Some food/food components have been the object of request of authorization to the use of health claims related to cognitive function in adults and compliant with the Regulation (EC) 1924/2006. Most of the requests have received a negative opinion by the European Food Safety Authority (EFSA) also because of the choice of not appropriate outcome variables (OVs) and methods of measurement (MMs) selected in the trials used to substantiate the claim. This manuscript referes to the collection, collation and critical analysis of OVs and MMs related to cognitive function in adults. OVs and MMs were collected from the EFSA Guidance document and the applications for authorization of health claims pursuant to the Articles 13(5). The critical analysis of OVs and MMs, performed by a literature review, was aimed at defining their appropriateness in the context of a specific claimed effect. The results highlight the importance of an adequate choice of OVs and MMs for an effective substantiation of the claims related to cognitive functioning. The information provided in this document may serve to EFSA for updating the guidance on the scientific requirements for health claims related to cognitive functions, but also for a better design of randomized controlled trials aimed at substantiating such health claims.

中文翻译：

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根据法规（EC）1924/2006提出的与成人认知功能有关的健康声称的声称效果，结果变量和测量方法。

一些食品/食品成分已成为授权使用与成年人认知功能相关的健康声明并符合1924/2006法规的对象。欧洲食品安全局（EFSA）的大多数要求也收到了负面意见，这也是因为在用于证实该要求的试验中选择了不合适的结果变量（OVs）和测量方法（MMs）。该手稿涉及与成人认知功能相关的OV和MM的收集，整理和批判性分析。OV和MM从EFSA指南文件以及根据第13（5）条提出的健康声明授权申请中收集。文献综述对OV和MM进行了批判性分析，目的是在特定要求的效果的背景下定义其适当性。结果突出了有关认知功能索赔的有效属实OVS和MMS的充分选择的重要性。本文档中提供的信息可能有助于EFSA更新有关与认知功能有关的健康要求的科学要求的指南，而且还可以更好地设计旨在证实此类健康要求的随机对照试验。