Clinical trial NCT03194035: Inflammation in an Ultra Endurance Race
Official title: Per Effort Study of Inflammatory Consequences of an Ultra Endurance Race (165km)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammation
Inflammatory Response
Keywords: inflammation
exercise
ultra endurance
Lead sponsor: Hôpital Necker-Enfants Malades
Sponsor class: OTHER
First posted: 2017-06-21
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

Detailed description: 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: Inclusion Criteria:

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

Exclusion Criteria:

1. Age lower than 18 years,
2. Subjects with a medical history (pulmonary pathology, cardiac, hypertension) or with a significant chronic inflammatory disease observed during the inclusion visit (the day before the race).
3. Female.

Primary outcomes:
measure: Per and post-exertional variations of IL1 during an ultra-endurance race in healthy volunteers.
timeFrame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
measure: Per and post-exertional variations of IL6 during an ultra-endurance race in healthy volunteers.
timeFrame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
measure: Per and post-exertional variations of TNF alpha during an ultra-endurance race in healthy volunteers.
timeFrame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
measure: Per and post-exertional variations of HMG beta during an ultra-endurance race in healthy volunteers.
timeFrame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
measure: Per and post-exertional variations of CRP during an ultra-endurance race in healthy volunteers.
timeFrame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
measure: Per and post-exertional variations of IL4 during an ultra-endurance race in healthy volunteers.
timeFrame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
measure: Per and post-exertional variations of IL10 during an ultra-endurance race in healthy volunteers.
timeFrame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
measure: Per and post-exertional variations of IL13 during an ultra-endurance race in healthy volunteers.
timeFrame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
measure: Per and post-exertional variations of lipids during an ultra-endurance race in healthy volunteers.
timeFrame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
measure: Per and post-exertional variations of LPS during an ultra-endurance race in healthy volunteers.
timeFrame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
measure: Per and post-exertional variations of lipoprotein during an ultra-endurance race in healthy volunteers.
timeFrame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
measure: Per and post-exertional variations of TGF beta during an ultra-endurance race in healthy volunteers.
timeFrame: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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