Defining functional foods 19 To further develop these markers, a state-of-the-art literature review will be necessary to identify, define and characterise potential markers. Furthermore, the basic scientific knowledge underpinning these markers will be evaluated The next step will include assessment of their relevance to phys function, to well-being and health and eventually to disease risk. A validation will then be necessary both for the methodology and biological relevance Finally, classification as indicator or factor will be made and potential dietary modulations demonstrated. New techniques such as those used by molecular and cellular biologists will be useful in identifying target groups who could benefit from the consumption of specific functional food 1. 4 Communicating functional claims 1. 4.1 A communication challenge As stated in the European consensus on scientific concepts of functional foods: 9 and as the market for functional foods grows, the question of how to e As the relationship between nutrition and gains public acceptanc communicate the specific advantages of such foods becomes increas- ingly important. Communication of health benefits to the public through intermediates such as health professionals, educators, the media and the food industry, is an essential element in improving public health and in the development of functional foods. Its importance also lies in avoiding problems associated with consumer confusion about health messages Of all the different forms of communication those concerning claims- made either directly as a statement on the label or package of food products, or indirectly through secondary supporting information remain an area of extensive discussion It is also the opinion of C B. Hudson that the links between nutrition science and food product development will flow through to consumers only if the required communication vehicles are put in place.However, the commi nication of health benefits and other physiological effects of functional foods remains a major challenge because science should remain the driving force; messages- claims- must be based on sound, objective and appropriate nce a d evidence must be consistent able to meet established scientific standards and Moreover, communication in nutrition generally comes from multiple sources that are sometimes contradictory, creating an impression of chaos. And chaotic information often generates ignorance and easily becomes misinformation(see Fg.1.3)
To further develop these markers, a state-of-the-art literature review will be necessary to identify, define and characterise potential markers. Furthermore, the basic scientific knowledge underpinning these markers will be evaluated. The next step will include assessment of their relevance to physiological function, to well-being and health and eventually to disease risk. A validation will then be necessary both for the methodology and biological relevance. Finally, classification as indicator or factor will be made and potential dietary modulations demonstrated. New techniques such as those used by molecular and cellular biologists will be useful in identifying target groups who could benefit from the consumption of specific functional foods. 1.4 Communicating functional claims 1.4.1 A communication challenge As stated in the European consensus on scientific concepts of functional foods:9 As the relationship between nutrition and health gains public acceptance and as the market for functional foods grows, the question of how to communicate the specific advantages of such foods becomes increasingly important. Communication of health benefits to the public, through intermediates such as health professionals, educators, the media and the food industry, is an essential element in improving public health and in the development of functional foods. Its importance also lies in avoiding problems associated with consumer confusion about health messages. Of all the different forms of communication, those concerning claims – made either directly as a statement on the label or package of food products, or indirectly through secondary supporting information – remain an area of extensive discussion. It is also the opinion of C.B. Hudson that ‘the links between nutrition science and food product development will flow through to consumers only if the required communication vehicles are put in place’. 28 However, the communication of health benefits and other physiological effects of functional foods remains a major challenge because: • science should remain the driving force; • messages – claims – must be based on sound, objective and appropriate evidence; and • evidence must be consistent, able to meet established scientific standards and plausible. Moreover, communication in nutrition generally comes from multiple sources that are sometimes contradictory, creating an impression of chaos. And chaotic information often generates ignorance and easily becomes misinformation (see Fig. 1.3). Defining functional foods 19
20 Functional foods Ind Public Scientists authorities information? Media organisatons Others Fig. 1.3 The communication challenge for functional food development 1.4.2 The scientific challenge Regarding functional foods, claims associated with specific food products are the preferable means of communicating to consumers. In application of the fundamental principle, any claim must be true and not misleading, it must be scientifically valid, unambiguous and clear to the consumer. However, these basic principles should be safeguarded without becoming a disincentive to the production of functional foods or to their acceptance by consumers. Even though a general definition of is widely accepted in the field of nutrition as any representation, which states, suggests or implies that a food has certain characteristics relating to its origin, nutritional properties.. or any other quality,one of the difficulties in communicating the benefits of functional foods is that distinct types of claims exist, and that in particular the term health claims, which is traditionally used to communicate the benefits of foods, is defined differently in different parts of the world Seeking clarity, Codex Alimentarius" has recently classified and defined four different categories of claims, but excluding the term health claim 1. Relate to dietary guidelines 2. Relate to nutrient content 3. Are comparative(reduced, less, more. . 4. Describe nutrient function(contains. that contributes to the development These claims refer to known nutrients and their role in growth, development and normal functions as well as to the concept of adequate nutrition. They are based on established, widely accepted knowledge but they do not refer to a particular effect over and above that expected from consuming a balanced diet. These laims are thus not really helpful to communicate the specific benefits of functional foods. Indeed, the claims for functional foods should be based on the
1.4.2 The scientific challenge Regarding functional foods, claims associated with specific food products are the preferable means of communicating to consumers. In application of the fundamental principle, any claim must be true and not misleading; it must be scientifically valid, unambiguous and clear to the consumer. However, these basic principles should be safeguarded without becoming a disincentive to the production of functional foods or to their acceptance by consumers. Even though a general definition of ‘claim’ is widely accepted in the field of nutrition as ‘any representation, which states, suggests or implies that a food has certain characteristics relating to its origin, nutritional properties . . . or any other quality’, 29 one of the difficulties in communicating the benefits of functional foods is that distinct types of claims exist, and that in particular the term ‘health claims’, which is traditionally used to communicate the benefits of foods, is defined differently in different parts of the world. Seeking clarity, Codex Alimentarius29 has recently classified and defined four different categories of claims, but excluding the term ‘health claim’: 1. Relate to dietary guidelines. 2. Relate to nutrient content. 3. Are comparative (reduced, less, more . . .). 4. Describe nutrient function (contains . . ., that contributes to the development of . . .). These claims refer to known nutrients and their role in growth, development and normal functions as well as to the concept of adequate nutrition. They are based on established, widely accepted knowledge but they do not refer to a particular effect over and above that expected from consuming a balanced diet. These claims are thus not really helpful to communicate the specific benefits of functional foods. Indeed, the claims for functional foods should be based on the # $ % & Fig. 1.3 The communication challenge for functional food development 20 Functional foods
Defining functional foods 21 scientific classification of markers(indicators and/or factors)for target functions and on the effects on these markers. If such an effect, which goes beyond what could be expected from the established role of diet in growth, development and other normal functions in the body, concerns a target function or a biological activity without direct reference to a particular disease or pathological process, claim will be made for an enhanced function. But, if the benefit is clearly a reduction of the risk of a disease or pathological process, claims will be made for disease risk reduction. These two types of claims, which are specific for functional foods, are the type A and type B claims respectively as they are described in the European consensus on scientific concepts of functional foods The type a claim is similar to the structure/function claim, whereas the type B claim can be regarded as equivalent to health claimin the USA respectively The type B claim also corresponds to health claimin Sweden. In its last proposed draft recommendations for the use of health claims, Codex Alimentarius has included type a and type B claims and defined them as: Type A or claims that concern specific beneficial effects of the consumption of foods and their constituents on physiological or psychological functions or biological activities but do not include nutrient function claims. Such claims relate to a positive contribution to health or a condition linked to health, to the improvement of a function or to modifying or preserving health Type B or risk of disease reduction claimsthat concern the reduction of a disease risk related to the consumption of a food or a food constituent in the context of the daily diet that might help reduce the risk of a specific disease or condition. One of the major issues still to be resolved, especially with these two types of claims, concerns the biological level at which evidence can be accepted satisfactorily demonstrating an enhanced function or reduction of disease ri This evidence should rely on all data available that can be grouped into three biological observations, pidemiological data, and For any given specific food product, supporting evidence for enhanced function or reduction of disease risk might not be available or even not three areas. All supporting evidence should, however, be consistent in itself able to meet accepted scientific standards of statistical as well as biological significance, especially dose-effect relationship, if relevant plausible in terms of the relationship between intervention and results especially in terms of mechanism(s)of action provided by a number of sources(including obligatory human studies) that give consistent findings able to generate scientific consensus
scientific classification of markers (indicators and/or factors) for target functions and on the effects on these markers. If such an effect, which goes beyond what could be expected from the established role of diet in growth, development and other normal functions in the body, concerns a target function or a biological activity without direct reference to a particular disease or pathological process, claim will be made for an enhanced function. But, if the benefit is clearly a reduction of the risk of a disease or pathological process, claims will be made for disease risk reduction. These two types of claims, which are specific for functional foods, are the type A and type B claims respectively as they are described in the European consensus on scientific concepts of functional foods.9 The type A claim is similar to the ‘structure/function claim’, whereas the type B claim can be regarded as equivalent to ‘health claim’ in the USA respectively. The type B claim also corresponds to ‘health claim’ in Sweden.30 In its last proposed draft recommendations for the use of health claims, Codex Alimentarius has included type A and type B claims and defined them as:31 • Type A or claims that concern specific beneficial effects of the consumption of foods and their constituents on physiological or psychological functions or biological activities but do not include nutrient function claims. Such claims relate to a positive contribution to health or a condition linked to health, to the improvement of a function or to modifying or preserving health. • Type B or ‘risk of disease reduction claims’ that concern the reduction of a disease risk related to the consumption of a food or a food constituent in the context of the daily diet that might help reduce the risk of a specific disease or condition. One of the major issues still to be resolved, especially with these two types of claims, concerns the biological level at which evidence can be accepted as ‘satisfactorily demonstrating’ an enhanced function or reduction of disease risk. This evidence should rely on all data available that can be grouped into three categories: • biological observations, • epidemiological data, and • intervention studies, mostly based on markers. For any given specific food product, supporting evidence for enhanced function or reduction of disease risk might not be available or even not necessary from all three areas.9 All supporting evidence should, however, be: • consistent in itself; • able to meet accepted scientific standards of statistical as well as biological significance, especially dose–effect relationship, if relevant; • plausible in terms of the relationship between intervention and results, especially in terms of mechanism(s) of action; • provided by a number of sources (including obligatory human studies) that give consistent findings able to generate scientific consensus. Defining functional foods 21
22 Functional foods 1.5 Case studies This section is aimed at illustrating the concepts of functional food by focusing on three major target functions for which relevance to the state of well-being and health as well as the reduction of risk of disease is established or very likely. It summarises the conclusions of expert groups that have recently reviewed the published literature to define the state of the art with respect to these specific functions, they have identified and reviewed nutritional options modulating these functions and have critically assessed the science base required for providing evidence that specific nutrients positively affect target functions 1.5.1 Gastrointestinal functions The gastrointestinal target functions which are associated with a balanced microflora together with an optimal gut associated lymphoid tissue(GALt)are relevant to the state of well-being and health and to the reduction of the risk of diseases. The colonic microflora is a complex ecosystem, the functions of which are a consequence of the combined action of the microbes that, besides interacting with the GALt, contribute to salvage of nutrient energy and produce end-metabolic products like short chain fatty acids(SCFAs) that play a role in cell differentiation, cell proliferation and metabolic regulatory processes. It is generally assumed that the group of potentially health-promoting bacteria includes principally bifidobacteria, and lactobacilli which are and possibly should remain the most important genera in humans. Changes in the composition of the faecal flora, a recognised surrogate marker of the residual clonic microbiota, can be considered as a marker, indicator and factor, of large bowel functions. They might play a role in gastrointestinal infections and diarrhoea, constipation, irritable bowel syndrome, inflammatory bowel diseases and colorectal cancer Probiotics(e.g. lactobacilli or bifidobacteria) and prebiotics (like chicory lulin and its hyde hydrolysate oligofructose) are recent concepts in nutrition that functional foods targeted towards gut function. Their effects include ment of have already and will in the future be used to support the develop stimulation of the activity of the galt (e.g. increased IgA response production of cytokines reduction in the duration of episodes of rotavirus infection; lange in the composition of the faecal flora to reach/maintain a composition in which bifidobacteria and/or lactobacilli become predominant in number, a situation that is preferred
1.5 Case studies This section is aimed at illustrating the concepts of functional food by focusing on three major target functions for which relevance to the state of well-being and health as well as the reduction of risk of disease is established or very likely. It summarises the conclusions of expert groups that have recently reviewed the published literature to define the state of the art with respect to these specific body functions; they have identified and reviewed nutritional options modulating these functions and have critically assessed the science base required for providing evidence that specific nutrients positively affect target functions.9, 24 1.5.1 Gastrointestinal functions9, 32 The gastrointestinal target functions which are associated with a balanced microflora together with an optimal gut associated lymphoid tissue (GALT) are relevant to the state of well-being and health and to the reduction of the risk of diseases. The colonic microflora is a complex ecosystem, the functions of which are a consequence of the combined action of the microbes that, besides interacting with the GALT, contribute to salvage of nutrient energy and produce end-metabolic products like short chain fatty acids (SCFAs) that play a role in cell differentiation, cell proliferation and metabolic regulatory processes. It is generally assumed that the group of potentially health-promoting bacteria includes principally bifidobacteria, and lactobacilli which are and possibly should remain the most important genera in humans. Changes in the composition of the faecal flora, a recognised surrogate marker of the residual colonic microbiota, can be considered as a marker, indicator and factor, of large bowel functions. They might play a role in gastrointestinal infections and diarrhoea, constipation, irritable bowel syndrome, inflammatory bowel diseases and colorectal cancer. Probiotics (e.g. lactobacilli or bifidobacteria) and prebiotics (like chicory inulin and its hydrolysate oligofructose) are recent concepts in nutrition that have already and will in the future be used to support the development of functional foods targeted towards gut function. Their effects include: • stimulation of the activity of the GALT (e.g. increased IgA response, production of cytokines); • reduction in the duration of episodes of rotavirus infection; • change in the composition of the faecal flora to reach/maintain a composition in which bifidobacteria and/or lactobacilli become predominant in number, a situation that is preferred; • increase in faecal mass (stool bulking) and stool frequency; • increase in calcium bioavailability via colonic absorption (e.g. inulin). 22 Functional foods
Defining functional foods 2 1.5.2 Defence against reactive oxidative species The generation of reactive oxidative species(ROS)is a general feature of any aerobic organism both during development and normal functions or pathological hanges. These ROS can damage essential macromolecules like DNA, lipids and proteins by initiating or promoting oxidative processes. Many of these (bio)chemical reactions are thought to be involved in miscellaneous pathological processes such as cataract, some cancers, cardiovascular diseases, rheumatoid arthritis and some neurodegenerative conditions. But it is becoming more and more evident that ROS also play an essential role in regulating gene expression and in participating in cell signalling. Maintaining a balance between production and destruction of RoS is thus a key element in well-being and health and it is ikely to play a role in reducing the risk of disease. Examples of target functions for functional food development in relation to the maintenance of such a balance preservation of the structure and functional activity of DNa that can be evaluated by measuring DNA integrity (COMET assay ), damaged DNA bases(e.g. 8 OH desoxyguanine)or specific gene expressions preservation of structural and functional integrity of circulating lipoproteins by measuring either lipid hydroperoxides or their derivatives (e.g malondialdehyde) or oxidised low-density-lipoproteins in plasma preservation of structural and functional integrity of protein The major functional foods to rebalance oxidative processes are vitamins(especially tocopherols, ascorbic acid and carotenoids); polyphenols such as flavonoids 1.5.3 Psychological and behavioural functions", 34 Some foods or food components provide an important function by changing mood or mental state. They are involved in creating more a sense of feeling well than "being well. Target functions for such foods and food components appetite, satiation and satiety, the most widely used markers of which are such lunger, desire to eat and fullness or quantitative assessment of energy and/or nutrient intake cognitive performance for which several markers are used like reaction to single stimulus test or complex interactive inputs, mood and vitality by focusing on behaviours such as sleep and activity, as well as feelings of tension, calmness, drowsiness, alertness assessed eithe subjectively (e.g. with questionnaires) or objectively (e.g. with electre physiological measurements) stress and distress management based on changes in physiological markers like heart rate, blood pressure catecholamines, blood opioid levels
1.5.2 Defence against reactive oxidative species9, 33 The generation of reactive oxidative species (ROS) is a general feature of any aerobic organism both during development and normal functions or pathological changes. These ROS can damage essential macromolecules like DNA, lipids and proteins by initiating or promoting oxidative processes. Many of these (bio)chemical reactions are thought to be involved in miscellaneous pathological processes such as cataract, some cancers, cardiovascular diseases, rheumatoid arthritis and some neurodegenerative conditions. But it is becoming more and more evident that ROS also play an essential role in regulating gene expression and in participating in cell signalling. Maintaining a balance between production and destruction of ROS is thus a key element in well-being and health and it is likely to play a role in reducing the risk of disease. Examples of target functions for functional food development in relation to the maintenance of such a balance are: • preservation of the structure and functional activity of DNA that can be evaluated by measuring DNA integrity (COMET assay), damaged DNA bases (e.g. 8 OH desoxyguanine) or specific gene expressions; • preservation of structural and functional integrity of circulating lipoproteins by measuring either lipid hydroperoxides or their derivatives (e.g. malondialdehyde) or oxidised low-density-lipoproteins in plasma; • preservation of structural and functional integrity of proteins. The major functional foods to rebalance oxidative processes are: • vitamins (especially tocopherols, ascorbic acid and carotenoids); • polyphenols such as flavonoids. 1.5.3 Psychological and behavioural functions9, 34 Some foods or food components provide an important function by changing mood or mental state. They are involved in creating more a sense of ‘feeling well’ than ‘being well’. Target functions for such foods and food components are: • appetite, satiation and satiety, the most widely used markers of which are either visual analogue scales to evaluate subjectively sensations such as hunger, desire to eat and fullness or quantitative assessment of energy and/or nutrient intake; • cognitive performance for which several markers are used like reaction to single stimulus test or complex interactive inputs; • mood and vitality by focusing on behaviours such as sleep and activity, as well as feelings of tension, calmness, drowsiness, alertness assessed either subjectively (e.g. with questionnaires) or objectively (e.g. with electrophysiological measurements); • stress and distress management based on changes in physiological markers like heart rate, blood pressure, blood catecholamines, blood opioid levels. Defining functional foods 23