<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/NCT04463030</url>
  </required_header>
  <id_info>
    <org_study_id>NIS161-004</org_study_id>
    <nct_id>NCT04463030</nct_id>
  </id_info>
  <brief_title>Antioxidant Bioavailability</brief_title>
  <official_title>Clinical Pilot Study on Antioxidant Uptake and Downstream Effects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Natural Immune Systems Inc</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Natural Immune Systems Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A small cross-over trial on 3 different doses of liposomal vitamin C, comparing vitamin C&#xD;
      uptake and downstream effects when 24 people consume 1, 2, and 5 grams on different test&#xD;
      days, compared to placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized, cross-over study design will be used to evaluate the effects of consumption of&#xD;
      4 different doses of liposomal vitamin C (0, 1, 2, and 5 grams). The study is of 5 weeks'&#xD;
      duration, with evaluation of a different dose at each of week 1, week 3 and week 5 with a one&#xD;
      week washout between each dose.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">June 25, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 25, 2022</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Randomized, placebo-controlled, single blind, cross-over trial</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of vitamin C levels</measure>
    <time_frame>6 hours</time_frame>
    <description>HPLC (High performance liquid chromatography)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of antioxidant status</measure>
    <time_frame>6 hours</time_frame>
    <description>FRAP (Ferric reducing antioxidant power) assay</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Evaluation of downstream effects reflecting antioxidant protection</measure>
    <time_frame>6 hours</time_frame>
    <description>lipid peroxidation</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Pharmacokinetics</condition>
  <arm_group>
    <arm_group_label>Liposomal vitamin C, 1 gram</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will consume 1 gram on study day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Liposomal vitamin C, 2 grams</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will consume 2 grams on study day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Liposomal vitamin C, 5 grams</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will consume 5 grams on study day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will consume placebo on study day</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Liposomal vitamin C, 1 gram</intervention_name>
    <description>after a blood draw 1 gram of vitamin c will be consumed followed by 3 additional blood draws</description>
    <arm_group_label>Liposomal vitamin C, 1 gram</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Liposomal vitamin C, 2 grams</intervention_name>
    <description>after a blood draw 2 grams of vitamin c will be consumed followed by 3 additional blood draws</description>
    <arm_group_label>Liposomal vitamin C, 2 grams</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Liposomal vitamin C, 5 grams</intervention_name>
    <description>after a blood draw 5 grams of vitamin c will be consumed followed by 3 additional blood draws</description>
    <arm_group_label>Liposomal vitamin C, 5 grams</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>after a blood draw placebo will be consumed followed by 3 additional blood draws</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult people of either gender;&#xD;
&#xD;
          -  BMI between 18.0 and 34.9 (inclusive);&#xD;
&#xD;
          -  Willing to abstain from coffee, tea, and soft-drinks for at least one hour prior to a&#xD;
             clinic visit;&#xD;
&#xD;
          -  Willing to abstain from alcohol for at least 12 hours prior to a clinic visit;&#xD;
&#xD;
          -  Willing to maintain a consistent habit of abstaining from exercising, tobacco use, and&#xD;
             nutritional supplements on the morning of a study visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cancer during past 12 months;&#xD;
&#xD;
          -  Chemotherapy during past 12 months;&#xD;
&#xD;
          -  Significant active uncontrolled illness (such as lymphoma, liver disease, kidney&#xD;
             failure, heart failure).&#xD;
&#xD;
          -  Previous major surgery to stomach or intestines [(absorption of test product may be&#xD;
             altered) minor surgery is not a problem, including appendix and gallbladder removal];&#xD;
&#xD;
          -  Currently taking nutritional supplements judged by the study coordinator to negate or&#xD;
             camouflage the effects of the test product;&#xD;
&#xD;
          -  Food allergies related to ingredients in test product;&#xD;
&#xD;
          -  Women who are pregnant, nursing, or trying to become pregnant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gitte Jensen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NIS Labs</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gitte Jensen, PhD</last_name>
    <phone>541-884-0112</phone>
    <email>gitte@nislabs.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Gitte Jensen</name>
      <address>
        <city>Klamath Falls</city>
        <state>Oregon</state>
        <zip>97601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gitte S. Jensen, PhD</last_name>
      <phone>541-884-0112</phone>
      <email>gitte@nislabs.com</email>
    </contact>
    <investigator>
      <last_name>Gitte S. Jensen, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>September 26, 2022</last_update_submitted>
  <last_update_submitted_qc>September 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Natural Immune Systems Inc</investigator_affiliation>
    <investigator_full_name>Gitte Jensen, Ph.D.</investigator_full_name>
    <investigator_title>Research Director</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamins</mesh_term>
    <mesh_term>Ascorbic Acid</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04463030
org study id: NIS161-004
nct id: NCT04463030
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A small cross-over trial on 3 different doses of liposomal vitamin C, comparing vitamin C
      uptake and downstream effects when 24 people consume 1, 2, and 5 grams on different test
      days, compared to placebo.
A randomized, cross-over study design will be used to evaluate the effects of consumption of
      4 different doses of liposomal vitamin C (0, 1, 2, and 5 grams). The study is of 5 weeks'
      duration, with evaluation of a different dose at each of week 1, week 3 and week 5 with a one
      week washout between each dose.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Randomized, placebo-controlled, single blind, cross-over trial
primary purpose: Basic Science
masking: Single (Investigator)
measure: Evaluation of vitamin C levels
time frame: 6 hours
description: HPLC (High performance liquid chromatography)
measure: Evaluation of antioxidant status
time frame: 6 hours
description: FRAP (Ferric reducing antioxidant power) assay
measure: Evaluation of downstream effects reflecting antioxidant protection
time frame: 6 hours
description: lipid peroxidation
arm group label: Liposomal vitamin C, 1 gram
arm group type: Active Comparator
description: Participants will consume 1 gram on study day
arm group label: Liposomal vitamin C, 2 grams
arm group type: Active Comparator
description: Participants will consume 2 grams on study day
arm group label: Liposomal vitamin C, 5 grams
arm group type: Active Comparator
description: Participants will consume 5 grams on study day
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants will consume placebo on study day
intervention type: Dietary Supplement
intervention name: Liposomal vitamin C, 1 gram
description: after a blood draw 1 gram of vitamin c will be consumed followed by 3 additional blood draws
arm group label: Liposomal vitamin C, 1 gram
intervention type: Dietary Supplement
intervention name: Liposomal vitamin C, 2 grams
description: after a blood draw 2 grams of vitamin c will be consumed followed by 3 additional blood draws
arm group label: Liposomal vitamin C, 2 grams
intervention type: Dietary Supplement
intervention name: Liposomal vitamin C, 5 grams
description: after a blood draw 5 grams of vitamin c will be consumed followed by 3 additional blood draws
arm group label: Liposomal vitamin C, 5 grams
intervention type: Dietary Supplement
intervention name: Placebo
description: after a blood draw placebo will be consumed followed by 3 additional blood draws
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gitte Jensen, PhD
role: Principal Investigator
affiliation: NIS Labs
last name: Gitte Jensen, PhD
phone: 541-884-0112
email: gitte@nislabs.com
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Natural Immune Systems Inc
investigator full name: Gitte Jensen, Ph.D.
investigator title: Research Director
mesh term: Vitamins
mesh term: Ascorbic Acid