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Examining the Change in Microbiome Diversity and Urine Metabolites After Lignite Extract Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03026621
Recruitment Status : Unknown
Verified January 2017 by Seraphic Group Inc.
Recruitment status was:  Recruiting
First Posted : January 20, 2017
Last Update Posted : January 20, 2017
Sponsor:
Information provided by (Responsible Party):
Seraphic Group Inc

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Microbiome Dietary Supplement: Lignite Extract Other: Herbal tea Not Applicable

Detailed Description:

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 Unpublished case reports have shown significant shifts in the microbiome when participant's diet changes from a high carbohydrate to a high fat diet.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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Examining the Change in Microbiome Diversity and Urine Metabolites After Lignite Extract Use
Study Start Date : January 2017
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
This will be an herbal tea the looks similar to the control.
Other: Herbal tea
This is an herbal tea that will look like the control
Other Name: Placebo

Experimental: Lignite Extract
This will be the Restore gut supplement
Dietary Supplement: Lignite Extract
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.
Other Name: Restore Gut Supplement




Primary Outcome Measures :
  1. Intestinal Microbiome [ Time Frame: 2 weeks ]
    Next generation genetic sequence will be taken


Secondary Outcome Measures :
  1. Oral Microbiome [ Time Frame: 2 weeks ]
    Next generation genetic sequence will be taken

  2. Urine metabolies [ Time Frame: 2 weeks ]
    Urine glyphosate, CD34, zonulin, creatine-albumin ratio and a urine analysis panel



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • People over 18 and under 80 who have never taken Restore gut supplement

Exclusion Criteria:,

  • pregnant women, prisoners, people with primary bowel disorder or who have taken antibiotics over the last four weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03026621


Contacts
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Contact: David Roberts, MPH 844 432-5488 droberts@seraphicgroup.com

Locations
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United States, Virginia
Biomic Sciences Recruiting
Charlottesville, Virginia, United States, 22902
Contact: David Roberts, MPH    844-432-5488    droberts@seraphicgroup.com   
Principal Investigator: David Roberts, MPH         
Sponsors and Collaborators
Seraphic Group Inc
Investigators
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Principal Investigator: David Roberts Seraphic Group

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Responsible Party: Seraphic Group Inc
ClinicalTrials.gov Identifier: NCT03026621    
Other Study ID Numbers: 104
First Posted: January 20, 2017    Key Record Dates
Last Update Posted: January 20, 2017
Last Verified: January 2017