Exercise FatigueNCT06165588
Proteomic and Physiological Markers of Exercise-induced Physiological Stress and Fatigue in Grand Tour Cycling
An observational study of Exercise Fatigue, run by KU Leuven at 1 site in Belgium.
Trial summary
This project aims to identify the effect of a 3-week grand tour (e.g. Tour de France) on physiological markers and the blood proteome in world-class cyclists. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise Fatigue
- What is being tested?
- Tour de France
- How many people
- 7 participants
- Where
- 1 siteBelgium
- Study dates
- 6 Jul 2019to 31 Aug 2023
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects participating in Tour de France
Who may be able to join
- Cyclist participating in the Tour de France
Who cannot join
- Younger than 18years old
Trial locations and contacts
1 site in 1 country.
About this study
This project aims to identify the effect of a 3-week grand tour (e.g. Tour de France) on physiological markers and the blood proteome in world-class cyclists.
Read the detailed description
Blood samples will be collected in world-tour cyclists in the fasted state (i) before, (ii) on the first resting day, (ii) on the second resting day, and (iv) on the final day of the Tour de France. Samples collected before and on the final day will be analyzed by proteomics, while sample from all timepoints will be assessed for specific cytokines to identify physiological markers of fatigue. In addition, questionnaires will be used to evaluate subjective feelings of fatigue and appetite.
- Conditions
- Exercise Fatigue
- Being tested
- Tour de France
- Keywords
- Cycling, Proteomics, Grand tour
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tour de FranceOther
Participating in the Tour de France as cyclist
| Study group | Role | What they receive |
|---|---|---|
| Cyclists | Elite cyclists participating in the Tour de France Receives: Other: Tour de France |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum proteome abundance of cyclists during Tour de France
Change in serum proteome between start and end of Tour de France
Measured: Start of the Tour de France (day 0) - last day of the Tour de France (day 23)
Serum GDF15 (Growth and differentiation factor 15) concentration
Serum GDF15 throughout the grand tour
Measured: Start of the Tour de France (day 0) - restday 1 (day 11) - restday 2 (day 17) - last day of the Tour de France (day 23)
Blood haemoglobin concentration
Haematological profile of cyclists
Measured: Start of the Tour de France (day 0) - restday 1 (day 11) - restday 2 (day 17) - last day of the Tour de France (day 23)
Secondary outcomes (6)
Serum Leptin concentration
Serum leptin
Measured: Start of the Tour de France (day 0) - restday 1 (day 11) - restday 2 (day 17) - last day of the Tour de France (day 23)
Red blood cell concentration
Red blood cells
Measured: Start of the Tour de France (day 0) - restday 1 (day 11) - restday 2 (day 17) - last day of the Tour de France (day 23)
White blood cell concentration
White blood cells
Measured: Start of the Tour de France (day 0) - restday 1 (day 11) - restday 2 (day 17) - last day of the Tour de France (day 23)
Serum ghrelin concentration
Blood ghrelin
Measured: Start of the Tour de France (day 0) - restday 1 (day 11) - restday 2 (day 17) - last day of the Tour de France (day 23)
Serum FGF21 (fibroblast growth factor 21) concentration
Blood FGF21
Measured: Start of the Tour de France (day 0) - restday 1 (day 11) - restday 2 (day 17) - last day of the Tour de France (day 23)
Serum free BDNF (brain-derived neutrophic factor) concentration
Blood BDNF
Measured: Start of the Tour de France (day 0) - restday 1 (day 11) - restday 2 (day 17) - last day of the Tour de France (day 23)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start6 Jul 2019
- Primary completion28 Jul 2019
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise FatigueStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiel Poffé, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165588
- Sponsor's protocol ID
- S63402
- Status last verified
- Dec 2023
- First submitted
- 31 Aug 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteomic and Physiological Markers of Exercise-induced Physiological Stress and Fatigue in Grand Tour Cycling
- ClinicalTrials.gov ID
- NCT06165588
- Acronym / sponsor ID
- S63402
- Conditions
- Exercise Fatigue
- Keywords
- Cycling, Proteomics, Grand tour
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 6 Jul 2019 (actual)
- Primary completion
- 28 Jul 2019 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 11 Dec 2023 (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.
This project aims to identify the effect of a 3-week grand tour (e.g. Tour de France) on physiological markers and the blood proteome in world-class cyclists.
Detailed description
Blood samples will be collected in world-tour cyclists in the fasted state (i) before, (ii) on the first resting day, (ii) on the second resting day, and (iv) on the final day of the Tour de France. Samples collected before and on the final day will be analyzed by proteomics, while sample from all timepoints will be assessed for specific cytokines to identify physiological markers of fatigue. In addition, questionnaires will be used to evaluate subjective feelings of fatigue and appetite.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cyclists | – | Other: Tour de FranceElite cyclists participating in the Tour de France |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects participating in Tour de France
Key inclusion criteria (1 listed)
- Cyclist participating in the Tour de France
Key exclusion criteria (1 listed)
- Younger than 18years old
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 |
|---|---|---|
| Tour de FranceParticipating in the Tour de France as cyclist | Other | Cyclists |
Primary outcome
Serum proteome abundance of cyclists during Tour de France
Time frame: Start of the Tour de France (day 0) - last day of the Tour de France (day 23)
Change in serum proteome between start and end of Tour de France
Serum GDF15 (Growth and differentiation factor 15) concentration
Time frame: Start of the Tour de France (day 0) - restday 1 (day 11) - restday 2 (day 17) - last day of the Tour de France (day 23)
Serum GDF15 throughout the grand tour
Blood haemoglobin concentration
Time frame: Start of the Tour de France (day 0) - restday 1 (day 11) - restday 2 (day 17) - last day of the Tour de France (day 23)
Haematological profile of cyclists
6 secondary outcomes
Serum Leptin concentration
Time frame: Start of the Tour de France (day 0) - restday 1 (day 11) - restday 2 (day 17) - last day of the Tour de France (day 23)
Red blood cell concentration
Time frame: Start of the Tour de France (day 0) - restday 1 (day 11) - restday 2 (day 17) - last day of the Tour de France (day 23)
White blood cell concentration
Time frame: Start of the Tour de France (day 0) - restday 1 (day 11) - restday 2 (day 17) - last day of the Tour de France (day 23)
Serum ghrelin concentration
Time frame: Start of the Tour de France (day 0) - restday 1 (day 11) - restday 2 (day 17) - last day of the Tour de France (day 23)
Serum FGF21 (fibroblast growth factor 21) concentration
Time frame: Start of the Tour de France (day 0) - restday 1 (day 11) - restday 2 (day 17) - last day of the Tour de France (day 23)
Serum free BDNF (brain-derived neutrophic factor) concentration
Time frame: Start of the Tour de France (day 0) - restday 1 (day 11) - restday 2 (day 17) - last day of the Tour de France (day 23)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exercise Fatigue, run by KU Leuven at 1 site in Belgium.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Serum proteome abundance of cyclists during Tour de France (time frame: Start of the Tour de France (day 0) - last day of the Tour de France (day 23)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2023.