<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/NCT03284554</url>
  </required_header>
  <id_info>
    <org_study_id>B342</org_study_id>
    <nct_id>NCT03284554</nct_id>
  </id_info>
  <brief_title>Encapsulated Nutrients' Acute Effects on Appetite; ENcapSulated, nUtRiEnts (ENSURE)</brief_title>
  <acronym>ENSURE</acronym>
  <official_title>Encapsulated Nutrients' Acute Effects on Appetite</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arne Astrup</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Biocare Copenhagen A/S</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Copenhagen</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>
      A double-blind, randomized crossover design with four arms including three experimental&#xD;
      conditions and placebo will be applied. After having successfully completed screening&#xD;
      procedures, eligible participants will be invited to four separate test days. The test days&#xD;
      cannot be within the same week, however there is no upper limit for days in between, as long&#xD;
      as the participants remain weight stable and do not change diet or physical activity level.&#xD;
      Significant changes in diet, physical activity level (evaluated by the sub-investigator) or&#xD;
      weight change ±3 kg over the course of the study (from screening to completion of the last&#xD;
      test day) results in exclusion of that subject.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For standardization, 48 hours before the test days, the participants will be asked to consume&#xD;
      a regular diet compliant to what they usually eat and no excessive alcohol consumption (not&#xD;
      above 5 units and no alcohol at all from 8 pm the night before the test days) or intense&#xD;
      physical activity compared to what they normally do is allowed. Additionally, the&#xD;
      participants must arrive at the study facilities in the morning after an overnight fast (from&#xD;
      10 pm) using non strenuous means of transportation. Furthermore, over the course of the study&#xD;
      (from screening (visit 1) to completion of the last test day (visit 5)), the participants are&#xD;
      not allowed to change body weight (±3 kg), diet or physical activity level (as judged by the&#xD;
      sub-investigator). The participants will be weighed and asked about compliance with&#xD;
      additional standardization in a room away from the other participants before initiating each&#xD;
      test day. Possible in-compliance with the standardization will be judged by the&#xD;
      sub-investigator whether to result in re-scheduling of the visit or to be recorded as a&#xD;
      protocol deviation.&#xD;
&#xD;
      Participants arrive at the study facility at 07:30 in the morning. Compliance with&#xD;
      standardization is controlled along with registration of possible adverse events and use of&#xD;
      concomitant medications. During the test days, participants are settled together in an open&#xD;
      office, where they are separated at individual tables. During the meals, participants are&#xD;
      settled into individual feeding cubicles, where they cannot see each other and are instructed&#xD;
      not to talk to each other.&#xD;
&#xD;
      Visual analogue scales (VAS') will be completed for measurement of fasting subjective&#xD;
      appetite levels.&#xD;
&#xD;
      The test products (capsules) will be provided 30 minutes prior to an ad libitum test&#xD;
      breakfast and 3 hour prior to an ad libitum test lunch.&#xD;
&#xD;
      Immediately before and after each episode of capsules and food consumption and at 30 minutes&#xD;
      intervals, VAS' will be completed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 13, 2017</start_date>
  <completion_date type="Actual">February 15, 2018</completion_date>
  <primary_completion_date type="Actual">February 15, 2018</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>
    <intervention_model_description>A double-blind, randomized crossover design with four arms including three experimental conditions and placebo</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double-blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Reduced energy intake</measure>
    <time_frame>up to day 4</time_frame>
    <description>Assessments of total ad libitum test meal energy intake when exposed to one or more of the encapsulated nutrients compared to the non-encapsulated nutrients and placebo</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective appetite sensations</measure>
    <time_frame>Three hours during each test day between test day 1, 2, 3 and 4 (acute effect)</time_frame>
    <description>Evaluations of each of the subjective appetite sensations assessed by visual analogue scale (VAS) (satiety, fullness, hunger, prospective food consumption, desire to eat)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective appetite sensations in relation to energy consumed</measure>
    <time_frame>up to day 4</time_frame>
    <description>Assessing the satiety quotient (SQ)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Subjective nausea assessments</measure>
    <time_frame>Three hours during each test day between test day 1, 2, 3 and 4 (acute effect)</time_frame>
    <description>VAS assessments for nausea throughout the study test day</description>
  </other_outcome>
  <other_outcome>
    <measure>Subjective nausea assessments</measure>
    <time_frame>up to day 4</time_frame>
    <description>End of day questionnaire assessing feeling of nausea after leaving the study facility</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Appetite; Lack or Loss, Nonorganic Origin</condition>
  <arm_group>
    <arm_group_label>Encapsulated nutients</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Encapsulated nutrients known to be able to stimulate GLP-1 and PYY release. Encapsulated with coating providing release at pH≈7.0 (in the distal part of the ileum).&#xD;
The encapsulated nutrients will be provided 30 minutes prior to the ad libitum test breakfast and 3 hour prior to the ad libitum test lunch, respectively.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-encapsulated nutrients</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Nutrients known to be able to stimulate GLP-1 and PYY release if they are encapsulated to provide release at pH ≈7.0 (in the distal part of the ileum). The same capsules in a non-coated form will be provided in order to study the effect of the coating.&#xD;
The non-encapsulated nutrients will be provided 30 minutes prior to the ad libitum test breakfast and 3 hour prior to the ad libitum test lunch, respectively.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Nutrients known to have limited stimulation on GLP-1 and PYY release. Encapsulated with coating providing release at pH≈7.0 (in the distal part of the ileum).&#xD;
The placebo capsules will be provided 30 minutes prior to the ad libitum test breakfast and 3 hour prior to the ad libitum test lunch, respectively.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Encapsulated nutrients</intervention_name>
    <description>Amino acid + Lipid; Probiotic bacteria</description>
    <arm_group_label>Encapsulated nutients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Non-encapsulated nutrients</intervention_name>
    <description>Amino acid + Lipid; Probiotic bacteria</description>
    <arm_group_label>Non-encapsulated nutrients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Nutrient not expected to stimulate release of GLP-1 and PYY</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants who have provided written informed consent&#xD;
&#xD;
          -  Healthy men&#xD;
&#xD;
          -  Age between 18 and 60 years&#xD;
&#xD;
          -  BMI between 18.5-32 kg/m2&#xD;
&#xD;
          -  Regular breakfast eaters (eating breakfast ≥ 4 times a week)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants unable to consume or known to get nausea from consuming 20 medium sized&#xD;
             capsules (placebo capsules will be provided at screening for test of ability to&#xD;
             consume the relevant amount of capsules)&#xD;
&#xD;
          -  Participants not able to comply with the study protocol, including consumption of the&#xD;
             specific study foods (pictures of study foods shown at screening)&#xD;
&#xD;
          -  Any known food allergies or food intolerance likely to affect the present study&#xD;
&#xD;
          -  Significant health problems as judged by the principal investigator&#xD;
&#xD;
          -  Taking any medication or supplements known to affect appetite or body weight within&#xD;
             the past month and/or during the study as judged by the study professional&#xD;
&#xD;
          -  Intake of probiotic supplements (any kind of supplements but not including foods&#xD;
             containing probiotic) &lt; 4 weeks before study start&#xD;
&#xD;
          -  Intake of probiotic supplements (any kind of supplements but not including foods&#xD;
             containing probiotic) during the study&#xD;
&#xD;
          -  Use of systemic medical treatment likely to interfere with evaluation of the study&#xD;
             parameters as judged by the principal investigator&#xD;
&#xD;
          -  Smoking, smoking cessation within the past 3 months or nicotine use (electronic&#xD;
             cigarettes, gum etc.). Irregular smokers accepted&#xD;
&#xD;
          -  Self-reporting currently dieting or having lost/gained significant amount of weight&#xD;
             (±3 kg) in the previous 3 months&#xD;
&#xD;
          -  Significant weight changes (±3 kg) over the course of the study (from screening to&#xD;
             completion of last test day)&#xD;
&#xD;
          -  Significant changes in physical activity patterns in the past 4 weeks or significant&#xD;
             changes over the course of the study (from screening to completion of last test day)&#xD;
             as judged by the sub-investigator&#xD;
&#xD;
          -  Significant changes in diet in the past 4 weeks or significant changes over the course&#xD;
             of the study (from screening to completion of last test day) as judged by the&#xD;
             sub-investigator&#xD;
&#xD;
          -  Participants who work in appetite related areas&#xD;
&#xD;
          -  Simultaneous or within the past month participating in other clinical trials that can&#xD;
             interfere with the study&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Selfreporting</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anders Sjödin, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Copenhagen, Department of Nutrition, Exercise and Sports</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Nutrition, Exercise and Sports</name>
      <address>
        <city>Copenhagen</city>
        <state>Frederiksberg</state>
        <zip>1958</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>February 15, 2018</last_update_submitted>
  <last_update_submitted_qc>February 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Copenhagen</investigator_affiliation>
    <investigator_full_name>Arne Astrup</investigator_full_name>
    <investigator_title>Professor, MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Satiety</keyword>
  <keyword>Nutrients</keyword>
  <keyword>Appetite</keyword>
  <keyword>Encapsulation</keyword>
  <keyword>Lipid</keyword>
  <keyword>Amino acid</keyword>
  <keyword>Probiotic bacteria</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anorexia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No IPD will be shared</ipd_description>
  </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/NCT03284554
org study id: B342
nct id: NCT03284554
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A double-blind, randomized crossover design with four arms including three experimental
      conditions and placebo will be applied. After having successfully completed screening
      procedures, eligible participants will be invited to four separate test days. The test days
      cannot be within the same week, however there is no upper limit for days in between, as long
      as the participants remain weight stable and do not change diet or physical activity level.
      Significant changes in diet, physical activity level (evaluated by the sub-investigator) or
      weight change ±3 kg over the course of the study (from screening to completion of the last
      test day) results in exclusion of that subject.
For standardization, 48 hours before the test days, the participants will be asked to consume
      a regular diet compliant to what they usually eat and no excessive alcohol consumption (not
      above 5 units and no alcohol at all from 8 pm the night before the test days) or intense
      physical activity compared to what they normally do is allowed. Additionally, the
      participants must arrive at the study facilities in the morning after an overnight fast (from
      10 pm) using non strenuous means of transportation. Furthermore, over the course of the study
      (from screening (visit 1) to completion of the last test day (visit 5)), the participants are
      not allowed to change body weight (±3 kg), diet or physical activity level (as judged by the
      sub-investigator). The participants will be weighed and asked about compliance with
      additional standardization in a room away from the other participants before initiating each
      test day. Possible in-compliance with the standardization will be judged by the
      sub-investigator whether to result in re-scheduling of the visit or to be recorded as a
      protocol deviation.

      Participants arrive at the study facility at 07:30 in the morning. Compliance with
      standardization is controlled along with registration of possible adverse events and use of
      concomitant medications. During the test days, participants are settled together in an open
      office, where they are separated at individual tables. During the meals, participants are
      settled into individual feeding cubicles, where they cannot see each other and are instructed
      not to talk to each other.

      Visual analogue scales (VAS') will be completed for measurement of fasting subjective
      appetite levels.

      The test products (capsules) will be provided 30 minutes prior to an ad libitum test
      breakfast and 3 hour prior to an ad libitum test lunch.

      Immediately before and after each episode of capsules and food consumption and at 30 minutes
      intervals, VAS' will be completed.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: A double-blind, randomized crossover design with four arms including three experimental conditions and placebo
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double-blind
measure: Reduced energy intake
time frame: up to day 4
description: Assessments of total ad libitum test meal energy intake when exposed to one or more of the encapsulated nutrients compared to the non-encapsulated nutrients and placebo
measure: Subjective appetite sensations
time frame: Three hours during each test day between test day 1, 2, 3 and 4 (acute effect)
description: Evaluations of each of the subjective appetite sensations assessed by visual analogue scale (VAS) (satiety, fullness, hunger, prospective food consumption, desire to eat)
measure: Subjective appetite sensations in relation to energy consumed
time frame: up to day 4
description: Assessing the satiety quotient (SQ)
measure: Subjective nausea assessments
time frame: Three hours during each test day between test day 1, 2, 3 and 4 (acute effect)
description: VAS assessments for nausea throughout the study test day
measure: Subjective nausea assessments
time frame: up to day 4
description: End of day questionnaire assessing feeling of nausea after leaving the study facility
arm group label: Encapsulated nutients
arm group type: Active Comparator
description: Encapsulated nutrients known to be able to stimulate GLP-1 and PYY release. Encapsulated with coating providing release at pH≈7.0 (in the distal part of the ileum).
The encapsulated nutrients will be provided 30 minutes prior to the ad libitum test breakfast and 3 hour prior to the ad libitum test lunch, respectively.
arm group label: Non-encapsulated nutrients
arm group type: Sham Comparator
description: Nutrients known to be able to stimulate GLP-1 and PYY release if they are encapsulated to provide release at pH ≈7.0 (in the distal part of the ileum). The same capsules in a non-coated form will be provided in order to study the effect of the coating.
The non-encapsulated nutrients will be provided 30 minutes prior to the ad libitum test breakfast and 3 hour prior to the ad libitum test lunch, respectively.
arm group label: Placebo
arm group type: Placebo Comparator
description: Nutrients known to have limited stimulation on GLP-1 and PYY release. Encapsulated with coating providing release at pH≈7.0 (in the distal part of the ileum).
The placebo capsules will be provided 30 minutes prior to the ad libitum test breakfast and 3 hour prior to the ad libitum test lunch, respectively.
intervention type: Dietary Supplement
intervention name: Encapsulated nutrients
description: Amino acid + Lipid; Probiotic bacteria
arm group label: Encapsulated nutients
intervention type: Dietary Supplement
intervention name: Non-encapsulated nutrients
description: Amino acid + Lipid; Probiotic bacteria
arm group label: Non-encapsulated nutrients
intervention type: Dietary Supplement
intervention name: Placebo
description: Nutrient not expected to stimulate release of GLP-1 and PYY
arm group label: Placebo
criteria: 
gender: Male
gender based: Yes
gender description: Selfreporting
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anders Sjödin, MD, PhD
role: Principal Investigator
affiliation: University of Copenhagen, Department of Nutrition, Exercise and Sports
facility: 
country: Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: University of Copenhagen
investigator full name: Arne Astrup
investigator title: Professor, MD, PhD
mesh term: Anorexia
sharing ipd: No
ipd description: No IPD will be shared