Clinical trial NCT06165588: Proteomic and Physiological Markers of Exercise-induced Physiological Stress and Fatigue in Grand Tour Cycling
Official title: Proteomic and Physiological Markers of Exercise-induced Physiological Stress and Fatigue in Grand Tour Cycling
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exercise Fatigue
Keywords: Cycling
Proteomics
Grand tour
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects participating in Tour de France

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

* Cyclist participating in the Tour de France

Exclusion Criteria:

* Younger than 18years old

Primary outcomes:
measure: Serum proteome abundance of cyclists during Tour de France
timeFrame: Start of the Tour de France (day 0) - last day of the Tour de France (day 23)
measure: Serum GDF15 (Growth and differentiation factor 15) concentration
timeFrame: 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)
measure: Blood haemoglobin concentration
timeFrame: 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 outcomes:
measure: Serum Leptin concentration
timeFrame: 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)
measure: Red blood cell concentration
timeFrame: 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)
measure: White blood cell concentration
timeFrame: 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)
measure: Serum ghrelin concentration
timeFrame: 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)
measure: Serum FGF21 (fibroblast growth factor 21) concentration
timeFrame: 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)
measure: Serum free BDNF (brain-derived neutrophic factor) concentration
timeFrame: 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)
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
state: Vlaams-Brabant
Study officials:
References: