The Effects of Hyperbaric Oxygen Therapy on Physical Capacity, Health, and Gut Microbiota in Healthy Male Adults
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
- 2
- 主要终点
- Volume of oxygen and carbon dioxide
研究概览
简要总结
The goal of this controlled, experimental study is to learn about the effects of 10 sessions of hyperbaric oxygen therapy on physical performance, vascular circulation, biochemical parameters, and composition of the intestinal microbiota in young healthy men depending on the frequency of single treatments.
The main questions it aims to answer are:
- Do 10 treatments of hyperbaric oxygen therapy induce significant changes in physical performance levels, vascular circulation, and concentrations of biochemical parameters in young, healthy men?
- Does the body's response to 10 treatments of hyperbaric oxygen therapy differ depending on the frequency of treatments?
- Does a series of hyperbaric oxygen therapy treatments induce significant changes in the composition of the intestinal microbiota, metabolome, and functional status of the intestines?
Participants are exposed to hyperoxia under hyperbaric conditions or form a control group with no treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 18-35;
- •Healthy, physically active men;
- •Subject who is knowingly willing to participate in the study;
- •Subject able to read, understand and sign an informed consent to participate.
排除标准
- •Inability to attend scheduled visits and/or follow study protocol;
- •Use of HBOT prior to study inclusion;
- •Severe or unstable physical impairment or severe cognitive deficits at study entry;
- •Pressure-sensitive chest diseases (including moderate or severe asthma) or pressure-sensitive ear or sinus diseases;
- •Active smoking;
- •Having suffered an injury within 3 months up to the date of the study;
- •Taking pre- and/or probiotics in the last 3 months before the study;
- •Inpatient hospital or emergency room stay in the last 4 weeks prior to study entry;
- •Travel to tropical countries during the last 4 weeks prior to the study;
- •Taking antibiotics, steroids and steroid-anabolic agents during the last 4 weeks before the study
结局指标
主要结局
Volume of oxygen and carbon dioxide
时间窗: baseline and the next morning after the last HBOT intervention; up to 24 days.
A cardiopulmonary exercise test (CPET) is conducted while an incremental running test on the treadmill using a portable breath-by-breath ergospirometer; VO2 and VCO2 are measured constantly.
Heart rate
时间窗: baseline and the next morning after the last HBOT intervention; up to 24 days.
Cardiopulmonary exercise test (CPET) is conducted while an incremental running test on the treadmill using a heart rate monitor.
Vascular circulation measures
时间窗: baseline (before and immediately after CPET), before and after 5th treatment, and the next morning after the last HBOT intervention (before and immediately after CPET); up to 24 days.
Nicotinamide adenine dinucleotide (NADH) content changes in the skin area are measured during transient ischemia and reperfusion with the use of the Flow Mediated Skin Fluorescence (FMSF) using The AngioExpert device (AngioExpert, Poland)
次要结局
- endothelial nitric oxide synthase (eNOS)(baseline and the next morning after the last HBOT intervention; up to 24 days.)
- Oxidative stress indicators(baseline and the next morning after the last HBOT intervention; up to 24 days.)
- F2-Isoprostanes (F2-IsoP)(baseline and the next morning after the last HBOT intervention; up to 24 days.)
- Nicotinamide (NAD) metabolites(baseline and the next morning after the last HBOT intervention; up to 24 days.)
- Indicators of intestinal inflammation (fecal calprotectin, claudin, occludin, zonulin, sIgA)(baseline and the next morning after the last HBOT intervention; up to 24 days.)
- Inflammatory cytokine profile(baseline and the next morning after the last HBOT intervention; up to 24 days.)
- Brain-derived neurotrophic factor concentration (BDNF)(baseline and the next morning after the last HBOT intervention; up to 24 days.)
- Body composition (body mass, fat mass, lean body mass, muscle mass)(baseline and the next morning after the last HBOT intervention; up to 24 days.)
- Gut microbiome and metabolome(baseline and the next morning after the last HBOT intervention; up to 24 days.)
- Hypoxia inducible factor-1 (HIF-1alfa)(baseline and the next morning after the last HBOT intervention; up to 24 days.)
- Vascular endothelial growth factor (VEGF)(baseline and after the intervention; up to 24 days.)