Crassostrea Gigas for Liver Health

Korean Medicine Hospital of Pusan National University96 enrolled

Overview

This study aimed to observe whether a hydrolyzed oyster extract improves liver health in participants whose alanine transaminase (ALT) levels are1-3 fold above the normal. A total of 96 participants will be randomly allocated to active (oyster) or placebo group (1:1). Each group will receive 750 mg of oyster extract or placebo per day for 8 weeks. Primary outcome will be the change in ALT level and secondary outcomes will be; (1) ratios of participants with normal ALT, aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT); (2) the change in serum bilirubin; (3) the change in multi-dimensional fatigue inventory; (4) the changes in serum lipids; (5) the changes in antioxidant enzymes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Nonalcoholic Fatty Liver

Interventions

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age over 19 * AST, ALT, and GGT levels above the upper limit of the normal but less than 3 times the upper limit of the normal * Participants with normal physical activity who sign an informed consent form * Fatty liver detected by ultrasound Exclusion Criteria: * Allergic reaction to oyster * Uncontrolled diabetes mellitus * Active viral hepatitis and any liver diseases that can affect trial outcomes (positive for HBs Ag or HCV Ab) * Liver cirrhosis of Child-Pugh class B or C * Chemotherapy or radiation therapy for cancer within 6 months * Cholelithiasis * Systemic medications that can affect liver function such as INH, valproic acid, tetracycline, allopurinol, phenytoin, phenelzine, sertraline, naproxen and diclofenac within 4 weeks * Medication of cholagogues, cholelitholytics \& hepatic protectors, antidotes, detoxifying agents, and drug abuse (drugs used in substance dependence) within 4 weeks * Alcoholism or excessive alcohol intake of more than 168 g/week in men and 112 g/week in women * Kidney diseases or serum creatinine level above 2.0 mg/dL * Uncontrolled hypertension or angina pectoris or myocardiac infarction * History of bowel resection (not including surgery on simple appendicitis) * Medication of antipsychotic drugs * Herbal medication within 2 months * Pregnancy or breastfeeding * Participation of other clinical trial(s) within 1 months from screening day * Uncooperativeness * Intake of dietary supplements within 4 weeks