Multi-level Molecular Profiling of Peak Performance in Endurance Sports (NCT05359744) | Clinical Trial Compass
CompletedNot Applicable
Multi-level Molecular Profiling of Peak Performance in Endurance Sports
Austria80 participantsStarted 2021-10-15
Plain-language 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.
Who can participate
Age range
18 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proteomics and autophagy processes
Timeframe: 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.