Inflammation in an Ultra Endurance Race

• Conditions: Inflammation; Inflammatory Response

• Registration Number: NCT03194035
• Lead Sponsor: Hôpital Necker-Enfants Malades

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.

Study Timeline

• Study First Submitted: 2017-06-16
• Study First Submitted QC: 2017-06-20
• Study First Posted: 2017-06-21
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-01
• Last Update Posted: 2018-08-03
• Study Start: 2018-10-01
• Primary Completion: 2018-10-01
• Study Completion: 2018-10-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 25

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Per and post-exertional variations of IL6 during an ultra-endurance race in healthy volunteers.	Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race	In this study, the investigators will measure variations of IL6 blood level
Per and post-exertional variations of IL1 during an ultra-endurance race in healthy volunteers.	Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race	In this study, the investigators will measure variations of IL1 blood level
Per and post-exertional variations of HMG beta during an ultra-endurance race in healthy volunteers.	Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race	In this study, the investigators will measure variations of HMG beta blood level
Per and post-exertional variations of TNF alpha during an ultra-endurance race in healthy volunteers.	Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race	In this study, the investigators will measure variations of TNF alpha blood level
Per and post-exertional variations of IL13 during an ultra-endurance race in healthy volunteers.	Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race	In this study, the investigators will measure variations of IL13 blood level
Per and post-exertional variations of lipids during an ultra-endurance race in healthy volunteers.	Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race	In this study, the investigators will measure variations of lipids blood level
Per and post-exertional variations of CRP during an ultra-endurance race in healthy volunteers.	Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race	In this study, the investigators will measure variations of CRP blood level
Per and post-exertional variations of IL4 during an ultra-endurance race in healthy volunteers.	Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race	In this study, the investigators will measure variations of IL4 blood level
Per and post-exertional variations of IL10 during an ultra-endurance race in healthy volunteers.	Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race	In this study, the investigators will measure variations of IL10 blood level
Per and post-exertional variations of LPS during an ultra-endurance race in healthy volunteers.	Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race	In this study, the investigators will measure variations of LPS blood level
Per and post-exertional variations of lipoprotein during an ultra-endurance race in healthy volunteers.	Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race	In this study, the investigators will measure variations of lipoprotein blood level
Per and post-exertional variations of TGF beta during an ultra-endurance race in healthy volunteers.	Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race	In this study, the investigators will measure variations of TGF beta blood level