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AzTrials

ExerciseMSSANCT05359744

Multi-level Molecular Profiling of Peak Performance in Endurance Sports

A study testing Performance testing in people with Exercise and Exercise Test, run by Paracelsus Medical University at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Exercise, Exercise Test, Physical Fitness
What is being tested?
Performance testing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteAustria
Study dates
15 Oct 2021to 15 Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Austria1 site
  • Paracelsus Medical University

    Salzburg, 5020

Other trials in Austria

About this study

Official title: A Pilot-study on 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.

Read the detailed description

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.

Being tested
Performance testing
Keywords
Exercise Test, Autophagy, Multi-omic, Fitness level
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Performance testingDiagnostic test

    Performance testing on a bicycle ergometer.

Study groups in NCT05359744
Study groupRoleWhat they receive
Elite cyclists, maleExperimentalBicycle 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.
Receives: Diagnostic Test: Performance testing
Recreational athletes, maleExperimentalBicycle 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.
Receives: Diagnostic Test: Performance testing
Recreational athletes, femaleExperimentalBicycle 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.
Receives: Diagnostic Test: Performance testing
Control, maleNo interventionVenous blood specimens will be collected at the same time points in the absence of exercise.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proteomics and autophagy processes

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

    Measured: 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)
  1. Salivary cortisol levels

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

    Measured: 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.

  2. Proteome patterns

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

    Measured: 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.

  3. Metabolic processes

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

    Measured: 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.

  4. Lipid profiling

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

    Measured: 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.

  5. Phosphoproteome patterns

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

    Measured: 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.

  6. Ubiquitinome patterns

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

    Measured: 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.

  7. Epigenetic patterns

    Evaluate epigentic methylation patterns through blood based epigenome analysis

    Measured: 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.

  8. Exosomal protein patterns

    Evaluate exosomal protein content through mass spectrometry based analysis

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2022
  2. Study start15 Oct 2021
  3. Primary completion15 Aug 2022
  4. Study completion15 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
3 groups undergoing intervention, 1 control group
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05359744
Sponsor's protocol ID
jestep032022
Acronym
MSSA
Status last verified
Feb 2026
First submitted
25 Apr 2022
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28476144
  • 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.

    PubMed 32695678
  • 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.

    PubMed 32470399
  • 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.

    PubMed 24643011
  • 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.

    PubMed 23428482
  • 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.

    PubMed 11428684
  • 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.

    PubMed 28348175

Questions about this trial

What is this clinical trial studying?

A study testing Performance testing in people with Exercise and Exercise Test, run by Paracelsus Medical University at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05359744, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.

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