<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/NCT01718431</url>
  </required_header>
  <id_info>
    <org_study_id>Dnr2010/457 - 3day</org_study_id>
    <nct_id>NCT01718431</nct_id>
  </id_info>
  <brief_title>Prebiotics as a Means to Modulate Gut Fermentation, Metabolism, Appetite and Cognition</brief_title>
  <official_title>Prebiotics as Means to Modulate Colonic Events, With the Purpose to Increase Beneficial Effects on Metabolism, Satiety and Cognition.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lund University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lund University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims at investigating the impact of colonic fermentation of intrinsic indigestible&#xD;
      carbohydrates in cereal whole kernels after three days consumption, on metabolic variables&#xD;
      and cognition. The study is performed in healthy, normal to slightly over-weight test&#xD;
      subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2010</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <phase>Early Phase 1</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>Area under the plasma concentration versus time curve (AUC) of the test meal</measure>
    <time_frame>Post-prandially after breakfast, 0-150 min</time_frame>
    <description>The differences in AUC between different risk markers, assessed in plasma or serum,after intake of the test meal in comparison to the reference meal is measured. Example of variables measured are glucose, insulin, appetite hormones, inflammatory markers, markers of colonic fermentation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cognitive performance</measure>
    <time_frame>Post-prandially after breakfast, 0-210 min</time_frame>
    <description>The cognitive performance of the test subjects is measured to investigate work memory and specific attention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective satiety</measure>
    <time_frame>post-prandially after breakfast, 0-150 min</time_frame>
    <description>The subjective sensation of satiety, hunger and desire to eat is measured using a questionnaire.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>indigestible carbohydrates</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>test meal: indigestible carbohydrates</description>
  </arm_group>
  <arm_group>
    <arm_group_label>reference</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>reference meal: no indigestible carbohydrates</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>test meal</intervention_name>
    <arm_group_label>indigestible carbohydrates</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>reference meal</intervention_name>
    <arm_group_label>reference</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI 19-28 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  gastrointestinal diseases&#xD;
&#xD;
          -  metabolic disorders&#xD;
&#xD;
          -  tobacco/snuff user&#xD;
&#xD;
          -  antibiotic/probiotic treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anne Nilsson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lund University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Applied Nutrition and Food Chemistry, Lund University</name>
      <address>
        <city>Lund</city>
        <zip>SE-221 00</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>May 2013</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>May 7, 2013</last_update_submitted>
  <last_update_submitted_qc>May 7, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 8, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lund University</investigator_affiliation>
    <investigator_full_name>Elin Johansson</investigator_full_name>
    <investigator_title>MSc, postgraduate student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Syndrome</mesh_term>
  </condition_browse>
  <!-- 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/NCT01718431
org study id: Dnr2010/457 - 3day
nct id: NCT01718431
lead sponsor: 
has dmc: No
This study aims at investigating the impact of colonic fermentation of intrinsic indigestible
      carbohydrates in cereal whole kernels after three days consumption, on metabolic variables
      and cognition. The study is performed in healthy, normal to slightly over-weight test
      subjects.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Area under the plasma concentration versus time curve (AUC) of the test meal
time frame: Post-prandially after breakfast, 0-150 min
description: The differences in AUC between different risk markers, assessed in plasma or serum,after intake of the test meal in comparison to the reference meal is measured. Example of variables measured are glucose, insulin, appetite hormones, inflammatory markers, markers of colonic fermentation.
measure: Cognitive performance
time frame: Post-prandially after breakfast, 0-210 min
description: The cognitive performance of the test subjects is measured to investigate work memory and specific attention.
measure: Subjective satiety
time frame: post-prandially after breakfast, 0-150 min
description: The subjective sensation of satiety, hunger and desire to eat is measured using a questionnaire.
arm group label: indigestible carbohydrates
arm group type: Experimental
description: test meal: indigestible carbohydrates
arm group label: reference
arm group type: Experimental
description: reference meal: no indigestible carbohydrates
intervention type: Other
intervention name: test meal
arm group label: indigestible carbohydrates
intervention type: Other
intervention name: reference meal
arm group label: reference
criteria: 
gender: All
minimum age: 50 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anne Nilsson, PhD
role: Principal Investigator
affiliation: Lund University
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Lund University
investigator full name: Elin Johansson
investigator title: MSc, postgraduate student
mesh term: Metabolic Syndrome