Optimum nutrition4 is a very new concept. It aims at maximizing the physiological as well as psychological functions of each individual through nutrition in order to ensure both well-being and health but at the same time, a minimum risk of disease throughout the lifespan. It relies on the hypothesis that the optimized consumption of food components will control and modulate body functions to maximize their efficiency. In such a context, "functional food" has been proposed as one approach to improve nutrition.
1.3.1 Functional Food: A Nutrition Concept
As the science of nutrition progresses, a wide variety of foods are or will, in the future, be characterized as functional food with a variety of components affecting a variety of body functions relevant to either a state of well-being and health and/or to the reduction of the risk of a disease. Consequently, the term functional food has as many definitions as the number of authors referring to it.
As discussed previously,5 these definitions range from simple to elaborate. Simple descriptions may be:
• Foods that may provide health benefits beyond basic nutrition6
• Foods or food products marketed with a health benefit message7
• Everyday food transformed into a potential life saver by the addition of a "magical" ingredient8
Elaborate definitions of functional foods may be:
• Food and drink products derived from naturally occurring substances consumed as part of the daily diet and possessing particular physiological benefits when ingested9
• Food derived from naturally occurring substances that can and should be consumed as part of the daily diet and that serve to regulate or otherwise affect a particular body process when ingested10
• Food similar in appearance to conventional food, which is consumed as part of a usual diet and has demonstrated physiological benefit and/or reduces the risk of chronic disease beyond nutritional functions11
• Food that encompasses potentially helpful products including any modified food or food ingredient that may provide a health benefit beyond that of the traditional nutrients it contains12
However, the term functional food cannot represent a single well defined and well-characterized entity. Instead, functional food has to be understood as a concept that belongs to nutrition and not to pharmacology. It deserves a category of its own, a category different from nutraceutical, farmafood (pharmafood), medifood, designer food, vitafood, or any other term that tends to mix up food and drugs. A functional food is, and must remain, a food not a drug and, except in very particular and very exceptional situations, it is not developed to have therapeutic effects. Moreover, its role regarding disease will, in most cases, be in "reducing the risk" rather than "preventing (i.e., suppressing)" it. The regular consumption of a truly functional food as part of the usual recommended diet should be prescribed because it has been scientifically proven to significantly reduce the likelihood of getting a particular disease.
To elaborate the concept of functional food, the following features need to be taken into consideration, and the food or food ingredient must be:
CONVENTIONAL EVERYDAY FOOD NATURAL OCCURRENCE PROOF OF EFFICACY EFFECTS BEYOND BASIC NUTRITION ENHANCEMENT OF FUNCTION(S) RELEVANCE OF TARGET FUNCTIONS TO WELL-BEING AND HEALTH REDUCTION OF DISEASE RISK IMPROVEMENT OF QUALITY OF LIFE
FIGURE 1.3 Functional food: Key features. © 2005 by CRC Press LLC
• A conventional, everyday food
• Naturally occurring
• Proven to have beneficial effects on target functions beyond nutritive value and basic nutrition
• Proven to enhance well-being and health, reduce the risk of a disease, or improve the quality of life including physical, psychological, and behavioral performances
1.3.2 Functional Food: A Consensus of the European Scientific Community
A European Commission Concerted Action program known as Functional Food Science in Europe (FUFOSE) was initiated in early 1996, coordinated by the European branch of the International Life Science Institute (ILSI Europe). In 1998, it reached a consensus (known as the "European Consensus on Scientific Concepts of Functional Foods"13) which proposes the following working definition of a functional food:
A food can be regarded as functional if it is satisfactorily demonstrated to affect beneficially one or more target functions in the body, beyond adequate nutritional effects, in a way that is relevant to either improved stage of health and well-being and/or reduction of risk of disease. A functional food must remain food and it must demonstrate its effects in amounts that can normally be expected to be consumed in the diet: it is not a pill or a capsule, but part of the normal food pattern.
This definition describes all the main features of functional foods, i.e.:
• Their food nature and their consumption as part of a normal food pattern
• The requirement for a scientific demonstration of the effects
• The beneficial effects on body functions beyond adequate nutritional effects
• The relevance of these effects to improved well-being and health and/or reduction of disease risk
It aims to stimulate research and development in the field of nutrition contributing to set standards for an optimized nutrition. From a practical point of view, a functional food can be:
• A food to which a component has been added
• A food from which a component has been removed
• A food in which the bioavailability of one or more components has been modified
• Any combination of these possibilities
1.3.3 The Strategy for Functional Food Development
As described in the European Consensus Document:13
"The design and development of functional foods is a key issue, as well as a scientific challenge, which should rely on basic scientific knowledge relevant to target functions and their possible modulation by food components." Emphasis is then put on the importance of "the effects of food components on well-identified and well-characterizes target functions in the body that are relevant to well-being and health issue, rather than, solely, on reduction of disease risk." In order to achieve such a development, it is necessary to identify potential functional foods or functional food components and, at least partly, to understand the mechanisms by which they modulate target functions (Figure 1.4).
These target functions have to be recognized or proven to be relevant to the state of well-being and health, and/or the reduction of a disease risk. When such a functional effect is demonstrated, it will be used to formulate hypotheses to be tested in human nutrition studies aimed at showing that adequate (in terms of dose, frequency, duration etc.) intake of the specified food or food component will improve one or more target functions, that are, either directly or indirectly in terms of a validated marker, relevant to an improved state of well-being and health and/or to a reduced disease risk.
Human nutrition studies should be hypothesis driven; they should aim at testing the effect of a food as part of the ordinary diet consumed, in most cases, by the general population or large, at-risk target groups; and they should not use a risk vs. benefit approach. Most of these studies will rely on change(s) in validated or relevant markers to demonstrate a positive modulation of target functions after (long-term) consumption of the potential functional foods. A double-blind type of design based
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