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首页> 外文期刊>Acta diabetologica. >Claimed effects, outcome variables and methods of measurement for health claims proposed under European Community Regulation 1924/2006 in the area of blood glucose and insulin concentrations
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Claimed effects, outcome variables and methods of measurement for health claims proposed under European Community Regulation 1924/2006 in the area of blood glucose and insulin concentrations

机译：在血糖和胰岛素浓度范围内的欧洲共同体监管下提出的欧洲共同体规定提出的效果，结果变量和测量方法

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摘要

Most requests for authorization to bear health claims under Articles 13(5) and 14 related to blood glucose and insulin concentration/regulation presented to the European Food Safety Authority (EFSA) receive a negative opinion. Reasons for such decisions are mainly ascribable to poor substantiation of the claimed effects. In this scenario, a project was carried out aiming at critically analysing the outcome variables (OVs) and methods of measurement (MMs) to be used to substantiate health claims, with the final purpose to improve the quality of applications provided by stakeholders to EFSA. This manuscript provides a position statement of the experts involved in the project, reporting the results of an investigation aimed to collect, collate and critically analyse the information relevant to claimed effects (CEs), OVs and MMs related to blood glucose and insulin levels and homoeostasis compliant with Regulation 1924/2006. The critical analysis of OVs and MMs was performed with the aid of the pertinent scientific literature and was aimed at defining their appropriateness (alone or in combination with others) to support a specific CE. The results can be used to properly select OVs and MMs in a randomized controlled trial, for an effective substantiation of the claims, using the reference method(s) whenever available. Moreover, results can help EFSA in updating the guidance for the scientific requirements of health claims.
机译：大多数授权要求在第13（5）条和14条中承担健康索赔和血糖和胰岛素浓度/调节的第14条（EFSA）接受负面舆论。此类决策的原因主要是对索赔效果的恶劣证实。在这种情况下，进行了一个项目，旨在批判地分析用于证实健康索赔的结果（OVS）和测量方法（MMS），最终目的是提高利益攸关方提供的申请质量。本手稿提供了该项目的专家的立场声明，报告了旨在收集，整理和批判性分析与血糖和胰岛素水平相关的索赔（CES），OV和MM相关的信息的调查结果符合1924/2006的规定。借助于相关的科学文献进行OVS和MMS的临界分析，旨在定义其适当性（单独或与他人组合）来支持特定的CE。结果可用于在随机对照试验中正确选择OVS和MMS，以便在可用的参考方法中使用参考方法进行有效证实权利要求。此外，结果可以帮助EFSA更新健康索赔的科学要求的指导。

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