<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/NCT02213549</url>
  </required_header>
  <id_info>
    <org_study_id>eki-996</org_study_id>
    <nct_id>NCT02213549</nct_id>
  </id_info>
  <brief_title>Effect of Coadministration of Ume Paste (Prunus Mume) and Ginger Powder</brief_title>
  <official_title>A Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Determine the Effect of Ume Paste and Ginger Powder in Prediabetic Subjects.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hiroshima University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>KAWAMOTO FOODS CO., LTD.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hiroshima University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to evaluate the effect of ume paste and ginger powder on glucose&#xD;
      metabolism in prediabetic subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in fasting plasma glucose from baseline</measure>
    <time_frame>Every 6 weeks (Overall 12 weeks)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in 2h glucose concentration after the oral glucose tolerance test (OGTT) from baseline</measure>
    <time_frame>Weeks 0 and 12</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in HbA1c from baseline</measure>
    <time_frame>Weeks 0 and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in glycoalbumin from baseline</measure>
    <time_frame>Weeks 0 and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting insulin from baseline</measure>
    <time_frame>Weeks 0 and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in homeostasis model assessment-insulin resistance (HOMA-R) from baseline</measure>
    <time_frame>Weeks 0 and 12</time_frame>
    <description>HOMA-R is calculated as fasting insulin (mU/mL) x fasting glucose (mg/dL) / 405</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum total cholesterol from baseline</measure>
    <time_frame>Every 6 weeks (Overall 12 weeks)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum LDL cholesterol from baseline</measure>
    <time_frame>Every 6 weeks (Overall 12 weeks)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum HDL cholesterol from baseline</measure>
    <time_frame>Every 6 weeks (Overall 12 weeks)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum triglyceride from baseline</measure>
    <time_frame>Every 6 weeks (Overall 12 weeks)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Prediabetes</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>3 placebo capsules/day for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ume paste and ginger powder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 experimental capsules/day for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Ume paste and ginger powder</intervention_name>
    <arm_group_label>Ume paste and ginger powder</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fasting plasma glucose 105-125 mg/dL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Taking anti-diabetic drugs&#xD;
&#xD;
          -  Taking drugs or functional food that may affect blood glucose level&#xD;
&#xD;
          -  Pregnant or nursing a child&#xD;
&#xD;
          -  Participation in any clinical trial within 90 days of the commencement of the trial&#xD;
&#xD;
          -  Renal or hepatic dysfunction&#xD;
&#xD;
          -  Heart disease&#xD;
&#xD;
          -  History of severe disease and/or major surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fumiko Higashikawa, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hiroshima University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hiroshima University</name>
      <address>
        <city>Hiroshima</city>
        <zip>734-8551</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <last_update_submitted>March 17, 2015</last_update_submitted>
  <last_update_submitted_qc>March 17, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 19, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hiroshima University</investigator_affiliation>
    <investigator_full_name>Fumiko Higashikawa</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prediabetic State</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/NCT02213549
org study id: eki-996
nct id: NCT02213549
lead sponsor: 
collaborator: 
has dmc: No
This study is designed to evaluate the effect of ume paste and ginger powder on glucose
      metabolism in prediabetic subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in fasting plasma glucose from baseline
time frame: Every 6 weeks (Overall 12 weeks)
measure: Change in 2h glucose concentration after the oral glucose tolerance test (OGTT) from baseline
time frame: Weeks 0 and 12
measure: Change in HbA1c from baseline
time frame: Weeks 0 and 12
measure: Change in glycoalbumin from baseline
time frame: Weeks 0 and 12
measure: Change in fasting insulin from baseline
time frame: Weeks 0 and 12
measure: Change in homeostasis model assessment-insulin resistance (HOMA-R) from baseline
time frame: Weeks 0 and 12
description: HOMA-R is calculated as fasting insulin (mU/mL) x fasting glucose (mg/dL) / 405
measure: Change in serum total cholesterol from baseline
time frame: Every 6 weeks (Overall 12 weeks)
measure: Change in serum LDL cholesterol from baseline
time frame: Every 6 weeks (Overall 12 weeks)
measure: Change in serum HDL cholesterol from baseline
time frame: Every 6 weeks (Overall 12 weeks)
measure: Change in serum triglyceride from baseline
time frame: Every 6 weeks (Overall 12 weeks)
arm group label: Placebo
arm group type: Placebo Comparator
description: 3 placebo capsules/day for 12 weeks
arm group label: Ume paste and ginger powder
arm group type: Experimental
description: 3 experimental capsules/day for 12 weeks.
intervention type: Dietary Supplement
intervention name: Placebo
arm group label: Placebo
intervention type: Dietary Supplement
intervention name: Ume paste and ginger powder
arm group label: Ume paste and ginger powder
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Fumiko Higashikawa, PhD
role: Principal Investigator
affiliation: Hiroshima University
facility: 
country: Japan
responsible party type: Principal Investigator
investigator affiliation: Hiroshima University
investigator full name: Fumiko Higashikawa
investigator title: Associate Professor
mesh term: Prediabetic State