Patricia Lucas-Schnarre05.01.08
A vigorous hike activates hundreds of genes. Similarly, an energy bar consumed at the top of the trail will also affect the way genes are expressed. Whether you are flexing a muscle or nourishing your body, biochemical reactions occur at the cellular level, and these reactions are controlled and influenced by one's genes.
The science of nutrigenomics seeks to understand how the food we consume exerts an impact upon on the functioning of our genes. There is a growing understanding that gene function plays a major role in our dynamic health states, and that DNA (which is what makes up genes) plays a role beyond determining our eye color, other easily observable traits, or even our risk of disease. This knowledge has begun to unlock a commercial opportunity for innovative nutritional products that influence gene expression.
Most consumers understand the relationship between food and health, and they often make choices based on that understanding. Last year the International Food Information Council (IFIC), Washington, D.C., conducted research, which looked into consumer attitudes toward functional foods. IFIC's data indicated that consumers not only believe that food plays a meaningful role in maintaining and improving health, but their awareness of specific links between food and health has notably increased over the past five years.
Nutrigenomics is quite compatible with this consumer trend. Since nutrigenomics uncovers how bioactive components of food work, and elucidates the cause-and-effect relationship between food and health, it can be used as a discovery tool to identify innovative nutritional products that can be marketed to provide a variety of health benefits. Fortunately, this relatively new technology also falls in line with another consumer expectation from the foods and beverages that they favor and trust-that the health benefits that their foods claim to provide must be based on sound science.
Establishing the connection between food and health status through the use of nutrigenomics was recently validated by WellGen, North Brunswick, NJ, a biotechnology company that uses nutrigenomics to discover and develop food ingredients for use in wellness products. Measuring the impact of its proprietary black tea extract on genes associated with inflammation, WellGen completed a lengthy R&D process that began with a sequence of laboratory tests to assess the beneficial effects of WellGen's ingredient. The process culminated with human tests that confirmed similar gene expression as that which was found in the initial laboratory tests.
The element that tied this system together was the use of biomarkers in the human studies. Biomarkers are objective, reliable endpoints such as blood pressure, cholesterol levels, or gene expression measures that can serve to shorten the research and development path. In its "Critical Path Opportunities List," FDA has already emphasized the importance of biomarkers in the drug discovery process. Human studies designed to support structure/function claims of food substances can employ biomarkers for robust study results that are relatively fast and economical, compared to studies that simply measure subjective endpoints.
As the scrutiny of the functional claims made by foods and dietary supplements has increased, and has driven the demand for more rigorous scientific support, the adaptation of a scientifically rigorous discovery approach in order to unequivocally demonstrate the benefits in processed foods is a solid strategy for maintaining trust and avoiding penalties. Moreover, subjective elements of studies, such as diminished pain or increased energy, can complement biomarker data and provide additional data to support consumer insights.
While 99.9% of human genes are the same, genetic variations occur that can impact things like an individual's pre-disposition to certain dietary components. It is known that one's genetic variations can dictate an individual's response to certain medicines, as well as to foods or dietary supplements. Nutrigenetics, or the science of personalized nutrition, studies how variations in genes among individuals can affect the reactions of an individual to specific dietary ingredients.
While nutrigenomics refers to how food chemicals can affect gene expression, nutrigenetics focuses on SNPs (pronounced "snips")-single nucleotide polymorphisms-which are the genetic differences that dictate an individual's response to food as it relates to his or her own particular states of health and disease. In the not-too-distant future, it will be reasonable for an individual to have a DNA analysis to determine the roadmap for avoiding disease and optimizing personal health.
Today, scientists are working with powerful databases to identify variations among genes in individuals and are working to establish correlations for susceptibility to various health conditions, as well as to understand the influence of such genetic variations on responses to dietary components. It is important to note that the science of understanding the relationships among small differences in DNA sequences and specific health states is in its infancy. What is very clear at this point is that only in very rare instances is a single SNP associated with a specific health state. Rather, there is increasing evidence that a given aberrant health state is almost always associated with multiple SNPs that interact in ways that are not yet understood.
The current commercial opportunity for nutrigenetics in the marketplace has taken the form of nutrigenetic testing kits that focus on a limited number of specific health states and specific genes. Unfortunately, a number of companies have launched nutrigenetic testing kit products that have raised skepticism and been harshly criticized. Most genetic tests on the market today are marketed as medical devices and are not regulated by the FDA. Without standards and oversight, it is difficult to assess their reliability. Following a request for an investigation, the Government Accountability Office (GAO) in a 2006 report warned the consumer to beware, and stated that these kits "mislead consumers by making predictions that are medically unproven and so ambiguous that they do not provide meaningful information."
Leaders in the field of nutrigenetics will need to do more rigorous work in order to create a sustainable business. Marketers of nutrigenetic home testing kits must demonstrate, through well-controlled clinical studies, the efficacy of applying nutrigenetics data to predictions of resultant health problems or benefits. At the same time, there must be assurances that these home test kits either measure up to industry standards or FDA regulation. Before the food industry can actively engage in this area, risks related to consumer dissatisfaction must be reduced.
In the case of DNA testing, a unique set of additional issues arises, particularly when it comes to privacy and ethics. Although many consumers are interested in knowing about their own genetic make-up, just as many, if not more, may not wish to have the testing done. According to a study carried out by the Natural Marketing Institute (NMI), Harleysville, PA, when asked if they would be interested in having their DNA tested and mapped in order to learn how to live healthier lives, almost 39% of adults answered affirmatively. However, over 41% were not interested.So, while the science around nutrigenetics may continue to advance, issues around privacy and ethics must also be addressed.
The recent commercial entries in the field of nutrigenetics employ a test-and-treat approach. These products require the consumer to submit a DNA sample for testing, usually in the form of a cheek swab, and in some instances also require the submission of a lifestyle and diet questionnaire. The DNA sample is mailed to a laboratory and the results are returned to the consumer with advice about how dietary intake can be modified to fit the genetic profile analysis.
Some of the criticism surrounding these genetic tests involves both the lack of regulation of the testing laboratories and the specific advice that they offer, especially in relation to lifestyle changes and dietary supplementation. The analyses are usually focused on a specific health concern, such as cardiovascular health or weight management. These recommendations sometimes lack the expected level of customization, which can be disappointing for a consumer who has paid a price that can range from $99 to $299 for the analysis. The limitations surrounding the scientific understanding of the correlations between health and genetic variations, and the limits on what an individual consumer will spend on nutrigenetic testing, may limit the near-term market opportunity.
Since the value of this business model is enhanced by a follow-on regimen that requires product purchases into the future, many of the genetic test kits are complemented by dietary supplement products that are included in the recommendations of the test report. Some experts are of the opinion that doctors should control the information and recommendations related to genetic screening; others argue that doctors have not been sufficiently trained in genetics and nutrition. Most recently, one industry participant has placed the authority figure in health food outlets. This approach may solve the issue of the consumer receiving test results outside of a selling environment, while reinforcing the notion of personalized attention provided by an authority figure linked to nutrition. In this instance, it will be the first time that retailers will be trained by a dietary supplement manufacturer about personalized nutrition, while having an incentive to talk to consumers about this topic. Solgar, Sciona-through their brand Mycellf-and Nutrilite are all active marketers in the area of nutrigenetics.
Thus far, nutrigenetics-based dietary products marketed as personalized nutrition products have been designed to complement genetic test kits and to provide individuals with dietary solutions that combat specific health issues growing out of genetic variation. In contrast to nutrigenetics, nutrigenomics products will rely on the science of genomics to support efficacy. Proprietary nutrigenomic bioactives will be developed from natural sources that can influence the expression of common human genes that are accepted by the scientific community as validated biomarkers for various health states. Nutrigenomics products will affect gene expression and, thus, will act at the most important step in the process of genes affecting health. The benefits from maintaining a healthy balance of gene expression can subsequently be measured in human studies.
In November 2007, WellGen, through Charles Bowman & Company, Holland, MI, launched the first nutrigenomics ingredient available to dietary supplement marketers. This proprietary bioactive extract helps to maintain normal gene expression to maintain a healthy inflammation response. From an understanding that begins with gene expression, the ingredient can also support claims for joint health, immune system function, sports performance and oxidative stress.
Nutrigenomics offers food and dietary supplement companies assurances that functional claims are based on sound science that generate quantifiable results. Some R&D departments in leading food companies, such as Nestle and Danone, are already employing nutrigenomics either directly or through partnerships to contribute to their positions in the wellness market. The value proposition of nutrigenomics will become clearer and more widely accepted as scientific support builds and there is a shift away from generic health claims and a diminished need for large, long-term studies to support health benefits.
To consumers, the terms nutrigenomics and nutrigenetics are scarcely distinguishable and are not understood. In a 2006 quantitative study (n=477) conducted by HealthFocus International, St. Petersburg, FL, on behalf of WellGen, data indicated that the awareness of "nutrigenomics" was quite low (9%) and similar in magnitude but exceeded in number by "nutrigenetics," which reported 14% awareness. For companies promoting nutrigenomics, there is an opportunity to shape public perception-rather than feeling the need to counter consumer doubt, as might be the case with nutrigenetics and the negative publicity that test kits have generated.
To further understand how best to communicate "nutrigenomics" to consumers, WellGen commissioned a study by the Hartman Group, Bellevue, WA, to define the term nutrigenomics through the words of core wellness consumers. Many positive associations were linked by these consumers with nutrigenomics, including: "a nutrition-based science that delivered therapeutic nutrition." One can foresee a future where the various terms associated with nutrigenomics and nutrigenetics naturally merge into a new consumer-friendly expression.
Several factors support the ongoing opportunity in nutrigenomics and personalized nutrition. The aging consumer demographic concerned with issues related to aging, coupled with shifting consumer attitudes, together heighten the importance of wellness and the recognition that food can be a source of improved health. Public health issues, such as those related to obesity and Type 2 diabetes are influencing industry decisions to focus upon wellness as an important vehicle for both growth and positive public attention. The science has advanced to a point of being commercially ready.
Nutrigenomics will become better understood and will be a highly valued technology for discovery and claims substantiation. The next two to three years will be a major growth period for ingredients developed using this very powerful technology.
Over the next 20 years, knowledge will build around genetic variations and individual responses to dietary components. During that time, it is possible that the approach used for nutrigenomic products could be safely used for validating some of the variations among individuals. While it is highly unlikely that we will find any gene variant that favors fried oreos over fish oil, the trend for individualism will become the standard through personalized health solutions based on studies of gene expression and genetic variation. In the here and now, however, the power of nutrigenomics is being applied to create the next generation of health and wellness foods.
About the author:
The science of nutrigenomics seeks to understand how the food we consume exerts an impact upon on the functioning of our genes. There is a growing understanding that gene function plays a major role in our dynamic health states, and that DNA (which is what makes up genes) plays a role beyond determining our eye color, other easily observable traits, or even our risk of disease. This knowledge has begun to unlock a commercial opportunity for innovative nutritional products that influence gene expression.
Studying the Link between Food & Health
Most consumers understand the relationship between food and health, and they often make choices based on that understanding. Last year the International Food Information Council (IFIC), Washington, D.C., conducted research, which looked into consumer attitudes toward functional foods. IFIC's data indicated that consumers not only believe that food plays a meaningful role in maintaining and improving health, but their awareness of specific links between food and health has notably increased over the past five years.
Nutrigenomics is quite compatible with this consumer trend. Since nutrigenomics uncovers how bioactive components of food work, and elucidates the cause-and-effect relationship between food and health, it can be used as a discovery tool to identify innovative nutritional products that can be marketed to provide a variety of health benefits. Fortunately, this relatively new technology also falls in line with another consumer expectation from the foods and beverages that they favor and trust-that the health benefits that their foods claim to provide must be based on sound science.
Establishing the connection between food and health status through the use of nutrigenomics was recently validated by WellGen, North Brunswick, NJ, a biotechnology company that uses nutrigenomics to discover and develop food ingredients for use in wellness products. Measuring the impact of its proprietary black tea extract on genes associated with inflammation, WellGen completed a lengthy R&D process that began with a sequence of laboratory tests to assess the beneficial effects of WellGen's ingredient. The process culminated with human tests that confirmed similar gene expression as that which was found in the initial laboratory tests.
The element that tied this system together was the use of biomarkers in the human studies. Biomarkers are objective, reliable endpoints such as blood pressure, cholesterol levels, or gene expression measures that can serve to shorten the research and development path. In its "Critical Path Opportunities List," FDA has already emphasized the importance of biomarkers in the drug discovery process. Human studies designed to support structure/function claims of food substances can employ biomarkers for robust study results that are relatively fast and economical, compared to studies that simply measure subjective endpoints.
As the scrutiny of the functional claims made by foods and dietary supplements has increased, and has driven the demand for more rigorous scientific support, the adaptation of a scientifically rigorous discovery approach in order to unequivocally demonstrate the benefits in processed foods is a solid strategy for maintaining trust and avoiding penalties. Moreover, subjective elements of studies, such as diminished pain or increased energy, can complement biomarker data and provide additional data to support consumer insights.
Nutrigenetics & Nutrigenomics
While 99.9% of human genes are the same, genetic variations occur that can impact things like an individual's pre-disposition to certain dietary components. It is known that one's genetic variations can dictate an individual's response to certain medicines, as well as to foods or dietary supplements. Nutrigenetics, or the science of personalized nutrition, studies how variations in genes among individuals can affect the reactions of an individual to specific dietary ingredients.
While nutrigenomics refers to how food chemicals can affect gene expression, nutrigenetics focuses on SNPs (pronounced "snips")-single nucleotide polymorphisms-which are the genetic differences that dictate an individual's response to food as it relates to his or her own particular states of health and disease. In the not-too-distant future, it will be reasonable for an individual to have a DNA analysis to determine the roadmap for avoiding disease and optimizing personal health.
Today, scientists are working with powerful databases to identify variations among genes in individuals and are working to establish correlations for susceptibility to various health conditions, as well as to understand the influence of such genetic variations on responses to dietary components. It is important to note that the science of understanding the relationships among small differences in DNA sequences and specific health states is in its infancy. What is very clear at this point is that only in very rare instances is a single SNP associated with a specific health state. Rather, there is increasing evidence that a given aberrant health state is almost always associated with multiple SNPs that interact in ways that are not yet understood.
The current commercial opportunity for nutrigenetics in the marketplace has taken the form of nutrigenetic testing kits that focus on a limited number of specific health states and specific genes. Unfortunately, a number of companies have launched nutrigenetic testing kit products that have raised skepticism and been harshly criticized. Most genetic tests on the market today are marketed as medical devices and are not regulated by the FDA. Without standards and oversight, it is difficult to assess their reliability. Following a request for an investigation, the Government Accountability Office (GAO) in a 2006 report warned the consumer to beware, and stated that these kits "mislead consumers by making predictions that are medically unproven and so ambiguous that they do not provide meaningful information."
Leaders in the field of nutrigenetics will need to do more rigorous work in order to create a sustainable business. Marketers of nutrigenetic home testing kits must demonstrate, through well-controlled clinical studies, the efficacy of applying nutrigenetics data to predictions of resultant health problems or benefits. At the same time, there must be assurances that these home test kits either measure up to industry standards or FDA regulation. Before the food industry can actively engage in this area, risks related to consumer dissatisfaction must be reduced.
In the case of DNA testing, a unique set of additional issues arises, particularly when it comes to privacy and ethics. Although many consumers are interested in knowing about their own genetic make-up, just as many, if not more, may not wish to have the testing done. According to a study carried out by the Natural Marketing Institute (NMI), Harleysville, PA, when asked if they would be interested in having their DNA tested and mapped in order to learn how to live healthier lives, almost 39% of adults answered affirmatively. However, over 41% were not interested.So, while the science around nutrigenetics may continue to advance, issues around privacy and ethics must also be addressed.
The Nutrigenetics Business Model
The recent commercial entries in the field of nutrigenetics employ a test-and-treat approach. These products require the consumer to submit a DNA sample for testing, usually in the form of a cheek swab, and in some instances also require the submission of a lifestyle and diet questionnaire. The DNA sample is mailed to a laboratory and the results are returned to the consumer with advice about how dietary intake can be modified to fit the genetic profile analysis.
Some of the criticism surrounding these genetic tests involves both the lack of regulation of the testing laboratories and the specific advice that they offer, especially in relation to lifestyle changes and dietary supplementation. The analyses are usually focused on a specific health concern, such as cardiovascular health or weight management. These recommendations sometimes lack the expected level of customization, which can be disappointing for a consumer who has paid a price that can range from $99 to $299 for the analysis. The limitations surrounding the scientific understanding of the correlations between health and genetic variations, and the limits on what an individual consumer will spend on nutrigenetic testing, may limit the near-term market opportunity.
Since the value of this business model is enhanced by a follow-on regimen that requires product purchases into the future, many of the genetic test kits are complemented by dietary supplement products that are included in the recommendations of the test report. Some experts are of the opinion that doctors should control the information and recommendations related to genetic screening; others argue that doctors have not been sufficiently trained in genetics and nutrition. Most recently, one industry participant has placed the authority figure in health food outlets. This approach may solve the issue of the consumer receiving test results outside of a selling environment, while reinforcing the notion of personalized attention provided by an authority figure linked to nutrition. In this instance, it will be the first time that retailers will be trained by a dietary supplement manufacturer about personalized nutrition, while having an incentive to talk to consumers about this topic. Solgar, Sciona-through their brand Mycellf-and Nutrilite are all active marketers in the area of nutrigenetics.
The Nutrigenomics Business Model
Thus far, nutrigenetics-based dietary products marketed as personalized nutrition products have been designed to complement genetic test kits and to provide individuals with dietary solutions that combat specific health issues growing out of genetic variation. In contrast to nutrigenetics, nutrigenomics products will rely on the science of genomics to support efficacy. Proprietary nutrigenomic bioactives will be developed from natural sources that can influence the expression of common human genes that are accepted by the scientific community as validated biomarkers for various health states. Nutrigenomics products will affect gene expression and, thus, will act at the most important step in the process of genes affecting health. The benefits from maintaining a healthy balance of gene expression can subsequently be measured in human studies.
In November 2007, WellGen, through Charles Bowman & Company, Holland, MI, launched the first nutrigenomics ingredient available to dietary supplement marketers. This proprietary bioactive extract helps to maintain normal gene expression to maintain a healthy inflammation response. From an understanding that begins with gene expression, the ingredient can also support claims for joint health, immune system function, sports performance and oxidative stress.
Nutrigenomics offers food and dietary supplement companies assurances that functional claims are based on sound science that generate quantifiable results. Some R&D departments in leading food companies, such as Nestle and Danone, are already employing nutrigenomics either directly or through partnerships to contribute to their positions in the wellness market. The value proposition of nutrigenomics will become clearer and more widely accepted as scientific support builds and there is a shift away from generic health claims and a diminished need for large, long-term studies to support health benefits.
The Future of Personalized Nutrition
To consumers, the terms nutrigenomics and nutrigenetics are scarcely distinguishable and are not understood. In a 2006 quantitative study (n=477) conducted by HealthFocus International, St. Petersburg, FL, on behalf of WellGen, data indicated that the awareness of "nutrigenomics" was quite low (9%) and similar in magnitude but exceeded in number by "nutrigenetics," which reported 14% awareness. For companies promoting nutrigenomics, there is an opportunity to shape public perception-rather than feeling the need to counter consumer doubt, as might be the case with nutrigenetics and the negative publicity that test kits have generated.
To further understand how best to communicate "nutrigenomics" to consumers, WellGen commissioned a study by the Hartman Group, Bellevue, WA, to define the term nutrigenomics through the words of core wellness consumers. Many positive associations were linked by these consumers with nutrigenomics, including: "a nutrition-based science that delivered therapeutic nutrition." One can foresee a future where the various terms associated with nutrigenomics and nutrigenetics naturally merge into a new consumer-friendly expression.
Several factors support the ongoing opportunity in nutrigenomics and personalized nutrition. The aging consumer demographic concerned with issues related to aging, coupled with shifting consumer attitudes, together heighten the importance of wellness and the recognition that food can be a source of improved health. Public health issues, such as those related to obesity and Type 2 diabetes are influencing industry decisions to focus upon wellness as an important vehicle for both growth and positive public attention. The science has advanced to a point of being commercially ready.
Nutrigenomics will become better understood and will be a highly valued technology for discovery and claims substantiation. The next two to three years will be a major growth period for ingredients developed using this very powerful technology.
Over the next 20 years, knowledge will build around genetic variations and individual responses to dietary components. During that time, it is possible that the approach used for nutrigenomic products could be safely used for validating some of the variations among individuals. While it is highly unlikely that we will find any gene variant that favors fried oreos over fish oil, the trend for individualism will become the standard through personalized health solutions based on studies of gene expression and genetic variation. In the here and now, however, the power of nutrigenomics is being applied to create the next generation of health and wellness foods.
