Turck Dominique, Castenmiller Jacqueline, De Henauw Stefaan, Hirsch-Ernst Karen Ildico, Kearney John, Knutsen Helle Katrine, Maciuk Alexandre, Mangelsdorf Inge, McArdle Harry J, Naska Androniki, Pelaez Carmen, Pentieva Kristina, Thies Frank, Tsabouri Sophia, Vinceti Marco, Bresson Jean-Louis, Siani Alfonso
EFSA J. 2019 Jun 11;17(6):e05715. doi: 10.2903/j.efsa.2019.5715. eCollection 2019 Jun.
Following an application from analyze & realize GmbH submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Ireland, 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 GlycoLite™. The Panel considers that the food, an aqueous extract from white kidney bean ( L.) standardised by its α-amylase inhibitory activity (GlycoLite™) which is the subject of the health claim, is sufficiently characterised. The claimed effect proposed by the applicant is 'helps to reduce body weight'. The proposed target population is 'overweight people from the age of 18 years who want to lose or manage their weight'. The Panel considers that a reduction in body weight is a beneficial physiological effect for overweight individuals. Two human intervention studies, carried out in the same centres and by the same research group, showed an effect of 3 g of GlycoLite™ on body weight when consumed daily for 12 weeks in the context of an energy restricted diet. The results have not been replicated in a different setting. One study of short duration and methodological limitations showed an effect of GlycoLite™ on body weight when eating . No evidence for a plausible mechanism by which GlycoLite™ could exert a reduction in body weight in humans has been provided. The Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship between the consumption of an aqueous extract from white kidney bean ( L.) standardised by its α-amylase inhibitory activity (GlycoLite™) and a reduction of body weight either under energy restriction or when eating .
根据analyze & realize GmbH通过爱尔兰主管当局提交的依据欧盟第1924/2006号法规第13(5)条授权健康声明的申请，欧洲食品安全局营养、新型食品和食品过敏原专家委员会（NDA）被要求就与GlycoLite™相关的健康声明的科学依据发表意见。专家委员会认为，作为健康声明主题的食品，即一种通过其α-淀粉酶抑制活性标准化的白芸豆水提取物（GlycoLite™），已得到充分描述。申请人提出的声称效果是“有助于减轻体重”。建议的目标人群是“18岁及以上想要减轻或控制体重的超重人群”。专家委员会认为，减轻体重对超重个体是一种有益的生理效应。在同一中心由同一研究小组进行的两项人体干预研究表明，在能量限制饮食的情况下，每天食用3克GlycoLite™，持续12周，对体重有影响。但该结果尚未在不同环境中得到重复验证。一项持续时间短且存在方法学局限性的研究表明，食用GlycoLite™对体重有影响。但尚未提供GlycoLite™在人体中减轻体重的合理作用机制的证据。专家委员会得出结论，所提供的证据不足以确立通过其α-淀粉酶抑制活性标准化的白芸豆水提取物（GlycoLite™）的消费与在能量限制或正常饮食情况下减轻体重之间的因果关系。
