Clinical trial NCT02992470: Crassostrea Gigas for Liver Health
Official title: Hydrolyzed Oyster Extract for Liver Health: a Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nonalcoholic Fatty Liver
Lead sponsor: Korean Medicine Hospital of Pusan National University
Sponsor class: OTHER
First posted: 2016-12-14
Enrollment: 96
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of serum alanine aminotransferase (ALT)
timeFrame: Baseline, 4 weeks and 8 weeks
Secondary outcomes:
measure: Change of serum aspartate aminotransferase (AST)
timeFrame: Baseline, 4 weeks and 8 weeks
measure: Change of gamma-glutamyl transferase (GGT)
timeFrame: Baseline, 4 weeks and 8 weeks
measure: Rate of participants with normalized ALT, AST and GGT
timeFrame: Baseline, 4 weeks and 8 weeks
measure: Change of serum bilirubin
timeFrame: Baseline, 4 weeks and 8 weeks
measure: Change of multi-dimensional fatigue inventory
timeFrame: Baseline, 4 weeks and 8 weeks
measure: Change of serum lipid profiles (triglyceride, total cholesterol, High-density lipoprotein and low-density lipoprotein cholesterol)
timeFrame: Baseline, 4 weeks and 8 weeks
measure: Change of antioxidant enzymes (superoxide dismutase, malondialdehyde, glutathione peroxidase)
timeFrame: Baseline, 4 weeks and 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Korean Medicine Hospital, Pusan National University
name: Jun-Yong Choi
role: PRINCIPAL_INVESTIGATOR
References: