Clinical trial NCT03256006: Study Inflammation During a 100 Miles
Official title: Per Effort Study of Inflammation During a 100 Miles
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Response
Keywords: sport exercise
ultra endurance
Lead sponsor: Hôpital Necker-Enfants Malades
Sponsor class: OTHER
First posted: 2017-08-21
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* female
* age\<18years

Primary outcomes:
measure: Variation per and post effort of interleukin 1 plasma level
timeFrame: 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
measure: Variation per and post effort of interleukin 6 plasma level
timeFrame: 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
measure: Variation of per and post effort of protein C reactive
timeFrame: 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
measure: Variation per and post effort of interleukin Tumor Necrosis Factor alpha
timeFrame: 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
measure: Variation per and post effort of interleukin 4 plasma level
timeFrame: 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
measure: Variation per and post effort of interleukin 10 plasma level
timeFrame: 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
measure: Variation per and post effort of interleukin 13 plasma level
timeFrame: 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
measure: Variation per and post effort of interleukin tumor growth factor beta plasma level
timeFrame: 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
measure: Variation per and post effort of lipids plasma level
timeFrame: 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
measure: Variation per and post effort of lipoproteins plasma level
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: