Implications
(i) Biosafety
Focus
(i) Safety
(ii) Oxidative stress and related parameters
(iii) Detection and quantification of substances and metabolites in body fluids
Models
(i) Human volunteers
Why testing safety on human volunteers?
Safety testing on human volunteers serves for confirmation of results obtained on experimental animals and/or cell cultures. This confirmation is necessary because of existing inter-species differences in enzymatic systems, e.g. biotrasforming cytochromes P450.
Assessment of safety (biological activity)
Tests:
(i) Health status monitoring, questionnaires
(ii) Parameters of clinical biochemistry and hematology
(iii) Oxidative stres related parameteres
(iv) DNA damage – single – stranded DNA breaks – Comet assay in peripheral lymphocytes
(v) Detection and quantification of substances and metabolites in body fluids
Aim: To assess whether the test substance/extract/phytopreparation will not display adverse effects on human volunteers.
Procedure: Human volunteers will be given the substance/extract/phytopreparation in the form of a food supplement. Questionnaires, medical examination, blood, and urine collection for determination of parameters of clinical biochemistry and hematology will be performed at the beginning, during and at the end of the study.