InflammationTRAIL-INFLANCT03194035

Inflammation in an Ultra Endurance Race

An observational study of Inflammation and Inflammatory Response, run by Hôpital Necker-Enfants Malades.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

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. Read more about this study

Who is it for?: Ages 18 to 70 years, men onlyHealthy volunteers can take part
Conditions the study is for: Inflammation, Inflammatory Response
What is being tested?: blood sample
How many people: 25 participants
Where: No sites listed yet
Study dates: 1 Oct 2018to 17 Oct 2018
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
Men only
Healthy volunteers accepted
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

Age lower than 18 years,
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).
Female.

About this study

Official title: 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.

Read the 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.

Conditions: Inflammation, Inflammatory Response
Being tested: blood sample
Keywords: inflammation, exercise, ultra endurance
Medical subject headings: Inflammation, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

blood sampleBiological
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 201817 Oct 2018

First posted21 Jun 2017
Study start1 Oct 2018 (estimated)
Primary completion1 Oct 2018 (estimated)
Study completion17 Oct 2018 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for InflammationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 25 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03194035
Sponsor's protocol ID: TRAIL-INFLA
Acronym: TRAIL-INFLA
Status last verified: Aug 2018
First submitted: 16 Jun 2017
Last updated: 3 Aug 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Inflammation trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Per Effort Study of Inflammatory Consequences of an Ultra Endurance Race (165km)
ClinicalTrials.gov ID: NCT03194035
Acronym / sponsor ID: TRAIL-INFLA / TRAIL-INFLA
Conditions: Inflammation, Inflammatory Response
Keywords: inflammation, exercise, ultra endurance
Study type: Observational
Recruitment status: Unknown status
Enrolment: 25 participants (estimated)
Lead sponsor: Hôpital Necker-Enfants MaladesUniversity, hospital or other
Study start: 1 Oct 2018 (estimated)
Primary completion: 1 Oct 2018 (estimated)
Study completion: 17 Oct 2018 (estimated)
First posted: 21 Jun 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 to 70 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

Age lower than 18 years,
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).
Female.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
blood sampleStudy 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.	Biological	–

Primary outcome

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
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
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
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
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
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
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
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
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
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
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
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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Inflammation and Inflammatory Response, run by Hôpital Necker-Enfants Malades.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03194035.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.