<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/NCT04491461</url>
  </required_header>
  <id_info>
    <org_study_id>152-018</org_study_id>
    <nct_id>NCT04491461</nct_id>
  </id_info>
  <brief_title>Acute Effects of an Herbal Tea on Immune Surveillance and Activation.</brief_title>
  <official_title>Acute Effects of an Herbal Tea Blend on Immune Surveillance and Activation Status of Natural Killer Cells.</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 24 people involving an herbal tea blend to test whether consuming&#xD;
      1 cup of tea triggers changes in the numbers of natural killer cells in the blood circulation&#xD;
      as evidence of immune cell trafficking within 2 hours.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized, cross-over, controlled study design will be used to evaluate the effects of&#xD;
      consumption of 1 cup of an herbal tea blend to consumption of the same volume of warm water.&#xD;
      The study is of 3 weeks' duration, with evaluation of the herbal tea blend versus warm water&#xD;
      at week 1 and week 2 with a one week washout between visits. On each visit, a baseline blood&#xD;
      draw is performed, followed by consuming of the herbal tea blend or warm water. Blood draws&#xD;
      are performed at 1 and 2 hours after consumption.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 27, 2020</start_date>
  <completion_date type="Actual">December 19, 2021</completion_date>
  <primary_completion_date type="Actual">October 25, 2021</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>The study uses a randomized double-blinded controlled cross-over study design.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change to natural killer cell numbers in blood circulation</measure>
    <time_frame>Changes at 1 and 2 hours after consumption</time_frame>
    <description>Flow cytometry evaluation of natural killer cell numbers</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change to natural killer cell activation status</measure>
    <time_frame>Changes at 1 and 2 hours after consumption</time_frame>
    <description>Flow cytometry evaluation of CD69 expression on natural killer cells in the blood circulation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Active Immune Response</condition>
  <arm_group>
    <arm_group_label>Herbal tea blend</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1 cup of herbal tea blend containing Rosehip and other berry extracts.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Warm water</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>1 cup of warm water.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Herbal tea blend</intervention_name>
    <description>1 cup of freshly brewed tea from an herbal tea blend.</description>
    <arm_group_label>Herbal tea blend</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Warm water</intervention_name>
    <description>1 cup of warm water</description>
    <arm_group_label>Warm water</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adults;&#xD;
&#xD;
          -  Age 18-75 years (inclusive);&#xD;
&#xD;
          -  Veins easy to see in both arms (to allow for the multiple blood draws);&#xD;
&#xD;
          -  Willing to comply with a 24-hour wash-out period for vitamins and nutritional&#xD;
             supplements;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous major gastrointestinal surgery (absorption of test product may be altered)&#xD;
             (minor surgery not a problem, including previous removal of appendix and gall&#xD;
             bladder);&#xD;
&#xD;
          -  Taking anti-inflammatory medications on a daily basis;&#xD;
&#xD;
          -  Currently experiencing intense stressful events/ life changes;&#xD;
&#xD;
          -  Currently in intensive athletic training (such as marathon runners);&#xD;
&#xD;
          -  Currently taking antipsychotic medications such as clozapine, Risperdal, Abilify,&#xD;
             Zyprexa or Seroquel;&#xD;
&#xD;
          -  Actively depressed;&#xD;
&#xD;
          -  An unusual sleep routine (examples: working graveyard shift, irregular routine with&#xD;
             frequent late nights, studying, partying);&#xD;
&#xD;
          -  Unwilling to maintain a constant intake of supplements over the duration of the study;&#xD;
&#xD;
          -  Anxiety about having blood drawn;&#xD;
&#xD;
          -  Women of childbearing potential: Pregnant, nursing, or trying to become pregnant;&#xD;
&#xD;
          -  Known food allergies related to ingredients in active test product.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GITTE JENSEN</last_name>
    <role>Study Director</role>
    <affiliation>NIS Labs</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gitte Jensen</name>
      <address>
        <city>Klamath Falls</city>
        <state>Oregon</state>
        <zip>97601-5904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>July 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 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>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04491461
org study id: 152-018
nct id: NCT04491461
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A small cross-over trial on 24 people involving an herbal tea blend to test whether consuming
      1 cup of tea triggers changes in the numbers of natural killer cells in the blood circulation
      as evidence of immune cell trafficking within 2 hours.
A randomized, cross-over, controlled study design will be used to evaluate the effects of
      consumption of 1 cup of an herbal tea blend to consumption of the same volume of warm water.
      The study is of 3 weeks' duration, with evaluation of the herbal tea blend versus warm water
      at week 1 and week 2 with a one week washout between visits. On each visit, a baseline blood
      draw is performed, followed by consuming of the herbal tea blend or warm water. Blood draws
      are performed at 1 and 2 hours after consumption.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: The study uses a randomized double-blinded controlled cross-over study design.
primary purpose: Basic Science
masking: None (Open Label)
measure: Change to natural killer cell numbers in blood circulation
time frame: Changes at 1 and 2 hours after consumption
description: Flow cytometry evaluation of natural killer cell numbers
measure: Change to natural killer cell activation status
time frame: Changes at 1 and 2 hours after consumption
description: Flow cytometry evaluation of CD69 expression on natural killer cells in the blood circulation
arm group label: Herbal tea blend
arm group type: Active Comparator
description: 1 cup of herbal tea blend containing Rosehip and other berry extracts.
arm group label: Warm water
arm group type: Sham Comparator
description: 1 cup of warm water.
intervention type: Dietary Supplement
intervention name: Herbal tea blend
description: 1 cup of freshly brewed tea from an herbal tea blend.
arm group label: Herbal tea blend
intervention type: Dietary Supplement
intervention name: Warm water
description: 1 cup of warm water
arm group label: Warm water
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: GITTE JENSEN
role: Study Director
affiliation: NIS Labs
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No