Clinical trial NCT03026621: Examining the Change in Microbiome Diversity and Urine Metabolites After Lignite Extract Use
Official title: Examining the Change in Microbiome Diversity and Urine Metabolites After Lignite Extract Use
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Microbiome
Lead sponsor: Seraphic Group Inc
Sponsor class: INDUSTRY
First posted: 2017-01-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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 Unpublished case reports have shown significant shifts in the microbiome when participant's diet changes from a high carbohydrate to a high fat diet.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

Eligibility 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

Primary outcomes:
measure: Intestinal Microbiome
timeFrame: 2 weeks
Secondary outcomes:
measure: Oral Microbiome
timeFrame: 2 weeks
measure: Urine metabolies
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: Biomic Sciences
state: Virginia
Study officials:
affiliation: Seraphic Group
name: David Roberts
role: PRINCIPAL_INVESTIGATOR
References: