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Inflammation in an Ultra Endurance Race (TRAIL-INFLA)

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ClinicalTrials.gov Identifier: NCT03194035
Recruitment Status : Not yet recruiting
First Posted : June 21, 2017
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Romain Jouffroy, 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.

Condition or disease Intervention/treatment
Inflammation Inflammatory Response 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.

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Per Effort Study of Inflammatory Consequences of an Ultra Endurance Race (165km)
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : October 17, 2018

Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Per and post-exertional variations of IL1 during an ultra-endurance race in healthy volunteers. [ Time Frame: 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

  2. Per and post-exertional variations of IL6 during an ultra-endurance race in healthy volunteers. [ Time Frame: 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

  3. Per and post-exertional variations of TNF alpha during an ultra-endurance race in healthy volunteers. [ Time Frame: 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

  4. Per and post-exertional variations of HMG beta during an ultra-endurance race in healthy volunteers. [ Time Frame: 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

  5. Per and post-exertional variations of CRP during an ultra-endurance race in healthy volunteers. [ Time Frame: 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

  6. Per and post-exertional variations of IL4 during an ultra-endurance race in healthy volunteers. [ Time Frame: 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

  7. Per and post-exertional variations of IL10 during an ultra-endurance race in healthy volunteers. [ Time Frame: 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

  8. Per and post-exertional variations of IL13 during an ultra-endurance race in healthy volunteers. [ Time Frame: 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

  9. Per and post-exertional variations of lipids during an ultra-endurance race in healthy volunteers. [ Time Frame: 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

  10. Per and post-exertional variations of LPS during an ultra-endurance race in healthy volunteers. [ Time Frame: 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

  11. Per and post-exertional variations of lipoprotein during an ultra-endurance race in healthy volunteers. [ Time Frame: 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

  12. Per and post-exertional variations of TGF beta during an ultra-endurance race in healthy volunteers. [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
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.

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Responsible Party: Romain Jouffroy, Principal Investigator, Hôpital Necker-Enfants Malades
ClinicalTrials.gov Identifier: NCT03194035     History of Changes
Other Study ID Numbers: TRAIL-INFLA
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Romain Jouffroy, Hôpital Necker-Enfants Malades:
inflammation
exercise
ultra endurance
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes