<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/NCT03245749</url>
  </required_header>
  <id_info>
    <org_study_id>RRD7/N02/A</org_study_id>
    <nct_id>NCT03245749</nct_id>
  </id_info>
  <brief_title>Effect of Oily Fish Intake, Sex, Age, BMI, and APOE Genotype on Plasma Long Chain n-3 Fatty Acid Composition</brief_title>
  <official_title>Effect of Oily Fish Intake, Sex, Age, BMI, and APOE Genotype on Plasma Long Chain n-3 Fatty Acid Composition</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southampton</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Food Standards Agency, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ocean Nutrition</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southampton</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the effect of habitual oily fish intake, sex,&#xD;
      age, BMI, and APOE genotype on plasma long chain n-3 fatty acid composition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The marine long chain n-3 polyunsaturated fatty acids (LC n-3 PUFAs) eicosapentaenoic acid&#xD;
      (EPA) and docosahexaenoic acid (DHA) are beneficial to cardiovascular and cognitive health&#xD;
      and the concentration of EPA and DHA present in blood and tissue lipids is positively&#xD;
      correlated with these effects.&#xD;
&#xD;
      As a result, national and global authorities recommend regular consumption of oily fish in&#xD;
      order to provide approximately 500 mg EPA+DHA per day in a healthy population. However, the&#xD;
      associations between EPA and DHA intake and blood and tissue status, and therefore&#xD;
      physiological benefits, are highly variable and the factors influencing this heterogeneity&#xD;
      are not well understood.&#xD;
&#xD;
      This study aims to investigate the effect of habitual oily fish intake as well as sex, age,&#xD;
      BMI, and Apolipoprotein E (APOE) genotype on LC n-3 PUFA status in plasma&#xD;
      phosphatidylcholine, non-esterified fatty acids, cholesteryl esters and triacylglycerols in&#xD;
      order to obtain greater knowledge of the determinants of LC n-3 PUFA status with the&#xD;
      potential to develop more robust, and perhaps subgroup specific, recommendations for EPA and&#xD;
      DHA intake.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2003</start_date>
  <completion_date type="Actual">March 2006</completion_date>
  <primary_completion_date type="Actual">September 2005</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma long chain n-3 polyunsaturated fatty acid concentrations</measure>
    <time_frame>Baseline</time_frame>
    <description>Concentrations of eicosapentaenoic acid (EPA), docosapentaenoic acid (DPA) and docosahexaenoic acid (DHA) in plasma phosphatidylcholine, non-esterified fatty acids, cholesteryl esters and triacylglycerols</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>APOE genotyping</measure>
    <time_frame>Baseline</time_frame>
    <description>APOE genotype determined from blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anthropometric measurements</measure>
    <time_frame>Baseline</time_frame>
    <description>Height and weight to determine BMI</description>
  </secondary_outcome>
  <enrollment type="Actual">374</enrollment>
  <condition>Plasma Omega-3 Status</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood and plasma samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals residing in Southampton, East Anglia, Glasgow and Newcastle&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed endocrine dysfunction including diabetes&#xD;
&#xD;
          -  Fasting glucose concentration &gt; 6.5 mmol/L&#xD;
&#xD;
          -  Myocardial infarction in the previous 2 years&#xD;
&#xD;
          -  The use of medication that may interfere with lipid metabolism&#xD;
&#xD;
          -  Fasting total cholesterol of &gt; 8.0 mmol/L&#xD;
&#xD;
          -  TG of &gt; 3.0 mmol/L&#xD;
&#xD;
          -  Currently following a weight loss diet&#xD;
&#xD;
          -  Taking n-3 fatty acid supplements&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Philip C Calder</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southampton</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Glasgow</name>
      <address>
        <city>Glasgow</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newcastle University</name>
      <address>
        <city>Newcastle upon Tyne</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univeristy of East Anglia</name>
      <address>
        <city>Norwich</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Reading</name>
      <address>
        <city>Reading</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Southampton</name>
      <address>
        <city>Southampton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <results_reference>
    <citation>Fisk HL, Irvine M, Miles EA, Lietz G, Mathers JC, Packard CJ, Armah CK, Kofler BM, Curtis PJ, Minihane AM, Calder PC. Association of oily fish intake, sex, age, BMI and APOE genotype with plasma long-chain n-3 fatty acid composition. Br J Nutr. 2018 Jul;120(1):23-32. doi: 10.1017/S000711451800106X. Epub 2018 May 6.</citation>
    <PMID>29729672</PMID>
  </results_reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>July 4, 2021</last_update_submitted>
  <last_update_submitted_qc>July 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>omega-3 status</keyword>
  <keyword>blood lipids</keyword>
  <keyword>Eicosapentaenoic acid (EPA)</keyword>
  <keyword>Docosahexaenoic acid (DHA)</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03245749
org study id: RRD7/N02/A
nct id: NCT03245749
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this study is to investigate the effect of habitual oily fish intake, sex,
      age, BMI, and APOE genotype on plasma long chain n-3 fatty acid composition.
The marine long chain n-3 polyunsaturated fatty acids (LC n-3 PUFAs) eicosapentaenoic acid
      (EPA) and docosahexaenoic acid (DHA) are beneficial to cardiovascular and cognitive health
      and the concentration of EPA and DHA present in blood and tissue lipids is positively
      correlated with these effects.

      As a result, national and global authorities recommend regular consumption of oily fish in
      order to provide approximately 500 mg EPA+DHA per day in a healthy population. However, the
      associations between EPA and DHA intake and blood and tissue status, and therefore
      physiological benefits, are highly variable and the factors influencing this heterogeneity
      are not well understood.

      This study aims to investigate the effect of habitual oily fish intake as well as sex, age,
      BMI, and Apolipoprotein E (APOE) genotype on LC n-3 PUFA status in plasma
      phosphatidylcholine, non-esterified fatty acids, cholesteryl esters and triacylglycerols in
      order to obtain greater knowledge of the determinants of LC n-3 PUFA status with the
      potential to develop more robust, and perhaps subgroup specific, recommendations for EPA and
      DHA intake.
observational model: Cohort
time perspective: Cross-Sectional
measure: Plasma long chain n-3 polyunsaturated fatty acid concentrations
time frame: Baseline
description: Concentrations of eicosapentaenoic acid (EPA), docosapentaenoic acid (DPA) and docosahexaenoic acid (DHA) in plasma phosphatidylcholine, non-esterified fatty acids, cholesteryl esters and triacylglycerols
measure: APOE genotyping
time frame: Baseline
description: APOE genotype determined from blood sample
measure: Anthropometric measurements
time frame: Baseline
description: Height and weight to determine BMI
Blood and plasma samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
last name: Philip C Calder
role: Principal Investigator
affiliation: University of Southampton
facility: 
facility: 
facility: 
facility: 
facility: 
country: United Kingdom
citation: Fisk HL, Irvine M, Miles EA, Lietz G, Mathers JC, Packard CJ, Armah CK, Kofler BM, Curtis PJ, Minihane AM, Calder PC. Association of oily fish intake, sex, age, BMI and APOE genotype with plasma long-chain n-3 fatty acid composition. Br J Nutr. 2018 Jul;120(1):23-32. doi: 10.1017/S000711451800106X. Epub 2018 May 6.
PMID: 29729672
responsible party type: Sponsor
sharing ipd: No