Documentation is the essential part of your application regardless whether you wish to demonstrate:
o Used in applications for novel food.
o Used in applications for:
In order to be able to use your studies to scientifically prove the endpoints of the study the study-layout must be accepted in science as an objective scientific methodology i.e. double blinded randomized, placebo controlled trials.
Quality requirements for studies with food ingredients or products require at least the same quality as a study in a medicinal product.
Actually certain studies require a larger number of participants in order to demonstrate significance. This is logical due to the fact that the physiological response to a food ingredient often is “weaker” than the one of a medicine thus increasing the number of participants needed to ensure significance.
To make sure that the study provides the necessary information, it is crucial to focus on choosing the right endpoints.
We are able to help you with our experience designing studies and moreover defining the right endpoints, biomarkers etc. thus ensuring that the study will actually be useful as documentation for efficacy.