Substantiating Immune Related Health Claims for Mushroom-Derived Polysaccharides

摘要

Mushrooms received attention for their supposed beneficial effect on health. In particular the mushroom-derived polysaccharides have been extensively studied by various groups because of their immunomodulating effects. Here, we reflect on human trials to demonstrate polysaccharide health effects using European Food Safety Authority (EFSA) guidelines for health claim substantiation. These guidelines describe the required knowledge on bioactivity, availability and mechanistic function of the polysaccharide and set-up of the human trial. So far, most clinical trials showing health effects of mushroom polysaccharides are likely insufficiently substantiated to meet EFSA requirements. Double blind placebo controlled human trial that use healthy subjects should be the focus to meet the EFSA guidelines. Biomarkers for immune based health maintenance like protective antibody response to vaccination, are good examples of EFSA approved strategies but many more should be identified and validated. We also propose the use of biochemical analysis, a set of standardized in vitro and ex vivo bioactivity assays, and standard operating procedures (SOPs) that are in line with EFSA guidelines to serve as supporting evidence to clinical trials and use these tools for product development and quality control of products.