Effects of Enriched Oxygen Mixtures and Exercise on Oxidative Stress and Stem Cells Proliferation in Athletes.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Change in Reactive oxygen species production
研究概览
简要总结
Currently, Hyperbaric Oxigen (HBO) is a widely used treatment for several conditions. There are 14 indications for HBO, officially recognized by the Undersea and Hyperbaric Medical Society (UHMS), but research is discovering other interesting applications.
HBO plays an important role in enhancing antioxidant defense mechanisms by increasing radical oxygen species (ROS) and nitric oxide species (NOS). This controlled oxidative stress has been shown to stop the vicious circle of inflammation - damage - hypoxia already seen in several diseases. Increased neoangiogenesis has been demonstrated at pressures of 2 atmospheres absolute (ATA), while effects helping ischemic tissues need pressures between 2.5 and 2.8 ATA to develop. Also, stem cell proliferation and mobilization have been demonstrated after HBO treatments.
During sports activities, metabolism generates waste products - mostly CO2, lactic acid, but also ROS. HBO could be useful in modulating antioxidant mechanisms and increasing stem cell mobilization, thus helping cells in the recovery after training and sportive competitions.
The authors hypothesize that:
- HBO can reduce oxidative stress and induce stem cell mobilization in healthy professional athletes;
- hyperoxic mixtures can reduce oxidative stress and induce stem cells mobilization in healthy professional athletes;
- HBO at low pressures (L-HBO at 1.45 ATA) is at least comparable to conventional HBO (at 2.5 ATA) in reducing oxidative stress and increasing stem cell mobilization.
The Authors will include healthy athletes. These will be randomly assigned to a control group, a L-HBO group, a HBO group, a 30% O2 group, or a 50% O2 group.
The Authors will assess oxidative stress changes and stem cells proliferation before and after 20 L-HBO/HBO/30% O2 mix/50% O2 mix treatments, and after 2 months after the end of treatments.
详细描述
Subjects will be recruited through public announcements in local gyms and gathered to explain the protocol. Those willing to participate will sign a written informed consent and recruited. To be included, all the subjects will undergo a general medical screening to allow hyperbaric treatments. This will include weight, height, non-invasive arterial blood pressure, and heart rate measurements.
After inclusion, subjects will be randomly assigned to three arms using an electronic number generator by personnel not directly involved in the experiment:
- Arm 1(control): no intervention.
- Arm 2 (L-HBO): treated with oxygen at 1.45 ATA for 60 min (inclusive of compression and decompression times, and an air break of 3 minutes breathing air);
- Arm 3 (HBO): treated with oxygen at 2.5 ATA for 60 min (inclusive of compression and decompression times, and an air break of 3 minutes breathing air).
- Arm 4 (30% O2): breathing an air mixture with 30% of oxygen at atmospheric pressure (1 ATA).
- Arm 5 (50% O2): breathing an air mixture with 50% of oxygen at atmospheric pressure (1 ATA).
Subjects included in Arm 2, 3, 4, 5 will undergo a total of 20 treatments. They will follow a personalized diet proportional to their energetic expenditure.
The Authors will identify 3 time-points in the protocol:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants, Care Provider, and Investigators will not be masked. Only outcome assessors will only evaluate data without knowing the arm the patients were assigned to.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •professional athletes
- •performing at least 3 training sessions/week
排除标准
- •previous pneumothorax
- •problems with compensation maneuvers
- •known epilepsy
- •active smoker
结局指标
主要结局
Change in Reactive oxygen species production
时间窗: On blood and saliva: at baseline (T0), at the completion of treatments (Time 1: 5 weeks after the baseline) and 2 months after the end of treatments (Time 2)
Reactive oxygen species production (μmol min-1) (by paramagnetic resonance)
Change in Total antioxidant capacity
时间窗: On blood and saliva: at baseline (T0), at the completion of treatments (Time 1: 5 weeks after the baseline) and 2 months after the end of treatments (Time 2)
Total antioxidant capacity (by paramagnetic resonance) (mM)
Change in Cortisol levels
时间窗: On saliva: at baseline (T0), at the completion of treatments (Time 1: 5 weeks after the baseline) and 2 months after the end of treatments (Time 2)
Cortisol (by competitive immunoassay) (ng/ml)
Change in nitrite and nitrate (NO2/NO3) concentration
时间窗: On urine: at baseline (T0), at the completion of treatments (Time 1: 5 weeks after the baseline) and 2 months after the end of treatments (Time 2)
nitrite and nitrate (NO2/NO3) concentration (by colorimetry based on the Griess reaction) (μM)
Change in inducible Nitric Oxide Synthase (iNOS)
时间窗: On urine: at baseline (T0), at the completion of treatments (Time 1: 5 weeks after the baseline) and 2 months after the end of treatments (Time 2)
inducible Nitric Oxide Synthase (by ELISA commercially available kit) (IU mL-1)
Change in aminothiols levels
时间窗: On blood: Change from Baseline (T0) aminothiols concentration after the exercise test (Time 1: the day after baseline measurements), and at the completion of treatments after a second exercise test (Time 3: 5 weeks after the baseline)
total (tot) and reduced (red) aminothiols (by fluorescence spectroscopy) (μmol L-1)
Change in Cytokines levels
时间窗: On blood: at baseline (T0), at the completion of treatments (Time 1: 5 weeks after the baseline) and 2 months after the end of treatments (Time 2)
IL-1 beta, IL-6, TNF-alfa (pg ml-1)
Change in lipid peroxidation markers
时间窗: On urine: at baseline (T0), at the completion of treatments (Time 1: 5 weeks after the baseline) and 2 months after the end of treatments (Time 2)
On urine samples, we will assess lipid peroxidation by measuring 8-isoprostane and 8-OH-deoxyguanosine concentration (by competitive immunoassay) - (pg mg-1 creatinine)
Change in Renal damage markers
时间窗: On urine: at baseline (T0), at the completion of treatments (Time 1: 5 weeks after the baseline) and 2 months after the end of treatments (Time 2)
On urine samples, we will assess renal damage by measuring creatinine (g-L-1), neopterin (μmol·mol-1 creatinine), and uric acid levels (mg/dl).
Change in 3-nitrotyrosine levels
时间窗: On urine: at baseline (T0), at the completion of treatments (Time 1: 5 weeks after the baseline) and 2 months after the end of treatments (Time 2)
3-nitrotyrosine (3-NT) (by competitive immunoassay)( nM·L-1)
Change in Stem cells mobilization
时间窗: On blood: at baseline (T0), at the completion of treatments (Time 1: 5 weeks after the baseline) and 2 months after the end of treatments (Time 2)
Stem cells (by flow cytometry) (%)
次要结局
未报告次要终点
研究者
Gerardo Bosco
Associate Professor
University of Padova