<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/NCT02215343</url>
  </required_header>
  <id_info>
    <org_study_id>MyNewGut, Task 3.3</org_study_id>
    <secondary_id>Grant Agreement no: 613979</secondary_id>
    <nct_id>NCT02215343</nct_id>
  </id_info>
  <brief_title>Effect of Prebiotic and PUFA on the Gut Microbiota and Metabolic Risk Markers</brief_title>
  <acronym>MyNewGut</acronym>
  <official_title>Effect of Prebiotic Fibre and Polyunsaturated Fatty Acid (PUFA) on the Gut Microbiota and Metabolic Risk Markers in a Metabolically Challenged Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>http://mynewgut.eu/partners</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Copenhagen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of this study is to investigate in detail how a high-(prebiotic)fibre diet&#xD;
      and a high-PUFA diet affect the gut microbiota composition in a metabolic challenged&#xD;
      population, and if the diet-induced modulation of the gut microbiota mediates changes in&#xD;
      metabolic risk markers.&#xD;
&#xD;
      Intake of both experimental diets over 4 weeks are expected to induce beneficial changes in&#xD;
      the gut microbiota composition and to affect markers for insulin sensitivity, lipid&#xD;
      metabolism and inflammation. The investigators hypothesize that the effect of both&#xD;
      interventions on the metabolic risk markers will be partly mediated by the diet-induced&#xD;
      changes in the gut microbiota composition.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in gut microbiota composition</measure>
    <time_frame>Week 0, 4, 8, 12</time_frame>
    <description>Gut microbiota composition will be analyzed by use of fecal samples.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in markers for insulin sensitivity</measure>
    <time_frame>Week 0, 4, 8, 12</time_frame>
    <description>Will be measured by use of fasting blood samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in markers for lipid metabolism</measure>
    <time_frame>Week 0, 4, 8, 12</time_frame>
    <description>Will be measured by use of fasting blood samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in markers for inflammation</measure>
    <time_frame>Week 0, 4, 8, 12</time_frame>
    <description>Will be measured by use of fasting blood samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Faecal SCFA and bile acid composition</measure>
    <time_frame>Week 0, 4, 8, 12</time_frame>
    <description>Will be analyzed by use of fecal samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipidomics</measure>
    <time_frame>Week 0, 4, 8, 12</time_frame>
    <description>Will be analyzed by use of fasting blood samples and fecal samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metabolomics</measure>
    <time_frame>Week 0, 4, 8, 12</time_frame>
    <description>Will be analyzed by use of fasting blood samples, urine and fecal samples.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in energy expenditure</measure>
    <time_frame>Week 0, 4, 8, 12</time_frame>
    <description>Resting energy expenditure will be measured by indirect calorimetry in a ventilated hood system</description>
  </other_outcome>
  <other_outcome>
    <measure>Gene expression</measure>
    <time_frame>Week 0, 4, 8, 12</time_frame>
    <description>Adipose tissue biopsies will be used for epigenetic analyses, gene and protein expression (no whole genome or exome sequencing).</description>
  </other_outcome>
  <other_outcome>
    <measure>Compliances markers</measure>
    <time_frame>Week 0, 4, 8, 12</time_frame>
    <description>Compliance will be evaluated from 3-days diet registration and self-reported intake of dietary supplements, PUFA complance markes (fatty acid composition) and body composition</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Overweight</condition>
  <arm_group>
    <arm_group_label>High fibre diet (wheat bran extract)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>High PUFA diet (fish oil supplement)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Wheat bran extract</intervention_name>
    <description>Patients will be provided with 15g of wheat bran extract (WBE) (Cargill R&amp;D Centre Europe).</description>
    <arm_group_label>High fibre diet (wheat bran extract)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Fish oil</intervention_name>
    <description>Patients will be provided with a fish oil supplement (capsules), containing 3-4g of N-3 fatty acids (Axellus A/S, Ishøj, Denmark).</description>
    <arm_group_label>High PUFA diet (fish oil supplement)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI: 25-40 kg/m2&#xD;
&#xD;
          -  Non-smoking&#xD;
&#xD;
          -  Indices of the Metabolic Syndrome defined by the International Diabetes Federation&#xD;
             (IDF 2006):&#xD;
&#xD;
        Central obesity (waist circumference; men: ≥94 cm and women: ≥80 cm) + any one of the&#xD;
        following; raised triglyceride level (≥1.7 mmol/L), reduced HDL cholesterol (men: &lt;1.03&#xD;
        mmol/L, women: &lt;1.29 mmol/L), raised BP (systolic ≥130 mm Hg or diastolic ≥85 mm Hg) or&#xD;
        raised fasting plasma glucose (≥5.6 mmol/L).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of antibiotics&#xD;
&#xD;
          -  Weight change &gt;3 kg 2 months prior to study start&#xD;
&#xD;
          -  Intensive physical training/ elite athlete&#xD;
&#xD;
          -  Medication for dyslipidemia, type 2 diabetes or elevated blood pressure&#xD;
&#xD;
          -  Dietary supplements with pro/prebiotics, dietary fibre or fish oil supplement&#xD;
&#xD;
          -  Lactation, pregnancy or planning of pregnancy during the study&#xD;
&#xD;
          -  Gastro intestinal and liver disorders&#xD;
&#xD;
          -  Chronic inflammatory disorders&#xD;
&#xD;
          -  Diagnosed psychiatric disorder including treatment required depression&#xD;
&#xD;
          -  Surgical treatment of obesity and abdominal surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lesli H Larsen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Nutrition, Exercise and sports, University of Copenhagen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Nutrition, Exercise and Sports, University of Copenhagen</name>
      <address>
        <city>Frederiksberg</city>
        <zip>1958</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <link>
    <url>http://www.mynewgut.eu/</url>
    <description>Project website</description>
  </link>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>May 18, 2020</last_update_submitted>
  <last_update_submitted_qc>May 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Copenhagen</investigator_affiliation>
    <investigator_full_name>Arne Astrup</investigator_full_name>
    <investigator_title>Professor, Dr.Med.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</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/NCT02215343
org study id: MyNewGut, Task 3.3
secondary id: Grant Agreement no: 613979
nct id: NCT02215343
lead sponsor: 
collaborator: 
has dmc: Yes
The main objective of this study is to investigate in detail how a high-(prebiotic)fibre diet
      and a high-PUFA diet affect the gut microbiota composition in a metabolic challenged
      population, and if the diet-induced modulation of the gut microbiota mediates changes in
      metabolic risk markers.

      Intake of both experimental diets over 4 weeks are expected to induce beneficial changes in
      the gut microbiota composition and to affect markers for insulin sensitivity, lipid
      metabolism and inflammation. The investigators hypothesize that the effect of both
      interventions on the metabolic risk markers will be partly mediated by the diet-induced
      changes in the gut microbiota composition.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in gut microbiota composition
time frame: Week 0, 4, 8, 12
description: Gut microbiota composition will be analyzed by use of fecal samples.
measure: Change in markers for insulin sensitivity
time frame: Week 0, 4, 8, 12
description: Will be measured by use of fasting blood samples
measure: Change in markers for lipid metabolism
time frame: Week 0, 4, 8, 12
description: Will be measured by use of fasting blood samples
measure: Change in markers for inflammation
time frame: Week 0, 4, 8, 12
description: Will be measured by use of fasting blood samples
measure: Faecal SCFA and bile acid composition
time frame: Week 0, 4, 8, 12
description: Will be analyzed by use of fecal samples.
measure: Lipidomics
time frame: Week 0, 4, 8, 12
description: Will be analyzed by use of fasting blood samples and fecal samples.
measure: Metabolomics
time frame: Week 0, 4, 8, 12
description: Will be analyzed by use of fasting blood samples, urine and fecal samples.
measure: Change in energy expenditure
time frame: Week 0, 4, 8, 12
description: Resting energy expenditure will be measured by indirect calorimetry in a ventilated hood system
measure: Gene expression
time frame: Week 0, 4, 8, 12
description: Adipose tissue biopsies will be used for epigenetic analyses, gene and protein expression (no whole genome or exome sequencing).
measure: Compliances markers
time frame: Week 0, 4, 8, 12
description: Compliance will be evaluated from 3-days diet registration and self-reported intake of dietary supplements, PUFA complance markes (fatty acid composition) and body composition
arm group label: High fibre diet (wheat bran extract)
arm group type: Experimental
arm group label: High PUFA diet (fish oil supplement)
arm group type: Experimental
intervention type: Dietary Supplement
intervention name: Wheat bran extract
description: Patients will be provided with 15g of wheat bran extract (WBE) (Cargill R&D Centre Europe).
arm group label: High fibre diet (wheat bran extract)
intervention type: Dietary Supplement
intervention name: Fish oil
description: Patients will be provided with a fish oil supplement (capsules), containing 3-4g of N-3 fatty acids (Axellus A/S, Ishøj, Denmark).
arm group label: High PUFA diet (fish oil supplement)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Lesli H Larsen, PhD
role: Principal Investigator
affiliation: Department of Nutrition, Exercise and sports, University of Copenhagen
facility: 
country: Denmark
url: http://www.mynewgut.eu/
description: Project website
responsible party type: Principal Investigator
investigator affiliation: University of Copenhagen
investigator full name: Arne Astrup
investigator title: Professor, Dr.Med.
mesh term: Overweight