The Impact of Grand Tour Cycling on Sleep and the Hematological and Metabolomic Profile in World-class Cyclists

NCT ID: NCT06386900

Last Updated: 2024-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Overreaching

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Cyclist

Intervention Type OTHER

Participating in the Grand Tour as cyclist

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cyclist

Participating in the Grand Tour as cyclist

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Cylist participating in a Grand Tour (e.g. Tour de France, Vuelta a España, Giro d'Italia)

Exclusion Criteria

* /
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

KU Leuven

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Chiel Poffé

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

KU Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

S67595

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

L-Citrulline and Endothelial Function
NCT05722860 RECRUITING PHASE1
Caffeine and Resistance Training in Older Adults
NCT06618261 ENROLLING_BY_INVITATION NA
Synthetic THC And Blood Pressure
NCT07231965 NOT_YET_RECRUITING PHASE2/PHASE3
Nitrate Supplementation; Duration
NCT02115893 COMPLETED PHASE4