Clinical Trial Design for Mushroom Ingredients

This course teaches you how to plan human studies on mushroom ingredients that can produce trustworthy results. It begins with an analysis of why many existing mushroom trials fall short, then covers research questions, endpoints and biomarkers, standardisation and characterisation of the test product, randomisation, blinding and placebo design, ethics approval, trial registration, Good Clinical Practice, and analysis and reporting using CONSORT.

Without better human studies, the field will continue to rely on preclinical data and weak claims. Researchers, R&D managers and clinical research staff need to design trials that are feasible, ethical and informative, and that use test products described precisely enough to be reproduced. This course provides that framework with practical examples specific to fungal ingredients, including the challenge of producing convincing placebos for mushroom powders. In your final project you will write a complete study protocol synopsis for a trial on a mushroom ingredient, including objectives, endpoints, product characterisation, design, sample size rationale and ethics and registration plan.