<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/NCT03773497</url>
  </required_header>
  <id_info>
    <org_study_id>HS63 - Broccoli Snack Study</org_study_id>
    <nct_id>NCT03773497</nct_id>
  </id_info>
  <brief_title>Bioavailability of Phytonutrients From Novel Preparations of Broccoli</brief_title>
  <official_title>Bioavailability of Phytonutrients From Novel Preparations of Broccoli</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 primary objective of this study is to determine the effects of different methods of&#xD;
      broccoli preparation on levels of urinary glucosinolate metabolites. The secondary objective&#xD;
      is to determine the effects of different methods of broccoli preparation on levels of plasma&#xD;
      carotenoids.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Consumption of Brassica vegetables (which include broccoli, cabbage, and kale) is inversely&#xD;
      associated with the incidence of several cancers, including cancers of the lung, stomach,&#xD;
      liver, colon, rectum, breast, endometrium, and ovaries. Brassica vegetables are a good source&#xD;
      of many nutrients including glucosinolates and carotenoids. Glucosinolates are&#xD;
      sulfur-containing compounds that are converted to bioactive metabolites by an enzyme called&#xD;
      myrosinase, which is released when the vesicles containing myrosinase are ruptured by chewing&#xD;
      or cutting. These bioactive compounds are considered to be active agents for cancer&#xD;
      prevention. Their ability to reduce risk of cancer may derive in part from their ability to&#xD;
      modulate foreign-substance metabolizing enzymes, which include enzymes called Phase I&#xD;
      cytochrome P450s and Phase II enzymes. Carotenoids may also have a role in cancer prevention&#xD;
      and other health benefits including reducing age-related macular degeneration, and therefore&#xD;
      merit research to reveal factors that affect their presence in the body.&#xD;
&#xD;
      The primary aim of this study is to investigate how various preparations of broccoli impact&#xD;
      levels of these healthful nutrients in humans.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 16, 2019</start_date>
  <completion_date type="Actual">June 28, 2019</completion_date>
  <primary_completion_date type="Actual">June 28, 2019</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>Other</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glucosinolate Metabolites will be measured</measure>
    <time_frame>Day 1</time_frame>
    <description>Urine will be analyzed for glucosinolate metabolites</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glucosinolate Metabolites will be measured</measure>
    <time_frame>Day 22</time_frame>
    <description>Urine will be analyzed for glucosinolate metabolites</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glucosinolate Metabolites will be measured</measure>
    <time_frame>Day 43</time_frame>
    <description>Urine will be analyzed for glucosinolate metabolites</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glucosinolate Metabolites will be measured</measure>
    <time_frame>Day 64</time_frame>
    <description>Urine will be analyzed for glucosinolate metabolites</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Carotenoids will be measured</measure>
    <time_frame>Days 1, 2, 3, 4, 11, 22, 23, 24, 25, 32, 43, 44, 45, 46, 53, 64, 65, 66, 67, 74</time_frame>
    <description>Carotenoids will be extracted from plasma</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Common snack combination</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects will consume a self-chosen, low-carotenoid diet, and on the first day, with breakfast, will consume a snack of a combination of common snack foods (pretzels, potato chips, and popcorn).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cheese broccoli</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects will consume a self-chosen, low-carotenoid diet, and on the first day, with breakfast, will consume a snack of oven-roasted, freeze-dried, cheese flavored broccoli.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cheese broccoli with Daikon radish powder</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects will consume a self-chosen, low-carotenoid diet, and on the first day, with breakfast, will consume a snack of oven-roasted, freeze-dried, cheese flavored broccoli with Daikon radish powder.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Uncooked broccoli with ranch-type dip</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects will consume a self-chosen, low-carotenoid diet, and on the first day, with breakfast, will consume a snack of uncooked, freeze-dried broccoli with ranch-type dip.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Common Snack Combination</intervention_name>
    <description>Combination of Chips, Pretzels, and Popcorn.</description>
    <arm_group_label>Common snack combination</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cheesy Broccoli Snack</intervention_name>
    <description>Oven-roasted, freeze-dried, cheese flavored broccoli</description>
    <arm_group_label>Cheese broccoli</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cheesy Broccoli with Daikon Radish Snack</intervention_name>
    <description>Oven-roasted, freeze-dried, cheese flavored broccoli with Daikon radish powder</description>
    <arm_group_label>Cheese broccoli with Daikon radish powder</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Uncooked Broccoli Snack</intervention_name>
    <description>Uncooked, freeze-dried broccoli with ranch-type dip</description>
    <arm_group_label>Uncooked broccoli with ranch-type dip</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between 21 and 75 years old at beginning of study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant, lactating, or intending to become pregnant during the study period&#xD;
&#xD;
          -  Women who have given birth during the previous 12 months&#xD;
&#xD;
          -  Presence of kidney disease, liver disease, gout, certain cancers, gastrointestinal&#xD;
             disease, hyperthyroidism, untreated or unstable hypothyroidism, pancreatic disease,&#xD;
             other metabolic diseases, or malabsorption syndromes requiring special diets&#xD;
&#xD;
          -  History of certain cancers within last 3 years&#xD;
&#xD;
          -  Known allergy or intolerance to Brassica vegetables&#xD;
&#xD;
          -  History of eating disorders or other dietary patterns which are not consistent with&#xD;
             the dietary intervention (e.g., vegetarians, very low-fat diets, high-protein diets)&#xD;
&#xD;
          -  Colonoscopy during three weeks prior to start of study&#xD;
&#xD;
          -  Unwillingness to abstain from probiotics or vitamin, mineral, herbal and&#xD;
             glucosinolate/isothiocyanate supplements for two weeks prior to the study and during&#xD;
             the study&#xD;
&#xD;
          -  Use of tobacco products within 6 months preceding study&#xD;
&#xD;
          -  Crohn's disease or diverticulitis&#xD;
&#xD;
          -  Suspected or known strictures, fistulas or physiological/mechanical GI obstruction&#xD;
&#xD;
          -  Use of certain medications (prescription or over-the-counter) that may interfere with&#xD;
             the study objectives&#xD;
&#xD;
          -  Type 2 diabetes requiring the use of diabetes pills, insulin, or non-insulin shots&#xD;
&#xD;
          -  Fasting glucose greater than or equal to 126 mg/dL&#xD;
&#xD;
          -  Unable or unwilling to give informed consent or communicate with study staff&#xD;
&#xD;
          -  Self-report of alcohol or substance abuse within the past 12 months and/or current&#xD;
             treatment for these problems (long-term participation in Alcoholics Anonymous is not&#xD;
             an exclusion)&#xD;
&#xD;
          -  Other medical, psychiatric, or behavioral factors that in the judgment of the&#xD;
             Principal Investigator may interfere with study participation or the ability to follow&#xD;
             the intervention protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>75 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>August 2019</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>August 30, 2019</last_update_submitted>
  <last_update_submitted_qc>August 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 3, 2019</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/NCT03773497
org study id: HS63 - Broccoli Snack Study
nct id: NCT03773497
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective of this study is to determine the effects of different methods of
      broccoli preparation on levels of urinary glucosinolate metabolites. The secondary objective
      is to determine the effects of different methods of broccoli preparation on levels of plasma
      carotenoids.
Consumption of Brassica vegetables (which include broccoli, cabbage, and kale) is inversely
      associated with the incidence of several cancers, including cancers of the lung, stomach,
      liver, colon, rectum, breast, endometrium, and ovaries. Brassica vegetables are a good source
      of many nutrients including glucosinolates and carotenoids. Glucosinolates are
      sulfur-containing compounds that are converted to bioactive metabolites by an enzyme called
      myrosinase, which is released when the vesicles containing myrosinase are ruptured by chewing
      or cutting. These bioactive compounds are considered to be active agents for cancer
      prevention. Their ability to reduce risk of cancer may derive in part from their ability to
      modulate foreign-substance metabolizing enzymes, which include enzymes called Phase I
      cytochrome P450s and Phase II enzymes. Carotenoids may also have a role in cancer prevention
      and other health benefits including reducing age-related macular degeneration, and therefore
      merit research to reveal factors that affect their presence in the body.

      The primary aim of this study is to investigate how various preparations of broccoli impact
      levels of these healthful nutrients in humans.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Double (Investigator, Outcomes Assessor)
measure: Glucosinolate Metabolites will be measured
time frame: Day 1
description: Urine will be analyzed for glucosinolate metabolites
measure: Glucosinolate Metabolites will be measured
time frame: Day 22
description: Urine will be analyzed for glucosinolate metabolites
measure: Glucosinolate Metabolites will be measured
time frame: Day 43
description: Urine will be analyzed for glucosinolate metabolites
measure: Glucosinolate Metabolites will be measured
time frame: Day 64
description: Urine will be analyzed for glucosinolate metabolites
measure: Carotenoids will be measured
time frame: Days 1, 2, 3, 4, 11, 22, 23, 24, 25, 32, 43, 44, 45, 46, 53, 64, 65, 66, 67, 74
description: Carotenoids will be extracted from plasma
arm group label: Common snack combination
arm group type: Other
description: Subjects will consume a self-chosen, low-carotenoid diet, and on the first day, with breakfast, will consume a snack of a combination of common snack foods (pretzels, potato chips, and popcorn).
arm group label: Cheese broccoli
arm group type: Other
description: Subjects will consume a self-chosen, low-carotenoid diet, and on the first day, with breakfast, will consume a snack of oven-roasted, freeze-dried, cheese flavored broccoli.
arm group label: Cheese broccoli with Daikon radish powder
arm group type: Other
description: Subjects will consume a self-chosen, low-carotenoid diet, and on the first day, with breakfast, will consume a snack of oven-roasted, freeze-dried, cheese flavored broccoli with Daikon radish powder.
arm group label: Uncooked broccoli with ranch-type dip
arm group type: Other
description: Subjects will consume a self-chosen, low-carotenoid diet, and on the first day, with breakfast, will consume a snack of uncooked, freeze-dried broccoli with ranch-type dip.
intervention type: Other
intervention name: Common Snack Combination
description: Combination of Chips, Pretzels, and Popcorn.
arm group label: Common snack combination
intervention type: Other
intervention name: Cheesy Broccoli Snack
description: Oven-roasted, freeze-dried, cheese flavored broccoli
arm group label: Cheese broccoli
intervention type: Other
intervention name: Cheesy Broccoli with Daikon Radish Snack
description: Oven-roasted, freeze-dried, cheese flavored broccoli with Daikon radish powder
arm group label: Cheese broccoli with Daikon radish powder
intervention type: Other
intervention name: Uncooked Broccoli Snack
description: Uncooked, freeze-dried broccoli with ranch-type dip
arm group label: Uncooked broccoli with ranch-type dip
criteria: 
gender: All
minimum age: 21 Years
maximum age: 75 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