<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02992470</url>
  </required_header>
  <id_info>
    <org_study_id>2016_11_Crassostrea gigas</org_study_id>
    <nct_id>NCT02992470</nct_id>
  </id_info>
  <brief_title>Crassostrea Gigas for Liver Health</brief_title>
  <official_title>Hydrolyzed Oyster Extract for Liver Health: a Randomized, Double-blind, Placebo-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Korean Medicine Hospital of Pusan National University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Korean Medicine Hospital of Pusan National University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aimed to observe whether a hydrolyzed oyster extract improves liver health in&#xD;
      participants whose alanine transaminase (ALT) levels are1-3 fold above the normal. A total of&#xD;
      96 participants will be randomly allocated to active (oyster) or placebo group (1:1). Each&#xD;
      group will receive 750 mg of oyster extract or placebo per day for 8 weeks. Primary outcome&#xD;
      will be the change in ALT level and secondary outcomes will be; (1) ratios of participants&#xD;
      with normal ALT, aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT); (2)&#xD;
      the change in serum bilirubin; (3) the change in multi-dimensional fatigue inventory; (4) the&#xD;
      changes in serum lipids; (5) the changes in antioxidant enzymes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of serum alanine aminotransferase (ALT)</measure>
    <time_frame>Baseline, 4 weeks and 8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of serum aspartate aminotransferase (AST)</measure>
    <time_frame>Baseline, 4 weeks and 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of gamma-glutamyl transferase (GGT)</measure>
    <time_frame>Baseline, 4 weeks and 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of participants with normalized ALT, AST and GGT</measure>
    <time_frame>Baseline, 4 weeks and 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of serum bilirubin</measure>
    <time_frame>Baseline, 4 weeks and 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of multi-dimensional fatigue inventory</measure>
    <time_frame>Baseline, 4 weeks and 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of serum lipid profiles (triglyceride, total cholesterol, High-density lipoprotein and low-density lipoprotein cholesterol)</measure>
    <time_frame>Baseline, 4 weeks and 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of antioxidant enzymes (superoxide dismutase, malondialdehyde, glutathione peroxidase)</measure>
    <time_frame>Baseline, 4 weeks and 8 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">96</enrollment>
  <condition>Nonalcoholic Fatty Liver</condition>
  <arm_group>
    <arm_group_label>Hydrolyzed oyster extract</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A 250 mg, film-coated oblong (rectangle) shaped tablet of oyster extract</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A 250 mg, film-coated oblong (rectangle) shaped tablet of maltodextrin</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Hydrolyzed oyster extract</intervention_name>
    <description>1 tablet of oyster extract t.i.d. for 8 weeks</description>
    <arm_group_label>Hydrolyzed oyster extract</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>1 tablet of maltodextrin t.i.d. for 8 weeks</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age over 19&#xD;
&#xD;
          -  AST, ALT, and GGT levels above the upper limit of the normal but less than 3 times the&#xD;
             upper limit of the normal&#xD;
&#xD;
          -  Participants with normal physical activity who sign an informed consent form&#xD;
&#xD;
          -  Fatty liver detected by ultrasound&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergic reaction to oyster&#xD;
&#xD;
          -  Uncontrolled diabetes mellitus&#xD;
&#xD;
          -  Active viral hepatitis and any liver diseases that can affect trial outcomes (positive&#xD;
             for HBs Ag or HCV Ab)&#xD;
&#xD;
          -  Liver cirrhosis of Child-Pugh class B or C&#xD;
&#xD;
          -  Chemotherapy or radiation therapy for cancer within 6 months&#xD;
&#xD;
          -  Cholelithiasis&#xD;
&#xD;
          -  Systemic medications that can affect liver function such as INH, valproic acid,&#xD;
             tetracycline, allopurinol, phenytoin, phenelzine, sertraline, naproxen and diclofenac&#xD;
             within 4 weeks&#xD;
&#xD;
          -  Medication of cholagogues, cholelitholytics &amp; hepatic protectors, antidotes,&#xD;
             detoxifying agents, and drug abuse (drugs used in substance dependence) within 4 weeks&#xD;
&#xD;
          -  Alcoholism or excessive alcohol intake of more than 168 g/week in men and 112 g/week&#xD;
             in women&#xD;
&#xD;
          -  Kidney diseases or serum creatinine level above 2.0 mg/dL&#xD;
&#xD;
          -  Uncontrolled hypertension or angina pectoris or myocardiac infarction&#xD;
&#xD;
          -  History of bowel resection (not including surgery on simple appendicitis)&#xD;
&#xD;
          -  Medication of antipsychotic drugs&#xD;
&#xD;
          -  Herbal medication within 2 months&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  Participation of other clinical trial(s) within 1 months from screening day&#xD;
&#xD;
          -  Uncooperativeness&#xD;
&#xD;
          -  Intake of dietary supplements within 4 weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jun-Yong Choi</last_name>
    <role>Principal Investigator</role>
    <affiliation>Korean Medicine Hospital, Pusan National University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jun-Yong Choi, PhD, KMD</last_name>
    <email>orientdoct@gmail.com</email>
  </overall_contact>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>December 12, 2016</last_update_submitted>
  <last_update_submitted_qc>December 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02992470
org study id: 2016_11_Crassostrea gigas
nct id: NCT02992470
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Investigator)
measure: Change of serum alanine aminotransferase (ALT)
time frame: Baseline, 4 weeks and 8 weeks
measure: Change of serum aspartate aminotransferase (AST)
time frame: Baseline, 4 weeks and 8 weeks
measure: Change of gamma-glutamyl transferase (GGT)
time frame: Baseline, 4 weeks and 8 weeks
measure: Rate of participants with normalized ALT, AST and GGT
time frame: Baseline, 4 weeks and 8 weeks
measure: Change of serum bilirubin
time frame: Baseline, 4 weeks and 8 weeks
measure: Change of multi-dimensional fatigue inventory
time frame: Baseline, 4 weeks and 8 weeks
measure: Change of serum lipid profiles (triglyceride, total cholesterol, High-density lipoprotein and low-density lipoprotein cholesterol)
time frame: Baseline, 4 weeks and 8 weeks
measure: Change of antioxidant enzymes (superoxide dismutase, malondialdehyde, glutathione peroxidase)
time frame: Baseline, 4 weeks and 8 weeks
arm group label: Hydrolyzed oyster extract
arm group type: Experimental
description: A 250 mg, film-coated oblong (rectangle) shaped tablet of oyster extract
arm group label: Placebo
arm group type: Placebo Comparator
description: A 250 mg, film-coated oblong (rectangle) shaped tablet of maltodextrin
intervention type: Dietary Supplement
intervention name: Hydrolyzed oyster extract
description: 1 tablet of oyster extract t.i.d. for 8 weeks
arm group label: Hydrolyzed oyster extract
intervention type: Dietary Supplement
intervention name: Placebo
description: 1 tablet of maltodextrin t.i.d. for 8 weeks
arm group label: Placebo
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jun-Yong Choi
role: Principal Investigator
affiliation: Korean Medicine Hospital, Pusan National University
last name: Jun-Yong Choi, PhD, KMD
email: orientdoct@gmail.com
responsible party type: Sponsor
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease