<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/NCT01731197</url>
  </required_header>
  <id_info>
    <org_study_id>GIL-1245</org_study_id>
    <nct_id>NCT01731197</nct_id>
  </id_info>
  <brief_title>Satiating Effects of Isolated Soy Proteins</brief_title>
  <official_title>Comparison of the Satiating Effects of Differentially Processed Isolated Soy Proteins</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>DuPont Nutrition and Health</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>DuPont Nutrition and Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Proteins are known to be more satiating than the other macronutrients; however, the type and&#xD;
      amount of protein needed to induce a significant effect on satiety (fullness between meals)&#xD;
      is sometimes difficult to determine. In this study, 2 differentially processed isolated soy&#xD;
      proteins will be tested for satiety using subjective visual analogue scales. The amount of&#xD;
      food consumed following intake of the isolated soy proteins will be measured 3 hours after&#xD;
      consuming the proteins. The hypothesis is that differentially processed isolated soy proteins&#xD;
      will show unique satiety responses.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Subjective Satiety</measure>
    <time_frame>3 hours</time_frame>
    <description>Measure subjective satiety using visual analogue scales</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ad Libitum Food Intake</measure>
    <time_frame>30 minutes</time_frame>
    <description>At the end of 3 hours after consuming test diets, measure the amount of food consumed for 30 mins</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Weight Management</condition>
  <arm_group>
    <arm_group_label>Test ISP-10</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 grams of the test ISP will be consumed as a dry-blended beverage</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test ISP-20</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 grams of the test ISP will be consumed as a dry-blended beverage</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control ISP-10</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>10 grams of the control ISP will be consumed as a dry-blended beverage</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control ISP-20</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20 grams of the control ISP will be consumed as a dry-blended beverage</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Dry-Blended Beverage</intervention_name>
    <arm_group_label>Control ISP-10</arm_group_label>
    <arm_group_label>Control ISP-20</arm_group_label>
    <arm_group_label>Test ISP-10</arm_group_label>
    <arm_group_label>Test ISP-20</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI between 20 and 30 kg/m2&#xD;
&#xD;
          -  Age between 18-65y&#xD;
&#xD;
          -  Unrestrained eater (score&lt;12)&#xD;
&#xD;
          -  Regularly consume 3 meals per day&#xD;
&#xD;
          -  Moderate exercise (eg running, aerobics classes, other sports activities) of no more&#xD;
             than 7 hours per week&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  use of drugs that influence carbohydrate or lipid metabolism (eg. hypoglycemic agents,&#xD;
             antibiotics taken less than 6 weeks before study entry, glucocorticoids,&#xD;
             anti-diarrheal medication, weight loss medication, and anti-diabetic medication)&#xD;
&#xD;
          -  presence of any significant disease (eg gastrointestinal diseases, diabetes, a CVD&#xD;
             event less than 12 weeks from study entry, current hepatic disease, etc)&#xD;
&#xD;
          -  use of special dietary treatments within 4 weeks of study (eg weight loss diet,&#xD;
             extremely high or low carbohydrate/protein/fat diet, use of meal replacements more&#xD;
             than once a day)&#xD;
&#xD;
          -  use of supplements within 1 week of study (does not include vitamin supplements or&#xD;
             supplements which are routinely taken and were initiated 4 weeks before the study and&#xD;
             which will be continued during the study period)&#xD;
&#xD;
          -  restrained eater (score&gt;12)&#xD;
&#xD;
          -  weight change (absolute body weight change of ≥ 10%) within the previous 6 weeks&#xD;
&#xD;
          -  alcohol intake &gt;2 drinks/day&#xD;
&#xD;
          -  food allergies of any kind&#xD;
&#xD;
          -  swallowing difficulties&#xD;
&#xD;
          -  exercising more than 7 hours per week&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Wolever, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Glycemic Index Laboratories, Inc</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alexandra Jenkins, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Glycemic Index Laboratories, Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Glycemic Index Laboratories</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5C2N8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>November 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>October 3, 2019</last_update_submitted>
  <last_update_submitted_qc>October 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>obesity, isolated soy protein, satiety, food intake</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01731197
org study id: GIL-1245
nct id: NCT01731197
lead sponsor: 
has dmc: No
Proteins are known to be more satiating than the other macronutrients; however, the type and
      amount of protein needed to induce a significant effect on satiety (fullness between meals)
      is sometimes difficult to determine. In this study, 2 differentially processed isolated soy
      proteins will be tested for satiety using subjective visual analogue scales. The amount of
      food consumed following intake of the isolated soy proteins will be measured 3 hours after
      consuming the proteins. The hypothesis is that differentially processed isolated soy proteins
      will show unique satiety responses.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Subjective Satiety
time frame: 3 hours
description: Measure subjective satiety using visual analogue scales
measure: Ad Libitum Food Intake
time frame: 30 minutes
description: At the end of 3 hours after consuming test diets, measure the amount of food consumed for 30 mins
arm group label: Test ISP-10
arm group type: Experimental
description: 10 grams of the test ISP will be consumed as a dry-blended beverage
arm group label: Test ISP-20
arm group type: Experimental
description: 20 grams of the test ISP will be consumed as a dry-blended beverage
arm group label: Control ISP-10
arm group type: Active Comparator
description: 10 grams of the control ISP will be consumed as a dry-blended beverage
arm group label: Control ISP-20
arm group type: Active Comparator
description: 20 grams of the control ISP will be consumed as a dry-blended beverage
intervention type: Dietary Supplement
intervention name: Dry-Blended Beverage
arm group label: Control ISP-10
arm group label: Control ISP-20
arm group label: Test ISP-10
arm group label: Test ISP-20
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Thomas Wolever, MD
role: Principal Investigator
affiliation: Glycemic Index Laboratories, Inc
last name: Alexandra Jenkins, PhD
role: Principal Investigator
affiliation: Glycemic Index Laboratories, Inc
facility: 
country: Canada
responsible party type: Sponsor