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

Alcoholic Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04320199
• Other study ID #: 02-2018-025
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Pusan National University Yangsan Hospital
• Contact: Sang Yeoup Lee, Professor
• Phone: 360-2860
• Email: saylee[@]pnu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcoholic Liver Disease
• Liver Diseases
• Liver Diseases, Alcoholic

Intervention

Dietary Supplement:
• Fermented Protaetia brevitarsis seulensis powder group
This group takes Fermented Protaetia brevitarsis seulensis powder for 8 weeks
• Placebo group
This group takes placebo for 8 weeks

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Yangsan Hospital	Pusan	Ami-dong

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of Gamma-Glutamyl Transpeptidase	Gamma-Glutamyl Transpeptidase	8 weeks
Secondary	Concentration of Aspartate aminotransferase	Aspartate aminotransferase	8 weeks
Secondary	Concentration of Alanine aminotransferase	Alanine aminotransferase	8 weeks
Secondary	Fatigue Severity Scale	Fatigue Severity Scale, minimum~maximum values (1~7), higher scores mean a worse outcome.	8 weeks