<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/NCT03025997</url>
  </required_header>
  <id_info>
    <org_study_id>NL59245.068.16</org_study_id>
    <secondary_id>163042</secondary_id>
    <nct_id>NCT03025997</nct_id>
  </id_info>
  <brief_title>Lipid Encapsulation for Ileal Brake Activation</brief_title>
  <official_title>The Effect of Orally Applied Encapsulated Lipids in Yoghurt on Satiety and Food Intake: a Randomized Single-blind Placebo-controlled Study With Cross-over Design</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wageningen University and Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Maastricht University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the ability of encapsulation of orally applied lipids in a yoghurt snack&#xD;
      to modify ad libitum food intake and satiety, without GI symptoms. Every subject receives two&#xD;
      treatments (active, and placebo) on two different days, following a randomized cross-over&#xD;
      design.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 24, 2017</start_date>
  <completion_date type="Actual">March 31, 2017</completion_date>
  <primary_completion_date type="Actual">March 31, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ad libitum food intake</measure>
    <time_frame>2 hours after yoghurt snack</time_frame>
    <description>t=0: standardized breakfast, t=90 minutes: yoghurt, t=210 minutes: ad libitum food intake</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Satiety feelings</measure>
    <time_frame>Up to 3.5 hours on each of the 2 test days.</time_frame>
    <description>Every 15-30 min, 5 attributes will be measured on a Visual Analogue Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>occurrence and severity of GI symptoms</measure>
    <time_frame>Up to 3.5 hours on each of the 2 test days.</time_frame>
    <description>Every 15-30 min, 4 attributes will be measured on a Visual Analogue Scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Appetite Regulation</condition>
  <arm_group>
    <arm_group_label>Active yoghurt</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Yoghurt snack containing encapsulated lipid</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo yoghurt</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Yoghurt snack containing non-encapsulated lipid&#xD;
+ empty encapsulation matrix</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Active yoghurt</intervention_name>
    <description>Active yoghurt (containing encapsulated lipid) will be ingested after a standardized breakfast, and subsequently satiety and food intake will be measured.</description>
    <arm_group_label>Active yoghurt</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo yoghurt</intervention_name>
    <description>Placebo yoghurt (containing non-encapsulated lipid) will be ingested after a standardized breakfast, and subsequently satiety and food intake will be measured.</description>
    <arm_group_label>Placebo yoghurt</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI between 25-30 kg/m2&#xD;
&#xD;
          -  Voluntary participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Milk (-protein or lactose)- allergy/intolerance&#xD;
&#xD;
          -  History of serious GI complaints/surgeries&#xD;
&#xD;
          -  Pregnancy, lactation&#xD;
&#xD;
          -  Excessive alcohol consumption (&gt;20 per week)&#xD;
&#xD;
          -  Abnormal eating behaviour&#xD;
&#xD;
          -  Intention to stop smoking&#xD;
&#xD;
          -  Reported unexplained weight loss or gain in the month prior to screening&#xD;
&#xD;
          -  Self-admitted HIV-positive state&#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>Adrian AM Masclee, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>azM/UM</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maastricht University</name>
      <address>
        <city>Maastricht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>November 16, 2017</last_update_submitted>
  <last_update_submitted_qc>November 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 29, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/97/NCT03025997/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>November 23, 2017</submitted>
    <returned>August 17, 2018</returned>
  </pending_results>
  <!-- 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/NCT03025997
org study id: NL59245.068.16
secondary id: 163042
nct id: NCT03025997
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study evaluates the ability of encapsulation of orally applied lipids in a yoghurt snack
      to modify ad libitum food intake and satiety, without GI symptoms. Every subject receives two
      treatments (active, and placebo) on two different days, following a randomized cross-over
      design.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: ad libitum food intake
time frame: 2 hours after yoghurt snack
description: t=0: standardized breakfast, t=90 minutes: yoghurt, t=210 minutes: ad libitum food intake
measure: Satiety feelings
time frame: Up to 3.5 hours on each of the 2 test days.
description: Every 15-30 min, 5 attributes will be measured on a Visual Analogue Scale
measure: occurrence and severity of GI symptoms
time frame: Up to 3.5 hours on each of the 2 test days.
description: Every 15-30 min, 4 attributes will be measured on a Visual Analogue Scale
arm group label: Active yoghurt
arm group type: Active Comparator
description: Yoghurt snack containing encapsulated lipid
arm group label: Placebo yoghurt
arm group type: Placebo Comparator
description: Yoghurt snack containing non-encapsulated lipid
+ empty encapsulation matrix
intervention type: Dietary Supplement
intervention name: Active yoghurt
description: Active yoghurt (containing encapsulated lipid) will be ingested after a standardized breakfast, and subsequently satiety and food intake will be measured.
arm group label: Active yoghurt
intervention type: Dietary Supplement
intervention name: Placebo yoghurt
description: Placebo yoghurt (containing non-encapsulated lipid) will be ingested after a standardized breakfast, and subsequently satiety and food intake will be measured.
arm group label: Placebo yoghurt
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Adrian AM Masclee, Prof.
role: Principal Investigator
affiliation: azM/UM
facility: 
country: Netherlands
responsible party type: Sponsor
provided document: 
submitted: November 23, 2017
returned: August 17, 2018