<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/NCT01713114</url>
  </required_header>
  <id_info>
    <org_study_id>PRV1223</org_study_id>
    <nct_id>NCT01713114</nct_id>
  </id_info>
  <brief_title>Effects of a Variety of Meals on Satiety</brief_title>
  <official_title>A Randomized, Controlled Crossover Trial to Assess the Effects of Varying Meals on Satiety</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hillshire Brands Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Biofortis Clinical Research, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>The Hillshire Brands Company</source>
  <brief_summary>
    <textblock>
      The primary objective of this study is to assess the acute effects of different meals on&#xD;
      satiety. It is hypothesized that a lower carbohydrate meal will result in greater feelings of&#xD;
      satiety and reduced food intake at a subsequent meal compared to the higher-carbohydrate or&#xD;
      meal skipping conditions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Satiety refers to feelings of fullness or lack of desire to eat following consumption of a&#xD;
      food or meal. A number of dietary factors have been shown to influence satiety, including&#xD;
      food volume, food weight, energy density, food palatability, and certain food ingredients.&#xD;
      The nutritional composition of a meal appears to also play a significant role in an&#xD;
      individual's feelings of satiety and ability to stay full until the next meal.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <primary_completion_date type="Anticipated">August 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>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite Area under the Curve - Visual Analog Scale</measure>
    <time_frame>Acute - up to 4 hrs</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Individual satiety measures - Area under the curve</measure>
    <time_frame>4 hrs</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Differences between test conditions in food intake, energy intake and areas under the curve.</measure>
    <time_frame>4 hrs</time_frame>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">38</enrollment>
  <condition>Focus of the Study is Satiety</condition>
  <arm_group>
    <arm_group_label>Low carbohydrate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Moderate carbohydrate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Higher Carbohydrate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Meal Skipping</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Acute measures of satiety and food intake at next meal</intervention_name>
    <arm_group_label>Higher Carbohydrate</arm_group_label>
    <arm_group_label>Low carbohydrate</arm_group_label>
    <arm_group_label>Meal Skipping</arm_group_label>
    <arm_group_label>Moderate carbohydrate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  premenopausal Females&#xD;
&#xD;
          -  Ages 18-55&#xD;
&#xD;
          -  BMI between 18.5-29.9&#xD;
&#xD;
          -  Willing to maintain weight throughout study period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has a history of any surgical intervention for the treatment of obesity&#xD;
&#xD;
          -  Recent history or use of weight loss drugs, herbal supplements or on a dieting program&#xD;
             or trying to loose weight&#xD;
&#xD;
          -  Gains or loses more than 6 pounds over the study period&#xD;
&#xD;
          -  Current or history of an eating disorder&#xD;
&#xD;
          -  Restrained eater&#xD;
&#xD;
          -  Excludes any foods or meals from their diet&#xD;
&#xD;
          -  History or presence of clinically important cardiac, renal, hepatic, endocrine,&#xD;
             pulmonary, gastrointestinal, biliary, pancreatic or neurologic disorders&#xD;
&#xD;
          -  Signs of an infection&#xD;
&#xD;
          -  Heavy user of caffeine or alcohol&#xD;
&#xD;
          -  Unconventional sleep patterns (e.g. works 3rd shift)&#xD;
&#xD;
          -  Subject is pregnant or planning to become pregnant during the study period&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Biofortis Clinical Research</name>
      <address>
        <city>Addison</city>
        <state>Illinois</state>
        <zip>60101</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Lawless, MD</last_name>
      <email>Andrea.Lawless@mxns.com</email>
    </contact>
    <contact_backup>
      <last_name>Kristen Sanoshy</last_name>
      <email>kristen.sanoshy@mxns.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <last_update_submitted>October 22, 2012</last_update_submitted>
  <last_update_submitted_qc>October 22, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 24, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01713114
org study id: PRV1223
nct id: NCT01713114
lead sponsor: 
collaborator: 
The primary objective of this study is to assess the acute effects of different meals on
      satiety. It is hypothesized that a lower carbohydrate meal will result in greater feelings of
      satiety and reduced food intake at a subsequent meal compared to the higher-carbohydrate or
      meal skipping conditions.
Satiety refers to feelings of fullness or lack of desire to eat following consumption of a
      food or meal. A number of dietary factors have been shown to influence satiety, including
      food volume, food weight, energy density, food palatability, and certain food ingredients.
      The nutritional composition of a meal appears to also play a significant role in an
      individual's feelings of satiety and ability to stay full until the next meal.
allocation: Randomized
intervention model: Crossover Assignment
masking: Double (Participant, Outcomes Assessor)
measure: Composite Area under the Curve - Visual Analog Scale
time frame: Acute - up to 4 hrs
measure: Individual satiety measures - Area under the curve
time frame: 4 hrs
measure: Differences between test conditions in food intake, energy intake and areas under the curve.
time frame: 4 hrs
arm group label: Low carbohydrate
arm group type: Experimental
arm group label: Moderate carbohydrate
arm group type: Experimental
arm group label: Higher Carbohydrate
arm group type: Experimental
arm group label: Meal Skipping
arm group type: Placebo Comparator
intervention type: Other
intervention name: Acute measures of satiety and food intake at next meal
arm group label: Higher Carbohydrate
arm group label: Low carbohydrate
arm group label: Meal Skipping
arm group label: Moderate carbohydrate
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor