- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06386900
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
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
|
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
Keywords
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.
Clinical Trials on Overreaching
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Stefan De SmetKU Leuven; Universiteit AntwerpenRecruitingExercise | Glucose Tolerance | Food Intake | Exercise Performance | Skeletal Muscle | Physical Fitness | Gut Microbiome | Hormones | Vascular Health | Metabolic Health | Muscle Adaptation | Butyrate | Overreaching | Anthropometric Measurements | Heart Rate Variability (HRV)Belgium