Personalised nutrition

A collaborative European Union FP7 project, Food4Me, was one of the first to explore comprehensively the opportunities and challenges of personalised nutrition. Eileen Gibney and other project partners describe the key findings.

Background

The sequencing of the human genome in 2003 was a major breakthrough in science, which many believed had the potential to revolutionise healthcare through the identification of individuals at risk of disease and the development of interventions specific for each individual’s genotype^[1]. This gave rise to the concept of personalised nutrition, where tailored dietary advice is delivered to individuals based primarily on genetic factors but also including other personal information, such as current diet and phenotype. This contrasts with most public health advice about diet, which is generic, non-specific healthy eating advice e.g. ‘eat at least five portions of fruit and vegetables daily’^[2]. Although the original concept of personalised nutrition focused on delivering advice based on genotype, from the outset, Food4Me took a broader view of the factors likely to be important in personalising dietary advice. As proof of principle, three levels of personalisation were chosen, which could be used separately or in combination, i.e. personalised dietary analysis, personalised phenotype analysis and personalised genotype analysis. While there was growing interest in gene-nutrient interactions, which could support the delivery of personalised nutrition, a comprehensive study examining the broader opportunities and challenges was lacking. Food4Me aimed to fill this knowledge gap. It was a multi-partner project funded by the European Union Seventh Framework Programme (FP7), which was the first to explore comprehensively the opportunities and challenges that personalised nutrition could offer, examining business and value creation models, consumer attitudes to personalised nutrition, technology and finally, the ethical and legal implications of personalised nutrition^[3]. This article gives an outline of some of the key activities and findings from the Food4Me study.

Value creation concepts for personalised nutrition

Scientific advances may face important barriers in becoming accepted and applied by society, even though benefits may seem obvious to researchers.

A fundamentally new development, such as personalised nutrition, is particularly challenging to evaluate because it touches upon two primary human needs: health and food. These are at the heart of a major societal debate as many of today’s public healthcare issues, such as obesity and diabetes, are largely a consequence of inappropriate dietary and lifestyle behaviours

There is an urgent need to help citizens to adjust their dietary behaviour to enhance their long-term health and well-being. Personalised nutrition offers a new approach by providing advice about healthy food choices and eating patterns to fit an individual’s needs and personal preferences. This inherent link between individual behaviour change and the corresponding societal impact means that the introduction and widespread adoption of personalised nutrition is likely to have significant societal consequences. Value creation models for personalised nutrition are interesting but also very challenging.

Personalised nutrition concepts need to integrate different elements, such as personal coaching principles and new technological tools ranging from self-sampling diagnostics, wearable lifestyle and food intake monitoring, to mobile interfaces for dietary coaching. Moreover, personalised nutrition concepts have the potential to substantially improve the value perception of food and its role in health and society. In order to explore future value creation models, it is necessary to consider the future societal context. Four scenarios about evolution of nutrition and health issues in Europe served as a basis to develop 10 very different value creation concepts for personalised nutrition. The extent to which these concepts may be inherently linked to changes in future society was explored.

The work demonstrated that personalised nutrition is a complex but promising concept because the essential goal is to achieve lasting improvements in dietary behavior and health. It therefore has the potential to relieve the current pressure on healthcare budgets and thus to bring significant benefits to society.

However, personalised nutrition services are unlikely to follow a conventional business model, but will instead require transition dynamics in which societal changes and business model developments occur simultaneously. Thus, public-private partnerships are most likely to be the best vehicle for developing personalised nutrition services. Given the important ethical issues that may arise, policy makers will be required to ensure that regulatory frameworks are in place to guarantee privacy of data in addition to freedom of choice. Without this, there is a significant risk that personalised nutrition services will be misused for commercial reasons or by societal actors to exert improper influences on citizens. There will be a need for scientific coherence in the personalised advice provided, because different scientific interpretations of the data will be counterproductive in the same way that contradictory food and dietary advice has caused much confusion in the recent past.

There is an urgent  need to help citizens  to adjust their dietary  behaviour to enhance  their long-term health and well-being'

The consumer and personalised nutrition   

The Food4Me study adopted a mixed-method approach (combining both qualitive exploratory data research and quantitive survey research)  to understand the consumer’s view of personalised nutrition and to afford the European public a voice in determining best practice in the design and delivery of services. Consumers who took part in the initial focus groups informed us that a first step in attracting users would be to build trust in service providers. Subsequent (second stage) survey results echoed this finding in that direct-to-consumer (D-T-C) personalised nutrition companies were rated lower on trust than government agencies, family doctors and national Departments of Health. Trust in providers could be enhanced in a number of ways, including through provision of data protection guarantees and ensuring that those delivering services are professionally qualified.

Preferences for service delivery were incongruent with theories of behaviour change based on Social Cognitive Theory (SCT)[4]. Consumers indicated that service design and provision should take into account individual goals related to diet, encourage independent choice and put the client (or service consumers) in control. This could be achieved through providing clients with regular feedback and progress on dietary health markers and enabling them to monitor their own progress toward the achievement of pre-set dietary health goals. The way services are delivered may also need to be personalised. Some consumers indicated they would prefer automated feedback, others preferred feedback by telephone or in person. Individual differences in motivations for food choice also need to be taken into account. To ensure a prescribed diet can be adhered to in social settings, advice may need to be adapted not only to the client’s dietary needs but also to their working environment and social circumstances as well as taking into account the dietary preferences and personalised nutrition requirements  of other household members.

The qualitative results indicated the existence of two potential markets for personalised nutrition within Europe. The first aligned personalised nutrition services with existing health provision. The second  focused on  the indiviual’s autonomy, anonymity and control that a commercial approach could deliver[5]. A proportion of consumers surveyed indicated willingness to pay a premium for personalised services. Some EU countries, however, may be more amenable to adopting private personalised nutrition services than others and as such could constitute potential pilot markets.

Best practice will entail treating clients as partners in the design of dietary interventions to promote their health. It is important for industry to work with existing health providers as well as with employers, retailers and food product developers in bringing the benefits of personalised nutrition to the wider  public[6]. 

Technology and personalised nutrition

The Food4Me project conducted a scouting exercise for new technologies and tools for use in nutrition and health monitoring and provided technical support and solutions to the proof of principle study. By definition, any type of service can only be personalised if appropriate information about the individual is available. Personalised nutrition services rely on knowledge of food choices or total food intake usually recorded by food frequency questionnaires and on phenotypic data (such as gender, age, body height, body mass, physical activity). This may be extended to include other measurements, such as blood glucose or cholesterol levels or blood pressure, as surrogate measures of health status. The analysis of genotype, either by profiling specific genetic variants e.g. single nucleotide polymorphisms (SNP) or by exome or whole genome sequencing, is also readily available. Assessment of the individual’s life style – particularly dietary habits and physical (in)activity – provide the closest link to nutrition-related chronic diseases, such as diabetes, coronary heart disease or cancers. Possible nutrient deficiencies, or at least intakes below the recommended levels, also need to be addressed, if identified. Finally, analysis needs to be translated into comprehensible and feasible recommendations for lifestyle changes, which take into account identified (via questionnaires) constraints, such as food allergies and intolerances or simply food dislikes.

Food4Me defined a panel of anthropometric parameters that the participants could record and report themselves when provided with instructions and information, such as videos for the necessary procedures in the languages of the different partner countries. In addition, the practicability of the methods and the validity and coherence of the data collected were assessed. Moreover, a database for validated gene-nutrient-health interactions was developed based on a meta-analysis of published studies and expert knowledge. An automated recommender system and meal coding system was created for the participants and a menu-planning module based on linear programming was developed for future applications in personalised nutrition. It provides a weekly meal plan with concise menu suggestions taking into account the dietary needs and also the food likes and dislikes of each individual.  

Does personalised nutrition work?  

A major undertaking of the Food4Me project has been the completion of a Proof-of-Principle (PoP) Randomised Controlled Trial (RCT) on the implementation of personalised nutrition. The RCT was designed to mimic a real-life internet-based personalised nutrition service and to provide insight into the effectiveness of the advice compared with non-personalised ‘one size fits all’ recommendations. The Food4Me PoP study was a four arm, internet-based, 6-month RCT conducted across seven European countries, which compared the effects of different levels of personalised nutrition on health-related outcomes^[7].

The study posed two primary research questions. First, does the personalisation of dietary advice assist and/or motivate participants to eat a healthier diet in comparison with non-personalised, conventional healthy eating guidelines?

Second, is personalisation based on individualised phenotypic or genotypic information more effective in motivating participants to make healthy changes, compared to personalisation based on analysis of current diet alone? To answer these questions, participants were randomised to either Level 0 to receive generic, non-personalised dietary advice (control), or to receive one of three levels of personalised dietary advice: based on the participant’s current diet alone (L1), based on current diet and phenotypic data (L2), or based on current diet, phenotypic and genetic data (L3).

The study collected genotypic information at baseline (0 months), and phenotypic measurements (weight, height and dry bloodspot samples) and information on diet and lifestyle at 0, 3 and 6 months for all participants. This large RCT, which incorporated several innovative features, including self-collection of blood by the participants using dry blood spot cards, generated a rich dataset, which was interrogated extensively. The principal finding was that participants who received personalised nutrition advice ate significantly healthier diets than the control group, regardless of whether this personalisation was based on their diet alone, their phenotype or their genotype^[7].

These results indicate little added value from using genomic information to personalise lifestyle-based interventions. However, the fact that those receiving personalised nutrition advice reported bigger improvements in dietary patterns after 6 months suggests that this advantage may be sustainable. The study also demonstrated that advice delivered via the internet offers promise as a scalable and effective route to improving dietary behaviours, which may have important public health benefit⁸.  

Ethical and legal issues surrounding personalised nutrition

To identify and address the ethical issues in relation to personalised nutrition, Food4Me focused on ethically relevant aspects that distinguish personalised nutrition from other health services.

Several areas of special ethical concern were identified in relation to personalised nutrition. The current scientific evidence for personalised nutritional advice is quite limited and fragmentary.

However, in specific cases of gene-diet interactions, individuals could benefit from following personalised rather than general dietary recommendations. What is an ethically responsible way forward in this situation? Arguing from a precautionary approach, it is suggested that personalised dietary advice should be offered only when there is strong scientific evidence for health benefits, followed by stepwise evaluation of unforeseen behavioural and psychological effects^[9]. Another important consideration is whether consumers can be offered personalised nutritional advice over the internet (by way of direct-to-consumer (D-T-C) genetic tests) in an ethically and legally safe and sound manner, securing different aspects of consumer protection.

Studies have shown that current D-T-C services for personalised nutrition often suffer from a questionable level of truthfulness and an imbalance between far-reaching promises of the effects of personalised advice and contrasting disclaimers. Current regulation in this area is incomplete and therefore there is a need to carefully examine personalised nutrition services offered via the internet in order to develop guidelines and rules that safeguard privacy, consumer protection and safety^[10]. Other important questions include whether personalisation of nutrition could negatively affect the social aspects of eating as well as our understanding of health and how a wider use of personalised nutrition may influence solutions to the societal dilemma of individualisation, where the societal goals for individual autonomy and justice may come into conflict with each other.  

Personalised nutrition could challenge the current legal situation and create a need for further development of the legal framework. A core result of this analysis is that neither the EU nor its Member States have legal instruments specifically dealing with personalised nutrition. Instead, owing to its nature and characteristics, personalised nutrition falls within the ambit of several legal instruments and the determination of which ones are applicable to any specific personalised nutrition offering necessitates reviewing the components of the proposed service. For instance, currently it is not clear whether personalised nutrition services should be considered as part of healthcare services or should fall under the conventional business D-T-C service contract.

The classification of a personalised nutrition offering as healthcare is dependent on the status of the various professionals involved in the service in a Member State. Such classification has a significant impact on the legal provisions applicable to the related personalised nutrition contract of service. While in the case of healthcare services, EU provisions are limited to patients’ rights in cross-border situations, non-healthcare services are subject to detailed harmonised rules guaranteeing the protection of consumers in all circumstances. In this sense, the legislation applicable to personalised nutrition as a service is very fragmented and results in legal uncertainty with regard to (1) the protection of the consumer and (2) the resulting obligations of personalised nutrition providers depending on the status of the professionals involved. Personalised nutrition offerings may also involve the use of various devices, such as instruments for self-testing. The current legal framework does not clearly address these new vehicles.

Conclusions

Food4Me has demonstrated that personalised nutrition is emerging as a novel concept that offers exciting alternative approaches to improving dietary behaviours with potential to enhance health and wellbeing and, therefore, to reduce healthcare costs. The Food4Me intervention study demonstrated that personalised nutrition can be feasible and effective and that the delivery of personalised advice and recommendations is more effective in changing dietary intakes than general healthy eating messages.

The work demonstrated, however, that successful implementation is not without its challenges. Delivering a full personalised nutrition service will require integration of a wide range of elements, from biomarker, genotype and dietary diagnostics to scientific interpretation algorithms, mobile interfaces, wearable monitoring devices, app development and big-data handling. Consumer trust in such services will be key and will help to shape successful delivery and implementation. Consumer protection and regulation will also be important.

Whilst the Food4Me project demonstrated dietary benefits, society will also have to consider that not everyone may care equally about their health and hence the assumed societal responsibility in maintaining individual health may not be subscribed to by everyone. If implemented at scale and over time, personalised nutrition has the potential to support positive changes in diet and lifestyle and to contribute to a reduction in the societal burden associated with diet-related health problems.