The Future of Nutrigenomics

The Center for Emerging Issues in Science (CEIS) is a think tank, established by the Life Sciences Research Office Inc. (LSRO; Bethesda, MD) to determine which emerging scientific and technical advances will shift the business landscape and to consider the implications and challenges this new area of science will create for specific industries.

Nutrigenomics, the science of how chemicals in food affect health by altering the expression and/or structure of an individual’s genetic makeup, was chosen to be the premier emerging issue to be addressed by CEIS.

LSRO assembled leading experts in science, technology, and business to consider the implications of nutrigenomics. The CEIS expert panel concluded that nutrigenomics will change the way that food, dietary supplement, and functional food companies do business because it will change the ways that individuals, scientists, and healthcare providers understand the effects of changes in diet on the individual. These changes will be realized in the context of personalized diets and personalized food and supplement products. The panel concluded that implementation of this technology will require new modes of interaction between agriculture, ingredient suppliers, food manufacturers, diagnostics makers, healthcare providers, and health insurance providers. The panel developed a framework to describe the interactions of various segments of industry in relation to nutrigenomic advances.

INTRODUCTION

Arguably, technological innovation is the trigger that initiates most scientific and business revolutions. New technologies open up new possibilities for scientific exploration, and scientists apply these technologies to build a new vision of the natural universe. Each of these visions is a paradigm, and as these paradigms are codified and become part of the common understanding of the general (nonscientific) community, they are the landscape upon which commercial entities grow and succeed. Thus, business and science innovations are intimately linked and both are propelled by advances in technology.

Technological and scientific advances are made daily, but only a few will trigger a scientific or business revolution. Examples of technologies that triggered revolutionary change include antibiotics, the Internet, wireless communication, polymerase chain reaction, microchip arrays, freeze-drying technology for foods, Roundup Ready soybeans, etc. Examples of technologies that had little or no impact include cold fusion, vitamin O, and megadoses of vitamin C. Predicting which are likely to trigger a shift in the landscape requires a firm grasp of the technologies, the current state of science, and of the affected industries.

It is difficult to accurately predict which of the many technologies will affect the landscape, and, by itself, predicting change is not enough. Companies will need more information to react to the availability of a new technology. Understanding how a technology will play out, how it will impact their lives or industry, and how to integrate it into their business plans can critically affect how well company management adapts to the changes. Management that anticipates how the new landscape will affect their ability to reach and deliver value to consumers will be able to position their companies to quickly adapt to it. Companies that anticipate change survive and thrive; those that only react to change fall behind and lose their competitive advantage.

NUTRIGENOMICS

LSRO founded CEIS to act as a think tank to identify landscape-shifting emerging issues in science and technology and analyze the potential effects on science and industry. The first charge assigned to CEIS was to address the consequences of the genomics/informatics revolution, in particular to assess the emerging area of nutrigenomics. The excitement about nutrigenomics comes from a growing awareness of the potential for modifications of food or diet to support health and reduce the risk of diet-related diseases. Thus, by identifying individual genetic predispositions for chronic diseases and the potential for individual response to dietary intervention, these diseases may be effectively prevented by proper dietary intake.

Nutrigenomics brings together the sciences of bioinformatics, nutrition, molecular biology, genomics, epidemiology, and molecular medicine. We are using the term nutrigenomics to encompass the fields of genomics, epigenomics, posttranslational modifications, proteomics, and metabolomics. CEIS convened a group of experts in science, technology, and business to explore nutrigenomics and to brainstorm the challenges this new area of science will create, especially in the area of personalized nutrition, diets, and supplements. The conclusions and recommendations of this expert panel are summarized herein.

The great success of the 20th century was identifying the essential nutrients and their deficiencies. This allowed for differential diagnosis of deficiency and universal recommendations. Nutritional advice and public health recommendations are made on a population-wide basis, based on statistical norms. The advantages of this process are in the simplicity of the recommendations, and the success can be measured in decreased deficiency-disease incidence and increased life span. However, viewing the benefits of diet as solely preventing nutrient deficiency is much too limiting; diet plays a wider role in either promoting health or preventing disease.

It is apparent that one size does not fit all. Thus, as we have become aware of the limitations of populationwide advice such as the food guide pyramid, second-generation approaches have proliferated with pyramids tailored for children, the elderly, ethnic groups, vegetarians, etc. Although these attempts are steps in the right direction, they do not take full advantage of the breakthroughs in biomedical science.Fortuitously, this realization has come at a time of great expansion of knowledge, the genomics/informatics revolution. The achievement of sequencing the genome has spurred efforts to characterize the proteome (the proteins expressed by the genome), the metabolome (the metabolic entities present in a cell, tissue, organ, organism, and species that are produced during different states of health and disease), the epigenome (DNA modifications that alter genome function but do not change DNA sequence), and other posttranslational modifications that influence gene expression. The great challenge of the 21st century will be to integrate this scientific understanding and provide diet, life-style, and drug recommendations to the individual to maintain health and prevent diseases rather than simply develop diagnostics and drugs to identify and attempt to cure them once they have emerged.

What will all this information mean to science, industry, and the individual? The sum total of this knowledge will be a better understanding of the influence of inheritance and environment on individual health and performance. We will better understand what role diet and environment play on gene expression and what limitations gene expression imposes on an individual’s responses. This opens the opportunity to have personalized medicine and personalized nutrition (see Figure 1).

We have begun to assemble the capabilities to profile (genomic, epigenomic, proteomic, metabolomic) each individual. Using these profiles, we can understand which drug will be effective, what levels might be toxic, whether a person should be eating a low-carbohydrate diet, whether the standard nutritional advice will be effective or countereffective, or whether a person has special nutrient requirements.

This information can allow healthcare professionals to provide personalized advice and avoid the inherent inadequacies of population-based recommendations. This goes far beyond the level of the new personalized food guide pyramid, which is inherently still population-based advice, and will bring health-promoting guidance down to the level of the individual. We have already begun to see Internet-based companies providing individual genomic profiles and advice optimized for that profile. The current version of these services may be more fluff than substance, but if it is properly developed by reliable and competent companies and based on sound scientific data, it holds great potential to reshape the industry.

The expert panel embraced this view of a personalized, health-promoting future, then identified and prioritized many areas of nutrition that are ripe for this type of approach, developed a multipartner model that will allow industry to take advantage of this approach, and identified the challenges to bring it to fruition. After an extensive review of the evidence for individual responsiveness to dietary intervention, the expert panel was convinced that we are on the cusp of a business revolution. Some of the expert panel conclusions and recommendations include the following:

(1) There is already evidence for consumer demand for personalized information, as long as consumers feel they have control of the information. The “worried, wealthy well” are likely to be the early adopters of personalized dietary advice and personalized products; other consumer segments will follow. The future industrial leaders will be those companies that are capable of simultaneously making those personalized foods preferred. This type of product will support higher margins than conventional functional foods.

(2) There is good evidence that nutritional intervention at the earliest possible points in the life cycle, e.g., during prepregnancy, pregnancy, early infancy, etc., will have profound effects on long-term health. Epigenetic and other posttranslational mechanisms are the wave of the future; however, the implications of lifelong effects of dietary choices, particularly early in life, could drive rapid adoption of certain segments of the consumer population to dietary choices that are a reflection of that heightened nutritional susceptibility of early childhood.

(3) Companies will not have to manufacture hundreds of different products tailored to each type of individual.The panel described a business model for personalized dietary products as an analogy to a shoe store. Rather than custom fitting shoes to each individual customer, as is possible with the luxury sector, the mass market is designed to produce and sell a limited number of stock products nonetheless tailored to various customer needs and preferences. Ultimately the number of products may increase and diversify as medical science discovers further nutrigenomic capacities and as production advances combine to provide a wider range of products that are thus the best fit for the customer’s needs.

(4) Personalized diet will require a strong diagnostics component. The diagnostic technology sector is already available but needs refinement to accurately identify the health status of the healthy and thus be more consumer friendly. As well as being critical to determining each individual’s needs, diagnostics will be important in providing the customer feedback about efficacy. Positive reinforcement and a sense of accomplishment has been a critical fault of many health promotion/disease prevention programs. Compliance and consumer interest wanes over time without it.

(5) This new personalized dietary advice will likely be mediated through some sort of healthcare provider (HCP) or other trusted source. The HCP will help interpret the diagnostic results, suggest personalized dietary advice, and provide monitoring feedback. It is unlikely that this HCP will be a physician, but perhaps pharmacists, nurses, dieticians, or trained paraprofessionals will fill the need. One model is Pharmica (Schriesheim, Germany), a company that has begun selling healthy foods and supplements and training pharmacists to become advisers. Health maintenance organizations (HMOs) could also be involved as HCPs and could even sell the products as one of their services. HMOs could wrap this into their existent health promotion efforts and attract the worried, wealthy-well segment as clientele.

(6) Personalized diet will only work if it is based on sound science. The dietary supplement and health food industry has heightened consumer wariness about reliability of claims and product performance. A new business paradigm based on validated personal assessment such as envisioned herein will not be based on promise, but rather on actual personal demonstrations of efficacy; hence, it will not be susceptible to bad press and consumer backlash.

(7) Personalized diet will depend on a strong bioinformatics component. Most of these technologies are already available but will require serious commitment to development and refinement to be fully operational. Analyzing the entire genome or metabolome of an individual currently will overwhelm the available informatics capabilities. Moreover, the manifold single nucleotide polymorphisms (SNPs), metabolic markers, etc., have yet to be completely identified and correlated with individual health status and disease susceptibility. However, subsets of the data are available and could be made into actionable recommendations now. We are close to implementing valuable personalized health promotion advice. Refinements and future development will be including more markers, integrating more information, and identifying more potentially susceptible health outcomes.

(8) Not all products will be immediately amenable to this personalized diet approach. Consumer acceptance in the short term will presumably depend on the proper choice of product that has consumer ‘permission’ to be individualized (orange juice, probiotics drinks, etc.).

(9) Not all health and physiologic targets have enough data at present to benefit from the new healthcare paradigm/approach. The expert panel reviewed and prioritized health outcomes and bioactive substances. Health and physiologic end points that are best positioned to take off include cardiovascular disease, cancer (prostate, colon, and breast), type 2 diabetes, taste acuity, and inflammation. Next in line are lactose intolerance, obesity, taste reception, immune diseases, and allergies. Also meriting consideration for health promotion through nutrigenomics are dementia, Alzheimer’s disease and other memory and cognition disorders, macular degeneration and cataracts, osteoarthritis, muscle atrophy, and gut function.

(10) No one company or industry will be able to get its nutrigenomic products off the ground alone. Marketplace success will require cooperation and communication among various industrial segments, though it is not certain how different segments will contribute. The expert panel developed a couple of models for implementation. These include participation of food producers, food manufacturers, dietary supplement manufacturers, healthcare providers, diagnostic companies, HMOs or health insurance companies, and venture capital or other investors. Similarly, scientific advances of the required knowledge will need the integration of different scientific expertise and the creation of scientific consortia to develop these emerging concepts into a mature field.

THE NEXT STEPS

The CEIS will reconvene the expert panel to expand on this analysis and consider detailed implications and challenges for one or more of the most promising health outcomes as identified in the first meeting. The panel will be expanded to ensure coverage of the various aspects of science, business, regulation, and investment.

Select sponsors will be invited to become subscribers to this service. Subscribers will be invited to attend the meeting and to receive the final report. Attendance to this meeting will be limited and initially only subscribers will have access to the outcome of the meeting. Ultimately, a summary of the CEIS report may be published by LSRO.

LSRO (Bethesda, MD) is a nonprofit company that provides objective, independent scientific analysis and advice to decision makers in industry and government. For more information, visit www.lsro.org or call 301/634-7030.