As a final validation of previous findings based on its technology platform ProDigest organizes proof-of-concept human intervention trials in collaboration with medical institutes.
The combination of the ProDigest in vitro technology with human intervention studies is the ideal strategy to design and perform the latter studies under optimal and cost-effective conditions.
Application of the technology platform allows to unravel and identify many of the crucial factors which determine the success of a human intervention study. This includes among others the elucidation of specific metabolic processes and possible interindividual variability, screening and selection of the most promising product lead and optimization of the best formulation strategy (e.g. encapsulation, slow-release strategies,…).
Availability of these in vitro data allows to organize a proof-of-concept human study with the most promising product and optimal formulation, thereby increasing the study’s chance of success. In addition, understanding the metabolic fate and interindividual variability allows to better select the target population, further increasing the quality and the power of the study. All these aspects lead to a cost-effective and high quality proof-of-concept study which provides all necessary information to support the functionality of a given compound.
Typical examples of ProDigest’s experience related to this integrated strategy are the evaluation of pro- and prebiotics and the bioavailability of active compounds generated by variable intestinal microbial metabolism (e.g. plant polyphenolics).