Abstract

When evaluating the efficacy of foods with health claims (FHC), each country sets different standards for efficacy evaluation endpoints in clinical trials, which may result in a barrier, namely the case that the claim that is allowed in Japan cannot be used on the label in another region and vice versa. We aimed to investigate the efficacy evaluation endpoints used in clinical trials of FFCs containing ID and submitted in Japan, in reference to the EU requirements for substantiating the claim, namely “reduction of post-prandial glycemic responses”. We detected only one difference in efficacy evaluation endpoints, which was insulin levels. We found 67 such clinical trials cited in systematic literature reviews on finished products or functional substance(s). Of these, 43 (64%) trials lacked insulin assessment. Particularly, for foods that were claimed to reduce post-prandial glycemic responses, the EU does not consider a claim to be substantiated unless insulin levels have been evaluated. Our findings suggest the need for standardization of requirements for FHC between Japan and the EU. This consideration will strengthen the evidence for clinical significance of ID and allow products labeled with this health claim to be more widely distributed.

摘要

在评估带有健康声明（FHC）的食品的功效时，各国对临床试验中的功效评估终点标准不同，这可能会造成障碍，即在日本允许的声明不能在标签上使用的情况在另一个地区，反之亦然。我们旨在研究在日本提交的含 ID 的 FFC 临床试验中使用的疗效评估终点，参考欧盟对证实该声明的要求，即“减少餐后血糖反应”。我们仅检测到疗效评估终点的一个差异，即胰岛素水平。我们在成品或功能性物质的系统文献综述中发现了 67 项此类临床试验。其中，43 (64%) 项试验缺乏胰岛素评估。特别，对于声称可以降低餐后血糖反应的食品，除非已经评估了胰岛素水平，否则欧盟不认为该声称得到证实。我们的研究结果表明，日本和欧盟之间需要对 FHC 的要求进行标准化。这种考虑将加强 ID 临床意义的证据，并允许标有这种健康声明的产品更广泛地分发。