An interventional study of Active O2 and Adelholzener Mineralwasser in Healthy, sponsored by Adelholzener Alpenquellen GmbH. Completed at 1 site in Germany. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-05-14.
Sponsored by Adelholzener Alpenquellen GmbH · Not applicable, Interventional, and Treatment
The aims of this study are:
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.
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].
In one study a significant increase in regulatory T-cells (Treg) has been assessed after 45 min of swim exercise in adolescents [11]. These cells play a major role in the inhibition of effector T cell function and thus have a pronounced immunosuppressive effect. Furthermore, it has been shown that Treg-cell activity is directly linked to the occurrence of hypoxia in damaged tissues [12].
Immune responses due to exercise are complex and depend on numerous additional factors (e.g. stress hormones, reactive oxygen species) as well as on the intensity of exercise level [13-15].
Nonetheless, oxygen susceptibility of regulatory immunocompetent cells as well as integrity of the mucosal barrier function may play an important role in protection and/or modification of the immune response including the integrity of epithelial tight junctions and M-cell related transcytosis of pathogens to highly organised lymphoid structures for effective immune responses [4; 12; 16]. A strong correlation between intestinal hypoxia during strenuous exercise and the magnitude of intestinal mucosa damage has been demonstrated by plasma levels of the surrogate parameter intestinal fatty acid binding protein (I-FABP), a specific biomarker for mucosal damage in the small intestine [4; 17].
The hypothesis to be investigated in this study is that the oxygen content of Active O2 may - at least in part - compensate the hypoxic situation in the surface of the gut wall, when ingested during and after exercise. Luminal supply of oxygenated water potentially might protect mucosal tissue from ischemia related damage and could modulate immune responses. As a consequence, the overall situation of the immune system might improve. Such an effect should be reflected in the pharmacodynamic parameters determined in this study.
A first interim analysis of the previous pilot part of this study, including the results of 12 healthy subjects, revealed statistically significant differences between both treatments for leukocytes, CD8+-lymphocytes and NK cells. Significant differences in cytokine production and additional immunological parameters were not detectable in comparison of both treatments and no trends were observed which might indicate any treatment effect. Therefore, the second part of this clinical trial will be performed with a focus on the pharmacodynamic parameters from the pilot part for which statistically significant differences between treatments have been observed. However, additional inclusion of I FABP analysis is considered reasonable as this surrogate parameter specifically reflects quantifiable impairment and potential local oxygen effects on intestinal mucosa barrier function.
According to EU regulation No 1924/2006 on nutrition and health claims made on foods, nutrition producing companies must show scientific data with substantiation as a prerequisite for advertisement dealing with health related claims [17]. Thus, the clinical trial is planned to further investigate a potentially beneficial effect of Active O2 when ingested during and after exercise.
This is the only study on the registry with Adelholzener Alpenquellen GmbH as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Active O2
Other: Adelholzener Mineralwasser
oxygenised table water containing at least 20 mg O2 per 500 ml (15-fold higher content in comparison to placebo), further excipients: natural mineral water: carbonic acid, oxygen, sodium, potassium, magnesium, calcium, fluoride, chloride, nitrate, sulfate, hydrocarbonate (according to the summary of analysis)
natural mineral water containing the following ingredients: carbonic acid, sodium, potassium, magnesium, calcium, fluoride, chloride, nitrate, sulphate, hydrocarbonate (according to the summary of analysis)
number of leukocytes
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.
Time frame: Baseline, 0h, 2h after termination of standardised exercise
number of lymphocytes
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.
Time frame: Baseline, 0h, 2h after termination of standardised exercise
number of monocytes
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.
Time frame: Baseline, 0h, 2h after termination of standardised exercise
number of granulocytes
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.
Time frame: Baseline, 0h, 2h after termination of standardised exercise
number of T-cells
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.
Time frame: Baseline, 0h, 2h after termination of standardised exercise
number of NK-cells
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.
Time frame: Baseline, 0h, 2h after termination of standardised exercise
number of CD4+ T-cells
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.
Time frame: Baseline, 0h, 2h after termination of standardised exercise
number of CD8+ T-cells
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.
Time frame: Baseline, 0h, 2h after termination of standardised exercise
CD4+/CD8+ Ratio
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.
Time frame: Baseline, 0h, 2h after termination of standardised exercise
I-FABP plasma concentration
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.
Time frame: Baseline, 0h, 2h after termination of standardised exercise
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)
For safety outcome measures separate analysis of each study part as well as pooled analysis including any safety data from both parts of the trial will be performed.
Time frame: from beginning of test product/placebo ingestion until discharge from the study (i.e. in average 1 week)
This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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