<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/NCT01726127</url>
  </required_header>
  <id_info>
    <org_study_id>2011-0872</org_study_id>
    <nct_id>NCT01726127</nct_id>
  </id_info>
  <brief_title>Green Vegetables and Women's Health</brief_title>
  <official_title>Effect of Cruciferous Vegetables or a Cruciferous Supplement on Urinary Estrogen Metabolites in Premenopausal Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Standard Process Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The 2010 Dietary Guidelines for Americans recommend that individuals consume 4.5 to 5 cups&#xD;
      fruits and vegetables daily. However, at current intake levels, fruit consumption will have&#xD;
      to improve by more than 100% and vegetable intake by 50% to meet this recommendation.&#xD;
      Importantly, intake of brightly colored fruits and vegetables is even lower when potatoes are&#xD;
      not considered. It is possible that improved fruit and vegetable intake will have beneficial&#xD;
      health effects. For example, higher intakes of fruits and vegetables, and particularly&#xD;
      cruciferous vegetables (e.g., broccoli, Brussels sprouts, cauliflower, etc.), are associated&#xD;
      with lower rates of many degenerative diseases, including some cancers, yet this group of&#xD;
      vegetables may continue to be under-consumed due to their strong flavors. A supplement made&#xD;
      from these vegetables (Cruciferous CompleteTM made by Standard Process Inc. Palmyra, WI)&#xD;
      contains a group of phytochemicals called glucosinolates that can shift estrogen metabolism&#xD;
      in a favorable way. One proposed biomarker of chemoprotection from breast cancer is the&#xD;
      urinary estrogen metabolite ratio of 2- to 16α-hydroxyestrogens (2:16). In the main study,&#xD;
      the effects of cruciferous vegetables (broccoli or Brussels sprouts), Cruciferous CompleteTM&#xD;
      whole food supplements, or placebos on this ratio of urinary estrogen metabolites in healthy&#xD;
      premenopausal women will be compared over an eight-week period. The investigators hypothesize&#xD;
      that treatment with daily supplements will increase the 2:16 ratio as compared to daily&#xD;
      consumption of a combination of Brussels sprouts and broccoli or a placebo, suggesting&#xD;
      reduced breast cancer risk.&#xD;
&#xD;
      In a sub-study, the relationships between serum α-carotene, β-carotene, β-cryptoxanthin,&#xD;
      lutein and lycopene with dietary carotenoid intake as measured by a food frequency&#xD;
      questionnaire and body composition will be evaluated in healthy premenopausal women.&#xD;
      Carotenoids are a family of lipophilic compounds found primarily in colorful plant tissues&#xD;
      and their concentration in human blood reflects dietary intake of carotenoid-rich foods.&#xD;
      Carotenoid levels in the blood of healthy women do not appear to be influenced by menstrual&#xD;
      status, but are inversely associated with body fatness. Thus, serum carotenoid concentrations&#xD;
      may serve as a functional marker for chronic disease risk associated with excess body fat.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</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>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Urinary 2:16 ratio</measure>
    <time_frame>8 weeks</time_frame>
    <description>Urinary 2:16 ratios between treatment groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Urinary 4OHE1 and 4OHE2</measure>
    <time_frame>8 weeks</time_frame>
    <description>Urinary concentrations of 4-hydroxyestrone (4OHE1) and 4-hydroxyestradiol (4OHE2) between treatment groups.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Body composition</measure>
    <time_frame>8 weeks</time_frame>
    <description>Association between body composition, urinary 2:16 ratio, and urinary 4OHE metabolites.</description>
  </other_outcome>
  <other_outcome>
    <measure>Stability of urinary 2:16 ratio.</measure>
    <time_frame>8 weeks</time_frame>
    <description>Change in the urinary 2:16 ratio over 8 weeks in the placebo group.</description>
  </other_outcome>
  <other_outcome>
    <measure>Sub-study: Serum carotenoids and dietary intake</measure>
    <time_frame>One blood draw on one day</time_frame>
    <description>Correlation between serum α-carotene, β-carotene, β-cryptoxanthin, lutein and lycopene and dietary intake.</description>
  </other_outcome>
  <other_outcome>
    <measure>Sub-study: Serum carotenoids and body composition</measure>
    <time_frame>One blood draw on one day</time_frame>
    <description>Correlation between serum carotenoids and body composition.</description>
  </other_outcome>
  <other_outcome>
    <measure>Dietary Intake</measure>
    <time_frame>8 weeks</time_frame>
    <description>Association between dietary intake, urinary 2:16 ratio, and urinary 4OHE metabolites.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Dietary Modification</condition>
  <arm_group>
    <arm_group_label>Broccoli and Brussels Sprouts</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will consume broccoli or Brussels sprouts (40g daily) for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cruciferous Complete</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will take Cruciferous CompleteTM supplements (2 capsules, 3 times daily) for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will take placebo capsules (2 capsules, 3 times daily) for 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Broccoli and Brussels Sprouts</intervention_name>
    <arm_group_label>Broccoli and Brussels Sprouts</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Cruciferous Complete</intervention_name>
    <arm_group_label>Cruciferous Complete</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Premenopausal women between the ages of 40-50; premenopause is defined as regular&#xD;
             menstrual cycles every 23-35 days&#xD;
&#xD;
          -  Willing to be randomized and compliant to the 3 study groups (whole cruciferous&#xD;
             vegetable intake, cruciferous supplement or placebo capsules)&#xD;
&#xD;
          -  Able to give informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Urinary 2:16 &gt; or = 3.&#xD;
&#xD;
          -  Current kidney or liver disease, adrenalectomy, or oophorectomy.&#xD;
&#xD;
          -  Use of tobacco products within the preceding three months, illegal use of medications&#xD;
             or use of illegal drugs or substances.&#xD;
&#xD;
          -  Current use of antibiotics, cimetidine or black cohosh.&#xD;
&#xD;
          -  Systemic administration of estrogen, or use of non-prescription hormones, tamoxifen,&#xD;
             or diabetes medication within the last three months.&#xD;
&#xD;
          -  Women under a physician-directed diet or those with a strong dislike of Brassica&#xD;
             vegetables.&#xD;
&#xD;
          -  Presence of cancer in the last 5 years, with the exception of fully resected basal or&#xD;
             squamous cell tumors.&#xD;
&#xD;
          -  Participation in an investigational drug study in the last 30 days.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sherry A. Tanumihardjo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Neil Binkley, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Wisconsin Osteoporosis Clinical Research Program Clinic</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>October 5, 2015</last_update_submitted>
  <last_update_submitted_qc>October 5, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 7, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01726127
org study id: 2011-0872
nct id: NCT01726127
lead sponsor: 
collaborator: 
has dmc: No
The 2010 Dietary Guidelines for Americans recommend that individuals consume 4.5 to 5 cups
      fruits and vegetables daily. However, at current intake levels, fruit consumption will have
      to improve by more than 100% and vegetable intake by 50% to meet this recommendation.
      Importantly, intake of brightly colored fruits and vegetables is even lower when potatoes are
      not considered. It is possible that improved fruit and vegetable intake will have beneficial
      health effects. For example, higher intakes of fruits and vegetables, and particularly
      cruciferous vegetables (e.g., broccoli, Brussels sprouts, cauliflower, etc.), are associated
      with lower rates of many degenerative diseases, including some cancers, yet this group of
      vegetables may continue to be under-consumed due to their strong flavors. A supplement made
      from these vegetables (Cruciferous CompleteTM made by Standard Process Inc. Palmyra, WI)
      contains a group of phytochemicals called glucosinolates that can shift estrogen metabolism
      in a favorable way. One proposed biomarker of chemoprotection from breast cancer is the
      urinary estrogen metabolite ratio of 2- to 16α-hydroxyestrogens (2:16). In the main study,
      the effects of cruciferous vegetables (broccoli or Brussels sprouts), Cruciferous CompleteTM
      whole food supplements, or placebos on this ratio of urinary estrogen metabolites in healthy
      premenopausal women will be compared over an eight-week period. The investigators hypothesize
      that treatment with daily supplements will increase the 2:16 ratio as compared to daily
      consumption of a combination of Brussels sprouts and broccoli or a placebo, suggesting
      reduced breast cancer risk.

      In a sub-study, the relationships between serum α-carotene, β-carotene, β-cryptoxanthin,
      lutein and lycopene with dietary carotenoid intake as measured by a food frequency
      questionnaire and body composition will be evaluated in healthy premenopausal women.
      Carotenoids are a family of lipophilic compounds found primarily in colorful plant tissues
      and their concentration in human blood reflects dietary intake of carotenoid-rich foods.
      Carotenoid levels in the blood of healthy women do not appear to be influenced by menstrual
      status, but are inversely associated with body fatness. Thus, serum carotenoid concentrations
      may serve as a functional marker for chronic disease risk associated with excess body fat.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Urinary 2:16 ratio
time frame: 8 weeks
description: Urinary 2:16 ratios between treatment groups.
measure: Urinary 4OHE1 and 4OHE2
time frame: 8 weeks
description: Urinary concentrations of 4-hydroxyestrone (4OHE1) and 4-hydroxyestradiol (4OHE2) between treatment groups.
measure: Body composition
time frame: 8 weeks
description: Association between body composition, urinary 2:16 ratio, and urinary 4OHE metabolites.
measure: Stability of urinary 2:16 ratio.
time frame: 8 weeks
description: Change in the urinary 2:16 ratio over 8 weeks in the placebo group.
measure: Sub-study: Serum carotenoids and dietary intake
time frame: One blood draw on one day
description: Correlation between serum α-carotene, β-carotene, β-cryptoxanthin, lutein and lycopene and dietary intake.
measure: Sub-study: Serum carotenoids and body composition
time frame: One blood draw on one day
description: Correlation between serum carotenoids and body composition.
measure: Dietary Intake
time frame: 8 weeks
description: Association between dietary intake, urinary 2:16 ratio, and urinary 4OHE metabolites.
arm group label: Broccoli and Brussels Sprouts
arm group type: Experimental
description: Subjects will consume broccoli or Brussels sprouts (40g daily) for 8 weeks.
arm group label: Cruciferous Complete
arm group type: Experimental
description: Subjects will take Cruciferous CompleteTM supplements (2 capsules, 3 times daily) for 8 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: Subjects will take placebo capsules (2 capsules, 3 times daily) for 8 weeks.
intervention type: Other
intervention name: Broccoli and Brussels Sprouts
arm group label: Broccoli and Brussels Sprouts
intervention type: Dietary Supplement
intervention name: Cruciferous Complete
arm group label: Cruciferous Complete
intervention type: Other
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sherry A. Tanumihardjo, PhD
role: Principal Investigator
affiliation: University of Wisconsin, Madison
last name: Neil Binkley, MD
role: Principal Investigator
affiliation: University of Wisconsin, Madison
facility: 
country: United States
responsible party type: Sponsor