Proteomic and Physiological Markers of Exercise-induced Physiological Stress and Fatigue in Grand Tour Cycling

December 8, 2023 updated by: Chiel Poffé, KU Leuven
This project aims to identify the effect of a 3-week grand tour (e.g. Tour de France) on physiological markers and the blood proteome in world-class cyclists.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Blood samples will be collected in world-tour cyclists in the fasted state (i) before, (ii) on the first resting day, (ii) on the second resting day, and (iv) on the final day of the Tour de France. Samples collected before and on the final day will be analyzed by proteomics, while sample from all timepoints will be assessed for specific cytokines to identify physiological markers of fatigue. In addition, questionnaires will be used to evaluate subjective feelings of fatigue and appetite.

Study Type

Observational

Enrollment (Actual)

7

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

  • Belgium
    • 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
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Subjects participating in Tour de France

Description

Inclusion Criteria:

  • Cyclist participating in the Tour de France

Exclusion Criteria:

  • Younger than 18years old

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
Cyclists
Elite cyclists participating in the Tour de France
Other: Tour de France
Participating in the Tour de France as cyclist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum proteome abundance of cyclists during Tour de France
Time Frame: Start of the Tour de France (day 0) - last day of the Tour de France (day 23)
Change in serum proteome between start and end of Tour de France
Start of the Tour de France (day 0) - last day of the Tour de France (day 23)
Serum GDF15 (Growth and differentiation factor 15) concentration
Time Frame: Start of the Tour de France (day 0) - restday 1 (day 11) - restday 2 (day 17) - last day of the Tour de France (day 23)
Serum GDF15 throughout the grand tour
Start of the Tour de France (day 0) - restday 1 (day 11) - restday 2 (day 17) - last day of the Tour de France (day 23)
Blood haemoglobin concentration
Time Frame: Start of the Tour de France (day 0) - restday 1 (day 11) - restday 2 (day 17) - last day of the Tour de France (day 23)
Haematological profile of cyclists
Start of the Tour de France (day 0) - restday 1 (day 11) - restday 2 (day 17) - last day of the Tour de France (day 23)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Leptin concentration
Time Frame: Start of the Tour de France (day 0) - restday 1 (day 11) - restday 2 (day 17) - last day of the Tour de France (day 23)
Serum leptin
Start of the Tour de France (day 0) - restday 1 (day 11) - restday 2 (day 17) - last day of the Tour de France (day 23)
Red blood cell concentration
Time Frame: Start of the Tour de France (day 0) - restday 1 (day 11) - restday 2 (day 17) - last day of the Tour de France (day 23)
Red blood cells
Start of the Tour de France (day 0) - restday 1 (day 11) - restday 2 (day 17) - last day of the Tour de France (day 23)
White blood cell concentration
Time Frame: Start of the Tour de France (day 0) - restday 1 (day 11) - restday 2 (day 17) - last day of the Tour de France (day 23)
White blood cells
Start of the Tour de France (day 0) - restday 1 (day 11) - restday 2 (day 17) - last day of the Tour de France (day 23)
Serum ghrelin concentration
Time Frame: Start of the Tour de France (day 0) - restday 1 (day 11) - restday 2 (day 17) - last day of the Tour de France (day 23)
Blood ghrelin
Start of the Tour de France (day 0) - restday 1 (day 11) - restday 2 (day 17) - last day of the Tour de France (day 23)
Serum FGF21 (fibroblast growth factor 21) concentration
Time Frame: Start of the Tour de France (day 0) - restday 1 (day 11) - restday 2 (day 17) - last day of the Tour de France (day 23)
Blood FGF21
Start of the Tour de France (day 0) - restday 1 (day 11) - restday 2 (day 17) - last day of the Tour de France (day 23)
Serum free BDNF (brain-derived neutrophic factor) concentration
Time Frame: Start of the Tour de France (day 0) - restday 1 (day 11) - restday 2 (day 17) - last day of the Tour de France (day 23)
Blood BDNF
Start of the Tour de France (day 0) - restday 1 (day 11) - restday 2 (day 17) - last day of the Tour de France (day 23)

Collaborators and Investigators

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

Sponsor

KU Leuven

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 6, 2019

Primary Completion (Actual)

July 28, 2019

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

August 31, 2023

First Submitted That Met QC Criteria

December 8, 2023

First Posted (Estimated)

December 11, 2023

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 8, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S63402

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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