xml: <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/NCT06019858</url>
    </required_header>
    <id_info>
      <org_study_id>20348</org_study_id>
      <nct_id>NCT06019858</nct_id>
    </id_info>
    <brief_title>A Clinical Trial to Assess the Effects of a Vitamin Shot on Energy Levels</brief_title>
    <official_title>A Clinical Trial to Assess the Effects of a Vitamin Shot on Energy Levels</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Vitamin Energy®</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Citruslabs</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Vitamin Energy®</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>
        This is a virtual, single-arm clinical trial that will last 30 days. Participants will drink&#xD;
        1 bottle of the Vitamin Energy® shot daily and complete questionnaires at baseline, Day 7,&#xD;
        Day 14, and Day 30.&#xD;
  &#xD;
        Participants' energy, mood, and cognitive function will be evaluated at baseline and at each&#xD;
        check-in. Bodyweight will also be assessed at baseline and Day 30. Likert scale responses&#xD;
        will be examined from baseline to each check-in. Participant responses on product feedback&#xD;
        will be presented as % scores.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 21, 2023</start_date>
    <completion_date type="Actual">July 20, 2023</completion_date>
    <primary_completion_date type="Actual">July 20, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in energy levels. [Baseline to Day 30]</measure>
      <time_frame>30 days</time_frame>
      <description>Survey-based assessment (0-5 scale) of participant reported energy levels.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in ability to concentration. [Baseline to Day 30]</measure>
      <time_frame>30 days</time_frame>
      <description>Survey-based assessment (0-5 scale) of participant reported concentration abilities.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in participant-perceived productivity. [Baseline to Day 30]</measure>
      <time_frame>30 days</time_frame>
      <description>Survey-based assessment (0-5 scale) of participants perception of their productivity during the day.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in mood. [Baseline to Day 30]</measure>
      <time_frame>30 days</time_frame>
      <description>Survey-based assessment (0-5 scale) of mood.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in brain fog. [Baseline to Day 30]</measure>
      <time_frame>30 days</time_frame>
      <description>Survey-based assessment (0-5 scale) of brain fog experienced by participants.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in body weight. [Baseline to Day 30]</measure>
      <time_frame>30 days</time_frame>
      <description>Participants will weight themselves at baseline and endline and provide their body weight.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">30</enrollment>
    <condition>Energy</condition>
    <condition>Fatigue</condition>
    <condition>Mood</condition>
    <condition>Weight Loss</condition>
    <condition>Cognition</condition>
    <arm_group>
      <arm_group_label>Vitamin Energy Shot</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will take one bottle daily of the Vitamin Energy® shot, in the morning.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Vitamin Energy Shot</intervention_name>
      <description>Vitamin Energy® shot is a naturally-caffeinated functional energy shot that contains:&#xD;
  Vitamin B3 Vitamin B6 Vitamin B12 Natural Caffeine (green tea extract) L-Carnitine Tartrate Potassium Sorbate Taurine Sucralose</description>
      <arm_group_label>Vitamin Energy Shot</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Men and women 18 years and over&#xD;
  &#xD;
          Self-reported issues with:&#xD;
  &#xD;
            -  Energy&#xD;
  &#xD;
            -  Focus&#xD;
  &#xD;
            -  Brain fog Participants who often feel fatigued Willing to maintain the same caffeine&#xD;
               consumption during the study period Generally healthy - don't live with any&#xD;
               uncontrolled chronic disease&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Any pre-existing chronic conditions that would prevent participants from adhering to the&#xD;
          protocol, including oncological and psychiatric disorders.&#xD;
  &#xD;
          Anyone with known severe allergic reactions. Women who are pregnant, breastfeeding, or&#xD;
          attempting to become pregnant Unwilling to follow the study protocol.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Citruslabs</name>
        <address>
          <city>Santa Monica</city>
          <state>California</state>
          <zip>90404</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</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>Weight Loss</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vitamins</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06019858
  org study id: 20348
  nct id: NCT06019858
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a virtual, single-arm clinical trial that will last 30 days. Participants will drink
        1 bottle of the Vitamin Energy® shot daily and complete questionnaires at baseline, Day 7,
        Day 14, and Day 30.
  
        Participants' energy, mood, and cognitive function will be evaluated at baseline and at each
        check-in. Bodyweight will also be assessed at baseline and Day 30. Likert scale responses
        will be examined from baseline to each check-in. Participant responses on product feedback
        will be presented as % scores.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Change in energy levels. [Baseline to Day 30]
  time frame: 30 days
  description: Survey-based assessment (0-5 scale) of participant reported energy levels.
  measure: Change in ability to concentration. [Baseline to Day 30]
  time frame: 30 days
  description: Survey-based assessment (0-5 scale) of participant reported concentration abilities.
  measure: Change in participant-perceived productivity. [Baseline to Day 30]
  time frame: 30 days
  description: Survey-based assessment (0-5 scale) of participants perception of their productivity during the day.
  measure: Changes in mood. [Baseline to Day 30]
  time frame: 30 days
  description: Survey-based assessment (0-5 scale) of mood.
  measure: Changes in brain fog. [Baseline to Day 30]
  time frame: 30 days
  description: Survey-based assessment (0-5 scale) of brain fog experienced by participants.
  measure: Change in body weight. [Baseline to Day 30]
  time frame: 30 days
  description: Participants will weight themselves at baseline and endline and provide their body weight.
  arm group label: Vitamin Energy Shot
  arm group type: Experimental
  description: Participants will take one bottle daily of the Vitamin Energy® shot, in the morning.
  intervention type: Other
  intervention name: Vitamin Energy Shot
  description: Vitamin Energy® shot is a naturally-caffeinated functional energy shot that contains:
  Vitamin B3 Vitamin B6 Vitamin B12 Natural Caffeine (green tea extract) L-Carnitine Tartrate Potassium Sorbate Taurine Sucralose
  arm group label: Vitamin Energy Shot
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Weight Loss
  mesh term: Vitamins
  sharing ipd: Undecided