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

December 11, 2023 updated by: Peking Union Medical College Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ginseng oligopeptide group
Other: Ginseng oligopeptide (Ginseng extract）
The experimental group was given ginseng oligopeptide preparation 1.2g per day orally.
Placebo Comparator: The placebo group
Other: Maltodextrin
The control group was treated with placebo maltodextrin 1.2g/d

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alanine aminotransferase (ALT)
Time Frame: The day of enrollment, day 60 and day 120 after enrollment.
Liver function
The day of enrollment, day 60 and day 120 after enrollment.
aspartate aminotransferase (AST)
Time Frame: The day of enrollment, day 60 and day 120 after enrollment.
Liver function
The day of enrollment, day 60 and day 120 after enrollment.
glutamyltransferase (GGT).
Time Frame: The day of enrollment, day 60 and day 120 after enrollment.
Liver function
The day of enrollment, day 60 and day 120 after enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 25, 2023

Primary Completion (Estimated)

December 25, 2024

Study Completion (Estimated)

December 25, 2025

Study Registration Dates

First Submitted

November 29, 2023

First Submitted That Met QC Criteria

December 11, 2023

First Posted (Estimated)

December 13, 2023

Study Record Updates

Last Update Posted (Estimated)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ginseng oligopeptide 1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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