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

Not Applicable

Recruiting

• Conditions: Alcoholic Liver Disease
• Interventions: Dietary Supplement: Fermented Protaetia brevitarsis seulensis powder group; Dietary Supplement: Placebo group

• Registration Number: NCT04320199
• Lead Sponsor: Pusan National University Yangsan Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-03-21
• Study First Submitted QC: 2020-03-21
• Study First Posted: 2020-03-24
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-07
• Last Update Posted: 2024-04-09
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fermented Protaetia brevitarsis seulensis powder group	Fermented Protaetia brevitarsis seulensis powder group	This group takes Fermented Protaetia brevitarsis seulensis powder for 8 weeks
Placebo group	Placebo group	This group takes placebo for 8 weeks

Primary Outcome Measures

Name	Time	Method
Concentration of Gamma-Glutamyl Transpeptidase	8 weeks	Gamma-Glutamyl Transpeptidase

Secondary Outcome Measures

Name	Time	Method
Concentration of Alanine aminotransferase	8 weeks	Alanine aminotransferase
Concentration of Aspartate aminotransferase	8 weeks	Aspartate aminotransferase
Fatigue Severity Scale	8 weeks	Fatigue Severity Scale, minimum\~maximum values (1\~7), higher scores mean a worse outcome.

Trial Locations

Locations (1)

Pusan National University Yangsan Hospital; 🇰🇷 Pusan, Ami-dong, Korea, Republic of