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

Korean Medicine Hospital of Pusan National University0 个研究点目标入组 96 人开始时间: 2016年12月1日最近更新: 2016年12月14日

适应症

试验速览

阶段: 不适用
发起方
入组人数: 96
主要终点: Change of serum alanine aminotransferase (ALT)

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Supportive Care
盲法: Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围: 19 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•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

排除标准

•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

结局指标

主要结局

Change of serum alanine aminotransferase (ALT)

时间窗: Baseline, 4 weeks and 8 weeks

次要结局

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)

研究者

发起方

Korean Medicine Hospital of Pusan National University

申办方类型

Other

责任方

Sponsor

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