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

NCT06386900 | Enrolling By Invitation DMC

• 1 other identifier: S67595
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overreaching

Keywords

Cycling; Grand Tour; Sleep; Metabolomics

Outcome Measures

Primary Outcomes (4)

• 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)

  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)

  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)

  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

  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

  Every night starting from one week before till the last night of the Grand Tour

• Light sleep

  Before the start of the Tour - restday 1 - restday 2 - end of Grand Tour

• Deep sleep

  Before the start of the Tour - restday 1 - restday 2 - end of Grand Tour

• REM sleep

  Before the start of the Tour - restday 1 - restday 2 - end of Grand Tour

• Red blood cell concentration

  Start of the Grand Tour - restday 1 of the Grand Tour - restday 2 of the Grand Tour - last day of the Grand Tour

Study Arms (1)

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).

Other: Cyclist

Interventions

Cyclist OTHER

Participating in the Grand Tour as cyclist

Elite cyclists participating in a Grand Tour

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Biospecimen

Retention: SAMPLES WITH DNA

* Whole blood * Urine

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 26, 2024
• Study Start: July 1, 2023
• Primary Completion: September 15, 2024
• Study Completion: December 1, 2024
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)