Crassostrea Gigas for Liver Health

Not Applicable

• Conditions: Nonalcoholic Fatty Liver
• Interventions: Dietary Supplement: Hydrolyzed oyster extract; Dietary Supplement: Placebo

• Registration Number: NCT02992470
• Lead Sponsor: Korean Medicine Hospital of Pusan National University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-12
• Study Start: 2016-12
• Study First Submitted: 2016-12-12
• Study First Submitted QC: 2016-12-12
• Last Update Submitted: 2016-12-12
• Study First Posted: 2016-12-14
• Last Update Posted: 2016-12-14
• Primary Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydrolyzed oyster extract	Hydrolyzed oyster extract	A 250 mg, film-coated oblong (rectangle) shaped tablet of oyster extract
Placebo	Placebo	A 250 mg, film-coated oblong (rectangle) shaped tablet of maltodextrin

Primary Outcome Measures

Name	Time	Method
Change of serum alanine aminotransferase (ALT)	Baseline, 4 weeks and 8 weeks

Secondary Outcome Measures

Name	Time	Method
Change of serum aspartate aminotransferase (AST)	Baseline, 4 weeks and 8 weeks
Change of gamma-glutamyl transferase (GGT)	Baseline, 4 weeks and 8 weeks
Rate of participants with normalized ALT, AST and GGT	Baseline, 4 weeks and 8 weeks
Change of serum bilirubin	Baseline, 4 weeks and 8 weeks
Change of multi-dimensional fatigue inventory	Baseline, 4 weeks and 8 weeks
Change of serum lipid profiles (triglyceride, total cholesterol, High-density lipoprotein and low-density lipoprotein cholesterol)	Baseline, 4 weeks and 8 weeks
Change of antioxidant enzymes (superoxide dismutase, malondialdehyde, glutathione peroxidase)	Baseline, 4 weeks and 8 weeks