Placebo Controlled Study for Characterisation of Immunological Effects and Safety of Active O2

NCT01333930 | Completed

• 1 other identifier: 1251ao10ct
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Healthy

Keywords

immunological effects; Active O2; strenuous exercise; procedures; pharmacodynamic parameters; blood sampling scheme

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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)

  from beginning of test product/placebo ingestion until discharge from the study (i.e. in average 1 week)

Study Arms (2)

Test product (Active O2)

EXPERIMENTAL

Other: Active O2

Placebo (Adelholzener Mineralwasser)

PLACEBO COMPARATOR

Other: Adelholzener Mineralwasser

Interventions

Active O2 OTHER

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)

Test product (Active O2)

Adelholzener Mineralwasser OTHER

natural mineral water containing the following ingredients: carbonic acid, sodium, potassium, magnesium, calcium, fluoride, chloride, nitrate, sulphate, hydrocarbonate (according to the summary of analysis)

Placebo (Adelholzener Mineralwasser)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adelholzener Alpenquellen GmbH: lead
• SocraTec R&D GmbH: collaborator
• SocraMetrics GmbH: collaborator
• Institut für Medizinische Diagnostik MVZ GbR: collaborator
• Sport- und Rehazentrum GbR: collaborator

Study Sites (1)

Sport- und Rehazentrum GbR

Erfurt, Thuringia, 99099, Germany

Location

Study Officials

• Frank Donath, MD

  SocraTec R&D GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2011
• First Posted: April 12, 2011
• Study Start: January 1, 2012
• Primary Completion: February 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 14, 2012

Record last verified: 2012-05

Locations

DE (1)