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Completed

NCT Number: NCT06165588

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

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.

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Key information

Conditions

Exercise Fatigue

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cyclist participating in the Tour de France

Exclusion criteria

  • Younger than 18years old

Treatment and study plan

Tour de France

Other

Participating in the Tour de France as cyclist

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2023
First posted
Dec 11, 2023
Registry last updated
Dec 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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