<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/NCT01708681</url>
  </required_header>
  <id_info>
    <org_study_id>NIFES-001</org_study_id>
    <secondary_id>2012/1084/REK vest</secondary_id>
    <nct_id>NCT01708681</nct_id>
  </id_info>
  <brief_title>Lean Seafood Intake and Postprandial Metabolism</brief_title>
  <acronym>LeSIP</acronym>
  <official_title>Ability of a Lean Seafood Diet to Modulate Postprandial Metabolism in Human-beings - a Controlled Intervention Study With Cross-over Design</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Nutrition and Seafood Research, Norway</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Research Council of Norway</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Institute of Nutrition and Seafood Research, Norway</source>
  <brief_summary>
    <textblock>
      Despite numerous studies of meal components in humans, little is still known about how&#xD;
      different meals influence on metabolism. The purpose of this study is to a gain knowledge of&#xD;
      how a balanced test meal with either lean seafood (example:cod) or meat as the main protein&#xD;
      source will:&#xD;
&#xD;
        1. affect the postprandial metabolism acutely (test-meal at beginning of the study)&#xD;
&#xD;
        2. affect the postprandial metabolism after 4 weeks controlled intervention (test meal at&#xD;
           end of intervention period)&#xD;
&#xD;
        3. affect gut microbiota composition&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">May 2013</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>Basic Science</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postprandial lipid measurement</measure>
    <time_frame>Change from baseline at 4 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postprandial glucose measurement</measure>
    <time_frame>Change from baseline at 4 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Postprandial metabolomic measurement</measure>
    <time_frame>Change from baseline at 4 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Gut microbiota composition</measure>
    <time_frame>Change from baseline at 4 weeks</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Hyperlipidemias</condition>
  <condition>Nutritional and Metabolic Diseases</condition>
  <condition>Nutrition Disorders</condition>
  <condition>Metabolic Diseases</condition>
  <condition>Glucose Metabolism Disorders</condition>
  <arm_group>
    <arm_group_label>Lean seafood</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cross-over design, half of the subject will receive lean seafood in study period I and the other half in study period II</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Meat, egg, milk</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cross-over design, half of the subject will receive meat, egg, milk in study period I and the other half in study period II</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Lean seafood</intervention_name>
    <arm_group_label>Lean seafood</arm_group_label>
    <arm_group_label>Meat, egg, milk</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Meat, egg, milk</intervention_name>
    <arm_group_label>Lean seafood</arm_group_label>
    <arm_group_label>Meat, egg, milk</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-65 years of age&#xD;
&#xD;
          -  Caucasian&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Hysterectomy&#xD;
&#xD;
          -  Abnormal bleeding last 6 months&#xD;
&#xD;
          -  Use of medication that affects lipid and glucose metabolism&#xD;
&#xD;
          -  Large (&gt;10%) alteration in body-weight the last 6 months&#xD;
&#xD;
          -  Chronic, metabolic or acute disease or major surgery within last 3 months&#xD;
&#xD;
          -  Dietary incompatibility with calcium supplementation and/ or seafood consumption&#xD;
             (allergy, intolerance, dislike)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bjørn Liaset, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>NIFES</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institute of Nutrition and Seafood Research</name>
      <address>
        <city>Bergen</city>
        <zip>5005</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <link>
    <url>http://www.nifes.no</url>
    <description>Related Info</description>
  </link>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <last_update_submitted>October 5, 2015</last_update_submitted>
  <last_update_submitted_qc>October 5, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 6, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Seafood</keyword>
  <keyword>Meat</keyword>
  <keyword>Egg</keyword>
  <keyword>Milk</keyword>
  <keyword>Postprandial lipid metabolism</keyword>
  <keyword>Postprandial glucose metabolism</keyword>
  <keyword>Triglycerides</keyword>
  <keyword>Cholesterol</keyword>
  <keyword>Postprandial incretins</keyword>
  <keyword>Postprandial hormones</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperlipidemias</mesh_term>
    <mesh_term>Metabolic Diseases</mesh_term>
    <mesh_term>Glucose Metabolism Disorders</mesh_term>
    <mesh_term>Nutrition Disorders</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/NCT01708681
org study id: NIFES-001
secondary id: 2012/1084/REK vest
nct id: NCT01708681
lead sponsor: 
collaborator: 
Despite numerous studies of meal components in humans, little is still known about how
      different meals influence on metabolism. The purpose of this study is to a gain knowledge of
      how a balanced test meal with either lean seafood (example:cod) or meat as the main protein
      source will:

        1. affect the postprandial metabolism acutely (test-meal at beginning of the study)

        2. affect the postprandial metabolism after 4 weeks controlled intervention (test meal at
           end of intervention period)

        3. affect gut microbiota composition
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Investigator)
measure: Postprandial lipid measurement
time frame: Change from baseline at 4 weeks
measure: Postprandial glucose measurement
time frame: Change from baseline at 4 weeks
measure: Postprandial metabolomic measurement
time frame: Change from baseline at 4 weeks
measure: Gut microbiota composition
time frame: Change from baseline at 4 weeks
arm group label: Lean seafood
arm group type: Experimental
description: Cross-over design, half of the subject will receive lean seafood in study period I and the other half in study period II
arm group label: Meat, egg, milk
arm group type: Active Comparator
description: Cross-over design, half of the subject will receive meat, egg, milk in study period I and the other half in study period II
intervention type: Dietary Supplement
intervention name: Lean seafood
arm group label: Lean seafood
arm group label: Meat, egg, milk
intervention type: Dietary Supplement
intervention name: Meat, egg, milk
arm group label: Lean seafood
arm group label: Meat, egg, milk
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bjørn Liaset, Dr
role: Principal Investigator
affiliation: NIFES
facility: 
country: Norway
url: http://www.nifes.no
description: Related Info
responsible party type: Sponsor
mesh term: Hyperlipidemias
mesh term: Metabolic Diseases
mesh term: Glucose Metabolism Disorders
mesh term: Nutrition Disorders