<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/NCT03287115</url>
  </required_header>
  <id_info>
    <org_study_id>HS58</org_study_id>
    <nct_id>NCT03287115</nct_id>
  </id_info>
  <brief_title>Biomarkers of Broccoli Intake: A Pilot Study</brief_title>
  <official_title>Biomarkers of Broccoli Intake: A Pilot Study to Characterize Novel Metabolites by Targeted Metabolic Profiling and Non-Targeted Metabolomics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>USDA Beltsville Human Nutrition Research Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>USDA Beltsville Human Nutrition Research Center</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 objectives of the study are 1) to characterize plasma and urinary metabolites that&#xD;
      originate from glucobrassicin, 1-methoxyglucobrassicin, 4-methoxyglucobrassicin, and&#xD;
      4-hydroxyglucobrassicin, which are the major indole glucosinolates found in broccoli, and 2)&#xD;
      to identify novel plasma and urinary metabolites following broccoli consumption that may have&#xD;
      roles in reducing the risk of cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Consumption of Brassica vegetables is inversely associated with incidence of several cancers,&#xD;
      including cancer of the lung, stomach, liver, colon, rectum, breast, endometrium, and&#xD;
      ovaries. Brassicas are a good source of many nutrients, but the unique characteristic of&#xD;
      Brassicas is their rich content of glucosinolates. Breakdown products of indole&#xD;
      glucosinolates in Brassica vegetables show promise for reducing the risk of cancer, but have&#xD;
      received comparatively less research attention than those of aliphatic glucosinolates. The&#xD;
      aim of this study is to investigate plasma and urinary metabolites of indole glucosinolates&#xD;
      from broccoli and to identify novel metabolites that may have roles in reducing cancer risk.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 6, 2017</start_date>
  <completion_date type="Actual">November 17, 2017</completion_date>
  <primary_completion_date type="Actual">November 17, 2017</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The change in glucosinolate metabolites will be measured in blood plasma and urine.</measure>
    <time_frame>On Day 11</time_frame>
    <description>To track the changes of indole glucosinolate metabolites, glucosinolate metabolites will be measured in both blood plasma and urine.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Broccoli</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will consume a dose of broccoli on day 11</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Broccoli consumption</intervention_name>
    <description>All subjects will eat broccoli on day 11</description>
    <arm_group_label>Broccoli</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non tobacco user&#xD;
&#xD;
          -  Cancer Free&#xD;
&#xD;
          -  Not currently taking glucosinolate/isothiocyanate containing supplements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Type 2 diabetes requiring the use of diabetes pills, insulin, or non-insulin shots&#xD;
&#xD;
          -  Use of blood-thinning medications such as Coumadin (warfarin), Dicumarol, or Miradon&#xD;
             (anisindione)&#xD;
&#xD;
          -  History of bariatric surgery or nutrient malabsorption disease (such as celiac&#xD;
             disease) or other metabolic disorders requiring special diet recommendations&#xD;
&#xD;
          -  Pregnant, lactating, or intending to become pregnant during the study period&#xD;
&#xD;
          -  Crohn's disease or diverticulitis&#xD;
&#xD;
          -  Suspected or known strictures, fistulas or physiological/mechanical GI obstruction&#xD;
&#xD;
          -  Self-report of alcohol or substance abuse within the past 12 months and/or current&#xD;
             acute treatment or rehabilitation program for these problems (long-term participation&#xD;
             in Alcoholics Anonymous is not an exclusion)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>USDA-ARS, Beltsville Human Nutrition Research Center</name>
      <address>
        <city>Beltsville</city>
        <state>Maryland</state>
        <zip>20705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>November 20, 2017</last_update_submitted>
  <last_update_submitted_qc>November 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>USDA Beltsville Human Nutrition Research Center</investigator_affiliation>
    <investigator_full_name>Craig Charron</investigator_full_name>
    <investigator_title>Research Molecular Biologist</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03287115
org study id: HS58
nct id: NCT03287115
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objectives of the study are 1) to characterize plasma and urinary metabolites that
      originate from glucobrassicin, 1-methoxyglucobrassicin, 4-methoxyglucobrassicin, and
      4-hydroxyglucobrassicin, which are the major indole glucosinolates found in broccoli, and 2)
      to identify novel plasma and urinary metabolites following broccoli consumption that may have
      roles in reducing the risk of cancer.
Consumption of Brassica vegetables is inversely associated with incidence of several cancers,
      including cancer of the lung, stomach, liver, colon, rectum, breast, endometrium, and
      ovaries. Brassicas are a good source of many nutrients, but the unique characteristic of
      Brassicas is their rich content of glucosinolates. Breakdown products of indole
      glucosinolates in Brassica vegetables show promise for reducing the risk of cancer, but have
      received comparatively less research attention than those of aliphatic glucosinolates. The
      aim of this study is to investigate plasma and urinary metabolites of indole glucosinolates
      from broccoli and to identify novel metabolites that may have roles in reducing cancer risk.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: The change in glucosinolate metabolites will be measured in blood plasma and urine.
time frame: On Day 11
description: To track the changes of indole glucosinolate metabolites, glucosinolate metabolites will be measured in both blood plasma and urine.
arm group label: Broccoli
arm group type: Experimental
description: Subjects will consume a dose of broccoli on day 11
intervention type: Other
intervention name: Broccoli consumption
description: All subjects will eat broccoli on day 11
arm group label: Broccoli
criteria: 
gender: All
minimum age: 21 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: USDA Beltsville Human Nutrition Research Center
investigator full name: Craig Charron
investigator title: Research Molecular Biologist
sharing ipd: No