Placebo Controlled Study for Characterisation of Immunological Effects and Safety of Active O2 - Full Text View

Purpose

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.

Condition	Intervention
Healthy	Other: Active O2 Other: Adelholzener Mineralwasser

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by Adelholzener Alpenquellen GmbH:

Primary Outcome Measures:

number of leukocytes [ Time Frame: Baseline, 0h, 2h after termination of standardised exercise ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

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) ] [ Designated as safety issue: Yes ]
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.

Enrollment:	44
Study Start Date:	January 2012
Study Completion Date:	April 2012
Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Test product (Active O2)	Other: Active O2 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)
Placebo Comparator: Placebo (Adelholzener Mineralwasser)	Other: Adelholzener Mineralwasser natural mineral water containing the following ingredients: carbonic acid, sodium, potassium, magnesium, calcium, fluoride, chloride, nitrate, sulphate, hydrocarbonate (according to the summary of analysis)

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01333930

Locations

Germany
Sport- und Rehazentrum GbR
Erfurt, Thuringia, Germany, 99099

Sponsors and Collaborators

Adelholzener Alpenquellen GmbH

SocraTec R&D GmbH

SocraMetrics GmbH

Institut für Medizinische Diagnostik MVZ GbR

Sport- und Rehazentrum GbR

Investigators

Principal Investigator:

Frank Donath, MD

SocraTec R&D GmbH

More Information

No publications provided

Responsible Party:	Adelholzener Alpenquellen GmbH
ClinicalTrials.gov Identifier:	NCT01333930 History of Changes
Other Study ID Numbers:	1251ao10ct
Study First Received:	April 8, 2011
Last Updated:	May 11, 2012
Health Authority:	Germany: Ethics Commission

Keywords provided by Adelholzener Alpenquellen GmbH:

immunological effects
Active O2
strenuous exercise

procedures
pharmacodynamic parameters
blood sampling scheme

ClinicalTrials.gov processed this record on May 21, 2013