<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/NCT01679496</url>
  </required_header>
  <id_info>
    <org_study_id>REK 2011/1951</org_study_id>
    <nct_id>NCT01679496</nct_id>
  </id_info>
  <brief_title>Fat Quality on Blood Lipids and Immune Response</brief_title>
  <acronym>NoMa</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oslo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Oslo Metropolitan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mills DA</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oslo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate blood LDL-cholesterol and level of inflammatory&#xD;
      markers after intake of food items with different fatty acid composition.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</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>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in LDL-cholesterol</measure>
    <time_frame>Change from baseline after 8 weeks</time_frame>
    <description>Change in LDL-cholesterol when compared to control diet</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in total cholesterol</measure>
    <time_frame>Change from baseline after 8 weeks</time_frame>
    <description>Change in total cholesterol when compared to control diet</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Inflammatory markers in circulation and at gene expression level in PBMC</measure>
    <time_frame>Inflammatory markers are measured at baseline and after 8 weeks intervention in circulation and at gene expression level in PBMC</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Markers of lipid metabolism at gene expression level in PBMC</measure>
    <time_frame>Markers of lipid metabolism at gene expression level in PBMC is measured at baseline and after 8 weeks of intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appetite hormones</measure>
    <time_frame>Appetite hormones is measured at baseline and after 8 weeks of intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gut peptides</measure>
    <time_frame>Gut peptides are measured at baseline and after 8 weeks of intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metabolites</measure>
    <time_frame>Metabolites are measured at baseline and after 8 weeks of intervention</time_frame>
    <description>Targeted and untargeted metabolomics will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Whole genome gene expression</measure>
    <time_frame>whole genome gene expression profiles are measured at baseline and after 8 weeks of intervention</time_frame>
    <description>Microarray</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Dietary Prevention</condition>
  <arm_group>
    <arm_group_label>Food items</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Food items low in saturated fat and high in polyunsaturated fat</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control food items</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Food items containing saturated fat and polyunsaturated fat according to a traditional Norwegian diet</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Food items</intervention_name>
    <description>Food items with different fatty acid composition</description>
    <arm_group_label>Control food items</arm_group_label>
    <arm_group_label>Food items</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  hsCRP &lt; 10 mg/L&#xD;
&#xD;
          -  total cholesterol 5-7.8 mmol/l(50-70 y)&#xD;
&#xD;
          -  total cholesterol 5.0-6.9 mmol/l (30-49 y)&#xD;
&#xD;
          -  total cholesterol 5.0-6.1 mmol/l (25-29 y)&#xD;
&#xD;
          -  LDL-cholesterol at or above 3.5 mmol/l&#xD;
&#xD;
          -  triglycerides at or lower 2.6 mmol/l&#xD;
&#xD;
          -  BMI 20-35&#xD;
&#xD;
          -  Stable bodyweight last 3 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic diseases&#xD;
&#xD;
          -  fasting glucose &gt; 6.0 mmol/l&#xD;
&#xD;
          -  increased ASAT and ALAT&#xD;
&#xD;
          -  medications affecting lipidmetabolism and inflammation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stine Ulven, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oslo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kirsten B Holven, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Nutrition, Institute for Basic Medical Sciences, University of Oslo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Oslo</name>
      <address>
        <city>Oslo</city>
        <zip>0316</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>August 24, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>August 16, 2021</last_update_submitted>
  <last_update_submitted_qc>August 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Oslo</investigator_affiliation>
    <investigator_full_name>Stine Marie Ulven</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>LDL-cholesterol</keyword>
  <!-- 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/NCT01679496
org study id: REK 2011/1951
nct id: NCT01679496
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to investigate blood LDL-cholesterol and level of inflammatory
      markers after intake of food items with different fatty acid composition.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in LDL-cholesterol
time frame: Change from baseline after 8 weeks
description: Change in LDL-cholesterol when compared to control diet
measure: Change in total cholesterol
time frame: Change from baseline after 8 weeks
description: Change in total cholesterol when compared to control diet
measure: Inflammatory markers in circulation and at gene expression level in PBMC
time frame: Inflammatory markers are measured at baseline and after 8 weeks intervention in circulation and at gene expression level in PBMC
measure: Markers of lipid metabolism at gene expression level in PBMC
time frame: Markers of lipid metabolism at gene expression level in PBMC is measured at baseline and after 8 weeks of intervention
measure: Appetite hormones
time frame: Appetite hormones is measured at baseline and after 8 weeks of intervention
measure: Gut peptides
time frame: Gut peptides are measured at baseline and after 8 weeks of intervention
measure: Metabolites
time frame: Metabolites are measured at baseline and after 8 weeks of intervention
description: Targeted and untargeted metabolomics will be measured
measure: Whole genome gene expression
time frame: whole genome gene expression profiles are measured at baseline and after 8 weeks of intervention
description: Microarray
arm group label: Food items
arm group type: Experimental
description: Food items low in saturated fat and high in polyunsaturated fat
arm group label: Control food items
arm group type: Placebo Comparator
description: Food items containing saturated fat and polyunsaturated fat according to a traditional Norwegian diet
intervention type: Other
intervention name: Food items
description: Food items with different fatty acid composition
arm group label: Control food items
arm group label: Food items
criteria: 
gender: All
minimum age: 25 Years
maximum age: 70 Years
healthy volunteers: No
last name: Stine Ulven, PhD
role: Principal Investigator
affiliation: University of Oslo
last name: Kirsten B Holven, PhD
role: Principal Investigator
affiliation: Department of Nutrition, Institute for Basic Medical Sciences, University of Oslo
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: University of Oslo
investigator full name: Stine Marie Ulven
investigator title: Professor