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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
Korean Medicine Hospital of Pusan National University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nonalcoholic Fatty Liver

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    December 12, 2016
    Last Updated
    December 12, 2016
    Sponsor
    Korean Medicine Hospital of Pusan National University
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    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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