Characterisation of Immunological Effects and Safety of Active O2 After Strenuous Exercise in Comparison With Placebo: a Double-blind, Placebo Controlled, Balanced Cross-over Study in Healthy Subjects of Both Genders With Good Fitness Level
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- number of leukocytes
研究概览
简要总结
The aims of this study are:
- Characterisation of immunological effects of Active O2 vs. placebo after ingestion during and post standardised strenuous exercise
- Characterisation of safety and tolerability of Active O2 in comparison with placebo after ingestion during and post standardised strenuous exercise considering Adverse Events observed in the study
Moreover, the suitability of the study design shall be investigated by means of the internal pilot part, i.e. concerning applied procedures, selected pharmacodynamic parameters and blood sampling scheme.
详细描述
The nutritional product Active O2 (Adelholzener Alpenquellen GmbH) is a table water which contains an oxygen amount of 40 mg/l, a 15-fold higher amount compared to non-oxygenised products.
In this study the evaluation of immunological parameters which characterise the function of the immune system is planned in subjects ingesting the test product Active O2 in comparison with a placebo group. The study rationale refers to an established mechanistic hypothesis, which links gastro-intestinal hypoxia during and after strenuous exercise with an impairment of the immune system function.
During periods of exercise and physiological stress situations, the body primarily focuses on blood supply of the cardiovascular system, skeletal muscles and skin. Therefore, it is assumed that immunological effects during and after strenuous exercise are related - at least in part - to reduced blood flow in splanchnic organs which in turn leads to hypoxia induced damage of intestinal tissue, particularly the mucosal tissue, and to enhanced permeability for pathogens [1-6].
A phenomenon well described in scientific literature is related to athletes suffering from infections, particularly in the upper respiratory tract, after strenuous exercise. Significantly higher endotoxin concentrations (lipopolysaccharides) could be detected in the blood of athletes after strenuous competitions when compared to control groups [7].
In scientific studies, a decrease in the number of circulating immune cells as well as a reduced host defence function after strenuous and sustained exercise has been demonstrated in-vivo and by application of immunological in-vitro methods. Significant decreases in T-lymphocytes, T-helper cells type 1 as well as in Natural Killer cells (NK) could be shown. However, B-cells and T-helper cells type 2 are not affected in a comparable magnitude [8-10].
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •sex: male/female
- •age: 18 - 40 years
- •body-mass index (BMI): ≥ 18 kg/m²
- •good state of health
- •good fitness level: determined by use of bicycle ergometer during screening phase in period pre
- •written informed consent, after having been informed about benefits and potential risks of the study, as well as details of the insurance taken out to cover the subjects participating in the study
排除标准
- •laboratory values out of normal range unless the deviation from normal is judged as not relevant for the study by the investigator
- •history of or current drug or alcohol dependence
- •regular intake of alcoholic food or beverages of ≥ 40 g pure ethanol for male or ≥ 20 g for female per day
- •subjects who are on a diet which could affect immune response
- •regular intake of caffeine containing food or beverages of ≥ 500 mg per day
- •blood donation or other blood loss of more than 400 ml within the last two months prior to individual enrolment of the subject
- •participation in a clinical trial/study during the last two months prior to individual enrolment of the subject
- •regular treatment with any systemically available medication (except hormonal replacement therapy, e.g. hormonal contraception, thyroxine)
- •pregnant or lactating women
- •female subjects who do not agree to apply adequate contraceptive methods as defined in Note for Guidance on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals (CPMP/ICH/286/95, modification), November 2000
- •subjects suspected or known not to follow instructions
- •subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the study
研究组 & 干预措施
Test product (Active O2)
干预措施: Active O2 (Other)
Placebo (Adelholzener Mineralwasser)
干预措施: Adelholzener Mineralwasser (Other)
结局指标
主要结局
number of leukocytes
时间窗: Baseline, 0h, 2h after termination of standardised exercise
Determination will be performed at the mentioned time points. Resulting values of each time point after termination of standardised exercise will be baseline corrected and results of both treatment periods will be compared. Due to design changes after the completion of an internal pilot part, both parts of the trial will be analysed and presented separately on a descriptive level (i.e. delta0, delta2). Additionally, data from parameters of both study parts will be combined using methods of meta-analysis.
number of lymphocytes
时间窗: Baseline, 0h, 2h after termination of standardised exercise
Determination will be performed at the mentioned time points. Resulting values of each time point after termination of standardised exercise will be baseline corrected and results of both treatment periods will be compared. Due to design changes after the completion of an internal pilot part, both parts of the trial will be analysed and presented separately on a descriptive level (i.e. delta0, delta2). Additionally, data from parameters of both study parts will be combined using methods of meta-analysis.
number of monocytes
时间窗: Baseline, 0h, 2h after termination of standardised exercise
Determination will be performed at the mentioned time points. Resulting values of each time point after termination of standardised exercise will be baseline corrected and results of both treatment periods will be compared. Due to design changes after the completion of an internal pilot part, both parts of the trial will be analysed and presented separately on a descriptive level (i.e. delta0, delta2). Additionally, data from parameters of both study parts will be combined using methods of meta-analysis.
number of granulocytes
时间窗: Baseline, 0h, 2h after termination of standardised exercise
Determination will be performed at the mentioned time points. Resulting values of each time point after termination of standardised exercise will be baseline corrected and results of both treatment periods will be compared. Due to design changes after the completion of an internal pilot part, both parts of the trial will be analysed and presented separately on a descriptive level (i.e. delta0, delta2). Additionally, data from parameters of both study parts will be combined using methods of meta-analysis.
number of T-cells
时间窗: Baseline, 0h, 2h after termination of standardised exercise
Determination will be performed at the mentioned time points. Resulting values of each time point after termination of standardised exercise will be baseline corrected and results of both treatment periods will be compared. Due to design changes after the completion of an internal pilot part, both parts of the trial will be analysed and presented separately on a descriptive level (i.e. delta0, delta2). Additionally, data from parameters of both study parts will be combined using methods of meta-analysis.
number of NK-cells
时间窗: Baseline, 0h, 2h after termination of standardised exercise
Determination will be performed at the mentioned time points. Resulting values of each time point after termination of standardised exercise will be baseline corrected and results of both treatment periods will be compared. Due to design changes after the completion of an internal pilot part, both parts of the trial will be analysed and presented separately on a descriptive level (i.e. delta0, delta2). Additionally, data from parameters of both study parts will be combined using methods of meta-analysis.
number of CD4+ T-cells
时间窗: Baseline, 0h, 2h after termination of standardised exercise
Determination will be performed at the mentioned time points. Resulting values of each time point after termination of standardised exercise will be baseline corrected and results of both treatment periods will be compared. Due to design changes after the completion of an internal pilot part, both parts of the trial will be analysed and presented separately on a descriptive level (i.e. delta0, delta2). Additionally, data from parameters of both study parts will be combined using methods of meta-analysis.
number of CD8+ T-cells
时间窗: Baseline, 0h, 2h after termination of standardised exercise
Determination will be performed at the mentioned time points. Resulting values of each time point after termination of standardised exercise will be baseline corrected and results of both treatment periods will be compared. Due to design changes after the completion of an internal pilot part, both parts of the trial will be analysed and presented separately on a descriptive level (i.e. delta0, delta2). Additionally, data from parameters of both study parts will be combined using methods of meta-analysis.
CD4+/CD8+ Ratio
时间窗: Baseline, 0h, 2h after termination of standardised exercise
Determination will be performed at the mentioned time points. Resulting values of each time point after termination of standardised exercise will be baseline corrected and results of both treatment periods will be compared. Due to design changes after the completion of an internal pilot part, both parts of the trial will be analysed and presented separately on a descriptive level (i.e. delta0, delta2). Additionally, data from parameters of both study parts will be combined using methods of meta-analysis.
I-FABP plasma concentration
时间窗: Baseline, 0h, 2h after termination of standardised exercise
Intestinal fatty acid binding protein; determination will be performed at the mentioned time points. Resulting values of each time point after termination of standardised exercise will be baseline corrected and results of both treatment periods will be compared. Due to design changes after the completion of an internal pilot part, both parts of the trial will be analysed and presented separately on a descriptive level (i.e. delta0, delta2). Additionally, data from parameters of both study parts will be combined using methods of meta-analysis.
次要结局
- Absolute and relative frequency of Adverse Events (number of AEs, intensity, relationship to the test product/placebo, outcome, and seriousness as well as period and treatment)(from beginning of test product/placebo ingestion until discharge from the study (i.e. in average 1 week))