Inflammation in an Ultra Endurance Race

Inflammation Clinical Trial

— TRAIL-INFLA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03194035
• Other study ID #: TRAIL-INFLA
• Status: Not yet recruiting
• Start date: October 1, 2018
• Est. completion date: October 17, 2018

Study information

• Verified date: August 2018
• Source: Hôpital Necker-Enfants Malades
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: October 17, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation
• Inflammatory Response

Intervention

Biological:
• blood sample
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Necker-Enfants Malades

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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