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

NCT06167902 | Unknown

• 1 other identifier: Ginseng oligopeptide 1.0
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (3)

• Alanine aminotransferase (ALT)

  Liver function

  The day of enrollment, day 60 and day 120 after enrollment.

• aspartate aminotransferase (AST)

  Liver function

  The day of enrollment, day 60 and day 120 after enrollment.

• glutamyltransferase (GGT).

  Liver function

  The day of enrollment, day 60 and day 120 after enrollment.

Study Arms (2)

Ginseng oligopeptide group

EXPERIMENTAL

Other: Ginseng oligopeptide (Ginseng extract）

The placebo group

PLACEBO COMPARATOR

Other: Maltodextrin

Interventions

Ginseng oligopeptide (Ginseng extract） OTHER

The experimental group was given ginseng oligopeptide preparation 1.2g per day orally.

Ginseng oligopeptide group

Maltodextrin OTHER

The control group was treated with placebo maltodextrin 1.2g/d

The placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Asian ginseng; maltodextrin

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Central Study Contacts

Wei Chen, Doctor

CONTACT

13911006820; txchenwei@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 13, 2023
• Study Start: December 25, 2023
• Primary Completion: December 25, 2024
• Study Completion: December 25, 2025
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share