<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/NCT01680315</url>
  </required_header>
  <id_info>
    <org_study_id>PH2012</org_study_id>
    <nct_id>NCT01680315</nct_id>
  </id_info>
  <brief_title>Calorie Anticipation and Food Intake</brief_title>
  <official_title>Differences in Physiological Responses of Satiety and Reward After (in)Consistent Calorie Cues.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Uppsala University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Uppsala University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The regulation of our food intake is on the short-term guided by appetite and satiety signals&#xD;
      generated by the sight and consumption of food. Food intake is not only regulated by appetite&#xD;
      and satiety signals - external cues also play an important role.&#xD;
&#xD;
      It has been observed that food intake and the pleasure derived from consumption is affected&#xD;
      by manipulation of the external cues.&#xD;
&#xD;
      The investigators will assess the contribution of food anticipation (calorie information) and&#xD;
      actual consumption of a test food (calorie intake) on in satiety responses (such as ghrelin&#xD;
      responses, appetite and subsequent food intake). The investigators expect the information on&#xD;
      the amount of calories, rather than the actual amount of calories in the food, to predict the&#xD;
      ghrelin responses and the subsequent intake of a second meal.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In a randomized cross-over design with 4 conditions, all participants will consume twice the&#xD;
      low-caloric food (once with the low-calorie information and once with the high-calorie&#xD;
      information) and twice the high-caloric food (again, once with the low-calorie information&#xD;
      and once with the high-calorie information) in a randomized order.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">July 2012</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>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Food intake</measure>
    <time_frame>60 min (Ad libitum test meal after 1 hr)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum concentrations total ghrelin</measure>
    <time_frame>60 min (4 samples - every 20 min)</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>appetite ratings</measure>
    <time_frame>80 min (5 samples - every 20 min)</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Serum cortisol concentrations</measure>
    <time_frame>60 min (4 samples - every 20 min)</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Eating Behaviour</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Calorie information</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low calorie yogurt&#xD;
High calorie yogurt&#xD;
with low calorie information sheet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Calorie information (high)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low calorie yogurt&#xD;
High calorie yogurt&#xD;
High calorie information sheet</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>low calorie yogurt</intervention_name>
    <description>all participants consumed twice the low-caloric food (once with the low-calorie information and once with the high-calorie information)</description>
    <arm_group_label>Calorie information</arm_group_label>
    <arm_group_label>Calorie information (high)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>high calorie yogurt</intervention_name>
    <description>all participants consumed twice the high-caloric food (once with the low-calorie information and once with the high-calorie information)</description>
    <arm_group_label>Calorie information</arm_group_label>
    <arm_group_label>Calorie information (high)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  female&#xD;
&#xD;
          -  healthy&#xD;
&#xD;
          -  being used to eat breakfast regularly (≥ 5 times a week).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hypersensitivity for the ingredients of the foods under study;&#xD;
&#xD;
          -  lack of appetite; following an energy-restricted diet or change in body weight &gt; 5 kg;&#xD;
             or&#xD;
&#xD;
          -  being a vegan or vegetarian. Participants reported not using products that are&#xD;
             artificially sweetened, nor sugar in coffee and/or tea.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pleunie Hogenkamp, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Uppsala University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uppsala University</name>
      <address>
        <city>Uppsala</city>
        <zip>75319</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>September 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>September 3, 2012</last_update_submitted>
  <last_update_submitted_qc>September 3, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 7, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Satiety,</keyword>
  <keyword>satiation,</keyword>
  <keyword>anticipation,</keyword>
  <keyword>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/NCT01680315
org study id: PH2012
nct id: NCT01680315
lead sponsor: 
has dmc: No
The regulation of our food intake is on the short-term guided by appetite and satiety signals
      generated by the sight and consumption of food. Food intake is not only regulated by appetite
      and satiety signals - external cues also play an important role.

      It has been observed that food intake and the pleasure derived from consumption is affected
      by manipulation of the external cues.

      The investigators will assess the contribution of food anticipation (calorie information) and
      actual consumption of a test food (calorie intake) on in satiety responses (such as ghrelin
      responses, appetite and subsequent food intake). The investigators expect the information on
      the amount of calories, rather than the actual amount of calories in the food, to predict the
      ghrelin responses and the subsequent intake of a second meal.
In a randomized cross-over design with 4 conditions, all participants will consume twice the
      low-caloric food (once with the low-calorie information and once with the high-calorie
      information) and twice the high-caloric food (again, once with the low-calorie information
      and once with the high-calorie information) in a randomized order.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Food intake
time frame: 60 min (Ad libitum test meal after 1 hr)
measure: Serum concentrations total ghrelin
time frame: 60 min (4 samples - every 20 min)
measure: appetite ratings
time frame: 80 min (5 samples - every 20 min)
measure: Serum cortisol concentrations
time frame: 60 min (4 samples - every 20 min)
arm group label: Calorie information
arm group type: Experimental
description: Low calorie yogurt
High calorie yogurt
with low calorie information sheet
arm group label: Calorie information (high)
arm group type: Experimental
description: Low calorie yogurt
High calorie yogurt
High calorie information sheet
intervention type: Behavioral
intervention name: low calorie yogurt
description: all participants consumed twice the low-caloric food (once with the low-calorie information and once with the high-calorie information)
arm group label: Calorie information
arm group label: Calorie information (high)
intervention type: Behavioral
intervention name: high calorie yogurt
description: all participants consumed twice the high-caloric food (once with the low-calorie information and once with the high-calorie information)
arm group label: Calorie information
arm group label: Calorie information (high)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pleunie Hogenkamp, PhD
role: Principal Investigator
affiliation: Uppsala University
facility: 
country: Sweden
responsible party type: Sponsor