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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Alcoholic Liver Disease

Intervention / Treatment
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* Dietary Supplement: Fermented Protaetia brevitarsis seulensis powder group
* Dietary Supplement: Placebo group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fermented Protaetia brevitarsis seulensis powder group<br>This group takes Fermented Protaetia brevitarsis seulensis powder for 8 weeks | Dietary Supplement: Fermented Protaetia brevitarsis seulensis powder group<br>* This group takes Fermented Protaetia brevitarsis seulensis powder for 8 weeks<br>|
| Placebo Comparator: Placebo group<br>This group takes placebo for 8 weeks | Dietary Supplement: Placebo group<br>* This group takes placebo for 8 weeks<br>|

What is the study measuring?
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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 |