Recruiting

Lignite Extract

Sponsor:

Seraphic Group Inc

Code:

NCT03026621

Conditions

Microbiome

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Lignite Extract

Herbal tea

Study Details

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.

Conditions

Microbiome

Study ID

NCT03026621

Start date

Jan, 2017

Status verified date

Jan, 2017

Completion date

Mar, 2017

Anticipated

Primary completion date

Mar, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

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

experimental: Lignite Extract

This will be the Restore gut supplement

Interventions

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.

Herbal tea

This is an herbal tea that will look like the control

Primary outcome measure

  • Intestinal Microbiome [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

David Roberts, MPH

844 432-5488droberts@seraphicgroup.com

Locations

Biomic Sciences

Recruiting

Charlottesville, Virginia, United States, 22902

Contacts

David Roberts, MPH

844-432-5488droberts@seraphicgroup.com

Principal Investigator:

David Roberts, MPH

More Information

Sponsor

Seraphic Group Inc

Last update posted

Jan 20, 2017

Last verified

Jan, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Seraphic Group Inc on 2017-01-20.