NCT03194035

Brief Summary

The aim of this study is to study the per and post-exertional variations of the pro and anti inflammatory markers during an ultra-endurance race in healthy volunteers.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

June 16, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 21, 2017

Completed
1.3 years until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2018

Completed
Last Updated

August 3, 2018

Status Verified

August 1, 2018

Enrollment Period

Same day

First QC Date

June 16, 2017

Last Update Submit

August 1, 2018

Conditions

InflammationInflammatory Response

Keywords

inflammationexerciseultra endurance

Outcome Measures

Primary Outcomes (12)

  • Per and post-exertional variations of IL1 during an ultra-endurance race in healthy volunteers.

    In this study, the investigators will measure variations of IL1 blood level

    Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race

  • Per and post-exertional variations of IL6 during an ultra-endurance race in healthy volunteers.

    In this study, the investigators will measure variations of IL6 blood level

    Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race

  • Per and post-exertional variations of TNF alpha during an ultra-endurance race in healthy volunteers.

    In this study, the investigators will measure variations of TNF alpha blood level

    Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race

  • Per and post-exertional variations of HMG beta during an ultra-endurance race in healthy volunteers.

    In this study, the investigators will measure variations of HMG beta blood level

    Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race

  • Per and post-exertional variations of CRP during an ultra-endurance race in healthy volunteers.

    In this study, the investigators will measure variations of CRP blood level

    Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race

  • Per and post-exertional variations of IL4 during an ultra-endurance race in healthy volunteers.

    In this study, the investigators will measure variations of IL4 blood level

    Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race

  • Per and post-exertional variations of IL10 during an ultra-endurance race in healthy volunteers.

    In this study, the investigators will measure variations of IL10 blood level

    Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race

  • Per and post-exertional variations of IL13 during an ultra-endurance race in healthy volunteers.

    In this study, the investigators will measure variations of IL13 blood level

    Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race

  • Per and post-exertional variations of lipids during an ultra-endurance race in healthy volunteers.

    In this study, the investigators will measure variations of lipids blood level

    Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race

  • Per and post-exertional variations of LPS during an ultra-endurance race in healthy volunteers.

    In this study, the investigators will measure variations of LPS blood level

    Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race

  • Per and post-exertional variations of lipoprotein during an ultra-endurance race in healthy volunteers.

    In this study, the investigators will measure variations of lipoprotein blood level

    Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race

  • Per and post-exertional variations of TGF beta during an ultra-endurance race in healthy volunteers.

    In this study, the investigators will measure variations of TGF beta blood level

    Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race

Interventions

blood sampleBIOLOGICAL

Study per and post-exertional changes in proinflammatory biological (IL1, IL6, TNF alpha, HMG beta1 and CRP) and anti inflammatory parameters (IL4, IL10 and IL13, TGF beta, LPS, lipoproteins, lipids) during an ultra endurance race.

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

25 healthy adult volunteers amateurly participating in the "100 miles South of France 2017 race ©" recruited electronically using an announcement on the race website.

You may qualify if:

  • Male older than 18 years,
  • Completion of an ultra-endurance race (distance greater than 50 kilometers) during the 24 months preceding the race.
  • Affiliation or beneficiary of a social security.

You may not qualify if:

  • Age lower than 18 years,
  • Female.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

InflammationMotor Activity

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 16, 2017

First Posted

June 21, 2017

Study Start

October 1, 2018

Primary Completion

October 1, 2018

Study Completion

October 17, 2018

Last Updated

August 3, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share