Nonalcoholic Fatty Liver
Conditions
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.
Interventions
DIETARY_SUPPLEMENTPlacebo
1 tablet of maltodextrin t.i.d. for 8 weeks
DIETARY_SUPPLEMENTHydrolyzed oyster extract
1 tablet of oyster extract t.i.d. for 8 weeks
Sponsors
Korean Medicine Hospital of Pusan National University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of serum alanine aminotransferase (ALT) | Baseline, 4 weeks and 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 serum aspartate aminotransferase (AST) | 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 |
| Change of multi-dimensional fatigue inventory | Baseline, 4 weeks and 8 weeks |
Contacts
Primary ContactJun-Yong Choi, PhD, KMD
Outcome results
None listed