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

Non-alcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06167902
• Other study ID #: Ginseng oligopeptide 1.0
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 25, 2023
• Est. completion date: December 25, 2025

Study information

• Verified date: December 2023
• Source: Peking Union Medical College Hospital
• Contact: Wei Chen, Doctor
• Phone: 13911006820
• Email: txchenwei[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 25, 2025
• Est. primary completion date: December 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

Intervention

Other:
• Ginseng oligopeptide (Ginseng extract)
The experimental group was given ginseng oligopeptide preparation 1.2g per day orally.
• Maltodextrin
The control group was treated with placebo maltodextrin 1.2g/d

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alanine aminotransferase (ALT)	Liver function	The day of enrollment, day 60 and day 120 after enrollment.
Primary	aspartate aminotransferase (AST)	Liver function	The day of enrollment, day 60 and day 120 after enrollment.
Primary	glutamyltransferase (GGT).	Liver function	The day of enrollment, day 60 and day 120 after enrollment.