healthy subjects
Conditions
Interventions
Group 1: Group 1: Four subjects belong to the control group. They ingest between 9:30-10:00 a clock on the day of the baseline assay and on the both following days at the same time 1000 mL silicon con
Sponsors
Uni-Zentrum Naturheilkunde / Institut für Infektionsprävention und KrankenhaushygieneUniversitätsklinikum Freiburg
Eligibility
Sex/Gender
Male
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: In the study healthy, male adults aged between 18 and 60 years, deciding self-determined about their attendance participate.
Exclusion criteria
Exclusion criteria: - acute or chronic diseases of every kind (except for hay fever) - regular intake of any drugs or medications (incl. herbal and homeopathic drugs) - drug addiction within the last year before start of the study - participation in another study within the last four weeks before start of the study - blood donation during the three weeks before the first pre-examination - insuffitient language skills to understand the subject information script
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximal silicon blood plasma level after the intake of TEA with 3000 mg/L silicon (group 3) compared to si-water with 300 mg/L silicon (group 1). | — |
Secondary
| Measure | Time frame |
|---|---|
| -Maximal silicon blood plasma level after intake of TEA with 300 mg/L (group 2) -Tolerability of TEA compounding on a numeric rating scale from 0 (very bad) to 10 (very good) on day three of ingestion -Kinetic: -course of silicon concentration in blood serum and urine -Safety: -the safety will be examined based on undesirable events with the evaluation of causality -The following laboratory parameters will be examined: -Blood values: -differential blood count, differentiation of lymphocytes, proliferation of t-cells out of EDTA-blood -kidney values: -creatinine and urea in blood serum -liver values: -GOT, GPT, ?-GT in blood serum | — |
Countries
Germany
Contacts
Public ContactAljoscha Waterstradt
Uni-Zentrum Naturheilkunde / Institut für Infektionsprävention und Krankenhaushygiene Universitätsklinikum Freiburg
Outcome results
None listed