<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/NCT02999321</url>
  </required_header>
  <id_info>
    <org_study_id>055-045</org_study_id>
    <nct_id>NCT02999321</nct_id>
  </id_info>
  <brief_title>The Effects of Aspartame on Appetite, Body Composition and Oral Glucose Tolerance</brief_title>
  <official_title>The Effects of Aspartame on Appetite, Body Composition and Oral Glucose Tolerance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Purdue University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ajinomoto USA, INC.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Purdue University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Assess the impact of chronic use of aspartame on glycemia, appetite and body composition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be randomly assigned to one of three parallel arms: 0% (water), 5 mg, 15mg&#xD;
      aspartame. Participants will have an oral glucose tolerance test at the beginning and end of&#xD;
      a 12 week intervention. . Participants will report to the lab weekly for 12 weeks to pick up&#xD;
      their next week's intervention products and measurements for body weight, waist&#xD;
      circumference, blood pressure and heart rate. They will consume their intervention products&#xD;
      daily for 12 weeks. They will record appetite sensations and collect a 24 hour urine sample&#xD;
      at weeks 0, 4, 8, and 12.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 17, 2016</start_date>
  <completion_date type="Actual">May 5, 2017</completion_date>
  <primary_completion_date type="Actual">May 5, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change oral glucose tolerance</measure>
    <time_frame>week 0 4 hours</time_frame>
    <description>sample taken at time point 0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change oral glucose tolerance</measure>
    <time_frame>week 0 4 hours</time_frame>
    <description>sample taken at time point 15 minutes post glucola</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change oral glucose tolerance</measure>
    <time_frame>week 0 4 hours</time_frame>
    <description>sample taken at time point 30 minutes post glucola</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change oral glucose tolerance</measure>
    <time_frame>week 0 4 hours</time_frame>
    <description>sample taken at time point 60 minutes post glucola</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change oral glucose tolerance</measure>
    <time_frame>week 0 4 hours</time_frame>
    <description>sample taken at time point 90 minutes post glucola</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change oral glucose tolerance</measure>
    <time_frame>week 0 4 hours</time_frame>
    <description>sample taken at time point 120 minutes post glucola</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change oral glucose tolerance</measure>
    <time_frame>week 0 4 hours</time_frame>
    <description>sample taken at time point 180 minutes post glucola</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change oral glucose tolerance</measure>
    <time_frame>week 0 4 hours</time_frame>
    <description>sample taken at time point 240 minutes post glucola</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change oral glucose tolerance</measure>
    <time_frame>week 12 4 hours</time_frame>
    <description>sample taken at time point 0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change oral glucose tolerance</measure>
    <time_frame>week 12 4 hours</time_frame>
    <description>sample taken at time point 15 minutes post glucola</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change oral glucose tolerance</measure>
    <time_frame>week 12 4 hours</time_frame>
    <description>sample taken at time point 30 minutes post glucola</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change oral glucose tolerance</measure>
    <time_frame>week 12 4 hours</time_frame>
    <description>sample taken at time point 60 minutes post glucola</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change oral glucose tolerance</measure>
    <time_frame>week 12 4 hours</time_frame>
    <description>sample taken at time point 90 minutes post glucola</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change oral glucose tolerance</measure>
    <time_frame>week 12 4 hours</time_frame>
    <description>sample taken at time point 120 minutes post glucola</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change oral glucose tolerance</measure>
    <time_frame>week 12 4 hours</time_frame>
    <description>sample taken at time point 180 minutes post glucola</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change oral glucose tolerance</measure>
    <time_frame>week 12 4 hours</time_frame>
    <description>sample taken at time point 240 minutes post glucola</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Appetite</measure>
    <time_frame>every hour for 1 day at week 0</time_frame>
    <description>questionnaire on hunger, fullness, desire to eat, prospective consumption, thirst taken hourly for one day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appetite</measure>
    <time_frame>every hour for 1 day at week 4</time_frame>
    <description>questionnaire on hunger, fullness, desire to eat, prospective consumption, thirst taken hourly for one day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appetite</measure>
    <time_frame>every hour for 1 day at week 8</time_frame>
    <description>questionnaire on hunger, fullness, desire to eat, prospective consumption, thirst taken hourly for one day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appetite</measure>
    <time_frame>every hour for 1 day at week 12</time_frame>
    <description>questionnaire on hunger, fullness, desire to eat, prospective consumption, thirst taken hourly for one day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition</measure>
    <time_frame>week 0</time_frame>
    <description>body composition measurement Plysmography (BOD POD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition</measure>
    <time_frame>week 12</time_frame>
    <description>body composition measurement Plysmography (BOD POD)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">93</enrollment>
  <condition>Oral Glucose Tolerance</condition>
  <arm_group>
    <arm_group_label>0% aspartame (water)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>participants will not have any aspartame, this is a control.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>5 mg aspartame</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>participants will receive 5 mg aspartame in a beverage.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>15mg aspartame</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>participants will receive 5 mg aspartame in a beverage, and 10mg in capsules.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>aspartame</intervention_name>
    <description>will be given 5mg aspartame or 15 mg aspartame</description>
    <arm_group_label>15mg aspartame</arm_group_label>
    <arm_group_label>5 mg aspartame</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>water</intervention_name>
    <description>control group</description>
    <arm_group_label>0% aspartame (water)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI 18-25&#xD;
&#xD;
          -  Fasting blood sugar between 72 and 108 mg/dl via capillary finger-stick.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard D Mattes, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Purdue University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Purdue Univeristy</name>
      <address>
        <city>West Lafayette</city>
        <state>Indiana</state>
        <zip>47907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>January 16, 2018</last_update_submitted>
  <last_update_submitted_qc>January 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Purdue University</investigator_affiliation>
    <investigator_full_name>Richard Mattes</investigator_full_name>
    <investigator_title>Professor of Nutrition Sciences</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02999321
org study id: 055-045
nct id: NCT02999321
lead sponsor: 
collaborator: 
has dmc: No
Assess the impact of chronic use of aspartame on glycemia, appetite and body composition.
Participants will be randomly assigned to one of three parallel arms: 0% (water), 5 mg, 15mg
      aspartame. Participants will have an oral glucose tolerance test at the beginning and end of
      a 12 week intervention. . Participants will report to the lab weekly for 12 weeks to pick up
      their next week's intervention products and measurements for body weight, waist
      circumference, blood pressure and heart rate. They will consume their intervention products
      daily for 12 weeks. They will record appetite sensations and collect a 24 hour urine sample
      at weeks 0, 4, 8, and 12.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: change oral glucose tolerance
time frame: week 0 4 hours
description: sample taken at time point 0
measure: change oral glucose tolerance
time frame: week 0 4 hours
description: sample taken at time point 15 minutes post glucola
measure: change oral glucose tolerance
time frame: week 0 4 hours
description: sample taken at time point 30 minutes post glucola
measure: change oral glucose tolerance
time frame: week 0 4 hours
description: sample taken at time point 60 minutes post glucola
measure: change oral glucose tolerance
time frame: week 0 4 hours
description: sample taken at time point 90 minutes post glucola
measure: change oral glucose tolerance
time frame: week 0 4 hours
description: sample taken at time point 120 minutes post glucola
measure: change oral glucose tolerance
time frame: week 0 4 hours
description: sample taken at time point 180 minutes post glucola
measure: change oral glucose tolerance
time frame: week 0 4 hours
description: sample taken at time point 240 minutes post glucola
measure: change oral glucose tolerance
time frame: week 12 4 hours
description: sample taken at time point 0
measure: change oral glucose tolerance
time frame: week 12 4 hours
description: sample taken at time point 15 minutes post glucola
measure: change oral glucose tolerance
time frame: week 12 4 hours
description: sample taken at time point 30 minutes post glucola
measure: change oral glucose tolerance
time frame: week 12 4 hours
description: sample taken at time point 60 minutes post glucola
measure: change oral glucose tolerance
time frame: week 12 4 hours
description: sample taken at time point 90 minutes post glucola
measure: change oral glucose tolerance
time frame: week 12 4 hours
description: sample taken at time point 120 minutes post glucola
measure: change oral glucose tolerance
time frame: week 12 4 hours
description: sample taken at time point 180 minutes post glucola
measure: change oral glucose tolerance
time frame: week 12 4 hours
description: sample taken at time point 240 minutes post glucola
measure: Appetite
time frame: every hour for 1 day at week 0
description: questionnaire on hunger, fullness, desire to eat, prospective consumption, thirst taken hourly for one day.
measure: Appetite
time frame: every hour for 1 day at week 4
description: questionnaire on hunger, fullness, desire to eat, prospective consumption, thirst taken hourly for one day
measure: Appetite
time frame: every hour for 1 day at week 8
description: questionnaire on hunger, fullness, desire to eat, prospective consumption, thirst taken hourly for one day
measure: Appetite
time frame: every hour for 1 day at week 12
description: questionnaire on hunger, fullness, desire to eat, prospective consumption, thirst taken hourly for one day
measure: Body composition
time frame: week 0
description: body composition measurement Plysmography (BOD POD)
measure: Body composition
time frame: week 12
description: body composition measurement Plysmography (BOD POD)
arm group label: 0% aspartame (water)
arm group type: Experimental
description: participants will not have any aspartame, this is a control.
arm group label: 5 mg aspartame
arm group type: Experimental
description: participants will receive 5 mg aspartame in a beverage.
arm group label: 15mg aspartame
arm group type: Experimental
description: participants will receive 5 mg aspartame in a beverage, and 10mg in capsules.
intervention type: Other
intervention name: aspartame
description: will be given 5mg aspartame or 15 mg aspartame
arm group label: 15mg aspartame
arm group label: 5 mg aspartame
intervention type: Other
intervention name: water
description: control group
arm group label: 0% aspartame (water)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Richard D Mattes, PhD
role: Principal Investigator
affiliation: Purdue University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Purdue University
investigator full name: Richard Mattes
investigator title: Professor of Nutrition Sciences
sharing ipd: Undecided