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

Study Overview
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Brief Summary
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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.

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 Unpublished case reports have shown significant shifts in the microbiome when participant's diet changes from a high carbohydrate to a high fat diet.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

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

Conditions
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Microbiome

Intervention / Treatment
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* Dietary Supplement: Lignite Extract
* Other: Herbal tea


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>This will be an herbal tea the looks similar to the control. | Other: Herbal tea<br>* This is an herbal tea that will look like the control<br>* Other names: Placebo;|
| Experimental: Lignite Extract<br>This will be the Restore gut supplement | Dietary Supplement: Lignite Extract<br>* 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.<br>* Other names: Restore Gut Supplement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intestinal Microbiome | Next generation genetic sequence will be taken | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral Microbiome | Next generation genetic sequence will be taken | 2 weeks | 
| Urine metabolies | Urine glyphosate, CD34, zonulin, creatine-albumin ratio and a urine analysis panel | 2 weeks |