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

Study Overview
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Brief Summary
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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.

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

Conditions
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Non-alcoholic Fatty Liver Disease

Intervention / Treatment
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* Other: Ginseng oligopeptide (Ginseng extract）
* Other: Maltodextrin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |