<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/NCT03013465</url>
  </required_header>
  <id_info>
    <org_study_id>HS55</org_study_id>
    <nct_id>NCT03013465</nct_id>
  </id_info>
  <brief_title>Daily Consumption of Well-Cooked Broccoli May Affect Glucosinolate Metabolites and Inflammatory Biomarkers</brief_title>
  <official_title>Daily Consumption of Well-Cooked Broccoli May Affect Glucosinolate Metabolites and Inflammatory Biomarkers</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 determine the influence of daily consumption of&#xD;
      well-cooked broccoli on plasma and urinary glucosinolate metabolites, and 2) to determine&#xD;
      inflammatory marker changes consistent with decreased cancer risk.&#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. Brassica vegetables are a good source of many nutrients, but the unique&#xD;
      characteristic of Brassicas (Broccoli in particular) is their rich content of glucosinolates.&#xD;
      Glucosinolates are sulfur-containing compounds that are converted to isothiocyanates (ITC) by&#xD;
      an enzyme in the plant called myrosinase, which is released when the vesicles containing&#xD;
      myrosinase are ruptured by chewing or cutting. The isothiocyanates are considered to be the&#xD;
      active agent for cancer prevention. Some of the mechanisms by which isothiocyanates likely&#xD;
      inhibit cancer include modulation of cytochrome P450 enzymes, induction of phase II enzymes,&#xD;
      and apoptosis.&#xD;
&#xD;
      The aim of this study is to investigate how daily consumption of broccoli with myrosinase&#xD;
      inactivated by cooking influences glucosinolate metabolism and absorption, and consequent&#xD;
      regulation of inflammatory markers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 27, 2017</start_date>
  <completion_date type="Actual">May 19, 2017</completion_date>
  <primary_completion_date type="Actual">May 19, 2017</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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The change in glucosinolate metabolites will be measured in blood plasma and urine</measure>
    <time_frame>At end of diet period 1 (week 3) and at the end of diet period 2 (week 12)</time_frame>
    <description>To track the change of endogenous broccoli isothiocyanates in this crossover study, glucosinolate metabolites will be measured in both blood plasma and urine</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body composition will be determined by dual energy x-ray absorptiometry (DEXA)</measure>
    <time_frame>Day 0, just prior to beginning the controlled diet</time_frame>
    <description>Determine fat, lean, and bone mineral mass, and visceral fat deposition in our subjects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The ability of fecal microbiota to metabolize glucosinolates will be determined</measure>
    <time_frame>once per week during diet periods 1 and 2 (weeks 1, 2, 3, 10, 11, and 12)</time_frame>
    <description>Fecal samples will be presented with glucoraphanin to determine the ability of fecal microbes to metabolize it</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fecal microbiota will be analyzed for microbial DNA</measure>
    <time_frame>once at the beginning and end of diet periods 1 and 2 (weeks 1, 3, 10, and 12)</time_frame>
    <description>Fecal microbial communities will be determined using DNA extracted from fecal samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Markers of gut health will be analyzed in blood</measure>
    <time_frame>once in the third week of diet periods 1 and 2 (weeks 3 and 12)</time_frame>
    <description>Zonulin in blood serum will be measured by ELISA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Markers of inflammation will be measured in blood</measure>
    <time_frame>at end of diet period 1 (week 3) and at end of diet period 2 (week 12)</time_frame>
    <description>Cytokines and acute phase proteins will be measured in blood</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Control Diet</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants will receive a controlled diet (base diet), typical of an American diet, with 0 g/day of broccoli (control).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Brassica Diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive a controlled diet with 100 g of broccoli at both breakfast and dinner daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control Diet</intervention_name>
    <description>Participants will receive a controlled diet with 0 g/d of broccoli. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet.</description>
    <arm_group_label>Control Diet</arm_group_label>
    <other_name>Base Diet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Base Diet with Broccoli</intervention_name>
    <description>Participants will receive a controlled diet with 100 g of broccoli at both breakfast and dinner daily. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet.</description>
    <arm_group_label>Brassica Diet</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;
             (anisinidione)&#xD;
&#xD;
          -  History of bariatric surgery or nutrient malabsorption disease&#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>May 2017</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>May 23, 2017</last_update_submitted>
  <last_update_submitted_qc>May 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 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/NCT03013465
org study id: HS55
nct id: NCT03013465
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objectives of the study are 1) to determine the influence of daily consumption of
      well-cooked broccoli on plasma and urinary glucosinolate metabolites, and 2) to determine
      inflammatory marker changes consistent with decreased cancer risk.
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. Brassica vegetables are a good source of many nutrients, but the unique
      characteristic of Brassicas (Broccoli in particular) is their rich content of glucosinolates.
      Glucosinolates are sulfur-containing compounds that are converted to isothiocyanates (ITC) by
      an enzyme in the plant called myrosinase, which is released when the vesicles containing
      myrosinase are ruptured by chewing or cutting. The isothiocyanates are considered to be the
      active agent for cancer prevention. Some of the mechanisms by which isothiocyanates likely
      inhibit cancer include modulation of cytochrome P450 enzymes, induction of phase II enzymes,
      and apoptosis.

      The aim of this study is to investigate how daily consumption of broccoli with myrosinase
      inactivated by cooking influences glucosinolate metabolism and absorption, and consequent
      regulation of inflammatory markers.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
measure: The change in glucosinolate metabolites will be measured in blood plasma and urine
time frame: At end of diet period 1 (week 3) and at the end of diet period 2 (week 12)
description: To track the change of endogenous broccoli isothiocyanates in this crossover study, glucosinolate metabolites will be measured in both blood plasma and urine
measure: Body composition will be determined by dual energy x-ray absorptiometry (DEXA)
time frame: Day 0, just prior to beginning the controlled diet
description: Determine fat, lean, and bone mineral mass, and visceral fat deposition in our subjects
measure: The ability of fecal microbiota to metabolize glucosinolates will be determined
time frame: once per week during diet periods 1 and 2 (weeks 1, 2, 3, 10, 11, and 12)
description: Fecal samples will be presented with glucoraphanin to determine the ability of fecal microbes to metabolize it
measure: Fecal microbiota will be analyzed for microbial DNA
time frame: once at the beginning and end of diet periods 1 and 2 (weeks 1, 3, 10, and 12)
description: Fecal microbial communities will be determined using DNA extracted from fecal samples
measure: Markers of gut health will be analyzed in blood
time frame: once in the third week of diet periods 1 and 2 (weeks 3 and 12)
description: Zonulin in blood serum will be measured by ELISA
measure: Markers of inflammation will be measured in blood
time frame: at end of diet period 1 (week 3) and at end of diet period 2 (week 12)
description: Cytokines and acute phase proteins will be measured in blood
arm group label: Control Diet
arm group type: Other
description: Participants will receive a controlled diet (base diet), typical of an American diet, with 0 g/day of broccoli (control).
arm group label: Brassica Diet
arm group type: Active Comparator
description: Participants will receive a controlled diet with 100 g of broccoli at both breakfast and dinner daily.
intervention type: Other
intervention name: Control Diet
description: Participants will receive a controlled diet with 0 g/d of broccoli. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet.
arm group label: Control Diet
other name: Base Diet
intervention type: Other
intervention name: Base Diet with Broccoli
description: Participants will receive a controlled diet with 100 g of broccoli at both breakfast and dinner daily. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet.
arm group label: Brassica Diet
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