<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/NCT01707914</url>
  </required_header>
  <id_info>
    <org_study_id>SGU-01</org_study_id>
    <secondary_id>81172655</secondary_id>
    <nct_id>NCT01707914</nct_id>
  </id_info>
  <brief_title>Clinical Investigation on the Effects of Bayberry Juice Treatment in Adult Subjects With Features of Fatty Liver Disease</brief_title>
  <official_title>Effects of Chinese Bayberry Juice on Liver Enzymes and Plasma Antioxidant Activity in Adult Subjects With Features of Fatty Liver Disease: a Randomised Placebo-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shaoguan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shaoguan University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chinese bayberry, one of six Myrica species native to China, is rich in anthocyanins, and&#xD;
      cyanidin-3-O-glucoside (C3G) was identified as a major anthocyanin component. In previous&#xD;
      animal studies from us and other investigators, anthocyanins have been shown to ameliorate&#xD;
      dyslipidemia and hepatic steatosis in different rodent models. The aim of the present study&#xD;
      was to examine the effects of Chinese bayberry juice (CBJ) on the serum lipid profile and on&#xD;
      levels of biomarkers related to antioxidant status in young adults with features of fatty&#xD;
      liver disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma lipids profile</measure>
    <time_frame>Four weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Nonalcoholic Fatty Liver Disease</condition>
  <arm_group>
    <arm_group_label>Chinese bayberry juice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Consume 500 mL CBJ/d (250 mL CBJ twice daily)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Consume 500 mL placebo/d (250 mL placebo twice daily)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Chinese bayberry juice</intervention_name>
    <description>Consume 500 mL CBJ/d (250 mL CBJ twice daily)</description>
    <arm_group_label>Chinese bayberry juice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject inclusion criteria were age 18-25 y,&#xD;
&#xD;
          -  BMI [body weight divided by height squared (in kg/m2)] &gt; 23,&#xD;
&#xD;
          -  lack of excessive alcohol ingestion confirmed by careful questioning by the primary&#xD;
             physician and dietitians (consumption of less than 70 g alcohol in female and 140 g in&#xD;
             male per week), and&#xD;
&#xD;
          -  the presence of two of the three following diagnostic criteria of the fatty liver&#xD;
             disease: increased hepatic echogenicity compared to the spleen or the kidneys,&#xD;
             blurring of liver vasculature and deep attenuation of the ultrasonographic signal.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  overuse of alcohol,&#xD;
&#xD;
          -  viral hepatitis,&#xD;
&#xD;
          -  type 1 or 2 diabetes,&#xD;
&#xD;
          -  gastrointestinal or connective diseases,&#xD;
&#xD;
          -  chronic pancreatitis,&#xD;
&#xD;
          -  liver cirrhosis,&#xD;
&#xD;
          -  kidney stones, or renal failure;&#xD;
&#xD;
          -  use of acetyl-salicylic acid or other antiplatelet drugs, statins of fibrates, oral&#xD;
             hypoglycemic drugs, nitrates, nonsteroidal antiinflammatory drugs, corticosteroids, or&#xD;
             drugs interfering with coagulation;&#xD;
&#xD;
          -  supplementation with vitamins or antioxidants.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wenyi Zhong, MD</last_name>
    <role>Study Director</role>
    <affiliation>Shaoguan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The affiliated hospital of Shaoguan University</name>
      <address>
        <city>Shaoguan</city>
        <state>Guangdong</state>
        <zip>512005</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2012</verification_date>
  <study_first_submitted>October 14, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>December 1, 2012</last_update_submitted>
  <last_update_submitted_qc>December 1, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 4, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>oxidative stress</keyword>
  <keyword>dyslipidemia</keyword>
  <keyword>inflammation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <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/NCT01707914
org study id: SGU-01
secondary id: 81172655
nct id: NCT01707914
lead sponsor: 
has dmc: Yes
Chinese bayberry, one of six Myrica species native to China, is rich in anthocyanins, and
      cyanidin-3-O-glucoside (C3G) was identified as a major anthocyanin component. In previous
      animal studies from us and other investigators, anthocyanins have been shown to ameliorate
      dyslipidemia and hepatic steatosis in different rodent models. The aim of the present study
      was to examine the effects of Chinese bayberry juice (CBJ) on the serum lipid profile and on
      levels of biomarkers related to antioxidant status in young adults with features of fatty
      liver disease.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Plasma lipids profile
time frame: Four weeks
arm group label: Chinese bayberry juice
arm group type: Experimental
description: Consume 500 mL CBJ/d (250 mL CBJ twice daily)
arm group label: Placebo
arm group type: Placebo Comparator
description: Consume 500 mL placebo/d (250 mL placebo twice daily)
intervention type: Dietary Supplement
intervention name: Chinese bayberry juice
description: Consume 500 mL CBJ/d (250 mL CBJ twice daily)
arm group label: Chinese bayberry juice
intervention type: Dietary Supplement
intervention name: placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: No
last name: Wenyi Zhong, MD
role: Study Director
affiliation: Shaoguan University
facility: 
country: China
responsible party type: Sponsor
mesh term: Liver Diseases
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease