<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/NCT02259023</url>
  </required_header>
  <id_info>
    <org_study_id>DFS2014</org_study_id>
    <nct_id>NCT02259023</nct_id>
  </id_info>
  <brief_title>Discretionary Food Sources and Stress Perception</brief_title>
  <official_title>Discretionary Food Sources and Stress Perception</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Minnesota</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose:&#xD;
&#xD;
      The objective of this study is to determine the effect different sources and forms of&#xD;
      discretionary foods have on stress perception in healthy adults in a free living, real world&#xD;
      setting.&#xD;
&#xD;
      Rationale:&#xD;
&#xD;
      The rationale for conducting this study is to test the effects of sugar-sweetened beverages&#xD;
      and grain-based desserts have on perceived health and stress perception, since the evidence&#xD;
      for this topic is limited.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <start_date>February 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stress Perception</measure>
    <time_frame>12 weeks</time_frame>
    <description>A questionnaire adapted from the SF-12 will be used to measure stress perception.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body Weight</measure>
    <time_frame>12 weeks</time_frame>
    <description>A digital scale will be used to measure body weight.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Stress Perception</condition>
  <condition>Discretionary Calories</condition>
  <condition>Over All Health</condition>
  <arm_group>
    <arm_group_label>Liquid: Sugar sweetened beverage consumption</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Consumption of sugar-sweetened beverages</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Solid: Grain based desserts and candy consumption</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Consumption of grain based desserts and/or candy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Liquid: Sugar sweetened beverage consumption</intervention_name>
    <description>Sugar sweetened beverage consumption</description>
    <arm_group_label>Liquid: Sugar sweetened beverage consumption</arm_group_label>
    <arm_group_label>Solid: Grain based desserts and candy consumption</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Solid: Grain based desserts and candy consumption</intervention_name>
    <description>Grain based desserts and candy consumption</description>
    <arm_group_label>Liquid: Sugar sweetened beverage consumption</arm_group_label>
    <arm_group_label>Solid: Grain based desserts and candy consumption</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults who consume sugar sweetened beverages and grain based desserts and candy on a&#xD;
             regular basis&#xD;
&#xD;
          -  Free from major illnesses or chronic disease&#xD;
&#xD;
          -  Willing to consume amount of beverages and food provided to supplement usual dietary&#xD;
             habits during each period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recently lost a significant amount or looking to lose weight&#xD;
&#xD;
          -  Recently begun a new diet or exercise regimen&#xD;
&#xD;
          -  Pregnant or nursing women&#xD;
&#xD;
          -  Report restrained eater or having less than 51% control over food preparation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew Odegaard, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Minnesota West Bank Office Building</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55454</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>October 24, 2017</last_update_submitted>
  <last_update_submitted_qc>October 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stress Perception</keyword>
  <keyword>Discretionary Calories</keyword>
  <keyword>Health</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/NCT02259023
org study id: DFS2014
nct id: NCT02259023
lead sponsor: 
has dmc: No
Purpose:

      The objective of this study is to determine the effect different sources and forms of
      discretionary foods have on stress perception in healthy adults in a free living, real world
      setting.

      Rationale:

      The rationale for conducting this study is to test the effects of sugar-sweetened beverages
      and grain-based desserts have on perceived health and stress perception, since the evidence
      for this topic is limited.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Stress Perception
time frame: 12 weeks
description: A questionnaire adapted from the SF-12 will be used to measure stress perception.
measure: Body Weight
time frame: 12 weeks
description: A digital scale will be used to measure body weight.
arm group label: Liquid: Sugar sweetened beverage consumption
arm group type: Experimental
description: Consumption of sugar-sweetened beverages
arm group label: Solid: Grain based desserts and candy consumption
arm group type: Experimental
description: Consumption of grain based desserts and/or candy
intervention type: Other
intervention name: Liquid: Sugar sweetened beverage consumption
description: Sugar sweetened beverage consumption
arm group label: Liquid: Sugar sweetened beverage consumption
arm group label: Solid: Grain based desserts and candy consumption
intervention type: Other
intervention name: Solid: Grain based desserts and candy consumption
description: Grain based desserts and candy consumption
arm group label: Liquid: Sugar sweetened beverage consumption
arm group label: Solid: Grain based desserts and candy consumption
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Andrew Odegaard, Ph.D.
role: Principal Investigator
affiliation: University of Minnesota
facility: 
country: United States
responsible party type: Sponsor