<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/NCT03017651</url>
  </required_header>
  <id_info>
    <org_study_id>16.20.CLI</org_study_id>
    <nct_id>NCT03017651</nct_id>
  </id_info>
  <brief_title>An Evaluation of Omega-3 Fatty Acid</brief_title>
  <official_title>An Evaluation of a Proprietary Omega-3 Fatty Acid Incorporated Into a MAG on Blood EPA and DHA Levels: a PK Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Société des Produits Nestlé (SPN)</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Miami Research Associates</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Société des Produits Nestlé (SPN)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This protocol will determine the pK profile of two different omega-3 fatty acid supplements&#xD;
      on plasma EPA and DHA levels.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This protocol is to assess the omega-3 blood levels of DHA and EPA following a single dose&#xD;
      administration of study products by means of pharmacokinetics over a 24 hour period of time&#xD;
      (post-dose).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUC0-t</measure>
    <time_frame>from 0 to 24 hours</time_frame>
    <description>The plasma pharmacokinetics (AUC0-t) resulting from a single oral dose administration will be estimated from 0 to 24 hours post-dose</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUC0-inf</measure>
    <time_frame>from 0 to infinity</time_frame>
    <description>The plasma pharmacokinetics (AUC0-t) resulting from a single oral dose administration will be estimated from o to infinity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax</measure>
    <time_frame>between 0 and 24 hours</time_frame>
    <description>The plasma pharmacokinetics (Cmax) resulting from a single oral dose administration will be estimated from 0 to 24 hours post-dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax</measure>
    <time_frame>between 0 and 24 hours</time_frame>
    <description>The plasma pharmacokinetics (tmax) resulting from a single oral dose administration will be estimated from 0 to 24 hours post-dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t½</measure>
    <time_frame>between 0 and 24 hours</time_frame>
    <description>The plasma pharmacokinetics (t1/2) resulting from a single oral dose administration will be estimated from 0 to 24 hours post-dose</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Overweight and Obesity</condition>
  <arm_group>
    <arm_group_label>OM3-supplement 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 g capsule for OM3-supplement 1 given once</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OM3-supplement 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1 g capsule for OM3-supplement 2 given once</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>OM3-supplement 1</intervention_name>
    <description>1g of OM3-supplement 1 will be given to subjects to look at DHA/EPA blood absorption</description>
    <arm_group_label>OM3-supplement 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>OM3-supplement 2</intervention_name>
    <description>1g of OM3-supplement 2 will be given to subjects to look at DHA/EPA blood absorption</description>
    <arm_group_label>OM3-supplement 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Male or female subjects between 18 and 65 years old (inclusive)&#xD;
&#xD;
          2. Body Mass Index (BMI) between 25.0 and 34.9 kg/m2 (inclusive) at Screening.&#xD;
&#xD;
          3. Subjects with normal or moderately elevated lipidemia (borderline lipids as defined by&#xD;
             the AACE - Total cholesterol ≤ 240 mg/dl; LDL ≤ 160 mg/dl; TG ≤ 199 mg/dl).&#xD;
&#xD;
          4. Subjects with no clinically significant findings in the physical examination, medical&#xD;
             history, vital signs, clinical laboratory test (hematology and serum chemistry)&#xD;
             results and as deemed by the Investigator.&#xD;
&#xD;
          5. Subjects must understand and agree to comply with the requirements of the study and&#xD;
             they must be willing to sign the informed consent indicating voluntary consent to&#xD;
             participate in the study prior to the initiation of Screening or study related&#xD;
             activities.&#xD;
&#xD;
          6. Male and female subjects of childbearing potential must agree to use one of the&#xD;
             following medically acceptable contraceptive methods for the duration of the study:&#xD;
             same-sex partner; double barrier (condom, diaphragm or cervical cap with spermicidal&#xD;
             foam, gel or cream); IUD (with or without hormones) in place or hormonal contraception&#xD;
             (oral, injectable, implantable, transdermal or vaginal) used consecutively for at&#xD;
             least 3 months prior to study product administration; vasectomized partner or&#xD;
             sterilization by bilateral insertion of Essure® or similar product for 6 months&#xD;
             minimum prior to study product administration; bilateral tubal ligation, hysterectomy&#xD;
             and/or bilateral oophorectomy; or be postmenopausal with amenorrhea for at least 1&#xD;
             year prior to study product administration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Currently using fish oil capsules (supplements or prescription products).&#xD;
&#xD;
          2. Regular use of omega-3 supplements (defined as greater than 500 mg/week) within 4&#xD;
             weeks of study product administration.&#xD;
&#xD;
          3. Currently using any medications that may impact dietary fat absorption (i.e.,&#xD;
             Orlistat, Alli, etc.).&#xD;
&#xD;
          4. Currently using any medications that may interfere with omega-3 uptake (i.e. blood&#xD;
             thinning medication or anticoagulants).&#xD;
&#xD;
          5. Currently using any lipid lowering medications (i.e. any cholesterol or triglyceride&#xD;
             lowering agent).&#xD;
&#xD;
          6. Currently consuming high amounts of EPA &amp; DHA in the diet (as defined by greater than&#xD;
             200 mg/day by FFQ)&#xD;
&#xD;
          7. Currently following a self-reported no-fat or ultra-restrictive (less than 15%)&#xD;
             Low-Fat Diet&#xD;
&#xD;
          8. Having the following medical conditions:&#xD;
&#xD;
             i. Malabsorptive disorders including but not limited to pancreatitis, Crohn's disease,&#xD;
             etc.&#xD;
&#xD;
             ii. Hypertriglyceridemia (as defined by the Inclusion and per PI discretion; Total&#xD;
             cholesterol &gt; 240 mg/dl; LDL &gt; 160 mg/dl; TG &gt; 199 mg/dl) iii. Type2 Diabetes Mellitus&#xD;
&#xD;
          9. Currently a smoker or nicotine user or has been nicotine free for less than 6 months&#xD;
&#xD;
         10. Use of any systemic medications, including OTC medications, herbal products, dietary&#xD;
             supplements or vitamins (not previously listed) within 1 week of study product&#xD;
             administration (occasional use of OTC analgesics such as acetaminophen may be allowed&#xD;
             as judged by the Investigator)&#xD;
&#xD;
         11. Evidence or history of allergic or adverse responses to either study product, any of&#xD;
             the product excipients or any comparable or similar products&#xD;
&#xD;
         12. Subjects who are not willing and not able to comply with scheduled visits and the&#xD;
             requirements of the study protocol.&#xD;
&#xD;
         13. Female subjects who are breastfeeding, pregnant or plan to become pregnant during this&#xD;
             study.&#xD;
&#xD;
         14. Current employee or immediate family member of the study sponsor or study site&#xD;
             personnel.&#xD;
&#xD;
         15. Currently participating or have participated in another clinical trial within 4 weeks&#xD;
             of study product administration&#xD;
&#xD;
         16. Donated blood, blood components, or significant loss of blood within 30 days of study&#xD;
             product administration&#xD;
&#xD;
         17. History of a clinically-significant illness within 4 weeks of study product&#xD;
             administration&#xD;
&#xD;
         18. History of hospitalization or treatment for clinically-significant drug or alcohol&#xD;
             use/abuse within 1 year of dosing.&#xD;
&#xD;
         19. Subject has poor venous access or difficulty swallowing capsules&#xD;
&#xD;
         20. Any other issue which, in the judgment of the Investigator, will make the subject&#xD;
             ineligible for study participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Diane Krieger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>QPS-MRA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>QPS/Miami Research Associates</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>May 15, 2017</last_update_submitted>
  <last_update_submitted_qc>May 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03017651
org study id: 16.20.CLI
nct id: NCT03017651
lead sponsor: 
collaborator: 
has dmc: No
This protocol will determine the pK profile of two different omega-3 fatty acid supplements
      on plasma EPA and DHA levels.
This protocol is to assess the omega-3 blood levels of DHA and EPA following a single dose
      administration of study products by means of pharmacokinetics over a 24 hour period of time
      (post-dose).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Single (Participant)
measure: AUC0-t
time frame: from 0 to 24 hours
description: The plasma pharmacokinetics (AUC0-t) resulting from a single oral dose administration will be estimated from 0 to 24 hours post-dose
measure: AUC0-inf
time frame: from 0 to infinity
description: The plasma pharmacokinetics (AUC0-t) resulting from a single oral dose administration will be estimated from o to infinity
measure: Cmax
time frame: between 0 and 24 hours
description: The plasma pharmacokinetics (Cmax) resulting from a single oral dose administration will be estimated from 0 to 24 hours post-dose
measure: tmax
time frame: between 0 and 24 hours
description: The plasma pharmacokinetics (tmax) resulting from a single oral dose administration will be estimated from 0 to 24 hours post-dose
measure: t½
time frame: between 0 and 24 hours
description: The plasma pharmacokinetics (t1/2) resulting from a single oral dose administration will be estimated from 0 to 24 hours post-dose
arm group label: OM3-supplement 1
arm group type: Experimental
description: 1 g capsule for OM3-supplement 1 given once
arm group label: OM3-supplement 2
arm group type: Active Comparator
description: 1 g capsule for OM3-supplement 2 given once
intervention type: Dietary Supplement
intervention name: OM3-supplement 1
description: 1g of OM3-supplement 1 will be given to subjects to look at DHA/EPA blood absorption
arm group label: OM3-supplement 1
intervention type: Dietary Supplement
intervention name: OM3-supplement 2
description: 1g of OM3-supplement 2 will be given to subjects to look at DHA/EPA blood absorption
arm group label: OM3-supplement 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Diane Krieger, MD
role: Principal Investigator
affiliation: QPS-MRA
facility: 
country: United States
responsible party type: Sponsor
mesh term: Overweight
sharing ipd: No