<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/NCT03781011</url>
  </required_header>
  <id_info>
    <org_study_id>201712030RIND</org_study_id>
    <nct_id>NCT03781011</nct_id>
  </id_info>
  <brief_title>Oral Carnitine Challenge Test Guides Personalized Therapy for Cardiovascular Disease</brief_title>
  <official_title>Investigation on Clinical Application of Oral Carnitine Challenge Test as a Guidance of Personalized Therapy for Patients With Cardiovascular Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators plan to use our recently developed oral carnitine challenge test (OCCT) as&#xD;
      a tool to exam individual's trimethylamine N-oxide (TMAO) production capacity from their gut&#xD;
      microbiota. By using data collected by OCCT, the investigators defined subjects as TMAO high&#xD;
      producer or TMAO low producer and apply low carnitine/choline diet as dietary intervention in&#xD;
      accordance. After dietary intervention for two months, the investigators repeated OCCT for&#xD;
      these participants and compare the TMAO production capacity before and after dietary&#xD;
      intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 19, 2018</start_date>
  <completion_date type="Anticipated">October 19, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 19, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>TMAO production capacity of gut microbiota</measure>
    <time_frame>2 months</time_frame>
    <description>TMAO production capacity measurement by OCCT</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index</measure>
    <time_frame>2 months</time_frame>
    <description>BMI (kg/m^2)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Platelet aggregation Assay</measure>
    <time_frame>2 months</time_frame>
    <description>Platelet Aggregation ability (% of maximum amplitude)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Dietary Modification</condition>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>TMAO high producer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low carnitine/choline diet intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TMAO low producer</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Low carnitine/choline diet intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Low carnitine/choline diet habit</intervention_name>
    <description>Patients will received dietary education and supervision by dietician to avoid high carnitine/choline foods including red meat, eggs...etc.</description>
    <arm_group_label>TMAO high producer</arm_group_label>
    <arm_group_label>TMAO low producer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with risks of cardiovascular disease (CAD) or CAD patients proved by coronary&#xD;
             angiography&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt; 20, hx of GI surgery, hx of malignancy, antibiotic or probiotic or carnitine&#xD;
             supplement use within one month, liver cirrhosis, end stage chronic renal disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ming-shiang Wu</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ming-Shiang Wu, MD PhD</last_name>
    <phone>02-23123456</phone>
    <phone_ext>65043</phone_ext>
    <email>mingshiang@ntu.edu.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ming-Shiang Wu</last_name>
      <phone>886-2-23123456</phone>
      <phone_ext>65043</phone_ext>
      <email>mingshiang@ntu.edu.tw</email>
    </contact>
    <investigator>
      <last_name>Ming-shiang Wu, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 17, 2018</last_update_submitted>
  <last_update_submitted_qc>December 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gut microbiota</keyword>
  <keyword>Trimethylamine N-oxide</keyword>
  <keyword>Oral carnitine challenge test</keyword>
  <keyword>Cardiovascular disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Choline</mesh_term>
  </intervention_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/NCT03781011
org study id: 201712030RIND
nct id: NCT03781011
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators plan to use our recently developed oral carnitine challenge test (OCCT) as
      a tool to exam individual's trimethylamine N-oxide (TMAO) production capacity from their gut
      microbiota. By using data collected by OCCT, the investigators defined subjects as TMAO high
      producer or TMAO low producer and apply low carnitine/choline diet as dietary intervention in
      accordance. After dietary intervention for two months, the investigators repeated OCCT for
      these participants and compare the TMAO production capacity before and after dietary
      intervention.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: TMAO production capacity of gut microbiota
time frame: 2 months
description: TMAO production capacity measurement by OCCT
measure: Body Mass Index
time frame: 2 months
description: BMI (kg/m^2)
measure: Platelet aggregation Assay
time frame: 2 months
description: Platelet Aggregation ability (% of maximum amplitude)
arm group label: TMAO high producer
arm group type: Experimental
description: Low carnitine/choline diet intervention
arm group label: TMAO low producer
arm group type: Active Comparator
description: Low carnitine/choline diet intervention
intervention type: Behavioral
intervention name: Low carnitine/choline diet habit
description: Patients will received dietary education and supervision by dietician to avoid high carnitine/choline foods including red meat, eggs...etc.
arm group label: TMAO high producer
arm group label: TMAO low producer
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ming-shiang Wu
role: Principal Investigator
affiliation: National Taiwan University Hospital
last name: Ming-Shiang Wu, MD PhD
phone: 02-23123456
phone ext: 65043
email: mingshiang@ntu.edu.tw
facility: 
status: Recruiting
contact: 
investigator: 
country: Taiwan
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Choline