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

Seraphic Group

Status: Unknown

Conditions: Microbiome

Treatments: Other: Herbal tea; Dietary Supplement: Lignite Extract

Study type: Interventional

Funder types: Industry

Identifiers

NCT03026621

104

Details and patient eligibility

About

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.

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 Unpublished case reports have shown significant shifts in the microbiome when participant's diet changes from a high carbohydrate to a high fat diet.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

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

This will be an herbal tea the looks similar to the control.

Treatment:

Other: Herbal tea

Lignite Extract

Experimental group

Description:

This will be the Restore gut supplement

Treatment:

Dietary Supplement: Lignite Extract