Inflammation in an Ultra Endurance Race (TRAIL-INFLA)

Per Effort Study of Inflammatory Consequences of an Ultra Endurance Race (165km)

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.

Study Overview

• Status: Unknown
• Conditions: Inflammation; Inflammatory Response
• Intervention / Treatment: Biological: blood sample

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 Type: Observational
• Enrollment (Anticipated): 25

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hôpital Necker-Enfants Malades

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2018
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): October 17, 2018

Study Registration Dates

• First Submitted: June 16, 2017
• First Submitted That Met QC Criteria: June 20, 2017
• First Posted (Actual): June 21, 2017

Study Record Updates

• Last Update Posted (Actual): August 3, 2018
• Last Update Submitted That Met QC Criteria: August 1, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: exercise; inflammation; ultra endurance
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: TRAIL-INFLA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No