Crassostrea Gigas for Liver Health

Korean Medicine Hospital of Pusan National University

Status: Unknown

Conditions: Nonalcoholic Fatty Liver

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Hydrolyzed oyster extract

Study type: Interventional

Funder types: Other

Identifiers

NCT02992470

2016_11_Crassostrea gigas

Details and patient eligibility

About

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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96 participants in 2 patient groups, including a placebo group

Hydrolyzed oyster extract

Experimental group

Description:

A 250 mg, film-coated oblong (rectangle) shaped tablet of oyster extract

Treatment:

Dietary Supplement: Hydrolyzed oyster extract

Placebo

Placebo Comparator group

Description:

A 250 mg, film-coated oblong (rectangle) shaped tablet of maltodextrin

Treatment:

Dietary Supplement: Placebo