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

April 24, 2024 updated by: Chiel Poffé, KU Leuven

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • KU Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

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)

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • /

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).
Participating in the Grand Tour as cyclist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
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)
Every night starting from one week before till the last night of the Grand Tour
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)
Every night starting from one week before till the last night of the Grand Tour
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
Start of the Grand Tour - restday 1 of the Grand Tour - restday 2 of the Grand Tour - last day of the Grand Tour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wakefulness after sleep onset
Time Frame: Every night starting from one week before till the last night of the Grand Tour
Percentage change in wakefulness after sleep onset during the Grand Tour (measured by OURA ring)
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
Percentage change in light sleep during the Grand Tour (measured by OURA ring)
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
Percentage change in deep sleep during the Grand Tour (measured by OURA ring)
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
Percentage change in REM sleep during the Grand Tour (measured by OURA ring)
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
Change in red blood cell 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
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
Absolute change in subjective fatigue during the Grand Tour (measured by 11-point scale)
Start of the Grand Tour - restday 1 of the Grand Tour - restday 2 of the Grand Tour - last day of the Grand Tour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

September 15, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

April 17, 2024

First Submitted That Met QC Criteria

April 24, 2024

First Posted (Actual)

April 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • S67595

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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