<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/NCT04499560</url>
  </required_header>
  <id_info>
    <org_study_id>20-7-1100</org_study_id>
    <nct_id>NCT04499560</nct_id>
  </id_info>
  <brief_title>The Effects of a Nutrition Supplement on Health Related Quality of Life</brief_title>
  <official_title>The Effects of a Nutrition Supplement on Health Related Quality of Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Franklin Health Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Young Living Essential Oils</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Franklin Health Research</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>
      The purpose of this study is to evaluate the health related benefits of a superfoods&#xD;
      nutrition supplement on health related quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After being informed about the study, participants will provide informed consent and be&#xD;
      randomized to one of two groups: intervention or control. Those in the intervention group&#xD;
      will consume two ounces of a superfoods drink each morning for 60 days. Outcomes will be&#xD;
      assessed at baseline, on day 30 and on day 60.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 3, 2020</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in sleep quality on Pittsburgh Sleep Quality Index (PSQI) on Day 60</measure>
    <time_frame>Baseline and day 60</time_frame>
    <description>The PSQI is a validated, self reporting instrument assessing sleep. Possible scores range from 0 to 21 with higher scores indicating lower quality sleep. The instrument contains 19 items.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in general wellbeing on the Physical Health Questionnaire (PHQ) on Day 60</measure>
    <time_frame>Baseline and day 60</time_frame>
    <description>The PHQ is a validated, self reporting instrument assessing general wellbeing through sleep, respiratory health, headache, and gastrointestinal symptoms. Possible scores on each item range from 1 to 7 with higher scores indicating greater frequency of symptoms. The instrument contains 14 items.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in cognitive wellness on the Self Report Measure of Cognitive Abilities (SRMCA) on Day 60</measure>
    <time_frame>Baseline and day 60</time_frame>
    <description>The SRMCA is a validated, self reporting instrument assessing cognitive wellbeing. Possible scores range from 0 to 27 with higher scores indicating greater cognitive wellbeing. The instrument contains 44 items.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of days with any cold symptoms as defined by the Jackson Symptom Score on day 60.</measure>
    <time_frame>Day 60</time_frame>
    <description>The Jackson Symptom Score is a validated, self reporting instrument which contains 8 cold and flu symptoms. Scores range from 0 (no symptoms) to 8 (every one of the listed symptoms.)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in stress on the Perceived Stress Scale (PSS) on Day 60</measure>
    <time_frame>Baseline and Day 60</time_frame>
    <description>The PSS is a validated, self reporting instrument assessing perceived stress. Possible scores range from 0 to 40 with higher scores indicating higher stress levels. The instrument contains ten items.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Sleep</condition>
  <condition>Stress</condition>
  <condition>Health, Subjective</condition>
  <condition>Inflammation</condition>
  <condition>Cognitive Symptom</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants consume 2 ounces of the supplement each morning for 60 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants do not make any changes to their health related routines</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Supplement Drink</intervention_name>
    <description>Superfoods based nutritional supplement</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  otherwise healthy&#xD;
&#xD;
          -  adults living in the US&#xD;
&#xD;
          -  is practicing adequate contraception or is abstaining from all activities which could&#xD;
             result in pregnancy&#xD;
&#xD;
          -  understands and agrees to comply with study procedures&#xD;
&#xD;
          -  provides informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  smoker&#xD;
&#xD;
          -  pregnant or may become pregnant&#xD;
&#xD;
          -  currently breastfeeding&#xD;
&#xD;
          -  currently taking antioxidant supplements&#xD;
&#xD;
          -  underlying chronic health conditions&#xD;
&#xD;
          -  COVID-19 diagnosis&#xD;
&#xD;
          -  demonstrated inability to comply with study procedures&#xD;
&#xD;
          -  history of allergy to citrus or berry fruits&#xD;
&#xD;
          -  has participated in an interventional clinical study within 31 days prior to&#xD;
             enrollment&#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>Jessie Hawkins, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Franklin Health Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Franklin School of Integrative Health Sciences</name>
      <address>
        <city>Franklin</city>
        <state>Tennessee</state>
        <zip>37067</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>February 25, 2021</last_update_submitted>
  <last_update_submitted_qc>February 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Franklin Health Research</investigator_affiliation>
    <investigator_full_name>Jessie Hawkins, PhD</investigator_full_name>
    <investigator_title>Research Director</investigator_title>
  </responsible_party>
  <keyword>immune health</keyword>
  <keyword>prevention</keyword>
  <keyword>phytonutrients</keyword>
  <keyword>superfoods</keyword>
  <keyword>antioxidant</keyword>
  <keyword>essential oils</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neurobehavioral Manifestations</mesh_term>
    <mesh_term>Inflammation</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/NCT04499560
org study id: 20-7-1100
nct id: NCT04499560
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the health related benefits of a superfoods
      nutrition supplement on health related quality of life.
After being informed about the study, participants will provide informed consent and be
      randomized to one of two groups: intervention or control. Those in the intervention group
      will consume two ounces of a superfoods drink each morning for 60 days. Outcomes will be
      assessed at baseline, on day 30 and on day 60.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change from baseline in sleep quality on Pittsburgh Sleep Quality Index (PSQI) on Day 60
time frame: Baseline and day 60
description: The PSQI is a validated, self reporting instrument assessing sleep. Possible scores range from 0 to 21 with higher scores indicating lower quality sleep. The instrument contains 19 items.
measure: Change from baseline in general wellbeing on the Physical Health Questionnaire (PHQ) on Day 60
time frame: Baseline and day 60
description: The PHQ is a validated, self reporting instrument assessing general wellbeing through sleep, respiratory health, headache, and gastrointestinal symptoms. Possible scores on each item range from 1 to 7 with higher scores indicating greater frequency of symptoms. The instrument contains 14 items.
measure: Change from baseline in cognitive wellness on the Self Report Measure of Cognitive Abilities (SRMCA) on Day 60
time frame: Baseline and day 60
description: The SRMCA is a validated, self reporting instrument assessing cognitive wellbeing. Possible scores range from 0 to 27 with higher scores indicating greater cognitive wellbeing. The instrument contains 44 items.
measure: Number of days with any cold symptoms as defined by the Jackson Symptom Score on day 60.
time frame: Day 60
description: The Jackson Symptom Score is a validated, self reporting instrument which contains 8 cold and flu symptoms. Scores range from 0 (no symptoms) to 8 (every one of the listed symptoms.)
measure: Change from baseline in stress on the Perceived Stress Scale (PSS) on Day 60
time frame: Baseline and Day 60
description: The PSS is a validated, self reporting instrument assessing perceived stress. Possible scores range from 0 to 40 with higher scores indicating higher stress levels. The instrument contains ten items.
arm group label: Intervention
arm group type: Experimental
description: Participants consume 2 ounces of the supplement each morning for 60 days.
arm group label: Control
arm group type: No Intervention
description: Participants do not make any changes to their health related routines
intervention type: Dietary Supplement
intervention name: Supplement Drink
description: Superfoods based nutritional supplement
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jessie Hawkins, PhD
role: Principal Investigator
affiliation: Franklin Health Research
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Franklin Health Research
investigator full name: Jessie Hawkins, PhD
investigator title: Research Director
mesh term: Neurobehavioral Manifestations
mesh term: Inflammation
sharing ipd: No