NCT02818413

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2017

Completed
Last Updated

August 29, 2017

Status Verified

August 1, 2017

Enrollment Period

10 months

First QC Date

June 28, 2016

Last Update Submit

August 28, 2017

Conditions

Athletic Performance

Keywords

Stool microbiomeStool metabolomeSingle nucleotide polymorphisms

Outcome Measures

Primary Outcomes (1)

  • Baseline identification of microbial community present in stool

    Approximately 1 week after collection of stool sample

Study Arms (1)

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

Interventions

Biospecimen collection and questionnairesOTHER

Biospecimen collection and questionnaires

U.S. Olympic Team and elite athletes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples will be retained for future research

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Brent A. Bauer, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine, General Internal Medicine

Study Record Dates

First Submitted

June 28, 2016

First Posted

June 29, 2016

Study Start

June 3, 2016

Primary Completion

March 21, 2017

Study Completion

March 21, 2017

Last Updated

August 29, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)