<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/NCT02226354</url>
  </required_header>
  <id_info>
    <org_study_id>HC-NHPD-196699</org_study_id>
    <nct_id>NCT02226354</nct_id>
  </id_info>
  <brief_title>Study of the Safety and Efficacy of Dietary Buglossoides Oil</brief_title>
  <official_title>Study of the Safety and Efficacy of Dietary Buglossoides Oil</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Réseau de Santé Vitalité Health Network</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Réseau de Santé Vitalité Health Network</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Seeds from the Buglossoides arvensis plant (trademarked as Ahiflower™) produce oil that is a&#xD;
      rich natural source (20%) of stearidonic acid (SDA), a metabolic intermediate between omega-3&#xD;
      fatty acids found in other plants (such as flax) and those found in fish oils.&#xD;
&#xD;
      The objectives of this study to collect safety data and to investigate the accumulation of&#xD;
      long chain n-3 polyunsaturated fatty acids in human lipids following oral supplementation&#xD;
      with Ahiflower oil in healthy adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-center, randomized, comparator-controlled, double-blind study in healthy&#xD;
      subjects. Forty subjects will be randomly assigned to 2 supplementation groups (n=20 per&#xD;
      group). One group will consume 10 ml of Buglossoides oil daily and one group will consume 10&#xD;
      ml of flax seed oil daily for a 4 week period. Baseline data will be obtained at week 0.&#xD;
      Subjects will return to the clinic after 2 weeks and again after 4 weeks for measurement of&#xD;
      safety and efficacy endpoints.&#xD;
&#xD;
      The efficacy parameters are statistically significant changes from baseline and between&#xD;
      groups in plasma, red blood cell and leukocyte omega-3 fatty acid content.&#xD;
&#xD;
      The primary efficacy endpoint will be:&#xD;
&#xD;
      Plasma EPA concentration expressed as μmol/L plasma.&#xD;
&#xD;
      The secondary efficacy endpoints will be:&#xD;
&#xD;
        1. Plasma 20:4n-3 and DPA individually as μmol/L;&#xD;
&#xD;
        2. Plasma 20:4n-3, EPA and DPA individually as % of total fatty acids;&#xD;
&#xD;
        3. Erythrocyte 20:4n-3, EPA and DPA individually as % of total fatty acids;&#xD;
&#xD;
        4. Mononuclear cell 20:4n-3, EPA and DPA individually as % of total fatty acids;&#xD;
&#xD;
        5. Neutrophil 20:4n-3, EPA and DPA individually as % of total fatty acids;&#xD;
&#xD;
        6. The omega-3 index (defined as the sum of red blood cell EPA and DHA concentrations),&#xD;
           expressed as % total fatty acids.&#xD;
&#xD;
      Safety endpoints will be:&#xD;
&#xD;
        1. fasting serum chemistry&#xD;
&#xD;
        2. fasting hematology profile&#xD;
&#xD;
        3. fasting blood lipid profile&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>Phase 1</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma eicosapentaenoic acid (EPA) concentration</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
    <description>Expressed as μmol/L plasma</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma eicosatetraenoic acid (ETA) concentration</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
    <description>Expressed as μmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma docosapentaenoic acid (DPA) concentration</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
    <description>Expressed as μmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma 20:4n-3, EPA and DPA individually as % of total fatty acids</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Erythrocyte 20:4n-3, EPA and DPA individually as % of total fatty acids</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mononuclear cell 20:4n-3, EPA and DPA individually as % of total fatty acids</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neutrophil 20:4n-3, EPA and DPA individually as % of total fatty acids</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Omega-3 index (defined as the sum of red blood cell EPA and DHA concentrations)</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
    <description>Expressed as % total fatty acids</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting serum chemistry: glucose</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting serum chemistry: calcium</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting serum chemistry: sodium</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting serum chemistry: potassium</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting serum chemistry: blood urea nitrogen</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting serum chemistry: creatinine</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting serum chemistry: alkaline phosphatase</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting serum chemistry: aspartate aminotransferase</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting serum chemistry: gamma-glutamyl transferase</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting serum chemistry: total bilirubin</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting serum chemistry: amylase</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting serum chemistry: uric acid</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting serum chemistry: albumin</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting hematology profile: white blood cell count</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting hematology profile: neutrophil count</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting hematology profile: red blood cell count</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting hematology profile: hemoglobin</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting hematology profile: hematocrit</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting hematology profile: platelet count</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting blood lipid profile: triglycerides</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting blood lipid profile: total cholesterol</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting blood lipid profile: LDL-C</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting blood lipid profile: non HDL-C</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting blood lipid profile: HDL-C</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting serum chemistry: chlorides</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimated glomerular filtration rate</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting serum chemistry: direct bilirubin</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting hematology profile: mean corpuscular volume</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting hematology profile: mean corpuscular hemoglobin</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting hematology profile: mean corpuscular hemoglobin concentration</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting hematology profile: red cell distribution width</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting hematology profile: mean platelet volume</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting hematology profile: lymphocyte concentration</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting hematology profile: monocyte count</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting hematology profile: eosinophil count</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting hematology profile: basophil count</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting hematology profile: immature granulocytes count</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting hematology profile: immature granulocytes (% of WBC)</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting hematology profile: neutrophil (% of WBC)</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting hematology profile: lymphocyte (% of WBC)</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting hematology profile: monocyte (% of WBC)</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting hematology profile: eosinophil (% of WBC)</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting hematology profile: basophil (% of WBC)</measure>
    <time_frame>Day 0, Day 14, Day 28</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Flaxseed oil</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>9.73ml Flaxseed oil once daily, for 28 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ahiflower oil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>9.73ml Ahiflower oil once daily, for 28 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Ahiflower oil</intervention_name>
    <description>9.73 ml per day for 28 days</description>
    <arm_group_label>Ahiflower oil</arm_group_label>
    <other_name>Buglossoides oil</other_name>
    <other_name>Buglossoides arvensis oil</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Flaxseed oil</intervention_name>
    <description>9.73ml per day for 28 days</description>
    <arm_group_label>Flaxseed oil</arm_group_label>
    <other_name>Linseed oil</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men or non-pregnant women, using an effective form of birth control (such as oral&#xD;
             contraceptives, injectable contraceptives or the barrier method such as a intrauterine&#xD;
             device (IUD) with a spermicide, a diaphragm with a spermicide, a condom with a&#xD;
             spermicide or a sponge with a spermicide) for at least 3 months prior to entry into&#xD;
             the study and continuing during participation in the study.&#xD;
&#xD;
          -  18 to 65 years of age, inclusive.&#xD;
&#xD;
          -  Body mass index (BMI) 18 - 35 kg/m2&#xD;
&#xD;
          -  Subject is willing to avoid alcohol consumption for 24h prior to every clinic visit.&#xD;
&#xD;
          -  The subject will not modify smoking habits during supplementation period.&#xD;
&#xD;
          -  No significant medical conditions that in the opinion of the qualified physician,&#xD;
             would preclude the subject's participation in the study.&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
          -  Willing to follow all study procedures including study visits, fasting blood draws,&#xD;
             stable body weight, normal eating habits, current activity level, and compliance with&#xD;
             study preparation.&#xD;
&#xD;
          -  Willing to not consume fish, crustaceans and shellfish for the duration of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or lactation. Women trying to conceive. Women who will try to conceive who&#xD;
             are unwilling to commit to the use of a medically approved form of contraception&#xD;
             throughout the study period. Method of contraception must be recorded in the case&#xD;
             report file.&#xD;
&#xD;
          -  Individual has a condition the study physician believes would interfere with the&#xD;
             participant's ability to provide informed consent, comply with his responsibilities&#xD;
             during the study, which might confound the interpretation of the study results or put&#xD;
             the person at undue risk.&#xD;
&#xD;
          -  Medical conditions including an active peptic ulcer, inflammatory bowel disease, or&#xD;
             gastrointestinal bleeding and any medical condition or prior gastrointestinal surgery&#xD;
             that could influence absorption, metabolism or excretion of the study supplement.&#xD;
&#xD;
          -  History or presence of significant, renal, hepatic, gastrointestinal, pulmonary,&#xD;
             biliary, neurological or endocrine disorders.&#xD;
&#xD;
          -  History or presence of cancer in the past 2 yrs, except for non-melanoma skin cancers&#xD;
             (e.g. basal or squamous cell carcinoma of the skin).&#xD;
&#xD;
          -  Clinically significant abnormal laboratory test results including but not limited to&#xD;
             LDL-cholesterol ≥ 4.1mM, triglyceride levels ≥3.95mM, fasting creatinine ≥ 1.5 mg/dL,&#xD;
             alkaline phosphatase or aspartate aminotransferase ≥ 1.5 times the upper limit of&#xD;
             normal.&#xD;
&#xD;
          -  Currently being treated for angina, arrhythmia and/or congestive heart failure.&#xD;
             History of myocardial infarction or stroke.&#xD;
&#xD;
          -  Presence of coronary heart disease or presence of multiple risk factors that result in&#xD;
             a greater than 20% chance for developing coronary artery disease within 10 years using&#xD;
             the Framingham risk index.&#xD;
&#xD;
          -  Uncontrolled hypertension (resting systolic blood pressure ≥ 160 mmHg or diastolic&#xD;
             blood pressure ≥ 100 mmHg).&#xD;
&#xD;
          -  Type 1 or 2 diabetes. Fasting glucose ≥ 100 mg/dL. HbA1c ≥ 6.0.&#xD;
&#xD;
          -  If a smoker, subject smokes no more than 1 pack (20 cigarettes) daily.&#xD;
&#xD;
          -  History (within 12 months) or current alcohol or substance abuse (no more than 14&#xD;
             consumptions per week; 1 consumption= 12 oz beer, 5 oz wine, 1.5 oz distilled&#xD;
             spirits).&#xD;
&#xD;
          -  Use of any lipid-altering medications (statins, bile acid sequestrants, cholesterol&#xD;
             absorption inhibitors, fibrates, prescription formulations of niacin).&#xD;
&#xD;
          -  Unstable use of thyroid medication. Stable, treated hypothyroidism is not an exclusion&#xD;
             criteria.&#xD;
&#xD;
          -  Use of any weight loss or lipid metabolism medication/supplement/program (including&#xD;
             lipase inhibitors) within 1 month of study period OR weight gain or loss &gt; 2 kg in the&#xD;
             past 3 months.&#xD;
&#xD;
          -  Currently taking fish oil or any other omega-3 or omega-6 polyunsaturated fatty acid&#xD;
             supplement/drug within three months of Visit 1 and throughout the study. Consumption&#xD;
             of fatty fish (salmon, herring, mackerel, albacore tuna, and sardines) more than twice&#xD;
             a month within three months of visit 1 and throughout the study period. Consumption&#xD;
             (more than twice a month) of any EPA/DHA enriched foods (e.g. DHA-enriched eggs)&#xD;
             within three months of Visit 1. Unwillingness to avoid all fish including shellfish&#xD;
             and crustaceans throughout the study period.&#xD;
&#xD;
          -  Use of alpha-linolenic acid-containing seeds and oils such as flax seed, perilla seed,&#xD;
             hemp, spirulina, walnut, mustard seed or black currant seeds/oil within three months&#xD;
             of Visit 1 and throughout the study.&#xD;
&#xD;
          -  Use of an investigational product within the previous 30 days.&#xD;
&#xD;
          -  Has donated blood up to 8 weeks before the start of the study. Not willing to cease&#xD;
             being a blood donor during the study.&#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>Marc Surette, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Université de Moncton</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rémi LeBlanc, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Dr Georges-L.-Dumont</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Université de Moncton</name>
      <address>
        <city>Moncton</city>
        <state>New Brunswick</state>
        <zip>E1A 3E9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>September 1, 2015</last_update_submitted>
  <last_update_submitted_qc>September 1, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Réseau de Santé Vitalité Health Network</investigator_affiliation>
    <investigator_full_name>Marc Surette</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Dietary vegetable oil</keyword>
  <keyword>Stearidonic acid</keyword>
  <keyword>Tissue</keyword>
  <keyword>Fatty Acid</keyword>
  <keyword>composition</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/NCT02226354
org study id: HC-NHPD-196699
nct id: NCT02226354
lead sponsor: 
has dmc: No
Seeds from the Buglossoides arvensis plant (trademarked as Ahiflower™) produce oil that is a
      rich natural source (20%) of stearidonic acid (SDA), a metabolic intermediate between omega-3
      fatty acids found in other plants (such as flax) and those found in fish oils.

      The objectives of this study to collect safety data and to investigate the accumulation of
      long chain n-3 polyunsaturated fatty acids in human lipids following oral supplementation
      with Ahiflower oil in healthy adults.
This is a single-center, randomized, comparator-controlled, double-blind study in healthy
      subjects. Forty subjects will be randomly assigned to 2 supplementation groups (n=20 per
      group). One group will consume 10 ml of Buglossoides oil daily and one group will consume 10
      ml of flax seed oil daily for a 4 week period. Baseline data will be obtained at week 0.
      Subjects will return to the clinic after 2 weeks and again after 4 weeks for measurement of
      safety and efficacy endpoints.

      The efficacy parameters are statistically significant changes from baseline and between
      groups in plasma, red blood cell and leukocyte omega-3 fatty acid content.

      The primary efficacy endpoint will be:

      Plasma EPA concentration expressed as μmol/L plasma.

      The secondary efficacy endpoints will be:

        1. Plasma 20:4n-3 and DPA individually as μmol/L;

        2. Plasma 20:4n-3, EPA and DPA individually as % of total fatty acids;

        3. Erythrocyte 20:4n-3, EPA and DPA individually as % of total fatty acids;

        4. Mononuclear cell 20:4n-3, EPA and DPA individually as % of total fatty acids;

        5. Neutrophil 20:4n-3, EPA and DPA individually as % of total fatty acids;

        6. The omega-3 index (defined as the sum of red blood cell EPA and DHA concentrations),
           expressed as % total fatty acids.

      Safety endpoints will be:

        1. fasting serum chemistry

        2. fasting hematology profile

        3. fasting blood lipid profile
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Plasma eicosapentaenoic acid (EPA) concentration
time frame: Day 0, Day 14, Day 28
description: Expressed as μmol/L plasma
measure: Plasma eicosatetraenoic acid (ETA) concentration
time frame: Day 0, Day 14, Day 28
description: Expressed as μmol/L
measure: Plasma docosapentaenoic acid (DPA) concentration
time frame: Day 0, Day 14, Day 28
description: Expressed as μmol/L
measure: Plasma 20:4n-3, EPA and DPA individually as % of total fatty acids
time frame: Day 0, Day 14, Day 28
measure: Erythrocyte 20:4n-3, EPA and DPA individually as % of total fatty acids
time frame: Day 0, Day 14, Day 28
measure: Mononuclear cell 20:4n-3, EPA and DPA individually as % of total fatty acids
time frame: Day 0, Day 14, Day 28
measure: Neutrophil 20:4n-3, EPA and DPA individually as % of total fatty acids
time frame: Day 0, Day 14, Day 28
measure: Omega-3 index (defined as the sum of red blood cell EPA and DHA concentrations)
time frame: Day 0, Day 14, Day 28
description: Expressed as % total fatty acids
measure: Fasting serum chemistry: glucose
time frame: Day 0, Day 14, Day 28
measure: Fasting serum chemistry: calcium
time frame: Day 0, Day 14, Day 28
measure: Fasting serum chemistry: sodium
time frame: Day 0, Day 14, Day 28
measure: Fasting serum chemistry: potassium
time frame: Day 0, Day 14, Day 28
measure: Fasting serum chemistry: blood urea nitrogen
time frame: Day 0, Day 14, Day 28
measure: Fasting serum chemistry: creatinine
time frame: Day 0, Day 14, Day 28
measure: Fasting serum chemistry: alkaline phosphatase
time frame: Day 0, Day 14, Day 28
measure: Fasting serum chemistry: aspartate aminotransferase
time frame: Day 0, Day 14, Day 28
measure: Fasting serum chemistry: gamma-glutamyl transferase
time frame: Day 0, Day 14, Day 28
measure: Fasting serum chemistry: total bilirubin
time frame: Day 0, Day 14, Day 28
measure: Fasting serum chemistry: amylase
time frame: Day 0, Day 14, Day 28
measure: Fasting serum chemistry: uric acid
time frame: Day 0, Day 14, Day 28
measure: Fasting serum chemistry: albumin
time frame: Day 0, Day 14, Day 28
measure: Fasting hematology profile: white blood cell count
time frame: Day 0, Day 14, Day 28
measure: Fasting hematology profile: neutrophil count
time frame: Day 0, Day 14, Day 28
measure: Fasting hematology profile: red blood cell count
time frame: Day 0, Day 14, Day 28
measure: Fasting hematology profile: hemoglobin
time frame: Day 0, Day 14, Day 28
measure: Fasting hematology profile: hematocrit
time frame: Day 0, Day 14, Day 28
measure: Fasting hematology profile: platelet count
time frame: Day 0, Day 14, Day 28
measure: Fasting blood lipid profile: triglycerides
time frame: Day 0, Day 14, Day 28
measure: Fasting blood lipid profile: total cholesterol
time frame: Day 0, Day 14, Day 28
measure: Fasting blood lipid profile: LDL-C
time frame: Day 0, Day 14, Day 28
measure: Fasting blood lipid profile: non HDL-C
time frame: Day 0, Day 14, Day 28
measure: Fasting blood lipid profile: HDL-C
time frame: Day 0, Day 14, Day 28
measure: Fasting serum chemistry: chlorides
time frame: Day 0, Day 14, Day 28
measure: Estimated glomerular filtration rate
time frame: Day 0, Day 14, Day 28
measure: Fasting serum chemistry: direct bilirubin
time frame: Day 0, Day 14, Day 28
measure: Fasting hematology profile: mean corpuscular volume
time frame: Day 0, Day 14, Day 28
measure: Fasting hematology profile: mean corpuscular hemoglobin
time frame: Day 0, Day 14, Day 28
measure: Fasting hematology profile: mean corpuscular hemoglobin concentration
time frame: Day 0, Day 14, Day 28
measure: Fasting hematology profile: red cell distribution width
time frame: Day 0, Day 14, Day 28
measure: Fasting hematology profile: mean platelet volume
time frame: Day 0, Day 14, Day 28
measure: Fasting hematology profile: lymphocyte concentration
time frame: Day 0, Day 14, Day 28
measure: Fasting hematology profile: monocyte count
time frame: Day 0, Day 14, Day 28
measure: Fasting hematology profile: eosinophil count
time frame: Day 0, Day 14, Day 28
measure: Fasting hematology profile: basophil count
time frame: Day 0, Day 14, Day 28
measure: Fasting hematology profile: immature granulocytes count
time frame: Day 0, Day 14, Day 28
measure: Fasting hematology profile: immature granulocytes (% of WBC)
time frame: Day 0, Day 14, Day 28
measure: Fasting hematology profile: neutrophil (% of WBC)
time frame: Day 0, Day 14, Day 28
measure: Fasting hematology profile: lymphocyte (% of WBC)
time frame: Day 0, Day 14, Day 28
measure: Fasting hematology profile: monocyte (% of WBC)
time frame: Day 0, Day 14, Day 28
measure: Fasting hematology profile: eosinophil (% of WBC)
time frame: Day 0, Day 14, Day 28
measure: Fasting hematology profile: basophil (% of WBC)
time frame: Day 0, Day 14, Day 28
arm group label: Flaxseed oil
arm group type: Active Comparator
description: 9.73ml Flaxseed oil once daily, for 28 days
arm group label: Ahiflower oil
arm group type: Experimental
description: 9.73ml Ahiflower oil once daily, for 28 days
intervention type: Dietary Supplement
intervention name: Ahiflower oil
description: 9.73 ml per day for 28 days
arm group label: Ahiflower oil
other name: Buglossoides oil
other name: Buglossoides arvensis oil
intervention type: Dietary Supplement
intervention name: Flaxseed oil
description: 9.73ml per day for 28 days
arm group label: Flaxseed oil
other name: Linseed oil
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marc Surette, PhD
role: Principal Investigator
affiliation: Université de Moncton
last name: Rémi LeBlanc, MD
role: Principal Investigator
affiliation: Centre Hospitalier Dr Georges-L.-Dumont
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Réseau de Santé Vitalité Health Network
investigator full name: Marc Surette
investigator title: Professor