Crassostrea Gigas for Liver Health

Nonalcoholic Fatty Liver Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02992470
• Other study ID #: 2016_11_Crassostrea gigas
• Status: Not yet recruiting
• Phase: N/A
• First received: December 12, 2016
• Last updated: December 12, 2016
• Start date: December 2016

Study information

• Verified date: December 2016
• Source: Korean Medicine Hospital of Pusan National University
• Contact: Jun-Yong Choi, PhD, KMD
• Email: orientdoct[@]gmail.com
• Is FDA regulated: No
• Health authority: Ministry of Food and Drug Safety: Republic of Korea
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver

Intervention

Dietary Supplement:
• Hydrolyzed oyster extract
1 tablet of oyster extract t.i.d. for 8 weeks
• Placebo
1 tablet of maltodextrin t.i.d. for 8 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Korean Medicine Hospital of Pusan National University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of serum alanine aminotransferase (ALT)		Baseline, 4 weeks and 8 weeks	No
Secondary	Change of serum aspartate aminotransferase (AST)		Baseline, 4 weeks and 8 weeks	No
Secondary	Change of gamma-glutamyl transferase (GGT)		Baseline, 4 weeks and 8 weeks	No
Secondary	Rate of participants with normalized ALT, AST and GGT		Baseline, 4 weeks and 8 weeks	No
Secondary	Change of serum bilirubin		Baseline, 4 weeks and 8 weeks	No
Secondary	Change of multi-dimensional fatigue inventory		Baseline, 4 weeks and 8 weeks	No
Secondary	Change of serum lipid profiles (triglyceride, total cholesterol, High-density lipoprotein and low-density lipoprotein cholesterol)		Baseline, 4 weeks and 8 weeks	No
Secondary	Change of antioxidant enzymes (superoxide dismutase, malondialdehyde, glutathione peroxidase)		Baseline, 4 weeks and 8 weeks	No