changes of T-Lymphocytes' composition in peripheral blood |
| Bile acid metabolism | Change from baseline composition of serum and fecal bile acids at 12 weeks | Composition of serum and fecal bile acids |
Countries
China
Outcome results
None listed