NCT03256006

Brief Summary

To study per and post effort variations of inflammatory biological markers during a 100 miles

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
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2018

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

August 10, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 21, 2017

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 18, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2018

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2018

Completed
Last Updated

August 3, 2018

Status Verified

August 1, 2018

Enrollment Period

Same day

First QC Date

August 10, 2017

Last Update Submit

August 1, 2018

Conditions

Inflammatory Response

Keywords

sport exerciseultra endurance

Outcome Measures

Primary Outcomes (10)

  • Variation per and post effort of interleukin 1 plasma level

    Plasma level of per and post effort of interleukin 1 will be measured

    Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race

  • Variation per and post effort of interleukin 6 plasma level

    Plasma level of per and post effort of interleukin 6 will be measured

    Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race

  • Variation of per and post effort of protein C reactive

    Plasma level of per and post effort of protein C reactive will be measured

    Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race

  • Variation per and post effort of interleukin Tumor Necrosis Factor alpha

    Plasma level of per and post effort of tumor necrosis alpha will be measured

    Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race

  • Variation per and post effort of interleukin 4 plasma level

    Plasma level of per and post effort of interleukin 4 will be measured

    Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race

  • Variation per and post effort of interleukin 10 plasma level

    Plasma level of per and post effort of interleukin 10 will be measured

    Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race

  • Variation per and post effort of interleukin 13 plasma level

    Plasma level of per and post effort of interleukin 13 will be measured

    Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race

  • Variation per and post effort of interleukin tumor growth factor beta plasma level

    Plasma level of per and post effort of tumor growth factor beta

    Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race

  • Variation per and post effort of lipids plasma level

    Plasma level of per and post effort of lipids

    Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race

  • Variation per and post effort of lipoproteins plasma level

    Plasma level of per and post effort of lipoproteins

    Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race

Interventions

Blood sampleOTHER

Blood sample to study per and post effort evolution markers of systemic inflammation

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy volunteers

You may qualify if:

  • adults (age\>18years)
  • completion of an ultra endurance race (50 miles) during the 2 years before

You may not qualify if:

  • female
  • age\<18years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

pro and anti inflammatory biomarkers (reactive oxygen species)

MeSH Terms

Interventions

Blood Specimen Collection

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

August 10, 2017

First Posted

August 21, 2017

Study Start

October 18, 2018

Primary Completion

October 18, 2018

Study Completion

October 29, 2018

Last Updated

August 3, 2018

Record last verified: 2018-08