OverreachingNCT06386900
The Impact of Grand Tour Cycling on Sleep and the Hematological and Metabolomic Profile in World-class Cyclists
An observational study of Overreaching, 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, Giro d'Italia, and Vuelta a España) on sleep, hematological parameters and the serum metabolome in world-class cyclists. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Overreaching
- What is being tested?
- Cyclist
- Type of treatment
- Injection or infusion
- How many people
- 16 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jul 2023to 1 Dec 2024
- 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 40 years
- Men only
- Adult
Study population: Elite cyclist participating in a Grand Tour (e.g. Tour de France, Vuelta a España, Giro d'Italia)
Who may be able to join
- Cylist participating in a Grand Tour (e.g. Tour de France, Vuelta a España, Giro d'Italia)
Who cannot join
- /
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Grand Tour Cyling on Sleep and the Hematological and Metabolomic Profile in World-class Cyclists
This project aims to identify the effect of a 3-week Grand Tour (e.g. Tour de France, Giro d'Italia, and Vuelta a España) on sleep, hematological parameters and the serum metabolome in world-class cyclists.
- Conditions
- Overreaching
- Being tested
- Cyclist
- Keywords
- Cycling, Grand Tour, Sleep, Metabolomics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclistOther
Participating in the Grand Tour as cyclist
| Study group | Role | What they receive |
|---|---|---|
| Elite cyclists participating in a Grand Tour | * Sleep metrics will be tracked by a smart ring (OURA Gen3, OURA Health Ltd, Oulu, Finland) starting from one month prior to the start till the end of the Grand Tour
* Nocturnal heart rate and heart rate variability will be collected by a smart ring (OURA Gen3, OURA Health Ltd, Oulu, Finland) starting from one month prior till the end of the Grand Tour
* Fasted whole blood samples and urine samples will be collected on the morning of (i) the first stage, (ii) the first restday, (iii) second restday, and (iv) last stage of the GrandTour (only in one Grand Tour for a total of 8 cyclists). Receives: Other: Cyclist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum metabolome abundance of cyclists participating in a Grand Tour
Changes in the abundance of serum metabolites within the cyclists between 4 timepoints (measured by mass spectrometry)
Measured: Start of the Grand Tour - restday 1 of the Grand Tour - restday 2 of the Grand Tour - last day of the Grand Tour
Sleep efficiency during the Grand Tour
Percentage change in sleep efficiency during the Grand Tour (measured by OURA ring)
Measured: Every night starting from one week before till the last night of the Grand Tour
Total sleep time during the Grand Tour
Change in total sleep time during the Grand Tour (measured by OURA ring)
Measured: Every night starting from one week before till the last night of the Grand Tour
Blood haemoglobin concentration
Change in the blood haemoglobin concentration during the Grand Tour
Measured: Start of the Grand Tour - restday 1 of the Grand Tour - restday 2 of the Grand Tour - last day of the Grand Tour
Secondary outcomes (6)
Wakefulness after sleep onset
Percentage change in wakefulness after sleep onset during the Grand Tour (measured by OURA ring)
Measured: Every night starting from one week before till the last night of the Grand Tour
Light sleep
Percentage change in light sleep during the Grand Tour (measured by OURA ring)
Measured: Before the start of the Tour - restday 1 - restday 2 - end of Grand Tour
Deep sleep
Percentage change in deep sleep during the Grand Tour (measured by OURA ring)
Measured: Before the start of the Tour - restday 1 - restday 2 - end of Grand Tour
REM sleep
Percentage change in REM sleep during the Grand Tour (measured by OURA ring)
Measured: Before the start of the Tour - restday 1 - restday 2 - end of Grand Tour
Red blood cell concentration
Change in red blood cell concentration during the Grand Tour
Measured: Start of the Grand Tour - restday 1 of the Grand Tour - restday 2 of the Grand Tour - last day of the Grand Tour
Subjective fatigue
Absolute change in subjective fatigue during the Grand Tour (measured by 11-point scale)
Measured: Start of the Grand Tour - restday 1 of the Grand Tour - restday 2 of the Grand Tour - last day of the Grand Tour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start1 Jul 2023
- Primary completion15 Sep 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverreachingStudies 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
- 16 participants (estimated)
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
- NCT06386900
- Sponsor's protocol ID
- S67595
- Status last verified
- Apr 2024
- First submitted
- 17 Apr 2024
- Last updated
- 26 Apr 2024
- 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 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Grand Tour Cyling on Sleep and the Hematological and Metabolomic Profile in World-class Cyclists
- ClinicalTrials.gov ID
- NCT06386900
- Acronym / sponsor ID
- S67595
- Conditions
- Overreaching
- Keywords
- Cycling, Grand Tour, Sleep, Metabolomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 26 Apr 2024 (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, Giro d'Italia, and Vuelta a España) on sleep, hematological parameters and the serum metabolome in world-class cyclists.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elite cyclists participating in a Grand Tour | – | Other: Cyclist* Sleep metrics will be tracked by a smart ring (OURA Gen3, OURA Health Ltd, Oulu, Finland) starting from one month prior to the start till the end of the Grand Tour * Nocturnal heart rate and heart rate variability will be collected by a smart ring (OURA Gen3, OURA Health Ltd, Oulu, Finland) starting from one month prior till the end of the Grand Tour * Fasted whole blood samples and urine samples will be collected on the morning of (i) the first stage, (ii) the first restday, (iii) second restday, and (iv) last stage of the GrandTour (only in one Grand Tour for a total of 8 cyclists). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Age groups
- Adult
- Study population
- Elite cyclist participating in a Grand Tour (e.g. Tour de France, Vuelta a España, Giro d'Italia)
Key inclusion criteria (1 listed)
- Cylist participating in a Grand Tour (e.g. Tour de France, Vuelta a España, Giro d'Italia)
Key exclusion criteria (1 listed)
- /
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 |
|---|---|---|
| CyclistParticipating in the Grand Tour as cyclist | Other | Elite cyclists participating in a Grand Tour |
Primary outcome
Serum metabolome abundance of cyclists participating in a Grand Tour
Time frame: Start of the Grand Tour - restday 1 of the Grand Tour - restday 2 of the Grand Tour - last day of the Grand Tour
Changes in the abundance of serum metabolites within the cyclists between 4 timepoints (measured by mass spectrometry)
Sleep efficiency during the Grand Tour
Time frame: Every night starting from one week before till the last night of the Grand Tour
Percentage change in sleep efficiency during the Grand Tour (measured by OURA ring)
Total sleep time during the Grand Tour
Time frame: Every night starting from one week before till the last night of the Grand Tour
Change in total sleep time during the Grand Tour (measured by OURA ring)
Blood haemoglobin concentration
Time frame: Start of the Grand Tour - restday 1 of the Grand Tour - restday 2 of the Grand Tour - last day of the Grand Tour
Change in the blood haemoglobin concentration during the Grand Tour
6 secondary outcomes
Wakefulness after sleep onset
Time frame: Every night starting from one week before till the last night of the Grand Tour
Light sleep
Time frame: Before the start of the Tour - restday 1 - restday 2 - end of Grand Tour
Deep sleep
Time frame: Before the start of the Tour - restday 1 - restday 2 - end of Grand Tour
REM sleep
Time frame: Before the start of the Tour - restday 1 - restday 2 - end of Grand Tour
Red blood cell concentration
Time frame: Start of the Grand Tour - restday 1 of the Grand Tour - restday 2 of the Grand Tour - last day of the Grand Tour
Subjective fatigue
Time frame: Start of the Grand Tour - restday 1 of the Grand Tour - restday 2 of the Grand Tour - last day of the Grand Tour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- 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 Overreaching, 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: status not confirmed, as of the sponsor's last update on 26 Apr 2024. 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?
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?
Serum metabolome abundance of cyclists participating in a Grand Tour (time frame: Start of the Grand Tour - restday 1 of the Grand Tour - restday 2 of the Grand Tour - last day of the Grand Tour). The study lists 4 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 26 Apr 2024.