<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/NCT03258983</url>
  </required_header>
  <id_info>
    <org_study_id>17-R115-A7415-22060 - 2016-229</org_study_id>
    <nct_id>NCT03258983</nct_id>
  </id_info>
  <brief_title>Alpha-linolenic Acid and the Risk of ASCVD</brief_title>
  <official_title>Alpha-linolenic Acid and the Risk of Atherosclerotic Cardiovascular Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aalborg University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Danish Heart Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aalborg University Hospital</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: The plant-derived omega-3 fatty acid alpha-linolenic acid (ALA, 18:3-n-3) may&#xD;
      reduce the risk of atherosclerotic cardiovascular disease, including incident myocardial&#xD;
      infarction, ischemic stroke and peripheral artery disease. However, the results of previous&#xD;
      studies have been inconsistent.&#xD;
&#xD;
      Objectives: To investigate the associations between dietary intake of ALA, adipose tissue&#xD;
      content of ALA, and the risk of the major atherosclerotic cardiovascular diseases incident&#xD;
      myocardial infarction, ischemic stroke and subtypes, and peripheral artery disease.&#xD;
&#xD;
      Methods: This project will be based on data from the Danish cohort study Diet, Cancer and&#xD;
      Health which consisted of 57,053 men and women at recruitment between 1993 and 1997. Dietary&#xD;
      intake of ALA will be assessed using a validated semiquantitative food-frequency&#xD;
      questionnaire and adipose tissue content will be determined with the use of gas&#xD;
      chromatography analyses of adipose tissue biopsies collected at baseline. Also, detailed&#xD;
      information on lifestyle factors, medical history and anthropometri was collected at&#xD;
      baseline.&#xD;
&#xD;
      Incident cases have been identified through national registries and the diagnoses have&#xD;
      previously been validated.&#xD;
&#xD;
      Analyses of dietary intake of ALA will be analysed using a traditional cohort design, whereas&#xD;
      analyses on adipose tissue content of ALA will be analysed based on a case-cohort design.&#xD;
      Hazard ratioes with 95% confidence intervals will be used to describe the associations&#xD;
      between the exposure variables and the outcome variables of interest.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 24, 1993</start_date>
  <completion_date type="Actual">July 10, 2013</completion_date>
  <primary_completion_date type="Actual">July 10, 2013</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incident acute myocardial infarction</measure>
    <time_frame>From baseline until July 2013</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incident ischemic stroke including total and subtypes of ischemic stroke</measure>
    <time_frame>From baseline until November 2009</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incident peripheral artery disease</measure>
    <time_frame>From baseline until December 2009</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incident fatal myocardial infarction</measure>
    <time_frame>From baseline until July 2013</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">57053</enrollment>
  <condition>Acute Myocardial Infarction</condition>
  <condition>Ischemic Stroke</condition>
  <condition>Peripheral Artery Disease</condition>
  <arm_group>
    <arm_group_label>The Diet, Cancer and Health cohort</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Alpha-linolenic acid</intervention_name>
    <description>Exposure to dietary intake of alpha-linolenic acid (ALA) will be assessed using a detailed food frequency questionaire filled in by participants included in the Diet, Cancer and Health cohort at baseline. Exposure to adipose tissue content of ALA will be determined by gas chromatography in all incident cases and in subcohort of 3500 participants randomly drawn from the total cohort.</description>
    <arm_group_label>The Diet, Cancer and Health cohort</arm_group_label>
    <other_name>ALA (18:3-n3)</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Subcutaneous adipose tissue, serum, plasma, ''buffycoat'', erytrocytes and urine is stored in&#xD;
      nitrogen vapour at the biobank of the Diet, Cancer and Health cohort study. Also, whole blood&#xD;
      in filter paper and toenail clippings has been stored within the biobank.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The Diet, Cancer and Health cohort was established over a period of 3.5 years between 1993&#xD;
        and 1997 by inviting 160,725 men and women to participate. All eligible participants were&#xD;
        native Danish citizens without a previous diagnosis of cancer, aged 50-64 years, and living&#xD;
        in the areas of Copenhagen and Aarhus. A total of 57053 accepted to participate in the&#xD;
        Diet, Cancer and Health cohort study.&#xD;
&#xD;
        A subcohort of 3500 participants were drawn randomly from the cohort at baseline.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Born in Denmark&#xD;
&#xD;
          -  Age between 50 and 64 years&#xD;
&#xD;
          -  Living in the areas of Copenhagen and Aarhus&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Christian S Bork, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Cardiology, Aalborg University Hospital, Denmark</affiliation>
  </overall_official>
  <reference>
    <citation>Tjonneland A, Olsen A, Boll K, Stripp C, Christensen J, Engholm G, Overvad K. Study design, exposure variables, and socioeconomic determinants of participation in Diet, Cancer and Health: a population-based prospective cohort study of 57,053 men and women in Denmark. Scand J Public Health. 2007;35(4):432-41. doi: 10.1080/14034940601047986.</citation>
    <PMID>17786808</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 19, 2017</study_first_submitted>
  <study_first_submitted_qc>August 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>August 19, 2017</last_update_submitted>
  <last_update_submitted_qc>August 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aalborg University Hospital</investigator_affiliation>
    <investigator_full_name>Christian Sørensen Bork</investigator_full_name>
    <investigator_title>Dr. Christian Sørensen Bork</investigator_title>
  </responsible_party>
  <keyword>Alpha-linolenic acid</keyword>
  <keyword>Dietary intake</keyword>
  <keyword>Adipose tissue</keyword>
  <keyword>Nutritional epidemiology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Infarction</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/NCT03258983
org study id: 17-R115-A7415-22060 - 2016-229
nct id: NCT03258983
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: The plant-derived omega-3 fatty acid alpha-linolenic acid (ALA, 18:3-n-3) may
      reduce the risk of atherosclerotic cardiovascular disease, including incident myocardial
      infarction, ischemic stroke and peripheral artery disease. However, the results of previous
      studies have been inconsistent.

      Objectives: To investigate the associations between dietary intake of ALA, adipose tissue
      content of ALA, and the risk of the major atherosclerotic cardiovascular diseases incident
      myocardial infarction, ischemic stroke and subtypes, and peripheral artery disease.

      Methods: This project will be based on data from the Danish cohort study Diet, Cancer and
      Health which consisted of 57,053 men and women at recruitment between 1993 and 1997. Dietary
      intake of ALA will be assessed using a validated semiquantitative food-frequency
      questionnaire and adipose tissue content will be determined with the use of gas
      chromatography analyses of adipose tissue biopsies collected at baseline. Also, detailed
      information on lifestyle factors, medical history and anthropometri was collected at
      baseline.

      Incident cases have been identified through national registries and the diagnoses have
      previously been validated.

      Analyses of dietary intake of ALA will be analysed using a traditional cohort design, whereas
      analyses on adipose tissue content of ALA will be analysed based on a case-cohort design.
      Hazard ratioes with 95% confidence intervals will be used to describe the associations
      between the exposure variables and the outcome variables of interest.
observational model: Cohort
time perspective: Prospective
measure: Incident acute myocardial infarction
time frame: From baseline until July 2013
measure: Incident ischemic stroke including total and subtypes of ischemic stroke
time frame: From baseline until November 2009
measure: Incident peripheral artery disease
time frame: From baseline until December 2009
measure: Incident fatal myocardial infarction
time frame: From baseline until July 2013
arm group label: The Diet, Cancer and Health cohort
intervention type: Other
intervention name: Alpha-linolenic acid
description: Exposure to dietary intake of alpha-linolenic acid (ALA) will be assessed using a detailed food frequency questionaire filled in by participants included in the Diet, Cancer and Health cohort at baseline. Exposure to adipose tissue content of ALA will be determined by gas chromatography in all incident cases and in subcohort of 3500 participants randomly drawn from the total cohort.
arm group label: The Diet, Cancer and Health cohort
other name: ALA (18:3-n3)
Subcutaneous adipose tissue, serum, plasma, ''buffycoat'', erytrocytes and urine is stored in
      nitrogen vapour at the biobank of the Diet, Cancer and Health cohort study. Also, whole blood
      in filter paper and toenail clippings has been stored within the biobank.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 64 Years
last name: Christian S Bork, MD
role: Principal Investigator
affiliation: Department of Cardiology, Aalborg University Hospital, Denmark
citation: Tjonneland A, Olsen A, Boll K, Stripp C, Christensen J, Engholm G, Overvad K. Study design, exposure variables, and socioeconomic determinants of participation in Diet, Cancer and Health: a population-based prospective cohort study of 57,053 men and women in Denmark. Scand J Public Health. 2007;35(4):432-41. doi: 10.1080/14034940601047986.
PMID: 17786808
responsible party type: Principal Investigator
investigator affiliation: Aalborg University Hospital
investigator full name: Christian Sørensen Bork
investigator title: Dr. Christian Sørensen Bork
mesh term: Ischemic Stroke
mesh term: Myocardial Infarction
mesh term: Peripheral Arterial Disease
mesh term: Infarction