<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/NCT01698294</url>
  </required_header>
  <id_info>
    <org_study_id>I 216812</org_study_id>
    <secondary_id>NCI-2012-01246</secondary_id>
    <secondary_id>I 216812</secondary_id>
    <secondary_id>U01CA161809</secondary_id>
    <nct_id>NCT01698294</nct_id>
  </id_info>
  <brief_title>Biomarkers in Post-Menopausal Women Receiving Flaxseed</brief_title>
  <official_title>A Pilot Study of the Flaxseed Effects on Hormones and Lignans: Role of Race, Genes, and Gut Microbiome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Roswell Park Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fred Hutchinson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>State University of New York at Buffalo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Roswell Park Cancer Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized clinical trial studies biomarkers in post-menopausal women receiving&#xD;
      flaxseed. Studying samples of blood, urine, and feces in the laboratory from participants&#xD;
      receiving flaxseed may help doctors understand the effects of flaxseed on biomarkers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine associations between the composition of the gut bacterial communities and&#xD;
      baseline levels of the mammalian lignans and steroid hormones.&#xD;
&#xD;
      II. To determine how variation in gut microbial community composition and in steroid hormone&#xD;
      and xenobiotic metabolizing genes affects the metabolism of mammalian lignans and steroid&#xD;
      hormones after exposure to a lignan-rich food (flaxseed).&#xD;
&#xD;
      III. To determine how these associations differ by race (i.e., African American and European&#xD;
      American women).&#xD;
&#xD;
      OUTLINE: Participants are randomized to 1 of 2 treatment groups.&#xD;
&#xD;
      GROUP I: Participants receive flaxseed orally (PO) daily for 6 weeks. After a usual diet&#xD;
      &quot;washout&quot; period of 8 weeks, patients crossover to Group II.&#xD;
&#xD;
      GROUP II: Participants maintain a usual diet for 6 weeks. After a usual diet &quot;washout&quot; period&#xD;
      of 8 weeks, patients crossover to Group I.&#xD;
&#xD;
      After completion of study treatment, participants are followed up for 30 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 14, 2012</start_date>
  <completion_date type="Actual">June 8, 2017</completion_date>
  <primary_completion_date type="Actual">June 8, 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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Relative percent of Eubacteria composition from quantitative polymerase chain reaction (qPCR) associated with lignan levels</measure>
    <time_frame>Up to week 21</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Steroid hormone and lignans levels after exposure to a lignan-rich food (flaxseed)</measure>
    <time_frame>Up to week 21</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">258</enrollment>
  <condition>No Evidence of Disease</condition>
  <arm_group>
    <arm_group_label>Group I (flaxseed)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive flaxseed PO daily for 6 weeks. After a usual diet &quot;washout&quot; period of 8 weeks, patients crossover to Group II.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II (usual diet)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants maintain a usual diet for 6 weeks. After a usual diet &quot;washout&quot; period of 8 weeks, patients crossover to Group I.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinical Observation</intervention_name>
    <description>Participants maintain usual diet and undergo clinical observation</description>
    <arm_group_label>Group II (usual diet)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Flaxseed</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Group I (flaxseed)</arm_group_label>
    <other_name>FLAX SEED</other_name>
    <other_name>Flour, Flaxseed</other_name>
    <other_name>Linseed</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Group I (flaxseed)</arm_group_label>
    <arm_group_label>Group II (usual diet)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Group I (flaxseed)</arm_group_label>
    <arm_group_label>Group II (usual diet)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant must understand the investigational nature of this study and sign an&#xD;
             Independent Ethics Committee/Institutional Review Board approved written informed&#xD;
             consent form prior to receiving any study related procedure&#xD;
&#xD;
          -  Participant must be a non-Hispanic white or non-Hispanic black (self-reported race)&#xD;
             woman 45 to 80 years of age and postmenopausal; postmenopausal will be defined as no&#xD;
             menstrual cycle in the past 12 months; women with a hysterectomy but with intact&#xD;
             ovaries will be included if aged &gt;= 55 years&#xD;
&#xD;
          -  Willingness to comply with the requirements of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unwilling or unable to follow protocol requirements&#xD;
&#xD;
          -  Self-reported race other than non-Hispanic white or non-Hispanic black&#xD;
&#xD;
          -  Use, in the 2 months prior to week 1 visit, of antibiotics, hormone replacement&#xD;
             therapy, nonprescription hormones or herbal supplements for menopausal symptoms, or&#xD;
             flaxseed supplements&#xD;
&#xD;
          -  Nut or seed allergy&#xD;
&#xD;
          -  Self-reported inflammatory bowel disease&#xD;
&#xD;
          -  Gastric bypass&#xD;
&#xD;
          -  Use of thyroid replacement medication (Synthroid or similar) for &lt; 1 year&#xD;
&#xD;
          -  Any condition which in the investigator's opinion deems the participant an unsuitable&#xD;
             candidate to receive flaxseed&#xD;
&#xD;
          -  Chemotherapy/radiation within the past year&#xD;
&#xD;
          -  Body weight greater than 400 pounds (limit of Tanita scale)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Spencer Rosario, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Roswell Park Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Roswell Park Cancer Institute</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14263</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>May 6, 2022</last_update_submitted>
  <last_update_submitted_qc>May 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>gut microbiome</keyword>
  <keyword>hormones</keyword>
  <keyword>women</keyword>
  <keyword>race</keyword>
  <keyword>phytoestrogens</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/NCT01698294
org study id: I 216812
secondary id: NCI-2012-01246
secondary id: I 216812
secondary id: U01CA161809
nct id: NCT01698294
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
This randomized clinical trial studies biomarkers in post-menopausal women receiving
      flaxseed. Studying samples of blood, urine, and feces in the laboratory from participants
      receiving flaxseed may help doctors understand the effects of flaxseed on biomarkers.
PRIMARY OBJECTIVES:

      I. To determine associations between the composition of the gut bacterial communities and
      baseline levels of the mammalian lignans and steroid hormones.

      II. To determine how variation in gut microbial community composition and in steroid hormone
      and xenobiotic metabolizing genes affects the metabolism of mammalian lignans and steroid
      hormones after exposure to a lignan-rich food (flaxseed).

      III. To determine how these associations differ by race (i.e., African American and European
      American women).

      OUTLINE: Participants are randomized to 1 of 2 treatment groups.

      GROUP I: Participants receive flaxseed orally (PO) daily for 6 weeks. After a usual diet
      "washout" period of 8 weeks, patients crossover to Group II.

      GROUP II: Participants maintain a usual diet for 6 weeks. After a usual diet "washout" period
      of 8 weeks, patients crossover to Group I.

      After completion of study treatment, participants are followed up for 30 days.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Relative percent of Eubacteria composition from quantitative polymerase chain reaction (qPCR) associated with lignan levels
time frame: Up to week 21
measure: Steroid hormone and lignans levels after exposure to a lignan-rich food (flaxseed)
time frame: Up to week 21
arm group label: Group I (flaxseed)
arm group type: Experimental
description: Participants receive flaxseed PO daily for 6 weeks. After a usual diet "washout" period of 8 weeks, patients crossover to Group II.
arm group label: Group II (usual diet)
arm group type: Active Comparator
description: Participants maintain a usual diet for 6 weeks. After a usual diet "washout" period of 8 weeks, patients crossover to Group I.
intervention type: Other
intervention name: Clinical Observation
description: Participants maintain usual diet and undergo clinical observation
arm group label: Group II (usual diet)
intervention type: Dietary Supplement
intervention name: Flaxseed
description: Given PO
arm group label: Group I (flaxseed)
other name: FLAX SEED
other name: Flour, Flaxseed
other name: Linseed
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Group I (flaxseed)
arm group label: Group II (usual diet)
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Group I (flaxseed)
arm group label: Group II (usual diet)
criteria: 
gender: Female
minimum age: 45 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Spencer Rosario, PhD
role: Principal Investigator
affiliation: Roswell Park Cancer Institute
facility: 
country: United States
responsible party type: Sponsor