<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/NCT01718418</url>
  </required_header>
  <id_info>
    <org_study_id>Dnr2010/457</org_study_id>
    <nct_id>NCT01718418</nct_id>
  </id_info>
  <brief_title>Role of Colonic Events on Metabolism and Appetite Control: A Synbiotic Approach</brief_title>
  <official_title>Prebiotics and Probiotics as Means to Modulate Colonic Events, With Specific Focus on Metabolism and Satiety</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>
      The purpose of the study is to evaluate food factors related to colonically derived&#xD;
      regulation of glucose metabolism (and related parameters) and satiety using a semi-acute meal&#xD;
      study in healthy subjects as experimental model.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</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>Differences in concentration of risk markers in blood, measured post-prandial after a breakfast meal.</measure>
    <time_frame>Post-prandially after breakfast, 0-210 min</time_frame>
    <description>Variables (blood glucose, insulin, incretin, inflammatory markers, markers of colonic fermentation) are measured after two-weeks ingestion of test products. The experimental day is terminated after a lunch meal.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>voluntary energy intake</measure>
    <time_frame>Post-prandially after breakfast, 0-210 min</time_frame>
    <description>Energy intake at lunch is measured after two-weeks ingestion of test products. The experimental day is terminated after the lunch meal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective satiety</measure>
    <time_frame>post-prandially after breakfast, 0-210 min</time_frame>
    <description>The subjective sensation of satiety, hunger and desire to eat is measured using a (VAS) questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in gut microbiota</measure>
    <time_frame>Faecal samples are collected after 14 days intake of test- and reference product</time_frame>
    <description>The effect on gut microbiota of 14 days intake of test- and reference product are investigated in faecal samples.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Obesity</condition>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>+ ind.CHO + prebiotics</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>test meal: intrinsic indigestible carbohydrates in combination with a combined probiotic supplement.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>+ ind.CHO - prebiotics</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>test meal: intrinsic indigestible carbohydrates in combination with placebo probiotic supplement.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>- ind.CHO - prebiotics</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>reference: no ind. carbohydrates and no probiotic supplement</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>test meal</intervention_name>
    <arm_group_label>+ ind.CHO + prebiotics</arm_group_label>
    <arm_group_label>+ ind.CHO - prebiotics</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>reference</intervention_name>
    <arm_group_label>- ind.CHO - prebiotics</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Normal fasting blood glucose, BMI 19-25 kg/m2, for women: hormon based contraceptives&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  gastrointestinal diseases or food allergies e.g. lactose-, gluten intolerance,&#xD;
             metabolic disorders e.g. diabetes, tobacco/snuff users. Antibiotic or probiotic usage&#xD;
             within two weeks, and during the study. Vegetarians&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>35 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, post-graduate 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/NCT01718418
org study id: Dnr2010/457
nct id: NCT01718418
lead sponsor: 
has dmc: No
The purpose of the study is to evaluate food factors related to colonically derived
      regulation of glucose metabolism (and related parameters) and satiety using a semi-acute meal
      study in healthy subjects as experimental model.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Differences in concentration of risk markers in blood, measured post-prandial after a breakfast meal.
time frame: Post-prandially after breakfast, 0-210 min
description: Variables (blood glucose, insulin, incretin, inflammatory markers, markers of colonic fermentation) are measured after two-weeks ingestion of test products. The experimental day is terminated after a lunch meal.
measure: voluntary energy intake
time frame: Post-prandially after breakfast, 0-210 min
description: Energy intake at lunch is measured after two-weeks ingestion of test products. The experimental day is terminated after the lunch meal.
measure: Subjective satiety
time frame: post-prandially after breakfast, 0-210 min
description: The subjective sensation of satiety, hunger and desire to eat is measured using a (VAS) questionnaire.
measure: Differences in gut microbiota
time frame: Faecal samples are collected after 14 days intake of test- and reference product
description: The effect on gut microbiota of 14 days intake of test- and reference product are investigated in faecal samples.
arm group label: + ind.CHO + prebiotics
arm group type: Experimental
description: test meal: intrinsic indigestible carbohydrates in combination with a combined probiotic supplement.
arm group label: + ind.CHO - prebiotics
arm group type: Experimental
description: test meal: intrinsic indigestible carbohydrates in combination with placebo probiotic supplement.
arm group label: - ind.CHO - prebiotics
arm group type: Experimental
description: reference: no ind. carbohydrates and no probiotic supplement
intervention type: Other
intervention name: test meal
arm group label: + ind.CHO + prebiotics
arm group label: + ind.CHO - prebiotics
intervention type: Other
intervention name: reference
arm group label: - ind.CHO - prebiotics
criteria: 
gender: All
minimum age: 20 Years
maximum age: 35 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, post-graduate student
mesh term: Metabolic Syndrome