Crassostrea Gigas for Liver Health
Not Applicable
- Conditions
- Nonalcoholic Fatty Liver
- 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
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
- 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