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NCT Number: NCT05359744

Multi-level Molecular Profiling of Peak Performance in Endurance Sports

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.

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Key information

Conditions

Exercise Behavior Exercise Test Healthy Motor Activity Physical Fitness

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Paracelsus Medical University

Salzburg, 5020, Austria

About this study

This is a non-randomized controlled trial performed at the Paracelsus Medical University, Salzburg, Austria. The study will recruit 80 healthy men and women. Subjects who meet the inclusion criteria will be allocated to four arms (n = 20 in all groups): 1. elite cyclists, 2. male recreational athletes, 3. female recreational athletes, 4. male control group.

After overnight fasting and medical check-up, groups 1-3 will undergo a bicycle ergometer-based exercise protocol designed to span low (aerobic) to severe (anaerobic) domains of exercise. The protocol consists of a 15 min aerobic warm-up phase followed by a ramp-bicycle ergometer protocol.

During exercise, performance-relevant data 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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Performance testing

Diagnostic Test

Performance testing on a bicycle ergometer.

Primary outcomes

  1. Proteomics and autophagy processes

    Time frame: 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.

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

Secondary outcomes

  1. Salivary cortisol levels

    Time frame: 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.

    Salivary cortisol levels in nmol per Liter (nmol/L) after will be evaluated and compared to the control group

  2. Proteome patterns

    Time frame: 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.

    Change in protein levels and protein phosphorylation by untargeted mass spectrometry-based proteomics and phosphoproteomics of isolated PBMCs (peripheral blood mononuclear cells).

  3. Metabolic processes

    Time frame: 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.

    Targeted and quantitative analysis by mass spectrometry of change in metabolites of Plasma.

  4. Lipid profiling

    Time frame: 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.

    Targeted and quantitative analysis by mass spectrometry of change in plasma Lipids.

  5. Phosphoproteome patterns

    Time frame: 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.

    Change in protein phosphorylation by untargeted mass spectrometry-based phosphoproteomics of isolated PBMCs (peripheral blood mononuclear cells).

  6. Ubiquitinome patterns

    Time frame: 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.

    Change in protein ubiquitination levels by untargeted mass spectrometry-based proteomics of isolated PBMCs (peripheral blood mononuclear cells).

  7. Epigenetic patterns

    Time frame: 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.

    Evaluate epigentic methylation patterns through blood based epigenome analysis

  8. Exosomal protein patterns

    Time frame: 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.

    Evaluate exosomal protein content through mass spectrometry based analysis

Sponsors and collaborators

Lead sponsor

Paracelsus Medical University

Other

Collaborators

  • Department of Psychiatry University of Bonn

Registry information

Official study title

A Pilot-study on Multi-level Molecular Profiling of Peak Performance in Endurance Sports

Acronym: MSSA

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 4, 2022
Registry last updated
Feb 17, 2026

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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