Turck Dominique, Bohn Torsten, Cámara Montaña, Castenmiller Jacqueline, de Henauw Stefaan, Hirsch-Ernst Karen-Ildico, Jos Ángeles, Maciuk Alexandre, Mangelsdorf Inge, McNulty Breige, Naska Androniki, Pentieva Kristina, Thies Frank, Craciun Ionut, Fiolet Thibault, Siani Alfonso
EFSA J. 2024 Nov 19;22(11):e9100. doi: 10.2903/j.efsa.2024.9100. eCollection 2024 Nov.
Following an application from Alzchem Trostberg GmbH, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Austria, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to creatine and improvement in cognitive function. The Panel considers that the food constituent, creatine, is sufficiently characterised. An improvement in cognitive function in one or more of its domains is a beneficial physiological effect. The applicant identified 21 human intervention studies on creatine supplementation and measures of cognitive function through a literature search. Two additional studies published after the search was conducted were identified through the reference list of a meta-analysis. In weighing the evidence, the Panel took into account that the acute effect of creatine on working memory, observed in two studies at 20 g/day for 5-7 days, was not seen at lower doses (2.2-14 g/day), or with continuous consumption (5 g/day for 6 weeks following a 5-day loading phase). Furthermore, the effect on response inhibition at 20 g/day for 7 days was an isolated finding among 10 intervention studies in healthy individuals, with no effects observed on other cognitive domains. The Panel also considered that the three intervention studies conducted in diseased individuals do not support an effect of creatine supplementation on cognition, and that the available evidence for a mechanism by which creatine could exert the claimed effect is weak. The Panel concludes that a cause-and-effect relationship has not been established between creatine supplementation and an improvement in cognitive function in one or more of its domains.
阿尔茨化学特罗斯特贝格有限公司依据欧盟第1924/2006号法规第13(5)条，通过奥地利主管当局提交了一份关于健康声称授权的申请，欧洲食品安全局营养、新型食品及食品过敏原专家委员会（NDA）被要求就与肌酸及认知功能改善相关的健康声称的科学依据发表意见。专家委员会认为，食品成分肌酸已得到充分表征。其一个或多个领域的认知功能改善是一种有益的生理效应。申请人通过文献检索确定了21项关于补充肌酸与认知功能测量的人体干预研究。通过一项荟萃分析的参考文献列表又确定了在检索之后发表的另外两项研究。在权衡证据时，专家委员会考虑到，在两项研究中观察到，每天服用20克肌酸、持续5 - 7天对工作记忆的急性影响，在较低剂量（每天2.2 - 14克）或持续服用（在5天负荷期后每天服用5克、持续6周）时并未出现。此外，在10项针对健康个体的干预研究中，每天服用20克肌酸、持续7天对反应抑制的影响是一个孤立的发现，在其他认知领域未观察到影响。专家委员会还认为，在患病个体中进行的三项干预研究不支持补充肌酸对认知有影响，并且关于肌酸可能发挥声称效果的机制的现有证据不足。专家委员会得出结论，补充肌酸与一个或多个领域的认知功能改善之间尚未确立因果关系。
