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

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ClinicalTrials.gov Identifier: NCT02818413
Recruitment Status : Completed
First Posted : June 29, 2016
Last Update Posted : August 29, 2017
Sponsor:
Collaborator:
Thorne Research Inc.
Information provided by (Responsible Party):
Brent A. Bauer, Mayo Clinic

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
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.

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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 : June 3, 2016
Actual Primary Completion Date : March 21, 2017
Actual Study Completion Date : March 21, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

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




Primary Outcome Measures :
  1. Baseline identification of microbial community present in stool [ Time Frame: Approximately 1 week after collection of stool sample ]

Biospecimen Retention:   Samples With DNA
Stool samples will be retained for future research


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Members of the U.S. Olympic teams and other elite athletes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02818413


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Thorne Research Inc.
Investigators
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Principal Investigator: Brent A. Bauer, M.D. Mayo Clinic
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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: June 29, 2016    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Brent A. Bauer, Mayo Clinic:
Stool microbiome
Stool metabolome
Single nucleotide polymorphisms