<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/NCT04499482</url>
  </required_header>
  <id_info>
    <org_study_id>PBRC 2020-010</org_study_id>
    <secondary_id>1K99AG065419-01A1</secondary_id>
    <nct_id>NCT04499482</nct_id>
  </id_info>
  <brief_title>Safety and Tolerability of Soy Fiber</brief_title>
  <official_title>Safety and Tolerability of Soy Fiber in the Elderly: A Dose Escalation Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pennington Biomedical Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Pennington Biomedical Research Center</source>
  <oversight_info>
    <has_dmc>Yes</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 is a dose escalation trial in the elderly with obesity to determine the maximum&#xD;
      tolerated dose of a novel dietary fiber from whole young soy pods (soy) delivered in foods.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The tolerability to 10 g, 20 g, and 30 g of soy will be tested. At each dose, eight subjects&#xD;
      will incorporate the foods containing soy into their usual diet for one week. The&#xD;
      tolerability to each dose will be evaluated and fecal short chain fatty acids will be&#xD;
      measured as a biomarker of compliance. Subjects who satisfy the eligibility criteria and&#xD;
      express willingness to consume the study foods will be enrolled.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 4, 2021</start_date>
  <completion_date type="Actual">April 14, 2022</completion_date>
  <primary_completion_date type="Actual">April 14, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Dose escalating cross over trial</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Treatment-emergent Adverse Events Following Each Dose of Soy</measure>
    <time_frame>One week at each dose</time_frame>
    <description>Dose safety will be investigated by compiling by treatment (e.g. 10 g dose, 20 g dose, 30 g dose) a list of adverse events such as frequency of headaches, nausea, vomiting. The study physician in consultation with the coordinator will review and determine safety</description>
  </primary_outcome>
  <primary_outcome>
    <measure>10 g Soy-related Gastrointestinal Symptoms</measure>
    <time_frame>One week</time_frame>
    <description>Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>20 g Soy-related Gastrointestinal Symptoms</measure>
    <time_frame>One week</time_frame>
    <description>Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>30 g Soy-related Gastrointestinal Symptoms</measure>
    <time_frame>One week</time_frame>
    <description>Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>10 g Soy-related Stool Frequency</measure>
    <time_frame>One week</time_frame>
    <description>Subjects will complete the stool frequency questionnaire. Stool frequency will be rated from 0 to more than 9 over three consecutive days in each week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>20 g Soy-related Stool Frequency</measure>
    <time_frame>One week</time_frame>
    <description>Subjects will complete the stool frequency questionnaire. Stool frequency will be rated from 0 to more than 9 over three consecutive days in each week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>30 g Soy-related Stool Frequency</measure>
    <time_frame>One week</time_frame>
    <description>Subjects will complete the stool frequency questionnaire. Stool frequency will be rated from 0 to more than 9 over three consecutive days in each week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>10 Soy-related Stool Consistency</measure>
    <time_frame>One week</time_frame>
    <description>Subjects will complete a stool consistency questionnaire. Stool consistency will be rated according to the Bristol Stool Scale where scores from three to five will be considered normal and 1, 2, 6, and 7 will be considered abnormal.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>20 g Soy-related Stool Consistency</measure>
    <time_frame>One week</time_frame>
    <description>Subjects will complete a stool consistency questionnaire. Stool consistency will be rated according to the Bristol Stool Scale where scores from three to five will be considered normal and 1, 2, 6, and 7 will be considered abnormal.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>30 g Soy-related Stool Consistency</measure>
    <time_frame>One week</time_frame>
    <description>Subjects will complete a stool consistency questionnaire. Stool consistency will be rated according to the Bristol Stool Scale where scores from three to five will be considered normal and 1, 2, 6, and 7 will be considered abnormal.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>10 g Soy Intake Effect on Fecal Short Chain Fatty Acids</measure>
    <time_frame>One week</time_frame>
    <description>Measurement of fecal short chain fatty acids in response to intake of soy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>20 g Soy Intake Effect on Fecal Short Chain Fatty Acids</measure>
    <time_frame>One week</time_frame>
    <description>Measurement of fecal short chain fatty acids in response to intake of soy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30 g Soy Intake Effect on Fecal Short Chain Fatty Acids</measure>
    <time_frame>One week</time_frame>
    <description>Measurement of fecal short chain fatty acids in response to intake of soy</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Safety Issues</condition>
  <condition>Tolerance</condition>
  <arm_group>
    <arm_group_label>Foods containing 10 g soy flour</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive foods containing 10 g of soy flour to be consumed everyday for one week. If they tolerate the dose, they will receive the next dose without any wash-out period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Foods containing 20 g soy flour</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive foods containing 20 g of soy flour to be consumed everyday for one week. If they tolerate the dose, they will receive the next dose without any wash-out period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Foods containing 30 g soy flour</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive foods containing 30 g of soy flour to be consumed everyday for one week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Food</intervention_name>
    <description>Soy-fiber containing food</description>
    <arm_group_label>Foods containing 10 g soy flour</arm_group_label>
    <arm_group_label>Foods containing 20 g soy flour</arm_group_label>
    <arm_group_label>Foods containing 30 g soy flour</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult (70 - 85 years).&#xD;
&#xD;
          -  Body mass index between 30 and 40 kg/m2.&#xD;
&#xD;
          -  No evidence of diabetes (fasting blood sugar &lt;126 mg/dL).&#xD;
&#xD;
          -  No evidence of dementia (MMSE score &gt; 25).&#xD;
&#xD;
          -  No evidence of depression. (Geriatric Depression Scale-15 [GDS-15] &lt; 6.&#xD;
&#xD;
          -  Are weight stable (&lt; 3 kg weight change in the past three months).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have type 1 or type 2 diabetes currently being treated by medication.&#xD;
&#xD;
          -  Report clinically significant gastrointestinal malabsorption syndromes such as chronic&#xD;
             diarrhea, or celiac disease.&#xD;
&#xD;
          -  Are being treated with medications that have a significant effect on insulin&#xD;
             resistance, obesity, and metabolic rate, or medications that significantly increase&#xD;
             body weight such as antidepressants, second-generation antipsychotics, systemic&#xD;
             glucocorticoids, and adrenergic blockers or stimulators (unless the dose and body&#xD;
             weight have been stable for six months).&#xD;
&#xD;
          -  Have serum triglyceride concentrations &gt; 400 mg/dl.&#xD;
&#xD;
          -  Clinically significant abnormal laboratory markers (as determined by the medical&#xD;
             investigator).&#xD;
&#xD;
          -  Subjects with anticipated surgery during the study period.&#xD;
&#xD;
          -  Subjects with a reported history of substance abuse or alcoholism or significant&#xD;
             psychiatric disorder that would interfere with the ability to complete the study.&#xD;
&#xD;
          -  Subjects who are current smokers or have smoked within the previous three months.&#xD;
             Smoking is not permitted during the study.&#xD;
&#xD;
          -  Subjects who are unable to provide a baseline blood or fecal sample or if they have&#xD;
             any condition that impedes testing of the study hypothesis or makes it unsafe to&#xD;
             consume the food being tested in the study (determined by the investigative team).&#xD;
&#xD;
          -  Women on hormone replacement therapy unless weight has been stable over the last six&#xD;
             months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Candida Rebello, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pennington Biomedical Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pennington Biomedical Research Center</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <results_first_submitted>March 29, 2023</results_first_submitted>
  <results_first_submitted_qc>May 16, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">May 18, 2023</results_first_posted>
  <last_update_submitted>May 16, 2023</last_update_submitted>
  <last_update_submitted_qc>May 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pennington Biomedical Research Center</investigator_affiliation>
    <investigator_full_name>Candida Rebello</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <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>March 4, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT04499482/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 4, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT04499482/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study enrolled 8 subjects. Each subject started at the 10g soy flour dose and crossed over to the 20 g soy flour dose after one week if they tolerated the 10 g soy flour dose, and subsequently to the 30g soy flour dose if they tolerated the 20g soy flour dose.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Foods Containing 10 g Soy Flour</title>
          <description>Participants will receive foods containing 10 g of soy flour to be consumed everyday for one week.&#xD;
Food: Soy-fiber containing food</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Foods Containing 10 g Soy Flour</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>One subject dropped from the study at Day 3 as the subject could not meet the demands of the study</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Foods Containing 20 g Soy Flour</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Foods Containing 30g Soy Flour</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The participant dropped from the study was excluded from the analysis. The data relates to seven participants who were tested for tolerance to the three doses of soy flour</population>
      <group_list>
        <group group_id="B1">
          <title>All Study Participants</title>
          <description>Participants will receive foods containing 10g, 20g, and 30g of soy flour to be consumed everyday for one week at each dose.&#xD;
Food: Soy-fiber containing food</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="7"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>One subject dropped from the study at day 3 of week one and was not included in the analysis</population>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="73" spread="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>One subject dropped from the study at Day 3 of week one and was not included in the analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <population>One subject dropped from the study at Day 3 of week one and was not included in the analysis.</population>
          <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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <population>Each of the seven subjects crossed over to the next treatment</population>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <population>Each of the seven subjects crossed over to the next treatment</population>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Treatment-emergent Adverse Events Following Each Dose of Soy</title>
        <description>Dose safety will be investigated by compiling by treatment (e.g. 10 g dose, 20 g dose, 30 g dose) a list of adverse events such as frequency of headaches, nausea, vomiting. The study physician in consultation with the coordinator will review and determine safety</description>
        <time_frame>One week at each dose</time_frame>
        <population>One subject dropped from the study at Day 3 of week one and was not included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Foods Containing 10 g Soy Flour</title>
            <description>Participants will receive foods containing 10 g of soy flour to be consumed everyday for one week.&#xD;
Food: Soy-fiber containing food</description>
          </group>
          <group group_id="O2">
            <title>Foods Containing 20 g Soy Flour</title>
            <description>Participants will receive foods containing 20 g of soy flour to be consumed everyday for one week.&#xD;
Food: Soy-fiber containing food</description>
          </group>
          <group group_id="O3">
            <title>Foods Containing 30 g Soy Flour</title>
            <description>Participants will receive foods containing 30 g of soy flour to be consumed everyday for one week.&#xD;
Food: Soy-fiber containing food</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-emergent Adverse Events Following Each Dose of Soy</title>
          <description>Dose safety will be investigated by compiling by treatment (e.g. 10 g dose, 20 g dose, 30 g dose) a list of adverse events such as frequency of headaches, nausea, vomiting. The study physician in consultation with the coordinator will review and determine safety</description>
          <population>One subject dropped from the study at Day 3 of week one and was not included in the analysis.</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="7"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>10 g Soy-related Gastrointestinal Symptoms</title>
        <description>Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.</description>
        <time_frame>One week</time_frame>
        <population>One subject dropped from the study at Day 3 of week one and was excluded from the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Foods Containing 10 g Soy Flour</title>
            <description>Participants will receive foods containing 10 g of soy flour to be consumed everyday for one week.&#xD;
Food: Soy-fiber containing food</description>
          </group>
        </group_list>
        <measure>
          <title>10 g Soy-related Gastrointestinal Symptoms</title>
          <description>Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.</description>
          <population>One subject dropped from the study at Day 3 of week one and was excluded from the analysis.</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="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Bloating</title>
              <category_list>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdominal Rumbling</title>
              <category_list>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Flatulence</title>
              <category_list>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdominal Pain</title>
              <category_list>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>20 g Soy-related Gastrointestinal Symptoms</title>
        <description>Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.</description>
        <time_frame>One week</time_frame>
        <population>One subject dropped out of the study on Day 3 of Week 1 and was not included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Foods Containing 20 g Soy Flour</title>
            <description>Participants will receive foods containing 20 g of soy flour to be consumed everyday for one week.&#xD;
Food: Soy-fiber containing food</description>
          </group>
        </group_list>
        <measure>
          <title>20 g Soy-related Gastrointestinal Symptoms</title>
          <description>Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.</description>
          <population>One subject dropped out of the study on Day 3 of Week 1 and was not included in the analysis.</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="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Bloating</title>
              <category_list>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdominal Rumbling</title>
              <category_list>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Flatulence</title>
              <category_list>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdominal pain</title>
              <category_list>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>30 g Soy-related Gastrointestinal Symptoms</title>
        <description>Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.</description>
        <time_frame>One week</time_frame>
        <population>One subject dropped out of the study on Day 3 of Week 1 and was not included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Foods Containing 30 g Soy Flour</title>
            <description>Participants will receive foods containing 30 g of soy flour to be consumed everyday for one week.&#xD;
Food: Soy-fiber containing food</description>
          </group>
        </group_list>
        <measure>
          <title>30 g Soy-related Gastrointestinal Symptoms</title>
          <description>Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.</description>
          <population>One subject dropped out of the study on Day 3 of Week 1 and was not included in the analysis.</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="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Bloating</title>
              <category_list>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdominal Rumbling</title>
              <category_list>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Flatulence</title>
              <category_list>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdominal Pain</title>
              <category_list>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>10 g Soy-related Stool Frequency</title>
        <description>Subjects will complete the stool frequency questionnaire. Stool frequency will be rated from 0 to more than 9 over three consecutive days in each week</description>
        <time_frame>One week</time_frame>
        <population>One subject dropped out of the study on Day 3 of Week 1 and was not included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Foods Containing 10 g Soy Flour</title>
            <description>Participants will receive foods containing 10 g of soy flour to be consumed everyday for one week.&#xD;
Food: Soy-fiber containing food</description>
          </group>
        </group_list>
        <measure>
          <title>10 g Soy-related Stool Frequency</title>
          <description>Subjects will complete the stool frequency questionnaire. Stool frequency will be rated from 0 to more than 9 over three consecutive days in each week</description>
          <population>One subject dropped out of the study on Day 3 of Week 1 and was not included in the analysis.</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="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>1-2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3-4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5-6</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>20 g Soy-related Stool Frequency</title>
        <description>Subjects will complete the stool frequency questionnaire. Stool frequency will be rated from 0 to more than 9 over three consecutive days in each week</description>
        <time_frame>One week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Foods Containing 20 g Soy Flour</title>
            <description>Participants will receive foods containing 20 g of soy flour to be consumed everyday for one week.&#xD;
Food: Soy-fiber containing food</description>
          </group>
        </group_list>
        <measure>
          <title>20 g Soy-related Stool Frequency</title>
          <description>Subjects will complete the stool frequency questionnaire. Stool frequency will be rated from 0 to more than 9 over three consecutive days in each week</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="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>1-2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3-4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5-6</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>30 g Soy-related Stool Frequency</title>
        <description>Subjects will complete the stool frequency questionnaire. Stool frequency will be rated from 0 to more than 9 over three consecutive days in each week</description>
        <time_frame>One week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Foods Containing 30 g Soy Flour</title>
            <description>Participants will receive foods containing 30 g of soy flour to be consumed everyday for one week.&#xD;
Food: Soy-fiber containing food</description>
          </group>
        </group_list>
        <measure>
          <title>30 g Soy-related Stool Frequency</title>
          <description>Subjects will complete the stool frequency questionnaire. Stool frequency will be rated from 0 to more than 9 over three consecutive days in each week</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="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>1-2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3-4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5-6</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>10 Soy-related Stool Consistency</title>
        <description>Subjects will complete a stool consistency questionnaire. Stool consistency will be rated according to the Bristol Stool Scale where scores from three to five will be considered normal and 1, 2, 6, and 7 will be considered abnormal.</description>
        <time_frame>One week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Foods Containing 10 g Soy Flour</title>
            <description>Participants will receive foods containing 10 g of soy flour to be consumed everyday for one week.&#xD;
Food: Soy-fiber containing food</description>
          </group>
        </group_list>
        <measure>
          <title>10 Soy-related Stool Consistency</title>
          <description>Subjects will complete a stool consistency questionnaire. Stool consistency will be rated according to the Bristol Stool Scale where scores from three to five will be considered normal and 1, 2, 6, and 7 will be considered abnormal.</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="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>3, Normal (Like sausage but with cracks)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4, Normal (Like sausage, smooth and soft</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5, Normal (Soft blobs with clear cut edges)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1, Abnormal(Separate hard lumps)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2, Abnormal (Sausage-shaped but lumpy)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>6, Abnormal (Fluffy pieces with ragged edges)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>7, Abnormal (Watery)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>20 g Soy-related Stool Consistency</title>
        <description>Subjects will complete a stool consistency questionnaire. Stool consistency will be rated according to the Bristol Stool Scale where scores from three to five will be considered normal and 1, 2, 6, and 7 will be considered abnormal.</description>
        <time_frame>One week</time_frame>
        <population>One subject was dropped from the study on Day 3 of week 1 and was not included in the analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Foods Containing 20 g Soy Flour</title>
            <description>Participants will receive foods containing 20 g of soy flour to be consumed everyday for one week.&#xD;
Food: Soy-fiber containing food</description>
          </group>
        </group_list>
        <measure>
          <title>20 g Soy-related Stool Consistency</title>
          <description>Subjects will complete a stool consistency questionnaire. Stool consistency will be rated according to the Bristol Stool Scale where scores from three to five will be considered normal and 1, 2, 6, and 7 will be considered abnormal.</description>
          <population>One subject was dropped from the study on Day 3 of week 1 and was not included in the analysis</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="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>3, Normal (Like a sausage, but with cracks)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4, Normal (Like sausage, smooth and soft)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5, Normal (Soft blobs with clear-cut edges)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1, Abnormal (Separate hard lumps)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2, Abnormal (Sausage-shaped but lumpy)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>6, Abnormal (Fluffy pieces with ragged edges)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>7, Abnormal (Watery)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>30 g Soy-related Stool Consistency</title>
        <description>Subjects will complete a stool consistency questionnaire. Stool consistency will be rated according to the Bristol Stool Scale where scores from three to five will be considered normal and 1, 2, 6, and 7 will be considered abnormal.</description>
        <time_frame>One week</time_frame>
        <population>One subject was dropped from the study at Day 3 and was not included in the analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Foods Containing 30 g Soy Flour</title>
            <description>Participants will receive foods containing 30 g of soy flour to be consumed everyday for one week.&#xD;
Food: Soy-fiber containing food</description>
          </group>
        </group_list>
        <measure>
          <title>30 g Soy-related Stool Consistency</title>
          <description>Subjects will complete a stool consistency questionnaire. Stool consistency will be rated according to the Bristol Stool Scale where scores from three to five will be considered normal and 1, 2, 6, and 7 will be considered abnormal.</description>
          <population>One subject was dropped from the study at Day 3 and was not included in the analysis</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="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>3, Normal (Like a sausage but with cracks)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4, Normal (Like a sausage, smooth and soft)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5, Normal (Soft blobs with clear-cut edges)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1, Abnormal (Separate hard lumps)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2, Abnormal (Sausage-shaped but lumpy)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>6, Abnormal (Fluffy pieces with ragged edges)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>7, Abnormal (Watery)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>10 g Soy Intake Effect on Fecal Short Chain Fatty Acids</title>
        <description>Measurement of fecal short chain fatty acids in response to intake of soy</description>
        <time_frame>One week</time_frame>
        <population>One subject was dropped from the study at Day 3 and was excluded from the analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Foods Containing 10 g Soy Flour</title>
            <description>Participants will receive foods containing 10 g of soy flour to be consumed everyday for one week.&#xD;
Food: Soy-fiber containing food</description>
          </group>
        </group_list>
        <measure>
          <title>10 g Soy Intake Effect on Fecal Short Chain Fatty Acids</title>
          <description>Measurement of fecal short chain fatty acids in response to intake of soy</description>
          <population>One subject was dropped from the study at Day 3 and was excluded from the analysis</population>
          <units>mg fecal short chain fatty acids/g dry f</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5736.93" spread="1615.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>20 g Soy Intake Effect on Fecal Short Chain Fatty Acids</title>
        <description>Measurement of fecal short chain fatty acids in response to intake of soy</description>
        <time_frame>One week</time_frame>
        <population>One subject was dropped from the study at Day 3 and was excluded from the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Foods Containing 20 g Soy Flour</title>
            <description>Participants will receive foods containing 20 g of soy flour to be consumed everyday for one week.&#xD;
Food: Soy-fiber containing food</description>
          </group>
        </group_list>
        <measure>
          <title>20 g Soy Intake Effect on Fecal Short Chain Fatty Acids</title>
          <description>Measurement of fecal short chain fatty acids in response to intake of soy</description>
          <population>One subject was dropped from the study at Day 3 and was excluded from the analysis.</population>
          <units>mg fecal short chain fatty acids/g dry f</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6577.87" spread="1615.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>30 g Soy Intake Effect on Fecal Short Chain Fatty Acids</title>
        <description>Measurement of fecal short chain fatty acids in response to intake of soy</description>
        <time_frame>One week</time_frame>
        <population>One subject was dropped from the study at Day 3 and was excluded from the analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Foods Containing 30 g Soy Flour</title>
            <description>Participants will receive foods containing 30 g of soy flour to be consumed everyday for one week.&#xD;
Food: Soy-fiber containing food</description>
          </group>
        </group_list>
        <measure>
          <title>30 g Soy Intake Effect on Fecal Short Chain Fatty Acids</title>
          <description>Measurement of fecal short chain fatty acids in response to intake of soy</description>
          <population>One subject was dropped from the study at Day 3 and was excluded from the analysis</population>
          <units>mg fecal short chain fatty acids/g dry f</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6191.89" spread="1615.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>One week at each dose</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Foods Containing 10g Soy Flour</title>
          <description>Participants will receive foods containing 10 g of soy flour to be consumed everyday for one week.&#xD;
Food: Soy-fiber containing food</description>
        </group>
        <group group_id="E2">
          <title>Foods Containing 20g Soy Flour</title>
          <description>Participants will receive foods containing 20 g of soy flour to be consumed everyday for one week.&#xD;
Food: Soy-fiber containing food</description>
        </group>
        <group group_id="E3">
          <title>Foods Containing 30g Soy Flour</title>
          <description>Participants will receive foods containing 30 g of soy flour to be consumed everyday for one week.&#xD;
Food: Soy-fiber containing food</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="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
              </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="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>flatulence</sub_title>
                <description>Mild flatulence</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <description>Mild constipation</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </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>Dr. Candida Rebello</name_or_title>
      <organization>Pennington Biomedical Research Center</organization>
      <phone>2252882411</phone>
      <email>Candida.Rebello@pbrc.edu</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/NCT04499482
org study id: PBRC 2020-010
secondary id: 1K99AG065419-01A1
nct id: NCT04499482
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a dose escalation trial in the elderly with obesity to determine the maximum
      tolerated dose of a novel dietary fiber from whole young soy pods (soy) delivered in foods.
The tolerability to 10 g, 20 g, and 30 g of soy will be tested. At each dose, eight subjects
      will incorporate the foods containing soy into their usual diet for one week. The
      tolerability to each dose will be evaluated and fecal short chain fatty acids will be
      measured as a biomarker of compliance. Subjects who satisfy the eligibility criteria and
      express willingness to consume the study foods will be enrolled.
allocation: Non-Randomized
intervention model: Crossover Assignment
intervention model description: Dose escalating cross over trial
primary purpose: Other
masking: None (Open Label)
measure: Number of Participants With Treatment-emergent Adverse Events Following Each Dose of Soy
time frame: One week at each dose
description: Dose safety will be investigated by compiling by treatment (e.g. 10 g dose, 20 g dose, 30 g dose) a list of adverse events such as frequency of headaches, nausea, vomiting. The study physician in consultation with the coordinator will review and determine safety
measure: 10 g Soy-related Gastrointestinal Symptoms
time frame: One week
description: Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.
measure: 20 g Soy-related Gastrointestinal Symptoms
time frame: One week
description: Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.
measure: 30 g Soy-related Gastrointestinal Symptoms
time frame: One week
description: Subjects will complete a gastrointestinal symptoms questionnaire. The ratings are none, mild, moderate, and severe.
measure: 10 g Soy-related Stool Frequency
time frame: One week
description: Subjects will complete the stool frequency questionnaire. Stool frequency will be rated from 0 to more than 9 over three consecutive days in each week
measure: 20 g Soy-related Stool Frequency
time frame: One week
description: Subjects will complete the stool frequency questionnaire. Stool frequency will be rated from 0 to more than 9 over three consecutive days in each week
measure: 30 g Soy-related Stool Frequency
time frame: One week
description: Subjects will complete the stool frequency questionnaire. Stool frequency will be rated from 0 to more than 9 over three consecutive days in each week
measure: 10 Soy-related Stool Consistency
time frame: One week
description: Subjects will complete a stool consistency questionnaire. Stool consistency will be rated according to the Bristol Stool Scale where scores from three to five will be considered normal and 1, 2, 6, and 7 will be considered abnormal.
measure: 20 g Soy-related Stool Consistency
time frame: One week
description: Subjects will complete a stool consistency questionnaire. Stool consistency will be rated according to the Bristol Stool Scale where scores from three to five will be considered normal and 1, 2, 6, and 7 will be considered abnormal.
measure: 30 g Soy-related Stool Consistency
time frame: One week
description: Subjects will complete a stool consistency questionnaire. Stool consistency will be rated according to the Bristol Stool Scale where scores from three to five will be considered normal and 1, 2, 6, and 7 will be considered abnormal.
measure: 10 g Soy Intake Effect on Fecal Short Chain Fatty Acids
time frame: One week
description: Measurement of fecal short chain fatty acids in response to intake of soy
measure: 20 g Soy Intake Effect on Fecal Short Chain Fatty Acids
time frame: One week
description: Measurement of fecal short chain fatty acids in response to intake of soy
measure: 30 g Soy Intake Effect on Fecal Short Chain Fatty Acids
time frame: One week
description: Measurement of fecal short chain fatty acids in response to intake of soy
arm group label: Foods containing 10 g soy flour
arm group type: Experimental
description: Participants will receive foods containing 10 g of soy flour to be consumed everyday for one week. If they tolerate the dose, they will receive the next dose without any wash-out period.
arm group label: Foods containing 20 g soy flour
arm group type: Experimental
description: Participants will receive foods containing 20 g of soy flour to be consumed everyday for one week. If they tolerate the dose, they will receive the next dose without any wash-out period.
arm group label: Foods containing 30 g soy flour
arm group type: Experimental
description: Participants will receive foods containing 30 g of soy flour to be consumed everyday for one week.
intervention type: Other
intervention name: Food
description: Soy-fiber containing food
arm group label: Foods containing 10 g soy flour
arm group label: Foods containing 20 g soy flour
arm group label: Foods containing 30 g soy flour
criteria: 
gender: All
minimum age: 70 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Candida Rebello, Ph.D.
role: Principal Investigator
affiliation: Pennington Biomedical Research Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Pennington Biomedical Research Center
investigator full name: Candida Rebello
investigator title: Assistant Professor
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 