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

Not Applicable

Not yet recruiting

• Conditions: Non-alcoholic Fatty Liver Disease
• Interventions: Other: Maltodextrin; Other: Ginseng oligopeptide (Ginseng extract）

• Registration Number: NCT06167902
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-29
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-11
• Last Update Submitted: 2023-12-11
• Study First Posted: 2023-12-13
• Last Update Posted: 2023-12-13
• Study Start: 2023-12-25
• Primary Completion: 2024-12-25
• Study Completion: 2025-12-25

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The placebo group	Maltodextrin	-
Ginseng oligopeptide group	Ginseng oligopeptide (Ginseng extract）	-

Primary Outcome Measures

Name	Time	Method
aspartate aminotransferase (AST)	The day of enrollment, day 60 and day 120 after enrollment.	Liver function
Alanine aminotransferase (ALT)	The day of enrollment, day 60 and day 120 after enrollment.	Liver function
glutamyltransferase (GGT).	The day of enrollment, day 60 and day 120 after enrollment.	Liver function