Crassostrea Gigas for Liver Health

Study Overview
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Brief Summary
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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.

Official Title
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Hydrolyzed Oyster Extract for Liver Health: a Randomized, Double-blind, Placebo-controlled Trial

Conditions
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Nonalcoholic Fatty Liver

Intervention / Treatment
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* Dietary Supplement: Hydrolyzed oyster extract
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydrolyzed oyster extract<br>A 250 mg, film-coated oblong (rectangle) shaped tablet of oyster extract | Dietary Supplement: Hydrolyzed oyster extract<br>* 1 tablet of oyster extract t.i.d. for 8 weeks<br>|
| Placebo Comparator: Placebo<br>A 250 mg, film-coated oblong (rectangle) shaped tablet of maltodextrin | Dietary Supplement: Placebo<br>* 1 tablet of maltodextrin t.i.d. for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of serum alanine aminotransferase (ALT) |  | Baseline, 4 weeks and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |