Athletic PerformanceTRMC-BioNCT02818413
Stool Microbiome, Pathogens, and Infectious Agents Among Olympic and Elite Athletes
An observational study of Athletic Performance, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Athletic Performance
- What is being tested?
- Biospecimen collection and questionnaires
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2016to 21 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Members of the U.S. Olympic teams and other elite athletes
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Athletic Performance
- Being tested
- Biospecimen collection and questionnaires
- Keywords
- Stool microbiome, Stool metabolome, Single nucleotide polymorphisms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen collection and questionnairesOther
Biospecimen collection and questionnaires
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Biospecimen collection and questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline identification of microbial community present in stool
Measured: Approximately 1 week after collection of stool sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study start3 Jun 2016
- Primary completion21 Mar 2017
- Study completion21 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Athletic PerformanceStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Thorne HealthTech, Inc
- Responsible party
- Principal investigator, Brent A. Bauer, Mayo Clinic
- Investigators
- Brent A. Bauer, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818413
- Sponsor's protocol ID
- 16-001515
- Acronym
- TRMC-Bio
- Status last verified
- Aug 2017
- First submitted
- 28 Jun 2016
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRMC-Bio "Molecular Profiling of Gut Microbiome, Microbiome Metabolome, Serum Chemistry, and Metabolism-Associated SNPs in Elite Athletes"
- ClinicalTrials.gov ID
- NCT02818413
- Acronym / sponsor ID
- TRMC-Bio / 16-001515
- Conditions
- Athletic Performance
- Keywords
- Stool microbiome, Stool metabolome, Single nucleotide polymorphisms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Thorne HealthTech, Inc
- Study start
- 3 Jun 2016 (actual)
- Primary completion
- 21 Mar 2017 (actual)
- Study completion
- 21 Mar 2017 (actual)
- First posted
- 29 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| U.S. Olympic Team and elite athletes | – | Other: Biospecimen collection and questionnairesBiospecimens will be collected from and questionnaires will be administered to U.S. Olympic team members and other elite athletes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Members of the U.S. Olympic teams and other elite athletes
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen collection and questionnairesBiospecimen collection and questionnaires | Other | U.S. Olympic Team and elite athletes |
Primary outcome
Baseline identification of microbial community present in stool
Time frame: Approximately 1 week after collection of stool sample
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brent A. Bauer, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Athletic Performance, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline identification of microbial community present in stool (time frame: Approximately 1 week after collection of stool sample). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2017.