HealthyNCT01333930
Placebo Controlled Study for Characterisation of Immunological Effects and Safety of Active O2
A study testing Active O2 and Adelholzener Mineralwasser in people with Healthy, run by Adelholzener Alpenquellen GmbH at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Active O2 and Adelholzener Mineralwasser
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2012to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Healthy
- Being tested
- Active O2, Adelholzener Mineralwasser
- Keywords
- immunological effects, Active O2, strenuous exercise, procedures, pharmacodynamic parameters, blood sampling scheme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active O2Other
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)
Adelholzener MineralwasserOther
natural mineral water containing the following ingredients: carbonic acid, sodium, potassium, magnesium, calcium, fluoride, chloride, nitrate, sulphate, hydrocarbonate (according to the summary of analysis)
| Study group | Role | What they receive |
|---|---|---|
| Test product (Active O2) | Experimental | Not described Receives: Other: Active O2 |
| Placebo (Adelholzener Mineralwasser) | Placebo comparator | Not described Receives: Other: Adelholzener Mineralwasser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 0h, 2h after termination of standardised exercise
Secondary outcomes (1)
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.
Measured: from beginning of test product/placebo ingestion until discharge from the study (i.e. in average 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Study startJan 2012
- Primary completionFeb 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adelholzener Alpenquellen GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SocraTec R&D GmbH, SocraMetrics GmbH, Institut für Medizinische Diagnostik MVZ GbR, Sport- und Rehazentrum GbR
- Responsible party
- Sponsor
- Investigators
- Frank Donath, MD, Principal investigator, SocraTec R&D GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333930
- Sponsor's protocol ID
- 1251ao10ct
- Status last verified
- May 2012
- First submitted
- 8 Apr 2011
- Last updated
- 14 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01333930
- Acronym / sponsor ID
- 1251ao10ct
- Conditions
- Healthy
- Keywords
- immunological effects, Active O2, strenuous exercise, procedures, pharmacodynamic parameters, blood sampling scheme
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Adelholzener Alpenquellen GmbHIndustry (pharma, biotech, devices)
- Collaborators
- SocraTec R&D GmbH, SocraMetrics GmbH, Institut für Medizinische Diagnostik MVZ GbR, Sport- und Rehazentrum GbR
- Study start
- Jan 2012
- Primary completion
- Feb 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 12 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test product (Active O2) | Experimental | Other: Active O2 |
| Placebo (Adelholzener Mineralwasser) | Placebo comparator | Other: Adelholzener Mineralwasser |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active O2oxygenised 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) | Other | Test product (Active O2) |
| Adelholzener Mineralwassernatural mineral water containing the following ingredients: carbonic acid, sodium, potassium, magnesium, calcium, fluoride, chloride, nitrate, sulphate, hydrocarbonate (according to the summary of analysis) | Other | Placebo (Adelholzener Mineralwasser) |
Primary outcome
number of leukocytes
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
1 secondary outcome
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)
Time frame: from beginning of test product/placebo ingestion until discharge from the study (i.e. in average 1 week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2012.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Donath, MD principal investigator
SocraTec R&D GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active O2 and Adelholzener Mineralwasser in people with Healthy, run by Adelholzener Alpenquellen GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of leukocytes (time frame: Baseline, 0h, 2h after termination of standardised exercise). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2012.