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

NCT01333930 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2012-05-14

No results posted yet for this study

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

Interventions

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)

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)

Sponsors & Collaborators

  • SocraTec R&D GmbH

    collaborator OTHER

  • SocraMetrics GmbH

    collaborator INDUSTRY

  • Institut für Medizinische Diagnostik MVZ GbR

    collaborator UNKNOWN

  • Sport- und Rehazentrum GbR

    collaborator UNKNOWN

  • Adelholzener Alpenquellen GmbH

    lead INDUSTRY

Principal Investigators

  • Frank Donath, MD · SocraTec R&D GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-02-29
Completion
2012-04-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01333930 on ClinicalTrials.gov