Alcoholic Liver Disease
Conditions
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.
Interventions
DIETARY_SUPPLEMENTFermented Protaetia brevitarsis seulensis powder group
This group takes Fermented Protaetia brevitarsis seulensis powder for 8 weeks
DIETARY_SUPPLEMENTPlacebo group
This group takes placebo for 8 weeks
Sponsors
Pusan National University Yangsan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of Gamma-Glutamyl Transpeptidase | 8 weeks | Gamma-Glutamyl Transpeptidase |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of Aspartate aminotransferase | 8 weeks | Aspartate aminotransferase |
| Concentration of Alanine aminotransferase | 8 weeks | Alanine aminotransferase |
| Fatigue Severity Scale | 8 weeks | Fatigue Severity Scale, minimum\ maximum values (1\ 7), higher scores mean a worse outcome. |
Countries
South Korea
Contacts
Primary ContactSang Yeoup Lee, Professor
Backup ContactYe Le Lee
Outcome results
None listed