NCT06165588

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 6, 2019

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2019

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed
Last Updated

December 11, 2023

Status Verified

December 1, 2023

Enrollment Period

22 days

First QC Date

August 31, 2023

Last Update Submit

December 8, 2023

Conditions

Keywords

CyclingProteomicsGrand tour

Outcome Measures

Primary Outcomes (3)

  • Serum proteome abundance of cyclists during Tour de France

    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

    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

    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 Outcomes (6)

  • Serum Leptin concentration

    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

    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

    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

    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

    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)

  • +1 more secondary outcomes

Study Arms (1)

Cyclists

Elite cyclists participating in the Tour de France

Other: Tour de France

Interventions

Participating in the Tour de France as cyclist

Cyclists

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects participating in Tour de France

You may qualify if:

  • Cyclist participating in the Tour de France

You may not qualify if:

  • Younger than 18years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 31, 2023

First Posted

December 11, 2023

Study Start

July 6, 2019

Primary Completion

July 28, 2019

Study Completion

August 31, 2023

Last Updated

December 11, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations