Innovative and sustainable processes for the development of Vitamin D nutraceutical from fish waste: extraction, formulation and clinical study for the evaluation of its bioavailability and clinical equivalence (VITADWASTE)

The current pandemic crisis related to Covid-19 is increasingly underlining the importance of having a healthy lifestyle, a proper diet, In this context, the bioeconomy represents a model of sustainable and resilient territorial growth that guarantees the preventive recovery of all products with high added value from renewable biological resources (e.g. by-products of the fishing industry). Vitamin D naturally occurs in two forms, D2 (ergocalciferol) and D3 (cholecalciferol) and for all fish species Vitamin D3 is the primary storage form. The ability of fish to store large quantities of Vitamin D3 in their tissues, makes them an excellent dietary source of Vitamin D3 for humans. Considering the activities related to the fishing sector such as fishery, aquaculture and fish processing industry, significant quantities of waste are daily produced having a high environmental impact. This precious waste, which is discarded because it does not meet the market specifications (between 20 and 80%), can be a great natural substrate available for the production of Vitamin D. The aim of this project is to use the waste of fish production as a substrate for the extraction, enrichment, characterization, formulation of Vitamin D3 nutraceuticals, and to study its pharmacokinetics and bioequivalence in a clinical study for converting, with an innovative approach, a pure waste in a resource destined to pharmaceutical and food industry. The project is divided into different WPs, each one dealing with a specific aspect that will be investigated through the collaboration of the four RUs involved in different activities according to their specific expertise. Green and non-conventional techniques such as Microwave-Assisted Extraction (MAE), Ultrasound-Assisted Extraction (UAE), Rapid Solid Liquid Dynamic Extraction (RSLDE), and Supercritical Fluid Extraction (SFE) will be studied for the extraction of Vitamin D from waste, and biotechnological treatments using proteases and lipases enzymes on the raw material will be tested in order to obtain better recoveries of Vitamin D. The presence of contaminants (PAHs, heavy metals) in fish waste will be assessed, and a formulation study based on microencapsulation followed by a bioaccessibility study will be carried out for obtaining a selected nutraceutical (fish Vitamin D3) to be tested in a clinical study to assess the pharmacokinetics and bioequivalence in comparison with a standard Vitamin D supplement. Considering the increasing global awareness of the importance of Vitamin D, and the high prevalence of its deficiency (40 % in Europe), the global demand for Vitamin D is expected to grow during the next years. Therefore, fish wastes could constitute ideal raw materials for the preparation of vitamin D nutraceuticals using a sustainable approach.