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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2025-12-31

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.

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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.

Conditions

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Alcoholic Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Fermented Protaetia brevitarsis seulensis powder group

This group takes Fermented Protaetia brevitarsis seulensis powder for 8 weeks

Group Type EXPERIMENTAL

Fermented Protaetia brevitarsis seulensis powder group

Intervention Type DIETARY_SUPPLEMENT

This group takes Fermented Protaetia brevitarsis seulensis powder for 8 weeks

Placebo group

This group takes placebo for 8 weeks

Group Type PLACEBO_COMPARATOR

Placebo group

Intervention Type DIETARY_SUPPLEMENT

This group takes placebo for 8 weeks

Interventions

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Fermented Protaetia brevitarsis seulensis powder group

This group takes Fermented Protaetia brevitarsis seulensis powder for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo group

This group takes placebo for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes