<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/NCT03026621</url>
  </required_header>
  <id_info>
    <org_study_id>104</org_study_id>
    <nct_id>NCT03026621</nct_id>
  </id_info>
  <brief_title>Examining the Change in Microbiome Diversity and Urine Metabolites After Lignite Extract Use</brief_title>
  <official_title>Examining the Change in Microbiome Diversity and Urine Metabolites After Lignite Extract Use</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seraphic Group Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seraphic Group Inc</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether or not 'Restore' lignite extract mineral&#xD;
      supplement impacts the microbiome composition of the mouth and gut. Additionally, participant&#xD;
      urine samples will be examined to determine whether or not 'Restore' mineral supplement&#xD;
      impacts the composition urine biomarkers and toxins.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OBJECTIVES:&#xD;
&#xD;
      The purpose of this study is to determine whether or not 'Restore' lignite extract mineral&#xD;
      supplement impacts the microbiome composition of the mouth and gut. Additionally, participant&#xD;
      urine samples will be examined to determine whether or not 'Restore' mineral supplement&#xD;
      impacts the composition urine biomarkers and toxins.&#xD;
&#xD;
      BACKGROUND &amp; RATIONALE There is mounting evidence that the composition of the microbiome can&#xD;
      change quickly. Unpublished case reports have shown significant shifts in the microbiome when&#xD;
      participant's diet changes from a high carbohydrate to a high fat diet. Clinically, the use&#xD;
      of 'Restore' mineral supplement has led to the bulking of stool in people using it for the&#xD;
      first time within one or two days of first dose, further indicating a change in the gut&#xD;
      microbiome.&#xD;
&#xD;
      Given these observations, this clinical trial was designed to examine how taking 'Restore'&#xD;
      mineral supplement may impact the microbiome by examining the gut bacteria composition at two&#xD;
      days, and again at two weeks. Our hypothesis is that taking Restore alone can lead to a&#xD;
      quantifiable shift in the diversity of the microbiome as measured by the Simpson's Diversity&#xD;
      Index, a mathematical measure of species diversity in a community. This index provides more&#xD;
      information about community composition than simply species richness by also taking into&#xD;
      account the relative abundances of different species.&#xD;
&#xD;
      There is also evidence that Restore mineral supplement can impact urine composition.&#xD;
      Specifically, we will be examining the change in the presence of zonulin, glyphosate,&#xD;
      creatinine-albumin ratio, and stem cells.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">March 2017</completion_date>
  <primary_completion_date type="Anticipated">March 2017</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>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intestinal Microbiome</measure>
    <time_frame>2 weeks</time_frame>
    <description>Next generation genetic sequence will be taken</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oral Microbiome</measure>
    <time_frame>2 weeks</time_frame>
    <description>Next generation genetic sequence will be taken</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urine metabolies</measure>
    <time_frame>2 weeks</time_frame>
    <description>Urine glyphosate, CD34, zonulin, creatine-albumin ratio and a urine analysis panel</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Microbiome</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This will be an herbal tea the looks similar to the control.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lignite Extract</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This will be the Restore gut supplement</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Lignite Extract</intervention_name>
    <description>The study design is a double-blind case-control trial, whereby half of the participants will be &quot;cases&quot; and will be asked to take 5mL 'Restore' mineral supplement three times each day. The other half of the participants will be &quot;controls&quot; and will be asked to take 5mL of a placebo three times each day. Both the study leader and the participants will be blinded to who receives Restore and who receive placebo.</description>
    <arm_group_label>Lignite Extract</arm_group_label>
    <other_name>Restore Gut Supplement</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Herbal tea</intervention_name>
    <description>This is an herbal tea that will look like the control</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  People over 18 and under 80 who have never taken Restore gut supplement&#xD;
&#xD;
        Exclusion Criteria:,&#xD;
&#xD;
          -  pregnant women, prisoners, people with primary bowel disorder or who have taken&#xD;
             antibiotics over the last four weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Roberts</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seraphic Group</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>David Roberts, MPH</last_name>
    <phone>844 432-5488</phone>
    <email>droberts@seraphicgroup.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Biomic Sciences</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22902</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Roberts, MPH</last_name>
      <phone>844-432-5488</phone>
      <email>droberts@seraphicgroup.com</email>
    </contact>
    <investigator>
      <last_name>David Roberts, MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>January 17, 2017</last_update_submitted>
  <last_update_submitted_qc>January 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03026621
org study id: 104
nct id: NCT03026621
lead sponsor: 
The purpose of this study is to determine whether or not 'Restore' lignite extract mineral
      supplement impacts the microbiome composition of the mouth and gut. Additionally, participant
      urine samples will be examined to determine whether or not 'Restore' mineral supplement
      impacts the composition urine biomarkers and toxins.
OBJECTIVES:

      The purpose of this study is to determine whether or not 'Restore' lignite extract mineral
      supplement impacts the microbiome composition of the mouth and gut. Additionally, participant
      urine samples will be examined to determine whether or not 'Restore' mineral supplement
      impacts the composition urine biomarkers and toxins.

      BACKGROUND & RATIONALE There is mounting evidence that the composition of the microbiome can
      change quickly. Unpublished case reports have shown significant shifts in the microbiome when
      participant's diet changes from a high carbohydrate to a high fat diet. Clinically, the use
      of 'Restore' mineral supplement has led to the bulking of stool in people using it for the
      first time within one or two days of first dose, further indicating a change in the gut
      microbiome.

      Given these observations, this clinical trial was designed to examine how taking 'Restore'
      mineral supplement may impact the microbiome by examining the gut bacteria composition at two
      days, and again at two weeks. Our hypothesis is that taking Restore alone can lead to a
      quantifiable shift in the diversity of the microbiome as measured by the Simpson's Diversity
      Index, a mathematical measure of species diversity in a community. This index provides more
      information about community composition than simply species richness by also taking into
      account the relative abundances of different species.

      There is also evidence that Restore mineral supplement can impact urine composition.
      Specifically, we will be examining the change in the presence of zonulin, glyphosate,
      creatinine-albumin ratio, and stem cells.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Intestinal Microbiome
time frame: 2 weeks
description: Next generation genetic sequence will be taken
measure: Oral Microbiome
time frame: 2 weeks
description: Next generation genetic sequence will be taken
measure: Urine metabolies
time frame: 2 weeks
description: Urine glyphosate, CD34, zonulin, creatine-albumin ratio and a urine analysis panel
arm group label: Placebo
arm group type: Placebo Comparator
description: This will be an herbal tea the looks similar to the control.
arm group label: Lignite Extract
arm group type: Experimental
description: This will be the Restore gut supplement
intervention type: Dietary Supplement
intervention name: Lignite Extract
description: The study design is a double-blind case-control trial, whereby half of the participants will be "cases" and will be asked to take 5mL 'Restore' mineral supplement three times each day. The other half of the participants will be "controls" and will be asked to take 5mL of a placebo three times each day. Both the study leader and the participants will be blinded to who receives Restore and who receive placebo.
arm group label: Lignite Extract
other name: Restore Gut Supplement
intervention type: Other
intervention name: Herbal tea
description: This is an herbal tea that will look like the control
arm group label: Placebo
other name: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David Roberts
role: Principal Investigator
affiliation: Seraphic Group
last name: David Roberts, MPH
phone: 844 432-5488
email: droberts@seraphicgroup.com
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor