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/NCT06023082</url>
    </required_header>
    <id_info>
      <org_study_id>20349</org_study_id>
      <nct_id>NCT06023082</nct_id>
    </id_info>
    <brief_title>A Single-Group Study to Examine the Efficacy of a Gut Health Supplement to Increase Metabolism, Improve Gut Health, and Support Weight Management</brief_title>
    <official_title>A Single-Group Study to Examine the Efficacy of a Gut Health Supplement to Increase Metabolism, Improve Gut Health, and Support Weight Management</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kilo Health</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Citruslabs</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Kilo Health</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 study will evaluate the efficacy of Colon Broom Premium on gut health, metabolism,&#xD;
        weight management, and energy levels. The study will be conducted as a virtual single-group&#xD;
        trial in which all 120 participants will use the test product. This study will last 12 weeks,&#xD;
        and participants will take the product daily. Participants will complete study-specific&#xD;
        questionnaires at Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week&#xD;
        12. Participants will also provide body weight measurements and body circumference&#xD;
        measurements at Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week&#xD;
        12.&#xD;
  &#xD;
        Before &amp; after photographs will be provided at Baseline and Week 12.&#xD;
  &#xD;
        The Colon Broom Premium supplement contains psyllium seed husk powder, L-carnitine tartrate,&#xD;
        CapsimaxⓇ cayenne fruit extract, chromium (as chromium picolinate), vitamin B6 (as pyridoxine&#xD;
        HCl), vitamin B12 (as cyanocobalamin), and Iron.&#xD;
  &#xD;
        The study Sponsor and product name will remain anonymous to participants throughout the&#xD;
        trial. The Sponsor name or product name will not be included in any participant-facing&#xD;
        documentation.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">July 26, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 1, 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>
      <masking_description>Participants will be blinded to the brand and name of the supplement they are taking.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Changes in gut health. [Baseline to Week 12]</measure>
      <time_frame>12 weeks</time_frame>
      <description>Survey-based assessment (0-5 scale) of participant-perceived gut health parameters.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in metabolism. [Baseline to Week 12]</measure>
      <time_frame>12 weeks</time_frame>
      <description>Survey-based assessment (0-5 scale) of participants' perception of their metabolism.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes in body weight. [Baseline to Week 12]</measure>
      <time_frame>12 weeks</time_frame>
      <description>Participants will provide body weight measurements using a weighing scales.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual changes in weight. [Baseline to Week 12]</measure>
      <time_frame>12 weeks</time_frame>
      <description>Participants will provide &quot;before&quot; and &quot;after&quot; pictures for virtual photo grading of visual changes in weight or body composition.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in tape measurements of the body. [Baseline to Week 12]</measure>
      <time_frame>12 weeks</time_frame>
      <description>Participants will provide tape measurements of their waist, hips, and individual thighs.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">120</enrollment>
    <condition>Gut Health</condition>
    <condition>Metabolism</condition>
    <condition>Weight Loss</condition>
    <condition>Energy</condition>
    <arm_group>
      <arm_group_label>Colon Broom Premium supplement</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will add 1 scoop (0.23 oz/ 6.47 g) to 12-14 fl oz of water, mix well and drink immediately. Participants will take the supplement 30 -60 minutes before their meal and will then drink an additional glass of water. Participants will be instructed not to take the supplement less than 2 hours before bedtime. The test product may be consumed before breakfast, lunch, or dinner.&#xD;
  First week: Start with 1 serving per day Rest of the study period: Increase to 2 servings per day at 2 different times during the day.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Colon Broom Premium supplement</intervention_name>
      <description>The product contains the following ingredients:&#xD;
  Psyllium Seed Husk Powder L-Carnitine Tartrate Capsimax® Cayenne Fruit Extract Chromium (as Chromium Picolinate) Vitamin B6 (as Pyridoxine HCl) Vitamin B12 (as Cyanocobalamin) Iron</description>
      <arm_group_label>Colon Broom Premium supplement</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female between ages 30-50&#xD;
  &#xD;
            -  Have a BMI of 25 or more&#xD;
  &#xD;
            -  Have self-reported issues with gas, bloating, constipation, heartburn/acid reflux,&#xD;
               abdominal pain, or digestion at least three times per week&#xD;
  &#xD;
            -  Be willing to maintain their standard dietary pattern, activity level, and body weight&#xD;
               for the duration of the study&#xD;
  &#xD;
            -  Be generally healthy - do not live with any uncontrolled chronic disease&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any pre-existing chronic conditions that would prevent participants from adhering to&#xD;
               the protocol, including oncological and psychiatric disorders&#xD;
  &#xD;
            -  Anyone who is currently undergoing, or planning to to undergo any gut or&#xD;
               weight-related procedures in the next 12 week.&#xD;
  &#xD;
            -  Anyone with a history of severe allergic reactions including but not limited to&#xD;
               psyllium seed husk powder and strawberries&#xD;
  &#xD;
            -  Anyone taking any prescription medications targeting the gut&#xD;
  &#xD;
            -  Anyone taking any supplements targeting the gut in the past month&#xD;
  &#xD;
            -  Use of antibiotics in the past 3 months&#xD;
  &#xD;
            -  Women who are pregnant, breastfeeding, or attempting to become pregnant&#xD;
  &#xD;
            -  Anyone unwilling to follow the study protocol&#xD;
  &#xD;
            -  Anyone following any particular dietary regime, such as a ketogenic diet or&#xD;
               intermittent fasting.&#xD;
  &#xD;
            -  Anyone who has had bariatric surgery in the past 6 months&#xD;
  &#xD;
            -  Anyone who has chronic constipation&#xD;
  &#xD;
            -  Anyone who has Irritable Bowel Disease (IBD)&#xD;
  &#xD;
            -  Anyone diagnosed with severe digestive issues&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>60 Years</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 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 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>Body Weight</mesh_term>
      <mesh_term>Weight Loss</mesh_term>
    </condition_browse>
    <!-- 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/NCT06023082
  org study id: 20349
  nct id: NCT06023082
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study will evaluate the efficacy of Colon Broom Premium on gut health, metabolism,
        weight management, and energy levels. The study will be conducted as a virtual single-group
        trial in which all 120 participants will use the test product. This study will last 12 weeks,
        and participants will take the product daily. Participants will complete study-specific
        questionnaires at Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week
        12. Participants will also provide body weight measurements and body circumference
        measurements at Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week
        12.
  
        Before & after photographs will be provided at Baseline and Week 12.
  
        The Colon Broom Premium supplement contains psyllium seed husk powder, L-carnitine tartrate,
        CapsimaxⓇ cayenne fruit extract, chromium (as chromium picolinate), vitamin B6 (as pyridoxine
        HCl), vitamin B12 (as cyanocobalamin), and Iron.
  
        The study Sponsor and product name will remain anonymous to participants throughout the
        trial. The Sponsor name or product name will not be included in any participant-facing
        documentation.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  masking description: Participants will be blinded to the brand and name of the supplement they are taking.
  measure: Changes in gut health. [Baseline to Week 12]
  time frame: 12 weeks
  description: Survey-based assessment (0-5 scale) of participant-perceived gut health parameters.
  measure: Changes in metabolism. [Baseline to Week 12]
  time frame: 12 weeks
  description: Survey-based assessment (0-5 scale) of participants' perception of their metabolism.
  measure: Changes in body weight. [Baseline to Week 12]
  time frame: 12 weeks
  description: Participants will provide body weight measurements using a weighing scales.
  measure: Visual changes in weight. [Baseline to Week 12]
  time frame: 12 weeks
  description: Participants will provide "before" and "after" pictures for virtual photo grading of visual changes in weight or body composition.
  measure: Changes in tape measurements of the body. [Baseline to Week 12]
  time frame: 12 weeks
  description: Participants will provide tape measurements of their waist, hips, and individual thighs.
  arm group label: Colon Broom Premium supplement
  arm group type: Experimental
  description: Participants will add 1 scoop (0.23 oz/ 6.47 g) to 12-14 fl oz of water, mix well and drink immediately. Participants will take the supplement 30 -60 minutes before their meal and will then drink an additional glass of water. Participants will be instructed not to take the supplement less than 2 hours before bedtime. The test product may be consumed before breakfast, lunch, or dinner.
  First week: Start with 1 serving per day Rest of the study period: Increase to 2 servings per day at 2 different times during the day.
  intervention type: Dietary Supplement
  intervention name: Colon Broom Premium supplement
  description: The product contains the following ingredients:
  Psyllium Seed Husk Powder L-Carnitine Tartrate Capsimax® Cayenne Fruit Extract Chromium (as Chromium Picolinate) Vitamin B6 (as Pyridoxine HCl) Vitamin B12 (as Cyanocobalamin) Iron
  arm group label: Colon Broom Premium supplement
  criteria: 
  gender: All
  minimum age: 30 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Body Weight
  mesh term: Weight Loss