<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/NCT03255187</url>
  </required_header>
  <id_info>
    <org_study_id>FDUEH-3</org_study_id>
    <nct_id>NCT03255187</nct_id>
  </id_info>
  <brief_title>Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution</brief_title>
  <official_title>Effect of Dietary Supplementation With Fish Oil in Alleviating Cardiopulmonary Hazards Associated With Air Pollution</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fudan University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study aims to evaluate whether dietary supplementation with fish oil can protect against&#xD;
      the cardiopulmonary alterations linked to air pollution&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators conduct a randomized controlled trial among 70 healthy college students in&#xD;
      Shanghai, China. These students fulfilling the recruitment criteria will be randomly divided&#xD;
      into two parallel groups to receive either fish oil [marine-derived n-3 polyunsaturated fatty&#xD;
      acids (PUFA)] or sunflower seed oil. Participants in fish oil group receive 2.5 g/day (two&#xD;
      1.25-g capsules daily) in divided doses. The sunflower seed oil capsules are identical. All&#xD;
      interventions started at 7:30 a.m.to avoid issues related to diurnal variation. Health&#xD;
      endpoints, including blood pressure, fractional exhaled nitric oxide and pulmonary function&#xD;
      were evaluated and biological samples such as morning urine, fast blood, saliva sample,buccal&#xD;
      cells and skin tape stripping will be collected at week 1 before supplemenatation, and week&#xD;
      8, week 10, week 12 as well as week 14 during the supplementation phase.The investigators&#xD;
      measure personal real-time exposure to PM2.5 and personal temperature and relative humidity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 9, 2017</start_date>
  <completion_date type="Actual">January 13, 2018</completion_date>
  <primary_completion_date type="Actual">January 13, 2018</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>
    <intervention_model_description>Participants are randomly assigned to two parallel groups at enrollment using a random-number table. And the investigators randomly assign the two groups in a double-blind fashion receive either ﬁsh oil or sunflower seed oil for 4 months.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Biomarkers of Antioxidant Activity-Total Antioxidant Capacity (TAC) and Superoxide Dismutase (SOD)</measure>
    <time_frame>Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.</time_frame>
    <description>Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We measure 2 biomarkers of antioxidant activity, including TAC and SOD. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Biomarkers of Inflammation-Interleukin-6 (IL-6) and Tumour Necrosis Factor-α (TNF-α)</measure>
    <time_frame>Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.</time_frame>
    <description>2 inflammatory biomarkers in our study including IL-6 and TNF-α are measured. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cogulation Biomarker-von Willebrand Factor (vWF)</measure>
    <time_frame>Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.</time_frame>
    <description>We measure vWF level in serum, one of the measured cogulation biomarkers in our study. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Biomarkers of Endothelial Function and Stress Hormone</measure>
    <time_frame>Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.</time_frame>
    <description>We measure endothelial function biomarkers, including E-selectin and endothelial nitric oxide synthase (eNOS), and 4 stress hormones, including corticotropin releasing hormone (CRH), adrenocorticotropic hormone (ACTH), cortisol and serotonin. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Endothelial Function Biomarker-Endothelin-1(ET-1)</measure>
    <time_frame>Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.</time_frame>
    <description>We measure ET-1 level in serum, an endothelial function biomarker. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cogulation Biomarker-Fibrinogen</measure>
    <time_frame>Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.</time_frame>
    <description>We measure the serum level of fibrinogen, one of the two measured cogulation biomarkers in our study. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>High-sensitivity C-reactive Protein (Hs-CRP)-an Inflammatory Biomarker</measure>
    <time_frame>Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.</time_frame>
    <description>The serum levels of hs-CRP are measured. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oxidized Low Density Lipoprotein (Ox-LDL)-an Oxidative Stress Biomarker</measure>
    <time_frame>Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.</time_frame>
    <description>Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We measure the serum level of ox-LDL. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glutathione Peroxidase (GSH-Px)-a Biomarker of Antioxidant Activity</measure>
    <time_frame>Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.</time_frame>
    <description>Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We also measure GSH-Px. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum Level of Lipid Peroxidation (LPO)-a Biomarker of Oxdative Stress</measure>
    <time_frame>Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.</time_frame>
    <description>Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We measure the serum level of LPO. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>Blood pressure are measured at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.</time_frame>
    <description>After sitting in a quiet room for at least 5 min, participants had their left upper arm blood pressure measured by trained technicians using an electronic sphygmomanometer at least three times with 3-min minimum intervals between measurements. The second and third sets of readings were averaged to obtain systolic BP (SBP) and diastolic BP (DBP). If the differences among the three measurements were bigger than 5 mmHg, a new round of measurements was arranged. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin Resistance</measure>
    <time_frame>Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.</time_frame>
    <description>The biomarker of insulin resistance is measured, calculated by fasting glucose and fasting insulin using the formula of [fasting insulin (mU/L) × fasting glucose (mmol/L)]/22.5. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin Inflammation Biomarkers</measure>
    <time_frame>Skin samplings are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.</time_frame>
    <description>2 infammation biomarkers from skin samplings are measured, including interleukin-1 Alpha (IL-1α) and Interleukin-1 receptor antagonist (IL-1Rα). The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin Oxidative Stress Biomarker-Carbonyl Protein</measure>
    <time_frame>Skin samplings are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months.</time_frame>
    <description>oxidative stress biomarker in skin samplings includes carbonyl protein. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lung Function-Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1)</measure>
    <time_frame>Lung function is measured at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.</time_frame>
    <description>Indicators of lung function include forced vital capacity (FVC) and andforced expiratory volume in 1 second (FEV1). The values in the Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lung Function-Peak Expiratory Flow (PEF)</measure>
    <time_frame>Lung function is measured at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.</time_frame>
    <description>Additional indicator of lung function includes peak expiratory flow (PEF). The values in the Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin Antioxidant Biomarker-Total Antioxidant Capacity (TAC)</measure>
    <time_frame>Skin samplings are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months.</time_frame>
    <description>we measure TAC level, an antioxidant biomarker in skin samplings. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin Antioxidant Biomarker-Glutataione (GSH)</measure>
    <time_frame>Skin samplings are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months.</time_frame>
    <description>we measure another skin antioxidant biomarker-GSH, . The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Oxidative Stress</condition>
  <condition>Inflammation</condition>
  <condition>Blood Pressure</condition>
  <condition>Vasoconstriction</condition>
  <condition>Coagulation</condition>
  <condition>Pulmonary Function</condition>
  <arm_group>
    <arm_group_label>Fish oil supplementation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sunflower seed oil supplementation</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Fish oil supplementation</intervention_name>
    <description>Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA [24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)].</description>
    <arm_group_label>Fish oil supplementation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Sunflower seed oil supplementation</intervention_name>
    <description>Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules.</description>
    <arm_group_label>Sunflower seed oil supplementation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Equal to or older than 18 years old.&#xD;
&#xD;
          -  No history of smoking and alcohol addiction.&#xD;
&#xD;
          -  No chronic diseases or respiratory or allergic diseases,such as&#xD;
             hypertension,diabetes,chronic obstructive pulmonary disease,other&#xD;
             respiratory/cardiovascular diseases, asthma, rhinitis or other allergic diseases&#xD;
             reported by volunteers.&#xD;
&#xD;
          -  No allergies to n-3 PUFA or fish.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current smokers or ever smokers&#xD;
&#xD;
          -  Chronic drug use due on cardiovascular or respiratory diseases&#xD;
&#xD;
          -  Participants are taking fish oil,anti-inflammatory drugs, or antioxidant supplements&#xD;
             (such as vitamin C or vitamin E)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>27 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Haidong Kan</last_name>
    <role>Study Director</role>
    <affiliation>School of Public Health，Fudan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Environmental Health, School of Public Health, Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>August 12, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <results_first_submitted>October 13, 2019</results_first_submitted>
  <results_first_submitted_qc>December 29, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">January 21, 2020</results_first_posted>
  <last_update_submitted>July 9, 2022</last_update_submitted>
  <last_update_submitted_qc>July 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Haidong Kan</investigator_full_name>
    <investigator_title>PhD and Professor</investigator_title>
  </responsible_party>
  <keyword>Biomarker</keyword>
  <keyword>Fish oil</keyword>
  <keyword>Oxidative stress</keyword>
  <keyword>Air pollution</keyword>
  <keyword>Cardiopulmonary system</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 15, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/87/NCT03255187/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment was conducted on Agust, 2017 in Fenglin Campus, Fudan University. A total of 93 participants were assessed for eligibility and 70 of them were finally recruited.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Fish Oil Supplementation</title>
          <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.&#xD;
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA [24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)].</description>
        </group>
        <group group_id="P2">
          <title>Sunflower Seed Oil Supplementation</title>
          <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.&#xD;
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Periodfrom Enrollment to First Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Period From First to Second Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Period From Second to Third Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Period From Third to Fourth Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Period at Fourth Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Fish Oil Supplementation</title>
          <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.&#xD;
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA [24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)].</description>
        </group>
        <group group_id="B2">
          <title>Sunflower Seed Oil Supplementation</title>
          <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.&#xD;
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="34"/>
            <count group_id="B2" value="31"/>
            <count group_id="B3" value="65"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.03" spread="2.26"/>
                    <measurement group_id="B2" value="22.87" spread="1.28"/>
                    <measurement group_id="B3" value="22.95" spread="1.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body mass index</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21.73" spread="3.23"/>
                    <measurement group_id="B2" value="21.56" spread="3.02"/>
                    <measurement group_id="B3" value="21.65" spread="3.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Physical activity</title>
          <description>Physical activity: mild, 90-180 minutes/week; moderate, 180-360 minutes/week; and vigorous, &gt;360 minutes/week.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Never</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="58"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Vigorous</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Biomarkers of Antioxidant Activity-Total Antioxidant Capacity (TAC) and Superoxide Dismutase (SOD)</title>
        <description>Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We measure 2 biomarkers of antioxidant activity, including TAC and SOD. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
        <time_frame>Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fish Oil Supplementation</title>
            <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.&#xD;
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA [24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)].</description>
          </group>
          <group group_id="O2">
            <title>Sunflower Seed Oil Supplementation</title>
            <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.&#xD;
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).</description>
          </group>
        </group_list>
        <measure>
          <title>Biomarkers of Antioxidant Activity-Total Antioxidant Capacity (TAC) and Superoxide Dismutase (SOD)</title>
          <description>Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We measure 2 biomarkers of antioxidant activity, including TAC and SOD. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
          <units>U/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TAC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.09" spread="2.15"/>
                    <measurement group_id="O2" value="5.80" spread="2.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SOD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="364.34" spread="42.69"/>
                    <measurement group_id="O2" value="356.59" spread="43.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Biomarkers of Inflammation-Interleukin-6 (IL-6) and Tumour Necrosis Factor-α (TNF-α)</title>
        <description>2 inflammatory biomarkers in our study including IL-6 and TNF-α are measured. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
        <time_frame>Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fish Oil Supplementation</title>
            <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.&#xD;
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA [24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)].</description>
          </group>
          <group group_id="O2">
            <title>Sunflower Seed Oil Supplementation</title>
            <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.&#xD;
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).</description>
          </group>
        </group_list>
        <measure>
          <title>Biomarkers of Inflammation-Interleukin-6 (IL-6) and Tumour Necrosis Factor-α (TNF-α)</title>
          <description>2 inflammatory biomarkers in our study including IL-6 and TNF-α are measured. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
          <units>pg/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IL-6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.72" spread="0.63"/>
                    <measurement group_id="O2" value="1.76" spread="5.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TNF-α</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.35" spread="0.47"/>
                    <measurement group_id="O2" value="0.54" spread="1.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cogulation Biomarker-von Willebrand Factor (vWF)</title>
        <description>We measure vWF level in serum, one of the measured cogulation biomarkers in our study. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
        <time_frame>Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fish Oil Supplementation</title>
            <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.&#xD;
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA [24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)].</description>
          </group>
          <group group_id="O2">
            <title>Sunflower Seed Oil Supplementation</title>
            <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.&#xD;
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).</description>
          </group>
        </group_list>
        <measure>
          <title>Cogulation Biomarker-von Willebrand Factor (vWF)</title>
          <description>We measure vWF level in serum, one of the measured cogulation biomarkers in our study. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
          <units>mIU/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1669.70" spread="1022.98"/>
                    <measurement group_id="O2" value="2144.30" spread="1674.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Biomarkers of Endothelial Function and Stress Hormone</title>
        <description>We measure endothelial function biomarkers, including E-selectin and endothelial nitric oxide synthase (eNOS), and 4 stress hormones, including corticotropin releasing hormone (CRH), adrenocorticotropic hormone (ACTH), cortisol and serotonin. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
        <time_frame>Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fish Oil Supplementation</title>
            <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.&#xD;
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA [24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)].</description>
          </group>
          <group group_id="O2">
            <title>Sunflower Seed Oil Supplementation</title>
            <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.&#xD;
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).</description>
          </group>
        </group_list>
        <measure>
          <title>Biomarkers of Endothelial Function and Stress Hormone</title>
          <description>We measure endothelial function biomarkers, including E-selectin and endothelial nitric oxide synthase (eNOS), and 4 stress hormones, including corticotropin releasing hormone (CRH), adrenocorticotropic hormone (ACTH), cortisol and serotonin. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
          <units>ng/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>E-selectin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.23" spread="5.38"/>
                    <measurement group_id="O2" value="14.16" spread="6.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>eNOS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.99" spread="9.19"/>
                    <measurement group_id="O2" value="4.29" spread="7.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CRH</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.96" spread="0.48"/>
                    <measurement group_id="O2" value="3.06" spread="0.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cortisol</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="168.01" spread="48.62"/>
                    <measurement group_id="O2" value="184.49" spread="68.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACTH</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.34" spread="0.10"/>
                    <measurement group_id="O2" value="0.39" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>serotonin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="153.56" spread="63.89"/>
                    <measurement group_id="O2" value="151.17" spread="61.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Endothelial Function Biomarker-Endothelin-1(ET-1)</title>
        <description>We measure ET-1 level in serum, an endothelial function biomarker. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
        <time_frame>Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fish Oil Supplementation</title>
            <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.&#xD;
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA [24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)].</description>
          </group>
          <group group_id="O2">
            <title>Sunflower Seed Oil Supplementation</title>
            <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.&#xD;
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).</description>
          </group>
        </group_list>
        <measure>
          <title>Endothelial Function Biomarker-Endothelin-1(ET-1)</title>
          <description>We measure ET-1 level in serum, an endothelial function biomarker. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
          <units>pg/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.80" spread="2.26"/>
                    <measurement group_id="O2" value="2.82" spread="4.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cogulation Biomarker-Fibrinogen</title>
        <description>We measure the serum level of fibrinogen, one of the two measured cogulation biomarkers in our study. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
        <time_frame>Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fish Oil Supplementation</title>
            <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.&#xD;
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA [24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)].</description>
          </group>
          <group group_id="O2">
            <title>Sunflower Seed Oil Supplementation</title>
            <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.&#xD;
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).</description>
          </group>
        </group_list>
        <measure>
          <title>Cogulation Biomarker-Fibrinogen</title>
          <description>We measure the serum level of fibrinogen, one of the two measured cogulation biomarkers in our study. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
          <units>µg/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.25" spread="1.06"/>
                    <measurement group_id="O2" value="2.63" spread="1.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>High-sensitivity C-reactive Protein (Hs-CRP)-an Inflammatory Biomarker</title>
        <description>The serum levels of hs-CRP are measured. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
        <time_frame>Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fish Oil Supplementation</title>
            <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.&#xD;
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA [24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)].</description>
          </group>
          <group group_id="O2">
            <title>Sunflower Seed Oil Supplementation</title>
            <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.&#xD;
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).</description>
          </group>
        </group_list>
        <measure>
          <title>High-sensitivity C-reactive Protein (Hs-CRP)-an Inflammatory Biomarker</title>
          <description>The serum levels of hs-CRP are measured. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
          <units>µg/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.81" spread="19.91"/>
                    <measurement group_id="O2" value="19.93" spread="30.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Oxidized Low Density Lipoprotein (Ox-LDL)-an Oxidative Stress Biomarker</title>
        <description>Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We measure the serum level of ox-LDL. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
        <time_frame>Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fish Oil Supplementation</title>
            <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.&#xD;
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA [24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)].</description>
          </group>
          <group group_id="O2">
            <title>Sunflower Seed Oil Supplementation</title>
            <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.&#xD;
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).</description>
          </group>
        </group_list>
        <measure>
          <title>Oxidized Low Density Lipoprotein (Ox-LDL)-an Oxidative Stress Biomarker</title>
          <description>Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We measure the serum level of ox-LDL. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.74" spread="9.85"/>
                    <measurement group_id="O2" value="40.11" spread="22.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Glutathione Peroxidase (GSH-Px)-a Biomarker of Antioxidant Activity</title>
        <description>Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We also measure GSH-Px. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
        <time_frame>Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fish Oil Supplementation</title>
            <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.&#xD;
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA [24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)].</description>
          </group>
          <group group_id="O2">
            <title>Sunflower Seed Oil Supplementation</title>
            <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.&#xD;
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).</description>
          </group>
        </group_list>
        <measure>
          <title>Glutathione Peroxidase (GSH-Px)-a Biomarker of Antioxidant Activity</title>
          <description>Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We also measure GSH-Px. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
          <units>mU/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="625.95" spread="157.42"/>
                    <measurement group_id="O2" value="581.51" spread="171.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Serum Level of Lipid Peroxidation (LPO)-a Biomarker of Oxdative Stress</title>
        <description>Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We measure the serum level of LPO. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
        <time_frame>Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fish Oil Supplementation</title>
            <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.&#xD;
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA [24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)].</description>
          </group>
          <group group_id="O2">
            <title>Sunflower Seed Oil Supplementation</title>
            <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.&#xD;
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Level of Lipid Peroxidation (LPO)-a Biomarker of Oxdative Stress</title>
          <description>Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We measure the serum level of LPO. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
          <units>µg/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.54" spread="0.15"/>
                    <measurement group_id="O2" value="0.58" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Blood Pressure</title>
        <description>After sitting in a quiet room for at least 5 min, participants had their left upper arm blood pressure measured by trained technicians using an electronic sphygmomanometer at least three times with 3-min minimum intervals between measurements. The second and third sets of readings were averaged to obtain systolic BP (SBP) and diastolic BP (DBP). If the differences among the three measurements were bigger than 5 mmHg, a new round of measurements was arranged. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
        <time_frame>Blood pressure are measured at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fish Oil Supplementation</title>
            <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.&#xD;
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA [24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)].</description>
          </group>
          <group group_id="O2">
            <title>Sunflower Seed Oil Supplementation</title>
            <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.&#xD;
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).</description>
          </group>
        </group_list>
        <measure>
          <title>Blood Pressure</title>
          <description>After sitting in a quiet room for at least 5 min, participants had their left upper arm blood pressure measured by trained technicians using an electronic sphygmomanometer at least three times with 3-min minimum intervals between measurements. The second and third sets of readings were averaged to obtain systolic BP (SBP) and diastolic BP (DBP). If the differences among the three measurements were bigger than 5 mmHg, a new round of measurements was arranged. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110.01" spread="11.39"/>
                    <measurement group_id="O2" value="111.55" spread="10.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.20" spread="6.05"/>
                    <measurement group_id="O2" value="67.29" spread="7.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Insulin Resistance</title>
        <description>The biomarker of insulin resistance is measured, calculated by fasting glucose and fasting insulin using the formula of [fasting insulin (mU/L) × fasting glucose (mmol/L)]/22.5. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
        <time_frame>Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fish Oil Supplementation</title>
            <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.&#xD;
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA [24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)].</description>
          </group>
          <group group_id="O2">
            <title>Sunflower Seed Oil Supplementation</title>
            <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.&#xD;
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).</description>
          </group>
        </group_list>
        <measure>
          <title>Insulin Resistance</title>
          <description>The biomarker of insulin resistance is measured, calculated by fasting glucose and fasting insulin using the formula of [fasting insulin (mU/L) × fasting glucose (mmol/L)]/22.5. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
          <units>mmol/L × mU/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.40" spread="0.94"/>
                    <measurement group_id="O2" value="1.42" spread="0.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Skin Inflammation Biomarkers</title>
        <description>2 infammation biomarkers from skin samplings are measured, including interleukin-1 Alpha (IL-1α) and Interleukin-1 receptor antagonist (IL-1Rα). The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
        <time_frame>Skin samplings are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fish Oil Supplementation</title>
            <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.&#xD;
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA [24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)].</description>
          </group>
          <group group_id="O2">
            <title>Sunflower Seed Oil Supplementation</title>
            <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.&#xD;
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).</description>
          </group>
        </group_list>
        <measure>
          <title>Skin Inflammation Biomarkers</title>
          <description>2 infammation biomarkers from skin samplings are measured, including interleukin-1 Alpha (IL-1α) and Interleukin-1 receptor antagonist (IL-1Rα). The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
          <units>pg/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IL-1α</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="184.49" spread="107.31"/>
                    <measurement group_id="O2" value="230.90" spread="163.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-1Rα</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.00" spread="93.48"/>
                    <measurement group_id="O2" value="42.00" spread="119.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Skin Oxidative Stress Biomarker-Carbonyl Protein</title>
        <description>oxidative stress biomarker in skin samplings includes carbonyl protein. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
        <time_frame>Skin samplings are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fish Oil Supplementation</title>
            <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.&#xD;
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA [24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)].</description>
          </group>
          <group group_id="O2">
            <title>Sunflower Seed Oil Supplementation</title>
            <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.&#xD;
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).</description>
          </group>
        </group_list>
        <measure>
          <title>Skin Oxidative Stress Biomarker-Carbonyl Protein</title>
          <description>oxidative stress biomarker in skin samplings includes carbonyl protein. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
          <units>µg/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.93" spread="15.37"/>
                    <measurement group_id="O2" value="44.89" spread="24.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lung Function-Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1)</title>
        <description>Indicators of lung function include forced vital capacity (FVC) and andforced expiratory volume in 1 second (FEV1). The values in the Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
        <time_frame>Lung function is measured at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fish Oil Supplementation</title>
            <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.&#xD;
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA [24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)].</description>
          </group>
          <group group_id="O2">
            <title>Sunflower Seed Oil Supplementation</title>
            <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.&#xD;
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).</description>
          </group>
        </group_list>
        <measure>
          <title>Lung Function-Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1)</title>
          <description>Indicators of lung function include forced vital capacity (FVC) and andforced expiratory volume in 1 second (FEV1). The values in the Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
          <units>L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>FVC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.18" spread="0.48"/>
                    <measurement group_id="O2" value="3.16" spread="0.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FEV1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.75" spread="0.64"/>
                    <measurement group_id="O2" value="3.73" spread="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lung Function-Peak Expiratory Flow (PEF)</title>
        <description>Additional indicator of lung function includes peak expiratory flow (PEF). The values in the Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
        <time_frame>Lung function is measured at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fish Oil Supplementation</title>
            <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.&#xD;
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA [24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)].</description>
          </group>
          <group group_id="O2">
            <title>Sunflower Seed Oil Supplementation</title>
            <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.&#xD;
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).</description>
          </group>
        </group_list>
        <measure>
          <title>Lung Function-Peak Expiratory Flow (PEF)</title>
          <description>Additional indicator of lung function includes peak expiratory flow (PEF). The values in the Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
          <units>L/s</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.55" spread="1.44"/>
                    <measurement group_id="O2" value="6.38" spread="1.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Skin Antioxidant Biomarker-Total Antioxidant Capacity (TAC)</title>
        <description>we measure TAC level, an antioxidant biomarker in skin samplings. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
        <time_frame>Skin samplings are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fish Oil Supplementation</title>
            <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.&#xD;
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA [24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)].</description>
          </group>
          <group group_id="O2">
            <title>Sunflower Seed Oil Supplementation</title>
            <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.&#xD;
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).</description>
          </group>
        </group_list>
        <measure>
          <title>Skin Antioxidant Biomarker-Total Antioxidant Capacity (TAC)</title>
          <description>we measure TAC level, an antioxidant biomarker in skin samplings. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
          <units>nmol/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.99" spread="95.34"/>
                    <measurement group_id="O2" value="35.73" spread="17.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Skin Antioxidant Biomarker-Glutataione (GSH)</title>
        <description>we measure another skin antioxidant biomarker-GSH, . The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
        <time_frame>Skin samplings are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fish Oil Supplementation</title>
            <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.&#xD;
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA [24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)].</description>
          </group>
          <group group_id="O2">
            <title>Sunflower Seed Oil Supplementation</title>
            <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.&#xD;
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).</description>
          </group>
        </group_list>
        <measure>
          <title>Skin Antioxidant Biomarker-Glutataione (GSH)</title>
          <description>we measure another skin antioxidant biomarker-GSH, . The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.</description>
          <units>ppb</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.21" spread="1.70"/>
                    <measurement group_id="O2" value="0.42" spread="1.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Differences in Metabolite Levels Detected in Serum Metabolomics Between the Two Groups</title>
        <description>Mass spectrometry-based serum metabolomics is non-targeted. The study is to find the differential metabolites in serum between fish oil and placebo groups.</description>
        <time_frame>Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>At the end of week 8, week 10, week 12 and week 14 during the period of supllementation</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Fish Oil Supplementation</title>
          <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.&#xD;
Fish oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA [24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)].</description>
        </group>
        <group group_id="E2">
          <title>Sunflower Seed Oil Supplementation</title>
          <description>This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.&#xD;
Sunflower seed oil supplementation: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules. Each capsule containes 14.4% palmitic acid (C16:0), 16.0% oleic acid (C18:1 n-9), and 57.6% linoleic acid (C18:2 n-6).</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Haidong Kan</name_or_title>
      <organization>Department of Environmental Health, School of Public Health, Fudan University</organization>
      <phone>86-21-54237908</phone>
      <email>kanh@fudan.edu.cn</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03255187
org study id: FDUEH-3
nct id: NCT03255187
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to evaluate whether dietary supplementation with fish oil can protect against
      the cardiopulmonary alterations linked to air pollution
The investigators conduct a randomized controlled trial among 70 healthy college students in
      Shanghai, China. These students fulfilling the recruitment criteria will be randomly divided
      into two parallel groups to receive either fish oil [marine-derived n-3 polyunsaturated fatty
      acids (PUFA)] or sunflower seed oil. Participants in fish oil group receive 2.5 g/day (two
      1.25-g capsules daily) in divided doses. The sunflower seed oil capsules are identical. All
      interventions started at 7:30 a.m.to avoid issues related to diurnal variation. Health
      endpoints, including blood pressure, fractional exhaled nitric oxide and pulmonary function
      were evaluated and biological samples such as morning urine, fast blood, saliva sample,buccal
      cells and skin tape stripping will be collected at week 1 before supplemenatation, and week
      8, week 10, week 12 as well as week 14 during the supplementation phase.The investigators
      measure personal real-time exposure to PM2.5 and personal temperature and relative humidity.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants are randomly assigned to two parallel groups at enrollment using a random-number table. And the investigators randomly assign the two groups in a double-blind fashion receive either ﬁsh oil or sunflower seed oil for 4 months.
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Biomarkers of Antioxidant Activity-Total Antioxidant Capacity (TAC) and Superoxide Dismutase (SOD)
time frame: Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.
description: Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We measure 2 biomarkers of antioxidant activity, including TAC and SOD. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
measure: Biomarkers of Inflammation-Interleukin-6 (IL-6) and Tumour Necrosis Factor-α (TNF-α)
time frame: Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.
description: 2 inflammatory biomarkers in our study including IL-6 and TNF-α are measured. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
measure: Cogulation Biomarker-von Willebrand Factor (vWF)
time frame: Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.
description: We measure vWF level in serum, one of the measured cogulation biomarkers in our study. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
measure: Biomarkers of Endothelial Function and Stress Hormone
time frame: Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.
description: We measure endothelial function biomarkers, including E-selectin and endothelial nitric oxide synthase (eNOS), and 4 stress hormones, including corticotropin releasing hormone (CRH), adrenocorticotropic hormone (ACTH), cortisol and serotonin. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
measure: Endothelial Function Biomarker-Endothelin-1(ET-1)
time frame: Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.
description: We measure ET-1 level in serum, an endothelial function biomarker. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
measure: Cogulation Biomarker-Fibrinogen
time frame: Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.
description: We measure the serum level of fibrinogen, one of the two measured cogulation biomarkers in our study. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
measure: High-sensitivity C-reactive Protein (Hs-CRP)-an Inflammatory Biomarker
time frame: Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.
description: The serum levels of hs-CRP are measured. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
measure: Oxidized Low Density Lipoprotein (Ox-LDL)-an Oxidative Stress Biomarker
time frame: Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.
description: Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We measure the serum level of ox-LDL. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
measure: Glutathione Peroxidase (GSH-Px)-a Biomarker of Antioxidant Activity
time frame: Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.
description: Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We also measure GSH-Px. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
measure: Serum Level of Lipid Peroxidation (LPO)-a Biomarker of Oxdative Stress
time frame: Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.
description: Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We measure the serum level of LPO. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
measure: Blood Pressure
time frame: Blood pressure are measured at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.
description: After sitting in a quiet room for at least 5 min, participants had their left upper arm blood pressure measured by trained technicians using an electronic sphygmomanometer at least three times with 3-min minimum intervals between measurements. The second and third sets of readings were averaged to obtain systolic BP (SBP) and diastolic BP (DBP). If the differences among the three measurements were bigger than 5 mmHg, a new round of measurements was arranged. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
measure: Insulin Resistance
time frame: Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.
description: The biomarker of insulin resistance is measured, calculated by fasting glucose and fasting insulin using the formula of [fasting insulin (mU/L) × fasting glucose (mmol/L)]/22.5. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
measure: Skin Inflammation Biomarkers
time frame: Skin samplings are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.
description: 2 infammation biomarkers from skin samplings are measured, including interleukin-1 Alpha (IL-1α) and Interleukin-1 receptor antagonist (IL-1Rα). The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
measure: Skin Oxidative Stress Biomarker-Carbonyl Protein
time frame: Skin samplings are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months.
description: oxidative stress biomarker in skin samplings includes carbonyl protein. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
measure: Lung Function-Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1)
time frame: Lung function is measured at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.
description: Indicators of lung function include forced vital capacity (FVC) and andforced expiratory volume in 1 second (FEV1). The values in the Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
measure: Lung Function-Peak Expiratory Flow (PEF)
time frame: Lung function is measured at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.
description: Additional indicator of lung function includes peak expiratory flow (PEF). The values in the Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
measure: Skin Antioxidant Biomarker-Total Antioxidant Capacity (TAC)
time frame: Skin samplings are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months.
description: we measure TAC level, an antioxidant biomarker in skin samplings. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
measure: Skin Antioxidant Biomarker-Glutataione (GSH)
time frame: Skin samplings are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months.
description: we measure another skin antioxidant biomarker-GSH, . The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.
arm group label: Fish oil supplementation
arm group type: Experimental
description: This group receive 2.5 g/day (two 1.25-g capsules daily) of fish oil (marine-derived n-3 PUFA) for 4 consecutive months.
arm group label: Sunflower seed oil supplementation
arm group type: Placebo Comparator
description: This group receive 2.5 g/day (two 1.25-g capsules daily) of placebo (sunflower seed oil) for 4 consecutive months.
intervention type: Dietary Supplement
intervention name: Fish oil supplementation
description: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA [24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)].
arm group label: Fish oil supplementation
intervention type: Dietary Supplement
intervention name: Sunflower seed oil supplementation
description: Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules.
arm group label: Sunflower seed oil supplementation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 27 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Haidong Kan
role: Study Director
affiliation: School of Public Health，Fudan University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Haidong Kan
investigator title: PhD and Professor
mesh term: Inflammation
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 