Effect of Fermented Protaetia Brevitarsis Seulensis Powder on Alcohol-induced Liver Disease

Effect of Fermented Protaetia Brevitarsis Seulensis Powder on Alcohol-induced Liver Disease: a Randomized Controlled Trial

The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Fermented Protaetia brevitarsis seulensis powder on Alcohol-induced Liver Disease in adults for 8 weeks.

Study Overview

• Status: Recruiting
• Conditions: Alcoholic Liver Disease
• Intervention / Treatment: Dietary supplement: Placebo group; Dietary supplement: Fermented Protaetia brevitarsis seulensis powder group

Detailed Description

Previous studies have indicated that Fermented Protaetia brevitarsis seulensis powder may have the ability to improve liver function in adults with alcohol-induced liver disease. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Fermented Protaetia brevitarsis seulensis powder on liver function in adults with alcohol-induced liver disease; the safety of the compound are also evaluate. The Investigators examine gamma-glutamyl transferase, alanine aminotransferase, aspartate aminotransferase, and other metabolic parameters at baseline, as well as after 4 and 8 weeks of intervention. Sixty adults were administered either 4,000 mg of Fermented Protaetia brevitarsis seulensis powder or a placebo each day for 8 weeks.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sang Yeoup Lee, Professor; Phone Number: 055 360-2860; Email: saylee@pnu.edu
• Study Contact Backup: Name: Ye Le Lee; Phone Number: 055 360-2860; Email: yeri1230@gmail.com

Study Locations

• Korea, Republic of
  • Ami-dong
    • Pusan, Ami-dong, Korea, Republic of, 602-739
      • Recruiting
      • Pusan National University Yangsan Hospital
      • Contact: Sang Yeoup Lee, MD; Phone Number: 360 360-1442; Email: saylee@pnu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Gamma-glutamyl transferase ranging from upper limit of reference to four times of upper limit

Exclusion Criteria:

• Abnormal liver or renal function (i.e., serum aminotransferase activity > 3 times of upper limit of reference range and serum creatinine concentrations > 1.2 mg/dL)
• Diabetes (diagnosed clinically or fasting glucose level > 126 mg/dL)
• History of viral hepatitis or cancer
• Uncontrolled hypertension
• History of serious cardiac disease such as angina or myocardial infarction
• History of gastrectomy
• History of medication for psychiatric disease
• Administration of oriental medicine including herbs within the past 4 weeks

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group; This group takes placebo for 8 weeks	Dietary supplement: Placebo group; This group takes placebo for 8 weeks
Experimental: Fermented Protaetia brevitarsis seulensis powder group; This group takes Fermented Protaetia brevitarsis seulensis powder for 8 weeks	Dietary supplement: Fermented Protaetia brevitarsis seulensis powder group; This group takes Fermented Protaetia brevitarsis seulensis powder for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of Gamma-Glutamyl Transpeptidase	Gamma-Glutamyl Transpeptidase	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of Aspartate aminotransferase	Aspartate aminotransferase	8 weeks
Concentration of Alanine aminotransferase	Alanine aminotransferase	8 weeks
Fatigue Severity Scale	Fatigue Severity Scale, minimum~maximum values (1~7), higher scores mean a worse outcome.	8 weeks

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital
• Investigators: Principal Investigator: Sang Yeoup Lee, Professor, Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 21, 2020
• First Submitted That Met QC Criteria: March 21, 2020
• First Posted (Actual): March 24, 2020

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: June 1, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Alcohol-Induced Disorders; Liver Diseases; Liver Diseases, Alcoholic
• Other Study ID Numbers: 02-2018-025

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
• product manufactured in and exported from the U.S.: No