Benefits: Tradition of Use, Experimental Models and Human Studies to Support Health Claims of Botanicals

Making health claims for botanical and plant food supplements (PFS) requires serious investigation and a collection of scientific evidence. The present chapter summarizes different aspects that should be considered for the evaluation of PFS benefits. Well-designed translational in vitro methods combined with human studies provide the best predictive information about their efficacy and safety. In vitro studies should rely on the most predictable cellular model to investigate the molecular mechanisms underlying the biological effect, based on approved standard operating protocols. Studies in the scientific literature generally do not consider the metabolic conversion of PFS and their active principles, as well as the chemical preparation of the extracts. To obtain the highest relevance for health claims, human studies should always describe inclusion criteria, group size, characterization of the intervention material, the control, blinding, duration of intervention and the reporting of study events. Furthermore, suitable use of in vivo validated biomarkers must be combined with large intervention studies to support health benefit of PFS.