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

Sponsor
Pusan National University Yangsan Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04320199
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
12
Actual Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Fermented Protaetia brevitarsis seulensis powder group
  • Dietary Supplement: Placebo group
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Effect of Fermented Protaetia Brevitarsis Seulensis Powder on Alcohol-induced Liver Disease: a Randomized Controlled Trial
Actual Study Start Date :
Jan 1, 2020
Actual Primary Completion Date :
Dec 30, 2020
Actual Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
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
Placebo Comparator: Placebo group

This group takes placebo for 8 weeks

Dietary Supplement: Placebo group
This group takes placebo for 8 weeks

Outcome Measures

Primary Outcome Measures

  1. Concentration of Gamma-Glutamyl Transpeptidase [8 weeks]

    Gamma-Glutamyl Transpeptidase

Secondary Outcome Measures

  1. Concentration of Aspartate aminotransferase [8 weeks]

    Aspartate aminotransferase

  2. Concentration of Alanine aminotransferase [8 weeks]

    Alanine aminotransferase

  3. Fatigue Severity Scale [8 weeks]

    Fatigue Severity Scale, minimum~maximum values (1~7), higher scores mean a worse outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pusan National University Yangsan Hospital Pusan Ami-dong Korea, Republic of 602-739

Sponsors and Collaborators

  • Pusan National University Yangsan Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sang Yeoup Lee, Professor, Pusan National University Yangsan Hospital
ClinicalTrials.gov Identifier:
NCT04320199
Other Study ID Numbers:
  • 02-2018-025
First Posted:
Mar 24, 2020
Last Update Posted:
Apr 28, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Liver Diseases
Liver Diseases, Alcoholic

Study Results

No Results Posted as of Apr 28, 2021