xml: <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/NCT05980884</url>
    </required_header>
    <id_info>
      <org_study_id>202303144RINA</org_study_id>
      <nct_id>NCT05980884</nct_id>
    </id_info>
    <brief_title>Evaluation of Microbial-derived TMAO Production From Carnitine Intake by Testing Fecal Bbu Gene</brief_title>
    <official_title>Evaluation of Microbial-derived TMAO Production From Carnitine Intake by Testing Fecal Bbu Gene</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>No</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 risk of cardiovascular diseases from red meat consumption varies among individuals due to&#xD;
        variations in gut microbiota. L-carnitine in red meat can be converted to TMAO in the body by&#xD;
        certain bacteria. Not everyone experiences a significant increase in TMAO levels after&#xD;
        consuming carnitine. Gut microbiota differences are observed between high and low TMAO&#xD;
        producers. The presence of the bbu gene in gut microbiota is linked to TMAO production. This&#xD;
        clinical research aims to determine if the bbu gene can predict TMAO levels after carnitine&#xD;
        intake.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The risk of developing cardiovascular diseases due to the consumption of red meat varies&#xD;
        among individuals, and this may be attributed to differences in the composition and function&#xD;
        of gut microbiota. Studies have found that red meat, rich in L-carnitine, may be metabolized&#xD;
        by certain anaerobic bacteria in the intestines to produce trimethylamine N-oxide (TMAO) in&#xD;
        the human body. Previous research utilizing the oral carnitine challenge test (OCCT) revealed&#xD;
        that not everyone experiences a significant increase in blood TMAO levels after consuming&#xD;
        carnitine. Moreover, individuals with high TMAO production and low TMAO production showed&#xD;
        distinct differences in their gut microbiota.&#xD;
  &#xD;
        Furthermore, we have discovered a significant correlation between the presence of the bbu&#xD;
        gene in gut microbiota and the production of TMAO in response to dietary carnitine intake.&#xD;
        Therefore, through the design of clinical research, we aim to investigate and assess whether&#xD;
        the abundance of the bbu gene in gut microbiota can predict the levels of TMAO produced in&#xD;
        the human body after consuming carnitine.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 24, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Blood TMAO level measured by LC-MS/MS</measure>
      <time_frame>up to 7-10 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Urine TMAO level measured by LC-MS/MS</measure>
      <time_frame>up to 7-10 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Fecal bbuB gene abundance measured by qPCR</measure>
      <time_frame>up to 7-10 days</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Carnitine intake measured by 24hr dietary record</measure>
      <time_frame>up to 7-10 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gut microbiome profiles measured by shotgun metagenome sequencing</measure>
      <time_frame>up to 7-10 days</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Gut Dysbiosis for TMAO Production From L-carnitine Consumption</condition>
    <arm_group>
      <arm_group_label>L-Carnitine supplementation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants are required to take a capsule containing 500mg L-carnitine/day continuous for 7-10 days. During the intervention, participants are asked to collect urine sample and dietary record each day. Blood and fecal samples will be collected before and after the intervention. Each participant needs to complete a food frequency questionnaire.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>L-carnitine</intervention_name>
      <description>Participants are required to take a capsule containing 500mg L-carnitine/day continuous for 7-10 days.</description>
      <arm_group_label>L-Carnitine supplementation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult with age between 18 to 70&#xD;
  &#xD;
            -  Must be able to swallow tablets&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Antibiotics use within one month&#xD;
  &#xD;
            -  L-carnitine supplement use within one month&#xD;
  &#xD;
            -  Chronic diarrhea&#xD;
  &#xD;
            -  Myasthenia gravis&#xD;
  &#xD;
            -  Diabetes mellitus&#xD;
  &#xD;
            -  Parathyroid disorders&#xD;
  &#xD;
            -  Chronic kidney disease&#xD;
  &#xD;
            -  Epilepsy&#xD;
  &#xD;
            -  Severe anemia&#xD;
  &#xD;
            -  Cardiovascular diseases.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Wei-Kai Wu, MD/PhD</last_name>
      <phone>+886958880236</phone>
      <email>weikaiwu0115@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>National Taiwan University Hospital</name>
        <address>
          <city>Taipei</city>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Wei-Kai Wu, MD/PhD</last_name>
        <phone>+886958880236</phone>
        <email>weikaiwu0115@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Wei-Kai Wu, MD/PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</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>Dysbiosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>The data will be uploaded to be public when the research is published</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05980884
  org study id: 202303144RINA
  nct id: NCT05980884
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The risk of cardiovascular diseases from red meat consumption varies among individuals due to
        variations in gut microbiota. L-carnitine in red meat can be converted to TMAO in the body by
        certain bacteria. Not everyone experiences a significant increase in TMAO levels after
        consuming carnitine. Gut microbiota differences are observed between high and low TMAO
        producers. The presence of the bbu gene in gut microbiota is linked to TMAO production. This
        clinical research aims to determine if the bbu gene can predict TMAO levels after carnitine
        intake.
  The risk of developing cardiovascular diseases due to the consumption of red meat varies
        among individuals, and this may be attributed to differences in the composition and function
        of gut microbiota. Studies have found that red meat, rich in L-carnitine, may be metabolized
        by certain anaerobic bacteria in the intestines to produce trimethylamine N-oxide (TMAO) in
        the human body. Previous research utilizing the oral carnitine challenge test (OCCT) revealed
        that not everyone experiences a significant increase in blood TMAO levels after consuming
        carnitine. Moreover, individuals with high TMAO production and low TMAO production showed
        distinct differences in their gut microbiota.
  
        Furthermore, we have discovered a significant correlation between the presence of the bbu
        gene in gut microbiota and the production of TMAO in response to dietary carnitine intake.
        Therefore, through the design of clinical research, we aim to investigate and assess whether
        the abundance of the bbu gene in gut microbiota can predict the levels of TMAO produced in
        the human body after consuming carnitine.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Blood TMAO level measured by LC-MS/MS
  time frame: up to 7-10 days
  measure: Urine TMAO level measured by LC-MS/MS
  time frame: up to 7-10 days
  measure: Fecal bbuB gene abundance measured by qPCR
  time frame: up to 7-10 days
  measure: Carnitine intake measured by 24hr dietary record
  time frame: up to 7-10 days
  measure: Gut microbiome profiles measured by shotgun metagenome sequencing
  time frame: up to 7-10 days
  arm group label: L-Carnitine supplementation
  arm group type: Experimental
  description: Participants are required to take a capsule containing 500mg L-carnitine/day continuous for 7-10 days. During the intervention, participants are asked to collect urine sample and dietary record each day. Blood and fecal samples will be collected before and after the intervention. Each participant needs to complete a food frequency questionnaire.
  intervention type: Dietary Supplement
  intervention name: L-carnitine
  description: Participants are required to take a capsule containing 500mg L-carnitine/day continuous for 7-10 days.
  arm group label: L-Carnitine supplementation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Wei-Kai Wu, MD/PhD
  phone: +886958880236
  email: weikaiwu0115@gmail.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Taiwan
  responsible party type: Sponsor
  mesh term: Dysbiosis
  sharing ipd: No
  ipd description: The data will be uploaded to be public when the research is published