Clinical trial NCT02818413: Stool Microbiome, Pathogens, and Infectious Agents Among Olympic and Elite Athletes
Official title: TRMC-Bio "Molecular Profiling of Gut Microbiome, Microbiome Metabolome, Serum Chemistry, and Metabolism-Associated SNPs in Elite Athletes"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Athletic Performance
Keywords: Stool microbiome
Stool metabolome
Single nucleotide polymorphisms
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Thorne HealthTech, Inc
First posted: 2016-06-29
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Members of the U.S. Olympic teams and other elite athletes

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.

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.

Eligibility 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

Primary outcomes:
measure: Baseline identification of microbial community present in stool
timeFrame: Approximately 1 week after collection of stool sample
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Brent A. Bauer, M.D.
role: PRINCIPAL_INVESTIGATOR
References: