Multi-level Molecular Profiling of Peak Performance in Endurance Sports

NCT05359744 | Completed

• 1 other identifier: jestep032022
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Physical activity triggers complex molecular responses, including changes in immune-, stress-, and metabolic pathways. For example, autophagy is essential for energy and cellular homeostasis through protein catabolism, and dysregulation results in compromised proteostasis, reduced exercise performance, and excessive secretion of signaling molecules and inflammatory proteins. However, previous research has been limited by the extend of molecules measured and biological processes covered. A better understanding of these processes through multi-omic analysis can improve knowledge of molecular changes in response to exercise. The main purpose of the investigators study is to analyze the effects of acute exercise in correlation to autophagy and other signaling cascades. Specifically, the investigators plan to perform multi-level molecular profiling in a cohort of healthy male elite cyclists and male and female recreational athletes, before, during, and after a bicycle ergometer test. The results will be compared to a control cohort without intervention.

Conditions

Exercise; Exercise Test; Physical Fitness; Healthy

Keywords

Exercise Test; Autophagy; Multi-omic; Fitness level

Outcome Measures

Primary Outcomes (1)

• Proteomics and autophagy processes

  Change in protein levels of autophagy biomarkers (LC3II \& p62) of isolated PBMCs (peripheral blood mononuclear cells) by Western Blotting.

  Before the exercise test (baseline), at the end of the 15 minute warm-up phase and 2 minutes, 10 minutes and 30 minutes after termination of the exercise test.

Secondary Outcomes (8)

• Salivary cortisol levels

  Before the exercise test (baseline), at the end of the 15 minute warm-up phase and 2 minutes, 10 minutes and 30 minutes after termination of the exercise test.

• Proteome patterns

  Before the exercise test (baseline), at the end of the 15 minute warm-up phase and 2 minutes, 10 minutes and 30 minutes after termination of the exercise test.

• Metabolic processes

  Before the exercise test (baseline), at the end of the 15 minute warm-up phase and 2 minutes, 10 minutes and 30 minutes after termination of the exercise test.

• Lipid profiling

  Before the exercise test (baseline), at the end of the 15 minute warm-up phase and 2 minutes, 10 minutes and 30 minutes after termination of the exercise test.

• Phosphoproteome patterns

  Before the exercise test (baseline), at the end of the 15 minute warm-up phase and 2 minutes, 10 minutes and 30 minutes after termination of the exercise test.

Study Arms (4)

Elite cyclists, male

EXPERIMENTAL

Bicycle ergometer-based exercise testing. 15 min aerobic warm-up phase (2 W/kg) followed by a standardized but individualized ramp-bicycle ergometer protocol to reach maximal exercise capacity after 8 - 12 minutes. The exclusively aerobic energy supply during warm-up will be assessed by constant respiratory quotient and constant arterial lactate concentration (\<0.5 mmol in the last 5 min). During exercise, respiratory gas exchange, heart rate, blood pressure, ECG and ratings of perceived exertion will be continuously monitored. Venous blood specimens will be collected before exercise (baseline), at the end of the warm-up as well as 2 min, 10 min, and 30 min in recovery.

Diagnostic Test: Performance testing

Recreational athletes, male

EXPERIMENTAL

Bicycle ergometer-based exercise testing. 15 min aerobic warm-up phase (1 W/kg) followed by a standardized but individualized ramp-bicycle ergometer protocol to reach maximal exercise capacity after 8 - 12 minutes. The exclusively aerobic energy supply during warm-up will be assessed by constant respiratory quotient and constant arterial lactate concentration (\<0.5 mmol in the last 5 min). During exercise, respiratory gas exchange, heart rate, blood pressure, ECG and ratings of perceived exertion will be continuously monitored. Venous blood specimens will be collected before exercise (baseline), at the end of the warm-up as well as 2 min, 10 min, and 30 min in recovery.

Diagnostic Test: Performance testing

Recreational athletes, female

EXPERIMENTAL

Bicycle ergometer-based exercise testing. 15 min aerobic warm-up phase (1 W/kg) followed by a standardized but individualized ramp-bicycle ergometer protocol to reach maximal exercise capacity after 8 - 12 minutes. The exclusively aerobic energy supply during warm-up will be assessed by constant respiratory quotient and constant arterial lactate concentration (\<0.5 mmol in the last 5 min). During exercise, respiratory gas exchange, heart rate, blood pressure, ECG and ratings of perceived exertion will be continuously monitored. Venous blood specimens will be collected before exercise (baseline), at the end of the warm-up as well as 2 min, 10 min, and 30 min in recovery.

Diagnostic Test: Performance testing

Control, male

NO INTERVENTION

Venous blood specimens will be collected at the same time points in the absence of exercise.

Interventions

Performance testing DIAGNOSTIC_TEST

Performance testing on a bicycle ergometer.

Elite cyclists, male; Recreational athletes, female; Recreational athletes, male

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All arms: ability to give written informed consent
• Arms 1- 3: inconspicuous medical examination (medical history, resting ECG, echocardiography)
• Elite athletes (arm1, cyclists): maximum oxygen uptake \> 65 ml/kg/KG
• Elite athletes (arm1, cyclists): participation in cycling competitions on a regular basis
• Recreational athletes (arms 2 and 3): maximum oxygen uptake \< 65 ml/kg/KG for male subjects and \< 55 ml/kg/KG for female subjects

You may not qualify if:

• All arms: unable to communicate adequately by language
• All arms: regular use of prescription drugs other than thyroxine or antihistamines
• All arms: alcohol consumption as equivalent doses averaging more than 40 g of pure alcohol per day
• All arms: use of illicit drugs
• All arms: known diseases of the cardiovascular system
• All arms: arterial hypertension over 160/90 mmHg at rest
• All arms: known pulmonary diseases, especially bronchial asthma
• All arms: surgery less than 4-6 months ago.
• All arms: abnormalities in the medical examination (medical history, resting ECG, echocardiography)
• Arms 1-3: orthopaedic diseases that preclude maximum exercise on a bicycle ergometer
• Elite athletes (arm1, cyclists): maximum oxygen uptake \< 65 ml/kg/KG
• Recreational athletes (arms 2 and 3): maximum oxygen uptake \> 65 ml/kg/KG for male subjects and \> 55 ml/kg/KG for female subjects
• Arm 3: positive urine ß-HCG

Sponsors & Collaborators

• Paracelsus Medical University: lead
• Department of Psychiatry University of Bonn: collaborator

Study Sites (1)

Paracelsus Medical University

Salzburg, 5020, Austria

Location

Related Publications (7)

• Hasin Y, Seldin M, Lusis A. Multi-omics approaches to disease. Genome Biol. 2017 May 5;18(1):83. doi: 10.1186/s13059-017-1215-1.

  PMID: 28476144 RESULT

• Nicora G, Vitali F, Dagliati A, Geifman N, Bellazzi R. Integrated Multi-Omics Analyses in Oncology: A Review of Machine Learning Methods and Tools. Front Oncol. 2020 Jun 30;10:1030. doi: 10.3389/fonc.2020.01030. eCollection 2020.

  PMID: 32695678 RESULT

• Contrepois K, Wu S, Moneghetti KJ, Hornburg D, Ahadi S, Tsai MS, Metwally AA, Wei E, Lee-McMullen B, Quijada JV, Chen S, Christle JW, Ellenberger M, Balliu B, Taylor S, Durrant MG, Knowles DA, Choudhry H, Ashland M, Bahmani A, Enslen B, Amsallem M, Kobayashi Y, Avina M, Perelman D, Schussler-Fiorenza Rose SM, Zhou W, Ashley EA, Montgomery SB, Chaib H, Haddad F, Snyder MP. Molecular Choreography of Acute Exercise. Cell. 2020 May 28;181(5):1112-1130.e16. doi: 10.1016/j.cell.2020.04.043.

  PMID: 32470399 RESULT

• Mukherjee K, Edgett BA, Burrows HW, Castro C, Griffin JL, Schwertani AG, Gurd BJ, Funk CD. Whole blood transcriptomics and urinary metabolomics to define adaptive biochemical pathways of high-intensity exercise in 50-60 year old masters athletes. PLoS One. 2014 Mar 18;9(3):e92031. doi: 10.1371/journal.pone.0092031. eCollection 2014.

  PMID: 24643011 RESULT

• De Pauw K, Roelands B, Cheung SS, de Geus B, Rietjens G, Meeusen R. Guidelines to classify subject groups in sport-science research. Int J Sports Physiol Perform. 2013 Mar;8(2):111-22. doi: 10.1123/ijspp.8.2.111.

  PMID: 23428482 RESULT

• Martin DT, McLean B, Trewin C, Lee H, Victor J, Hahn AG. Physiological characteristics of nationally competitive female road cyclists and demands of competition. Sports Med. 2001;31(7):469-77. doi: 10.2165/00007256-200131070-00002.

  PMID: 11428684 RESULT

• Hoffman NJ. Omics and Exercise: Global Approaches for Mapping Exercise Biological Networks. Cold Spring Harb Perspect Med. 2017 Oct 3;7(10):a029884. doi: 10.1101/cshperspect.a029884.

  PMID: 28348175 RESULT

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Jens Stepan, MD, PhD

  Department of Obstetrics and Gynecology, University Hospital Salzburg, Austria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 3 groups undergoing intervention, 1 control group

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: May 4, 2022
• Study Start: October 15, 2021
• Primary Completion: August 15, 2022
• Study Completion: August 15, 2022
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)