European Journal of Nutrition. 2013;52(7):1685-1699
Markers are a well-known and useful tools used in nutrition sciences to estimate the effects of nutrition interventions on health. The ILSI Europe Functional Foods Task Force reviewed existing criteria for the evaluation of markers related to nutrition, health and disease and proposed generic criteria for evaluation.
Markers are a well-known and useful tools used in nutrition sciences to estimate the effects of nutrition interventions on health outcomes, when these are not directly measurable. However, there is currently a lack of scientific consensus in the validation of markers in nutrition research; since validated markers are needed for benefit assessments. For example, the lack of validated markers is one of the difficulties encountered in the preparation of health claim dossiers. Moreover, by presenting a list of markers that are considered to be well validated, it would be possible to gather comparable data in future studies. Although there are clear advantages to using markers it is recognized that there is not a schematic approach to validate markers. Therefore the aim of the manuscript is to illustrate an overview of the definitions used for (bio)marker, adherent terminology and to gather information on potential criteria for validation. The following are identified as essential elements in the evaluation of markers: (1) the marker has a causal biological link with the endpoint, (2) there is a significant association between marker and endpoint in the target population, (3) marker changes consistently with the endpoint, e.g., in response to an intervention, and (4) change in the marker explains a substantial proportion of the change in the endpoint in response to the intervention.
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