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

NCT03026621 | Unknown

• 1 other identifier: 104
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Intestinal Microbiome

  Next generation genetic sequence will be taken

  2 weeks

Secondary Outcomes (2)

• Oral Microbiome

  2 weeks

• Urine metabolies

  2 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Other: Herbal tea

Lignite Extract

EXPERIMENTAL

This will be the Restore gut supplement

Dietary Supplement: Lignite Extract

Interventions

Lignite Extract DIETARY_SUPPLEMENT

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.

Also known as: Restore Gut Supplement

Lignite Extract

Herbal tea OTHER

This is an herbal tea that will look like the control

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Seraphic Group Inc: lead

Study Sites (1)

Biomic Sciences

Charlottesville, Virginia, 22902, United States

RECRUITING

MeSH Terms

Interventions

Coal; Teas, Herbal

Intervention Hierarchy (Ancestors)

Fossil Fuels; Complex Mixtures; Energy-Generating Resources; Environment; Environment and Public Health; Plant Preparations; Biological Products; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• David Roberts

  Seraphic Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Roberts, MPH

CONTACT

844 432-5488; droberts@seraphicgroup.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 20, 2017
• Study Start: January 1, 2017
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: January 20, 2017

Record last verified: 2017-01

Locations

US (1)