Stool Microbiome, Pathogens, and Infectious Agents Among Olympic and Elite Athletes (TRMC-Bio)

August 28, 2017 updated by: Brent A. Bauer, Mayo Clinic

TRMC-Bio "Molecular Profiling of Gut Microbiome, Microbiome Metabolome, Serum Chemistry, and Metabolism-Associated SNPs in Elite Athletes"

This research is being done to investigate fecal microbiome and metabolome as well as serum analytes and single nucleotide polymorphisms in Olympic athletes in comparison with other elite athletes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Olympic athletes, non-Olympic elite athletes, and other active adults may have genetic and metabolic profiles that are unique. These profiles may contribute to the caliber of their athletic performance, and they may provide keys to understanding select genetic and metabolic conditions.

Therefore, the specific aims of this project are as follows:

  • Specific Aim 1: Characterize the fecal microbial communities in athletes participating in the summer 2016 games and in athletes not participating in the Olympic games
  • Specific Aim 2: Characterize the fecal microbiome metabolome (untargeted) in athletes participating in the summer 2016 games and in athletes not participating in the Olympic games
  • Specific Aim 3: Characterize selected serum analytes and single nucleotide polymorphisms (SNPs) of elite athletes participating in the Summer 2016 games and in athletes not participating in the Olympic games, via serum and saliva analyses, respectively
  • Specific Aim 4: Retain specimens from Olympic athletes participating in the summer 2016 games and in athletes not participating in the Olympic games for future research
  • Specific Aim 7: Examine for the presence of Zika virus RNA in study participants who exhibit symptoms

Stool, urine, and blood specimens will be collected to study the stool metabolome, as well as serum analytes and single nucleotide polymorphisms, and the nature and extent of exposure to pathogens and infectious agents. These will be compared between Olympic athletes and other non-Olympic elite athletes.

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Members of the U.S. Olympic teams and other elite athletes

Description

Inclusion Criteria:

  • Member of the Summer 2016 U.S. Olympic team and/or other elite athlete
  • English speaking
  • Willing to provide informed consent and biospecimens
  • Willing to complete questionnaires regarding normal bowel habits and general health

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
U.S. Olympic Team and elite athletes
Biospecimens will be collected from and questionnaires will be administered to U.S. Olympic team members and other elite athletes
Other: Biospecimen collection and questionnaires
Biospecimen collection and questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Baseline identification of microbial community present in stool
Time Frame: Approximately 1 week after collection of stool sample
Approximately 1 week after collection of stool sample

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Thorne Research Inc.

Investigators

  • Principal Investigator: Brent A. Bauer, M.D., Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2016

Primary Completion (Actual)

March 21, 2017

Study Completion (Actual)

March 21, 2017

Study Registration Dates

First Submitted

June 28, 2016

First Submitted That Met QC Criteria

June 28, 2016

First Posted (Estimate)

June 29, 2016

Study Record Updates

Last Update Posted (Actual)

August 29, 2017

Last Update Submitted That Met QC Criteria

August 28, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 16-001515

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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