The Metabolic Effects of Ginseng Oligopeptide Preparation on Non- Alcoholic Fatty Liver Disease With Obesity: a Randomized Controlled Double-blind Trial

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Not yet enrolling

Conditions: Non-alcoholic Fatty Liver Disease

Treatments: Other: Maltodextrin; Other: Ginseng oligopeptide (Ginseng extract）

Study type: Interventional

Funder types: Other

Identifiers

NCT06167902

Ginseng oligopeptide 1.0

Details and patient eligibility

About

To investigate the effect of ginseng oligopeptide on nonalcoholic fatty liver disease with obesity and clarify its intervention mechanism in theory, which will contribute to the prevention and treatment of non-alcoholic fatty liver more scientifically and effectively.The patients were randomly divided into two groups. One group of patients took ginseng oligopeptide orally, and the other group took placebo. The liver function, blood lipid, blood glucose, liver B ultrasound and other indicators were observed to further determine the efficacy.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meet the diagnostic criteria for non-alcoholic fatty liver disease ;
• Aged 18-65 years old;
• ALT, AST, GGT≤2×Upper Limit Of Normal（ULN）;
• BMI≥28Kg/㎡;
• Patients signed the relevant informed consent on a voluntary basis.

Exclusion criteria

• Under 18 years old and over 65 years old;
• Allergic to the ingredients of ginseng oligopeptide preparation;
• Serum ALT, AST, GGT>2ULN;
• Currently taking oral hepatoprotective drugs such as reduced glutathione, polyene phosphatidylcholine, and silibinin, etc.;
• Subjects participating in other clinical trials;
• Pregnant or lactating women;
• Complicated with serious diseases of the digestive system or other systems, such as chronic gastrointestinal diseases and chronic diseases causing digestive malabsorption,Kidney disease, hematological system or autoimmune diseases;
• Other populations that were deemed by the investigators to be ineligible for the trial may reduce or complicate enrollment patients with chemotherapy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

200 participants in 2 patient groups, including a placebo group

Ginseng oligopeptide group

Experimental group

Treatment:

Other: Ginseng oligopeptide (Ginseng extract）

The placebo group

Placebo Comparator group

Treatment:

Other: Maltodextrin