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

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT02818413
• Collaborator: Thorne Research Inc. (Industry)
• Enrollment: 32
• Location: 1
• Actual Duration (Months): 9.6
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Athletic Performance	Other: Biospecimen collection and questionnaires

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 Design

• Study Type: Observational
• Actual Enrollment: 32 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: TRMC-Bio "Molecular Profiling of Gut Microbiome, Microbiome Metabolome, Serum Chemistry, and Metabolism-Associated SNPs in Elite Athletes"
• Actual Study Start Date: Jun 3, 2016
• Actual Primary Completion Date: Mar 21, 2017
• Actual Study Completion Date: Mar 21, 2017

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Baseline identification of microbial community present in stool [Approximately 1 week after collection of stool sample]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic
• Thorne Research Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Brent A. Bauer, Professor of Medicine, General Internal Medicine, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT02818413
• Other Study ID Numbers: 16-001515
• First Posted: Jun 29, 2016
• Last Update Posted: Aug 29, 2017
• Last Verified: Aug 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Brent A. Bauer, Professor of Medicine, General Internal Medicine, Mayo Clinic: Stool microbiome; Stool metabolome; Single nucleotide polymorphisms

Study Results

No Results Posted as of Aug 29, 2017