A Pilot-study on Multi-level Molecular Profiling of Peak Performance in Endurance Sports
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Proteomics and autophagy processes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Elite cyclists, male
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.
干预措施: Performance testing (Diagnostic Test)
Recreational athletes, male
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.
干预措施: Performance testing (Diagnostic Test)
Recreational athletes, female
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.
干预措施: Performance testing (Diagnostic Test)
Control, male
Venous blood specimens will be collected at the same time points in the absence of exercise.
结局指标
主要结局
Proteomics and autophagy processes
时间窗: 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.
次要结局
- 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.)
- Ubiquitinome 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.)
- Epigenetic 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.)
- Exosomal protein 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.)
- 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.)
研究者
Jens Stepan, MD, PhD
Principal Investigator
Paracelsus Medical University