<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/NCT02999399</url>
  </required_header>
  <id_info>
    <org_study_id>1610M96281</org_study_id>
    <nct_id>NCT02999399</nct_id>
  </id_info>
  <brief_title>Glucobrassicin-Brussel Sprout Effect on D10 Phe Metabolism</brief_title>
  <official_title>Assessing the Effect of Glucobrassicin-Rich Brussels Sprouts on the Metabolism of Deuterated Phenanthrene: Developing Food-Based Chemoprevention of Tobacco-Related Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Masonic Cancer Center, University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Masonic Cancer Center, University of Minnesota</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine whether glucobrassicin-rich Brussels sprouts can favorably modify the metabolism&#xD;
      of the polycyclic aromatic hydrocarbon deuterated phenanthrene ([D10]phe) in current and&#xD;
      former smokers&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will be given 1 microgram of [D10]phe, and all urine will be collected for 6 h&#xD;
      afterwards to quantify baseline levels of [D10]phenanthrene tetraol ([D10]pheT) and&#xD;
      [D10]phenanthrols ([D10]HOP). Within 3 days of this baseline measurement, subjects will&#xD;
      consume 200 micromoles of glucobrassicin in the form of raw Brussels sprouts (~200-300 grams)&#xD;
      at the study center once daily for 7 consecutive days. Urine will be collected for 24 h after&#xD;
      vegetable consumption on days 3 ± 1 and 6 of the feeding intervention for&#xD;
      3,3'-diindolylmethane (DIM) quantification. On day 7 of the feeding intervention, a second&#xD;
      dose of 1 microgram of [D10]phe will be administered at the study center after vegetable&#xD;
      consumption, followed by another 6 h urine collection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2016</start_date>
  <completion_date type="Actual">March 22, 2021</completion_date>
  <primary_completion_date type="Actual">March 22, 2021</primary_completion_date>
  <phase>Phase 1</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>Change in [D10]phenanthrene tetraol</measure>
    <time_frame>7 days</time_frame>
    <description>Compare level of urinary [D10]phenanthrene tetraol before and after 7 days of Brussels sprout consumption.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in [D10]phenanthrols</measure>
    <time_frame>7 days</time_frame>
    <description>Compare level of urinary [D10]phenanthrene phenanthrols before and after 7 days of Brussels sprout consumption.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in [D10]phenanthrene tetraol:[D10]phenanthrol ratio</measure>
    <time_frame>7 days</time_frame>
    <description>Compare level of urinary [D10]phenanthrene phenanthrols before and after 7 days of Brussels sprout consumption.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Urinary 3,3'-diindolylmethane (DIM)</measure>
    <time_frame>Day 3 and Day 6</time_frame>
    <description>Urinary DIM will be quantified after Brussels sprout consumption on day 3 and day 6 of the feeding intervention for urinary DIM quantification</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Smoking</condition>
  <arm_group>
    <arm_group_label>[D10]phe and Brussels sprouts</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects are given 1 microgram [D10]phe before and after consuming Brussels sprouts once daily for 7 consecutive days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Brussel Sprouts</intervention_name>
    <description>Subjects are given ~150 g of Brussels sprouts once daily for 7 consecutive days.</description>
    <arm_group_label>[D10]phe and Brussels sprouts</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Deuterated Phenanthrene</intervention_name>
    <description>Subjects are given 1 microgram of deuterated phenanthrene [D10]phe at baseline and after 7 days of Brussels sprout consumption. Urine is collected for 6 hours after each dose.</description>
    <arm_group_label>[D10]phe and Brussels sprouts</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult ≥ 18 years old&#xD;
&#xD;
          -  Current or former smoker by self-report&#xD;
&#xD;
          -  Willing to abstain from cruciferous vegetable consumption other than the study&#xD;
             vegetable during the study period&#xD;
&#xD;
          -  Able to understand the experimental nature of the study and provide informed consent&#xD;
&#xD;
          -  Negative urine pregnancy test for women of childbearing potential within 7 days of&#xD;
             baseline [D10]phe dosing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic proton pump inhibitor, H2-blocker (i.e., ranitidine, famotidine), and/or&#xD;
             calcium carbonate use&#xD;
&#xD;
          -  History of gastric bypass surgery, gastric banding, bowel resection, malabsorption&#xD;
             syndromes such as celiac sprue or pancreatic insufficiency, or other conditions that&#xD;
             may affect gastric absorption&#xD;
&#xD;
          -  Current use of tobacco products other than cigarettes (i.e. snuff, snuz, smokeless&#xD;
             tobacco, cigars, pipes) or use of these products within 3 months of study registration&#xD;
&#xD;
          -  Major or chronic medical disease, including heart disease, poorly controlled diabetes,&#xD;
             etc., to be adjudicated by the principal investigator&#xD;
&#xD;
          -  Women who are pregnant, intend to become pregnant within 3 months of the study period,&#xD;
             or who are breastfeeding&#xD;
&#xD;
          -  Current or recent (within 12 months) problems with drug use or alcohol dependence by&#xD;
             self-report Antibiotic use within 2 months of study enrollment or during the study by&#xD;
             self-report Alcohol dependence, abuse, or history of dependence/abuse by self-report&#xD;
             Vegetarians&#xD;
&#xD;
          -  History of respiratory tract cancer&#xD;
&#xD;
          -  Use of metronidazole or antabuse during the study&#xD;
&#xD;
          -  Taking ibuprofen, naproxen, other NSAIDs, steroids (except inhaled steroids) within 14&#xD;
             days of study registration&#xD;
&#xD;
          -  Allergy to Brussels sprouts&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Naomi Fujioka, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>February 15, 2023</last_update_submitted>
  <last_update_submitted_qc>February 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Smoker</keyword>
  <keyword>Former smoker</keyword>
  <!-- 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/NCT02999399
org study id: 1610M96281
nct id: NCT02999399
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
To determine whether glucobrassicin-rich Brussels sprouts can favorably modify the metabolism
      of the polycyclic aromatic hydrocarbon deuterated phenanthrene ([D10]phe) in current and
      former smokers
Subjects will be given 1 microgram of [D10]phe, and all urine will be collected for 6 h
      afterwards to quantify baseline levels of [D10]phenanthrene tetraol ([D10]pheT) and
      [D10]phenanthrols ([D10]HOP). Within 3 days of this baseline measurement, subjects will
      consume 200 micromoles of glucobrassicin in the form of raw Brussels sprouts (~200-300 grams)
      at the study center once daily for 7 consecutive days. Urine will be collected for 24 h after
      vegetable consumption on days 3 ± 1 and 6 of the feeding intervention for
      3,3'-diindolylmethane (DIM) quantification. On day 7 of the feeding intervention, a second
      dose of 1 microgram of [D10]phe will be administered at the study center after vegetable
      consumption, followed by another 6 h urine collection.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in [D10]phenanthrene tetraol
time frame: 7 days
description: Compare level of urinary [D10]phenanthrene tetraol before and after 7 days of Brussels sprout consumption.
measure: Change in [D10]phenanthrols
time frame: 7 days
description: Compare level of urinary [D10]phenanthrene phenanthrols before and after 7 days of Brussels sprout consumption.
measure: Change in [D10]phenanthrene tetraol:[D10]phenanthrol ratio
time frame: 7 days
description: Compare level of urinary [D10]phenanthrene phenanthrols before and after 7 days of Brussels sprout consumption.
measure: Urinary 3,3'-diindolylmethane (DIM)
time frame: Day 3 and Day 6
description: Urinary DIM will be quantified after Brussels sprout consumption on day 3 and day 6 of the feeding intervention for urinary DIM quantification
arm group label: [D10]phe and Brussels sprouts
arm group type: Experimental
description: All subjects are given 1 microgram [D10]phe before and after consuming Brussels sprouts once daily for 7 consecutive days.
intervention type: Other
intervention name: Brussel Sprouts
description: Subjects are given ~150 g of Brussels sprouts once daily for 7 consecutive days.
arm group label: [D10]phe and Brussels sprouts
intervention type: Drug
intervention name: Deuterated Phenanthrene
description: Subjects are given 1 microgram of deuterated phenanthrene [D10]phe at baseline and after 7 days of Brussels sprout consumption. Urine is collected for 6 hours after each dose.
arm group label: [D10]phe and Brussels sprouts
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Naomi Fujioka, MD
role: Principal Investigator
affiliation: University of Minnesota
facility: 
country: United States
responsible party type: Sponsor