Project deliverables

WP1 - Bussiness modelling

The challenge for any collaborative R&D projectis to ensure that it creates value for individuals or businesses. This interim report provides an initial overview of PREVENTOMICS business modelling framework in the context of the Business Model Innovation (BMI) process. This document defines the initial business plan for each enterprise participating in the project consortium, aiming to provide a thorough assessment of the different business cases that main sustain the service provision once the EC grant finishes in 2022. This information will be useful for the next stage of this work package, in which a Minimum Viable Product conceptualisation will be created. On the other hand, it will also feed the annual PUDR (Plan of use and dissemination of project results). The derived business frameworks will also be tested with various conversations with potential customers and users.

This report ispart of the Work Package (WP) 1 of the PREVENTOMICS project. The aim of this report is to find out consumers’ opinions about and attitude towards personalizednutrition, the tools used to arrive at this personalisednutrition and the use of Apps and digital platforms. We will also study the requirements that an App or platform must meet to be in line with data protection regulations or the GDPR. The data protectionis ahighly relevant topic. And even more so when working with health data, personal data classified as highly sensitive.

The scope of this deliverable is to describe the analysis conducted and the outputs obtained in the definition of the Minimum Viable Product (MVP). This report provides an overview of the main features of the PREVENTOMICS solution as well as provide actionable insights for PREVENTOMICS technological/service development phase. This document defines some of the fundamental assumptions on how PREVENTOMICS solution has to be developed according the user’s expectations and market’s needs.

First, this document describes the market research conducted among some of the project partners. Second, it shows, after having defined the target customers, hypothesis about what customers want and expect from the PREVENTOMICS solution. Third, it provides a framework for prioritising the project solution features. After having showed an overview of the market needs, the document describes the competitor analysis conducted to see what our competition looks like. Finally, the document describes how to address the real pain points that exist in the market and presents some of the learning cards collected so far.

WP2 - Biomarkers and health status correlation

The scope of the deliverable 2.1 is to outline the status of 6 biomarker clusters: carbohydrate metabolism, lipid metabolism, oxidative stress, microbiota status, protein metabolism and inflammation that are associated with metabolic dysregulation. To do so, a set of key representative plasma and urine metabolites and proteins have been compiled and will be measured in samples from clinical and observational cohorts of the consortium partners (e.g. BIOCLAIMS).

These biomarkers have been determined by different analytical systems (liquid chromatography and gas chromatography coupled to mass spectrometry, nuclear magnetic resonance, ELISA and enzymatic methods).

Serum biomarkers will be substantiated in comprehensively characterized individuals (molecular markers, including tissue transcriptome; physical, mental, clinical, metabolic parameters; dietary information) differing in sex, age, physical activity (sedentary/ active) and health status (healthy, statin users).

The aim of this deliverable is to provide objective information on the actual diet of European consumers through the analysis of biomarkers of intake of food groups and specific foodstuffs. This information will be provided upon analysis of the samples provided by EURECAT and the samples of the 4 PREVENTOMICS intervention studies that will be conducted, once an adequate sample size has been achieved and the results have been validated. This deliverable highlights the utility of the developed methodological platform to reach an objective dietary assessment though biomarkers of food intake.

This deliverable includes a selection of the biomarkers of food intake that have to be further validated and eventually included in the final version of the PREVENTOMICS Decision Support System (DSS) to allow the identification of the dietary habits of the subjects involved in the 4 PREVENTOMICS RCTs. Therefore, all the operational and decision processes that lead to the list of candidate biomarkers of food intake are illustrated. The relation between food intake biomarkers and food categories is also explained.

The scope of the deliverable is to outline:
a) To determine the range of reference values for each classic biomarker on the basis of bibliographic data and own research.
b) Selection of complete set of classic biochemical variables related to health status which will be determined for the integration with metabolomics and genetics variables in individuals participating in PREVENTOMICS pilot studies.

In order to assess the ranges of classic clinical biomarkers associated with metabolic and inflammatory complications of obesity, a review of the literature was made. In addition, on the basis of research results obtained from earlier projects, ranges of standards for classic variables for the Polish, British and Spanish populations were estimated. Currently, EURECAT is analyzing the circulating levels of these biomarkers in blood and urine samples of about 200 non-obese healthy and 150 obese unhealthy volunteers Denmark (PROKA study) and The Netherlands (The Maastricht Study). Biomarker reference values are being estimated in metabolically healthy non-obese subjects as well as in metabolically healthy and metabolically unhealthy obese individuals. The deliverable 2.3 provides key output for WP3, WP4 and WP5 enabling the reasoning and decision support system. The protocols for the collection of biological material for laboratory determinations were agreed with the PREVENTOMICS partners. Biomarker determination methods have been developed and agreed by PREVENTOMICS partners also, which is reflected in the SOPs attached to the report.

WP3 - Self-management services for consumer empowerement

This deliverable describes the approach determined to model data and build both systems: The Decision Support System (DSS) and the Nutrition Recommender System (NRS) in WP3. First, this document shows an overview of WP3 in the context of the DSS and the NRS building. Second, it describes the multisource data collected to cover different aspects of humanbeing’s health. Regarding data, it is also described how a test users’ database will be created by using synthetic data. Third the main inputs, processes and outputs from both the DSS and the NRS are described. Finally, it is described in a general way the outputs of the NRS and how they will be used within other applications of the project. Information presented in this document is useful for the next stage of this work package, in which the DSS and the NRS will be created and tested.

This report describes a preliminary version of the Decision Support System (DSS) designed to generate the personalized nutrition recommendations from users’ multi-level data. First, an overview of the DSS architecture and a detailed description of all its components is provided. Second, we present the data analysis conducted to define and validate, together with the expert’s knowledge, the DSS processes related to the assessment of a user metabolic health. Third, we specify the technologies used for the system development. Finally, final considerations and next steps are outlined

WP4 - PREVENTOMICS personalised nutrition integration

This deliverable describes the PREVENTOMICS platform, its components and related communication interfaces required for their interaction. The work reported in this deliverable is the outcome of Task 4.1 “PREVENTOMICS platform design and communication interfaces specification” which purpose is to elaborate on the PREVENTOMICS architecture. More specifically the deliverable provides the details of the project technical approach that forms the basis for the implementation of the PREVENTOMICS platform and related features, while meeting the requirements of the business cases which the project aims to support. The solution being implemented in PREVENTOMICS aims support two main business cases: PREVENTOMICS “as a whole” business case and PREVENTOMICS “individual” business cases.

For project partners to reach a common understanding regarding the proposed solution and resolve issues related to the technical approach, a focused two days technical workshop, organized by partner ICCS, was held in Athens, Greece in 19th and 20th of June 2019. The purpose of the meeting was twofold. First, questions and open issues related to the “PREVENTOMICS customer journey” were addressed. The journey considers the various actors who use the platform and the related “front stage” interactions, the respective “touch points” and the required “backstage actions” that need to be supported by ICT. Second, various approaches and ideas regarding the PREVENTOMICS architecture were discussed and decisions were made regarding the components that are part of the platform and the interfaces that are required for their interactions.

Following the definition of the PREVENTOMICS journey, a list of components and the set of use cases that these components should support in order to deliver the required functionalities, have been defined. The use cases drive the design of the components and the specifications of the PREVENTOMICS apps which will be described in more details as part of deliverables D4.2 “Go-Live of ALDI new mobile app version integrating PREVENTOMICS”, D4.3 “Simple Feast’s server back-end integrating PREVENTOMICS” and D4.4 “METADIETA novel software including PREVENTOMICS DSS”. In total, nineteen (19) use cases have been defined.

Based on these use cases we have designed an open, extendible and modular PREVENTOMICS platform architecture. The architecture comprises of several components grouped in three main layers which altogether comprise the PREVENTOMICS platform to be validated within the project duration. The basis of the platform is the Data layer which hosts all the required information to run the PREVENTOMICS personalized nutrition models and the data related to the user profile. The PREVENTOMICS DSS-NRS provides all the required functionalities to register and  capture information from the user as well functionalities to import the blood/urine/saliva test results. A front-end web interface is used for registering the user, a process that involves the generation of a unique id with the use of the external Auth0 service as well as the filling of a set of questionnaires where users provide input that is used by the PREVENTOMICS models as well as the platform evaluation. In the PREVENTOMICS project there are three main dietary apps which are used to showcase and validate the benefits of personalized nutrition: the METADIETA software and app for dieticians and patients with diabetes, the SimpleFeast recipe recommendation app and the ALDI microsite that recommends products from the ALDI supermarket. Each app consists of a backend module and a frontend interface for the users.

To be published

WP5 - Consumer-centered interventions

WP6 - Regulatory, economics and health impact

This deliverable outlines the ethical behaviour in PREVENTOMICS and the principles underlying the conduct of studies within PREVENTOMICS that require external ethical review and approval. All activities within PREVENTOMICS and all interactions among PREVENTOMICS partners will be conducted according to this ethics management framework.

PREVENTOMICS partners will adhere to the highest standards of research integrity and to all relevant national, EU and international regulations and laws as they apply to the specific activities.

PREVENTOMICS will include research activities conducted in experimental animals and in human subjects. In the planning and conduct of such activities, all ethical issues will be fully considered. No research will begin until all requisite approvals are in place. All experimental work will be conducted according to the relevant approvals.

This report is presenting necessary laws and regulations in order to tackle the food production instances both in Denmark and Spain. The work for deliverable 6.2 is taken into account when working with the Danish pilot within PREVENTOMICS.

This report is tightly connected to the WP 5 (Consumer-centred interventions). The objective of WP 5 is to carry out interventional studies with real end-users in a multi-cultural and multi-social environment to demonstrate the efficiency and efficacy of the application of individual metabolomic signature to the personalization of nutrition. More specifically, CARINSA will design and apply different food ingredients with functional capacity that could be used for the personalized food delivery in the Danish pilot by SIMPLE FEAST (in early 2021). What is more, this report will be used in WP 4 (PREVENTOMICS personalized nutrition integration). The goal of WP 4 is to integrate PREVENTOMICS DSS into the different platform and digital channels of the three companies (ALDI, SF and META) assuring the delivery of personalized recommendations. This includes creating the communication protocols and interfaces as well as assuring continuous validation.

This report is divided into three parts. Firstly, a list of EU food regulations is presented that are applicable both in Denmark and Spain. Secondly, an overview of food legislation regulatory in Denmark is presented. And lastly, the same overview is done for Spain. The presented regulations are important in the framework of PREVENTOMICS and will be taken into account by SF (Simple Feast) and CAR (Carinsa).

WP7 - Market impact management and dissemination

This deliverable is the initial version of the project’s DataManagement Plan and explains the proposed actions for the overall control of PREVENTOMICS’s data and publications. The deliverable embarks with a summarisation of thetypes and sources of data and continues with the description of the practices for safeguarding that the PREVENTOMICS research data are findable, accessible, interoperable and re-usable (FAIR). An account of the allocated resources for data management is included. The deliverable concludes with an appreciation of the data security and ethical considerations principles to be adopted.

This deliverable details the communication materials that have been prepared from M1-M12 and the plans for the following months.

Read the deliverable here

PREVENTOMICS project shows an enormous potential as combines metabolomics sciences and information communications technology to make a significant step forward in the empowerment of citizens and in promoting a long-lasting personalized nutrition.

The success of PREVENTOMICS and the realisation of its maximum impact will be achieved via the direct exploitation of the main expected result: a novel mFood platform and its derived modular technologies. The mFood platform developed during the PREVENTOMICS project includes the dynamic software platform and algorithms, the pre-required analytics services (combination of genetic, biological, nutritional and psychological) and the derived dataset combining all the anonymized data gathered from the conducted tests. This unique-in-its-kind service is interoperable with existing software applications related to health status monitoring and dietary guidance and opens the door to the personalization of any type of nutrition advice and health treatment.

PREVENTOMICS envisaged exploitation routes; including efficient technology transfer to strategic future rollout and commercialisation agents as well as integration into existing business cases from consortium SMEs well-positioned in the food manufacturing and nutrition services; grants a smooth transition from R&I to scale-up and market adoption.

The present deliverable presents the definition and steps made towards execution of well-coordinated exploitation and dissemination activities (WP7) aligned with all other tasks developed in the project.

To be published

WP8 - Project management

This document has been elaborated for the PREVENTOMICS project with the aim to present the Collaborative Platform that the Consortium is using to manage the project. This collaboration tool is implemented over the tool SharePoint.

This platform is used as a website with user restricted access, for confidentiality reasons. This document will focus on the key aspects of the application – document management and team collaboration.

This deliverable provides all project partners with a summary of the main project procedures (project monitoring, reporting, financial management, etc.) It contains documentation and communication standards in order to enable good communication within the consortium. This document also describes the quality plan.

The PREVENTOMICS project (GA 818318), aims to ‘Empower consumers to PREVENT diet-related diseases through OMICS sciences’. The PREVENTOMICS project aims to build a science-based app to support consumers in food choices. Health-biomarkers based on omics sciences constitute the basis of the app. As the project is constituted by different building blocks with its intrinsic challenges (e.g. health-biomarkers; building an app-platform, setting up analytical methods for circulating marker; human interventions; bioinformatical analysis; business models …)  identification of risk-areas and anticipation of possible future risks that may rise from project execution is of utmost importance. This deliverable reviews the risks anticipated during proposal stage as well as includes new ones as a result of project development.

WP9 - Ethics requirements

PREVENTOMICS will include four studies in human participants. Human research will be conducted in accordance with the Ethical Management Framework described in D6.1 and the ethical standards described therein. The scope of this deliverable is to:

  1. Describe the procedures and criteria that will be used to identify and recruit research participants into human studies;
  2. Provide the final (or near-final) version of each study protocol;
  3. Provide information on informed consent procedures including the provision of an exemplar Informed Consent Form;
  4. Provide an exemplar Participant Information Sheet
  5. Provide copies of letters of approval from ethics committees where these have been given (it is required that one approval be received by the time of this deliverable);
  6. Describe the process for registration of each study at an approved registry
  7. Report on the status of posting results in the study registries.

Procedures and criteria to identify and recruit research participants are described. As exemplars, the protocol, informed consent form and participant information sheet for one of the studies are included. A copy of the ethical approval letter for one of the studies is included. It is anticipated that all studies will receive approval by end of quarter 1 of 2020. Study registration will be done after approval is received but before participant recruitment begins. In keeping with current practice, study results will not be posted until each study is complete, researchers have completed their statistical analysis and interpretation, and any IP opportunities that arise have been fully considered.

The scope of this deliverable is to outline details concerning the human cells/tissues/fluids that will be obtained and used during PREVENTOMICS.

To be published.