Crassostrea Gigas for Liver Health
Primary Purpose
Nonalcoholic Fatty Liver
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hydrolyzed oyster extract
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Nonalcoholic Fatty Liver
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Hydrolyzed oyster extract
Placebo
Arm Description
A 250 mg, film-coated oblong (rectangle) shaped tablet of oyster extract
A 250 mg, film-coated oblong (rectangle) shaped tablet of maltodextrin
Outcomes
Primary Outcome Measures
Change of serum alanine aminotransferase (ALT)
Secondary Outcome Measures
Change of serum aspartate aminotransferase (AST)
Change of gamma-glutamyl transferase (GGT)
Rate of participants with normalized ALT, AST and GGT
Change of serum bilirubin
Change of multi-dimensional fatigue inventory
Change of serum lipid profiles (triglyceride, total cholesterol, High-density lipoprotein and low-density lipoprotein cholesterol)
Change of antioxidant enzymes (superoxide dismutase, malondialdehyde, glutathione peroxidase)
Full Information
NCT ID
NCT02992470
First Posted
December 12, 2016
Last Updated
December 12, 2016
Sponsor
Korean Medicine Hospital of Pusan National University
1. Study Identification
Unique Protocol Identification Number
NCT02992470
Brief Title
Crassostrea Gigas for Liver Health
Official Title
Hydrolyzed Oyster Extract for Liver Health: a Randomized, Double-blind, Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Korean Medicine Hospital of Pusan National University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Fatty Liver
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hydrolyzed oyster extract
Arm Type
Experimental
Arm Description
A 250 mg, film-coated oblong (rectangle) shaped tablet of oyster extract
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
A 250 mg, film-coated oblong (rectangle) shaped tablet of maltodextrin
Intervention Type
Dietary Supplement
Intervention Name(s)
Hydrolyzed oyster extract
Intervention Description
1 tablet of oyster extract t.i.d. for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
1 tablet of maltodextrin t.i.d. for 8 weeks
Primary Outcome Measure Information:
Title
Change of serum alanine aminotransferase (ALT)
Time Frame
Baseline, 4 weeks and 8 weeks
Secondary Outcome Measure Information:
Title
Change of serum aspartate aminotransferase (AST)
Time Frame
Baseline, 4 weeks and 8 weeks
Title
Change of gamma-glutamyl transferase (GGT)
Time Frame
Baseline, 4 weeks and 8 weeks
Title
Rate of participants with normalized ALT, AST and GGT
Time Frame
Baseline, 4 weeks and 8 weeks
Title
Change of serum bilirubin
Time Frame
Baseline, 4 weeks and 8 weeks
Title
Change of multi-dimensional fatigue inventory
Time Frame
Baseline, 4 weeks and 8 weeks
Title
Change of serum lipid profiles (triglyceride, total cholesterol, High-density lipoprotein and low-density lipoprotein cholesterol)
Time Frame
Baseline, 4 weeks and 8 weeks
Title
Change of antioxidant enzymes (superoxide dismutase, malondialdehyde, glutathione peroxidase)
Time Frame
Baseline, 4 weeks and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun-Yong Choi, PhD, KMD
Email
orientdoct@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun-Yong Choi
Organizational Affiliation
Korean Medicine Hospital, Pusan National University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Crassostrea Gigas for Liver Health
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