During Phase 1 of the CARODEL project, WP2, WP3 and WP4 were run in parallel.
WP2 (“Production”) was designed to optimize the production of the different carotenoid formulations that were tested in the other research WPs.
WP3 (“Evaluation of the carotenoids delivery and effect in the GIT”) was designed to elucidate - by means of in vitro research and animal studies - the intestinal fate and bioavailability of the carotenoids when administered either as purified carotenoids extracted from the Bacillus strain, when contained in the vegetative cells or when contained in the spores of the strain. Furthermore, the effects of the Bacillus strain on the intestinal environment were assessed upon administration as spores or vegetative cells. The aim of this part of the project was to determine the optimal formulation to be used in the human trial, in terms of carotenoid bioavailability profile and, if possible, potential to modulate the intestinal environment.
In parallel, in WP4 (“Evaluation of the safety of the carotenoid-producing Bacillus strain”), all the necessary steps in order to prove the safety of the carotenoids and the carotenoid-producing strain in relation to the novel food and QPS regulations, respectively (e.g. toxicology, antibiotic resistance, genome sequencing, and characterization of the carotenoids) were performed.
In Phase 2 of the project, the best formulation identified in WP3 and supported by the data on safety determined in WP4 was tested in a human study within WP 5 (“Human intervention trial”). Analyses were conducted by the different partners to determine the bioavailability of the ingested carotenoids, the effects on the human host in terms of CVD biomarkers and the impact on the gastrointestinal microbial composition and metabolic activity.
Finally, in WP6 (“Regulatory and life cycle assessment”) the consortium defined the regulatory strategy, evaluated the consumer perception of the novel concept, identified the necessary additional R&D steps and, finally, prepared a life cycle assessment plan. Moreover, the results of WP7 are an IP strategy to protect the outcomes of the project and an exploitation plan of all the results generated in the project.