<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/NCT03781778</url>
  </required_header>
  <id_info>
    <org_study_id>RG1003387</org_study_id>
    <secondary_id>NCI-2018-02802</secondary_id>
    <secondary_id>10079</secondary_id>
    <secondary_id>P30CA015704</secondary_id>
    <nct_id>NCT03781778</nct_id>
  </id_info>
  <brief_title>Pilot Trial of Resistant Starch in Stage I-III Colorectal Cancer Survivors</brief_title>
  <official_title>Randomized, Controlled Trial of Resistant Starch in Stage I-Ill Colorectal Cancer Survivors Pilot Study: The Fiber for Health After Cancer Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fred Hutchinson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Fred Hutchinson Cancer 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>
      This phase II, randomized pilot trial studies the effect of the consumption of foods made&#xD;
      with resistant starch compared to foods made with corn starch on biomarkers that may be&#xD;
      related to colorectal cancer progression in stage I-III colorectal cancer survivors. Foods&#xD;
      made with resistant starch may beneficially influence markers of inflammation, insulin&#xD;
      resistance, and the composition of gut bacteria in colorectal cancer survivors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants are randomized to 1 of 2 groups.&#xD;
&#xD;
      GROUP I (INTERVENTION GROUP): Participants eat a diet consisting of resistant starch foods&#xD;
      daily for 8 weeks. Study provided foods are in addition to their own usual daily diet.&#xD;
&#xD;
      GROUP II (CONTROL GROUP): Participants eat a diet consisting of regular corn starch foods&#xD;
      daily for 8 weeks. Study provided foods are in addition to their own usual daily diet.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Terminated due to expiration of funding&#xD;
  </why_stopped>
  <start_date type="Actual">May 7, 2019</start_date>
  <completion_date type="Actual">October 1, 2020</completion_date>
  <primary_completion_date type="Actual">October 1, 2020</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>Blinded, block randomization based on sex and BMI.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Assignment to the active versus control group will be blinded using a computer program and will be designated as &quot;diet A&quot; and &quot;diet B&quot;. Investigators will be unblinded once the study and data analyses have been completed.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility: Accrual</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>The accrual rate will be estimated with number of participants at full enrollment at 12 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility: Adherence</measure>
    <time_frame>From start of intervention to ending intervention: up to 8 weeks</time_frame>
    <description>The adherence endpoint pertains to adherence to the intervention and is defined as consuming 75% or more of study foods on 75% of days from baseline to 8 weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility: Retention</measure>
    <time_frame>From start of intervention to the 8-week timepoint</time_frame>
    <description>The retention endpoint is defined as at least 80% of enrolled participants providing blood and stool samples at the week 8 timepoint.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Variability of Biomarkers of Insulin Resistance and Inflammation (Adiponectin)</measure>
    <time_frame>Baseline to follow-up at week 8</time_frame>
    <description>Adiponectin was measured at baseline and week 8 (follow-up) and reported using descriptive statistics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variability in Biomarkers of Insulin Resistance and Inflammation (C-reactive Protein, CRP)</measure>
    <time_frame>Baseline to follow-up at week 8</time_frame>
    <description>CRP was measured at baseline and week 8 (follow-up) and reported using descriptive statistics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variability in Gut Microbial Communities From Human Stool Samples - ALPHA DIVERSITY AND GENERA</measure>
    <time_frame>Baseline to follow-up at weeks 2 and 8</time_frame>
    <description>This measure assesses variability in gut microbial communities from human stool samples collected during the study by changes in alpha diversity and genera in response to the intervention. We will use multivariate and univeriate approaches to assess significant changes int he microbiome in response to the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variability in Gut Microbial Communities From Human Stool Samples -- BETA DIVERSITY</measure>
    <time_frame>Baseline to followup at weeks 2 and 8</time_frame>
    <description>This measure assesses variability in gut microbial communities from human stool samples collected during the study by changes in global microbial community (beta diversity) in response to the intervention. We will use multivariate and univeriate approaches to assess significant changes in the microbiome in response to the intervention.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Colon Cancer</condition>
  <condition>Rectal Cancer</condition>
  <condition>Cancer Survivor</condition>
  <condition>Colorectal Adenocarcinoma</condition>
  <condition>Stage I Colorectal Cancer AJCC v8</condition>
  <condition>Stage II Colorectal Cancer AJCC v8</condition>
  <condition>Stage IIA Colorectal Cancer AJCC v8</condition>
  <condition>Stage IIB Colorectal Cancer AJCC v8</condition>
  <condition>Stage IIC Colorectal Cancer AJCC v8</condition>
  <condition>Stage III Colorectal Cancer AJCC v8</condition>
  <condition>Stage IIIA Colorectal Cancer AJCC v8</condition>
  <condition>Stage IIIB Colorectal Cancer AJCC v8</condition>
  <condition>Stage IIIC Colorectal Cancer AJCC v8</condition>
  <arm_group>
    <arm_group_label>Group I (resistant starch foods)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients eat a diet consisting of resistant starch foods daily for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II (foods with regular corn starch)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients eat a diet consisting of regular corn starch foods daily for 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dietary Intervention (resistant starch)</intervention_name>
    <description>Eat foods with resistant starch</description>
    <arm_group_label>Group I (resistant starch foods)</arm_group_label>
    <other_name>Dietary Modification</other_name>
    <other_name>intervention, dietary</other_name>
    <other_name>Nutrition Intervention</other_name>
    <other_name>Nutrition Interventions</other_name>
    <other_name>Nutritional Interventions</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dietary Intervention (regular starch)</intervention_name>
    <description>Eat foods with regular corn starch</description>
    <arm_group_label>Group II (foods with regular corn starch)</arm_group_label>
    <other_name>Dietary Modification</other_name>
    <other_name>intervention, dietary</other_name>
    <other_name>Nutrition Intervention</other_name>
    <other_name>Nutrition Interventions</other_name>
    <other_name>Nutritional Interventions</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Group I (resistant starch foods)</arm_group_label>
    <arm_group_label>Group II (foods with regular corn starch)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  History of diagnosed American Joint Committee on Cancer (AJCC) stage I-III colorectal&#xD;
             adenocarcinoma.&#xD;
&#xD;
          -  Completed all treatment of colorectal adenocarcinoma within past 4-36 months.&#xD;
&#xD;
          -  Current Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2&#xD;
             (per physician).&#xD;
&#xD;
          -  Ability to consent and follow study protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active cancer.&#xD;
&#xD;
          -  Prior diagnosis of diabetes that is currently uncontrolled (defined as hemoglobin&#xD;
             [Hgb] A1c &gt; 8.0).&#xD;
&#xD;
          -  Active inflammatory bowel disease (i.e., patients who are symptomatic despite medical&#xD;
             therapy). This includes irritable bowel syndrome, Crohn's disease, or any other&#xD;
             inflammatory bowel disorder.&#xD;
&#xD;
          -  Known food allergy/intolerances to wheat, gluten, dairy or eggs.&#xD;
&#xD;
          -  Use of antibiotic(s) within the last 3 months prior to enrollment.&#xD;
&#xD;
          -  Women who are pregnant and/or breastfeeding.&#xD;
&#xD;
          -  Current body mass index (BMI) &lt; 18.5 kg/m^2.&#xD;
&#xD;
          -  Uncontrolled constipation.&#xD;
&#xD;
          -  Inability to speak and fully understand English.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marian Neuhouser</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fred Hutch/University of Washington Cancer Consortium</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fred Hutch/University of Washington Cancer Consortium</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <results_first_submitted>September 28, 2021</results_first_submitted>
  <results_first_submitted_qc>November 16, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">December 14, 2021</results_first_posted>
  <last_update_submitted>September 9, 2022</last_update_submitted>
  <last_update_submitted_qc>September 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fred Hutchinson Cancer Center</investigator_affiliation>
    <investigator_full_name>Marian Neuhouser</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Resistant Starch</keyword>
  <keyword>Colorectal Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 4, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT03781778/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>1-Active (Resistant Starch)</title>
          <description>Participants receive daily study snack foods prepared with resistant starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days.</description>
        </group>
        <group group_id="P2">
          <title>2-Control (Regular Starch)</title>
          <description>Participants receive daily study snack foods prepared with regular starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Started Intervention</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>at time of enrollment</population>
      <group_list>
        <group group_id="B1">
          <title>1-Active (Resistant Starch)</title>
          <description>Participants receive daily study snack foods prepared with resistant starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days.</description>
        </group>
        <group group_id="B2">
          <title>2-Control (Regular Starch)</title>
          <description>Participants receive daily study snack foods prepared with regular starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="4"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62" lower_limit="55" upper_limit="68"/>
                    <measurement group_id="B2" value="50" lower_limit="38" upper_limit="79"/>
                    <measurement group_id="B3" value="58.5" lower_limit="38" upper_limit="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="177.54" lower_limit="168.00" upper_limit="180.10"/>
                    <measurement group_id="B2" value="173.75" lower_limit="156.21" upper_limit="187.00"/>
                    <measurement group_id="B3" value="176.00" lower_limit="156.21" upper_limit="187.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="85.88" lower_limit="67.90" upper_limit="96.16"/>
                    <measurement group_id="B2" value="88.95" lower_limit="50.58" upper_limit="113.10"/>
                    <measurement group_id="B3" value="85.90" lower_limit="50.58" upper_limit="113.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m^2</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.7" lower_limit="21.2" upper_limit="32.7"/>
                    <measurement group_id="B2" value="27.2" lower_limit="20.7" upper_limit="38.5"/>
                    <measurement group_id="B3" value="27.65" lower_limit="20.7" upper_limit="38.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI Category</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Underweight</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Normal weight</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Overweight</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Obese I</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Obese II+</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>T-stage</title>
          <description>Participants were staged clinically by the interdisciplinary clinical oncology team per American Joint Committee on Cancer Staging Criteria for colorectal carcinoma (AJCC 8th edition). AJCC Stage Groupings I-III for colorectal carcinoma were eligible for the trial. Prognostic outcomes are considered better for lower stages and worse for higher stages.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>T0</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>T1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>T2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>T3</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>T4a</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>T4b</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>N-stage</title>
          <description>Participants were staged clinically by the interdisciplinary clinical oncology team per American Joint Committee on Cancer Staging Criteria for colorectal carcinoma (AJCC 8th edition). AJCC Stage Groupings I-III for colorectal carcinoma were eligible for the trial. Prognostic outcomes are considered better for lower stages and worse for higher stages.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>N0</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>N1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>N1a</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>N1b</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>N1c</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>N2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>N2a</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>N2b</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Feasibility: Accrual</title>
        <description>The accrual rate will be estimated with number of participants at full enrollment at 12 months.</description>
        <time_frame>Up to 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>1-Active (Resistant Starch)</title>
            <description>Participants receive daily study snack foods prepared with resistant starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days.</description>
          </group>
          <group group_id="O2">
            <title>2-Control (Regular Starch)</title>
            <description>Participants receive daily study snack foods prepared with regular starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Feasibility: Accrual</title>
          <description>The accrual rate will be estimated with number of participants at full enrollment at 12 months.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Feasibility: Adherence</title>
        <description>The adherence endpoint pertains to adherence to the intervention and is defined as consuming 75% or more of study foods on 75% of days from baseline to 8 weeks.</description>
        <time_frame>From start of intervention to ending intervention: up to 8 weeks</time_frame>
        <population>Overall number of participants analyzed for the adherence measure: 7 (per protocol)</population>
        <group_list>
          <group group_id="O1">
            <title>1-Active (Resistant Starch)</title>
            <description>Participants receive daily study snack foods prepared with resistant starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days.</description>
          </group>
          <group group_id="O2">
            <title>2-Control (Regular Starch)</title>
            <description>Participants receive daily study snack foods prepared with regular starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Feasibility: Adherence</title>
          <description>The adherence endpoint pertains to adherence to the intervention and is defined as consuming 75% or more of study foods on 75% of days from baseline to 8 weeks.</description>
          <population>Overall number of participants analyzed for the adherence measure: 7 (per protocol)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Feasibility: Retention</title>
        <description>The retention endpoint is defined as at least 80% of enrolled participants providing blood and stool samples at the week 8 timepoint.</description>
        <time_frame>From start of intervention to the 8-week timepoint</time_frame>
        <population>All participants enrolled, in accordance with protocol and Statistical Analysis Plan</population>
        <group_list>
          <group group_id="O1">
            <title>1-Active (Resistant Starch)</title>
            <description>Participants receive daily study snack foods prepared with resistant starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days.</description>
          </group>
          <group group_id="O2">
            <title>2-Control (Regular Starch)</title>
            <description>Participants receive daily study snack foods prepared with regular starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Feasibility: Retention</title>
          <description>The retention endpoint is defined as at least 80% of enrolled participants providing blood and stool samples at the week 8 timepoint.</description>
          <population>All participants enrolled, in accordance with protocol and Statistical Analysis Plan</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Variability of Biomarkers of Insulin Resistance and Inflammation (Adiponectin)</title>
        <description>Adiponectin was measured at baseline and week 8 (follow-up) and reported using descriptive statistics.</description>
        <time_frame>Baseline to follow-up at week 8</time_frame>
        <population>Of the 10 participants enrolled to the study, blood was collected at the baseline and week 8 follow-up timepoints on just 5 participants.</population>
        <group_list>
          <group group_id="O1">
            <title>1-Active (Resistant Starch)</title>
            <description>Participants receive daily study snack foods prepared with resistant starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days.</description>
          </group>
          <group group_id="O2">
            <title>2-Control (Regular Starch)</title>
            <description>Participants receive daily study snack foods prepared with regular starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Variability of Biomarkers of Insulin Resistance and Inflammation (Adiponectin)</title>
          <description>Adiponectin was measured at baseline and week 8 (follow-up) and reported using descriptive statistics.</description>
          <population>Of the 10 participants enrolled to the study, blood was collected at the baseline and week 8 follow-up timepoints on just 5 participants.</population>
          <units>ug/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Adiponectin - baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.33" spread="0.54"/>
                    <measurement group_id="O2" value="1.95" spread="0.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adiponectin - followup</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.14" spread="0.55"/>
                    <measurement group_id="O2" value="2.08" spread="1.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Variability in Biomarkers of Insulin Resistance and Inflammation (C-reactive Protein, CRP)</title>
        <description>CRP was measured at baseline and week 8 (follow-up) and reported using descriptive statistics.</description>
        <time_frame>Baseline to follow-up at week 8</time_frame>
        <population>Of the 10 participants enrolled to the study, blood was collected at the baseline and week 8 followup timepoints on just 5 participants.</population>
        <group_list>
          <group group_id="O1">
            <title>1-Active (Resistant Starch)</title>
            <description>Participants receive daily study snack foods prepared with resistant starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days.</description>
          </group>
          <group group_id="O2">
            <title>2-Control (Regular Starch)</title>
            <description>Participants receive daily study snack foods prepared with regular starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Variability in Biomarkers of Insulin Resistance and Inflammation (C-reactive Protein, CRP)</title>
          <description>CRP was measured at baseline and week 8 (follow-up) and reported using descriptive statistics.</description>
          <population>Of the 10 participants enrolled to the study, blood was collected at the baseline and week 8 followup timepoints on just 5 participants.</population>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>C-reactive protein - baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.24" spread="0.74"/>
                    <measurement group_id="O2" value="1.98" spread="2.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C-reactive protein - followup</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.93" spread="2.37"/>
                    <measurement group_id="O2" value="1.67" spread="1.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Variability in Gut Microbial Communities From Human Stool Samples - ALPHA DIVERSITY AND GENERA</title>
        <description>This measure assesses variability in gut microbial communities from human stool samples collected during the study by changes in alpha diversity and genera in response to the intervention. We will use multivariate and univeriate approaches to assess significant changes int he microbiome in response to the intervention.</description>
        <time_frame>Baseline to follow-up at weeks 2 and 8</time_frame>
        <population>Of the 10 participants enrolled to this study, fecal samples were collected at baseline and followup for 7 participants. Of these 7 participants, one participant on Arm 1 dropped out of the study after week 2 hence the week 8 followup fecal was not obtained. For the remaining 6 participants, fecal samples from all three time-points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>1-Active (Resistant Starch)</title>
            <description>Participants receive daily study snack foods prepared with resistant starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days.</description>
          </group>
          <group group_id="O2">
            <title>2-Control (Regular Starch)</title>
            <description>Participants receive daily study snack foods prepared with regular starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Variability in Gut Microbial Communities From Human Stool Samples - ALPHA DIVERSITY AND GENERA</title>
          <description>This measure assesses variability in gut microbial communities from human stool samples collected during the study by changes in alpha diversity and genera in response to the intervention. We will use multivariate and univeriate approaches to assess significant changes int he microbiome in response to the intervention.</description>
          <population>Of the 10 participants enrolled to this study, fecal samples were collected at baseline and followup for 7 participants. Of these 7 participants, one participant on Arm 1 dropped out of the study after week 2 hence the week 8 followup fecal was not obtained. For the remaining 6 participants, fecal samples from all three time-points were analyzed.</population>
          <units>Relative abundance</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Alpha diversity - baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1344" spread="243.50"/>
                    <measurement group_id="O2" value="1458" spread="265.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alpha diversity - first follow-up (week 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1376" spread="21.70"/>
                    <measurement group_id="O2" value="1111" spread="364.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alpha diversity - second follow-up (week 8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1288" spread="2.83"/>
                    <measurement group_id="O2" value="1321" spread="75.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Faecalibacterium Prausnitzii - baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.09" spread="1.31"/>
                    <measurement group_id="O2" value="2.62" spread="2.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Faecalibacterium Prausnitzii - first follow-up (week 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.84" spread="1.02"/>
                    <measurement group_id="O2" value="1.77" spread="2.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Faecalibacterium Prausnitzii - second follow-up (week 8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.98" spread="0.52"/>
                    <measurement group_id="O2" value="2.09" spread="1.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Akkermansia mucinipiila - baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.36" spread="0.22"/>
                    <measurement group_id="O2" value="0.35" spread="0.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Akkermansia mucinipiila - first follow-up (week 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.19" spread="0.05"/>
                    <measurement group_id="O2" value="0.18" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Akkermansia mucinipiila - second follow-up (week 8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.19" spread="0.02"/>
                    <measurement group_id="O2" value="0.39" spread="0.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Variability in Gut Microbial Communities From Human Stool Samples -- BETA DIVERSITY</title>
        <description>This measure assesses variability in gut microbial communities from human stool samples collected during the study by changes in global microbial community (beta diversity) in response to the intervention. We will use multivariate and univeriate approaches to assess significant changes in the microbiome in response to the intervention.</description>
        <time_frame>Baseline to followup at weeks 2 and 8</time_frame>
        <population>Analysis limitation: due to low participant recruitment, there was insufficient number of stool samples available to detect and compute beta diversity.</population>
        <group_list>
          <group group_id="O1">
            <title>1-Active (Resistant Starch)</title>
            <description>Participants receive daily study snack foods prepared with resistant starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days.</description>
          </group>
          <group group_id="O2">
            <title>2-Control (Regular Starch)</title>
            <description>Participants receive daily study snack foods prepared with regular starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Variability in Gut Microbial Communities From Human Stool Samples -- BETA DIVERSITY</title>
          <description>This measure assesses variability in gut microbial communities from human stool samples collected during the study by changes in global microbial community (beta diversity) in response to the intervention. We will use multivariate and univeriate approaches to assess significant changes in the microbiome in response to the intervention.</description>
          <population>Analysis limitation: due to low participant recruitment, there was insufficient number of stool samples available to detect and compute beta diversity.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From start of intervention to ending the intervention: up to 8 weeks.</time_frame>
      <desc>Method of assessment: weekly participant-completed questionnaire. The number of participants (n=7) analyzed for adverse events (&quot;number at risk&quot; below) is fewer than the number enrolled (n=10) because 3 participants withdrew consent prior to starting the intervention.</desc>
      <group_list>
        <group group_id="E1">
          <title>1-Active (Resistant Starch)</title>
          <description>Participants receive daily study snack foods prepared with resistant starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days.</description>
        </group>
        <group group_id="E2">
          <title>2-Control (Regular Starch)</title>
          <description>Participants receive daily study snack foods prepared with regular starch. Dosing is 15g of starch daily for the first 14 days, then 30g of starch daily for the remaining 42 days.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gassiness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Bloating</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Increased frequency of bowel movements</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Heartburn</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Loose stool</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Marian L. Neuhouser, PhD</name_or_title>
      <organization>Fred Hutchinson Cancer Research Center</organization>
      <phone>2066674797</phone>
      <email>mneuhous@fredhutch.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03781778
org study id: RG1003387
secondary id: NCI-2018-02802
secondary id: 10079
secondary id: P30CA015704
nct id: NCT03781778
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This phase II, randomized pilot trial studies the effect of the consumption of foods made
      with resistant starch compared to foods made with corn starch on biomarkers that may be
      related to colorectal cancer progression in stage I-III colorectal cancer survivors. Foods
      made with resistant starch may beneficially influence markers of inflammation, insulin
      resistance, and the composition of gut bacteria in colorectal cancer survivors.
Participants are randomized to 1 of 2 groups.

      GROUP I (INTERVENTION GROUP): Participants eat a diet consisting of resistant starch foods
      daily for 8 weeks. Study provided foods are in addition to their own usual daily diet.

      GROUP II (CONTROL GROUP): Participants eat a diet consisting of regular corn starch foods
      daily for 8 weeks. Study provided foods are in addition to their own usual daily diet.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Blinded, block randomization based on sex and BMI.
primary purpose: Prevention
masking: Double (Participant, Investigator)
masking description: Assignment to the active versus control group will be blinded using a computer program and will be designated as "diet A" and "diet B". Investigators will be unblinded once the study and data analyses have been completed.
measure: Feasibility: Accrual
time frame: Up to 12 months
description: The accrual rate will be estimated with number of participants at full enrollment at 12 months.
measure: Feasibility: Adherence
time frame: From start of intervention to ending intervention: up to 8 weeks
description: The adherence endpoint pertains to adherence to the intervention and is defined as consuming 75% or more of study foods on 75% of days from baseline to 8 weeks.
measure: Feasibility: Retention
time frame: From start of intervention to the 8-week timepoint
description: The retention endpoint is defined as at least 80% of enrolled participants providing blood and stool samples at the week 8 timepoint.
measure: Variability of Biomarkers of Insulin Resistance and Inflammation (Adiponectin)
time frame: Baseline to follow-up at week 8
description: Adiponectin was measured at baseline and week 8 (follow-up) and reported using descriptive statistics.
measure: Variability in Biomarkers of Insulin Resistance and Inflammation (C-reactive Protein, CRP)
time frame: Baseline to follow-up at week 8
description: CRP was measured at baseline and week 8 (follow-up) and reported using descriptive statistics.
measure: Variability in Gut Microbial Communities From Human Stool Samples - ALPHA DIVERSITY AND GENERA
time frame: Baseline to follow-up at weeks 2 and 8
description: This measure assesses variability in gut microbial communities from human stool samples collected during the study by changes in alpha diversity and genera in response to the intervention. We will use multivariate and univeriate approaches to assess significant changes int he microbiome in response to the intervention.
measure: Variability in Gut Microbial Communities From Human Stool Samples -- BETA DIVERSITY
time frame: Baseline to followup at weeks 2 and 8
description: This measure assesses variability in gut microbial communities from human stool samples collected during the study by changes in global microbial community (beta diversity) in response to the intervention. We will use multivariate and univeriate approaches to assess significant changes in the microbiome in response to the intervention.
arm group label: Group I (resistant starch foods)
arm group type: Experimental
description: Patients eat a diet consisting of resistant starch foods daily for 8 weeks.
arm group label: Group II (foods with regular corn starch)
arm group type: Active Comparator
description: Patients eat a diet consisting of regular corn starch foods daily for 8 weeks.
intervention type: Other
intervention name: Dietary Intervention (resistant starch)
description: Eat foods with resistant starch
arm group label: Group I (resistant starch foods)
other name: Dietary Modification
other name: intervention, dietary
other name: Nutrition Intervention
other name: Nutrition Interventions
other name: Nutritional Interventions
intervention type: Other
intervention name: Dietary Intervention (regular starch)
description: Eat foods with regular corn starch
arm group label: Group II (foods with regular corn starch)
other name: Dietary Modification
other name: intervention, dietary
other name: Nutrition Intervention
other name: Nutrition Interventions
other name: Nutritional Interventions
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Group I (resistant starch foods)
arm group label: Group II (foods with regular corn starch)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marian Neuhouser
role: Principal Investigator
affiliation: Fred Hutch/University of Washington Cancer Consortium
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Fred Hutchinson Cancer Center
investigator full name: Marian Neuhouser
investigator title: Professor
mesh term: Colorectal Neoplasms
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 