Turck Dominique, Bohn Torsten, Castenmiller Jacqueline, De Henauw Stefaan, Hirsch-Ernst Karen Ildico, Knutsen Helle Katrine, Maciuk Alexandre, Mangelsdorf Inge, McArdle Harry J, Naska Androniki, Pentieva Kristina, Thies Frank, Tsabouri Sophia, Vinceti Marco, Bresson Jean-Louis, Fiolet Thibault, Siani Alfonso
EFSA J. 2023 Oct 11;21(10):e08239. doi: 10.2903/j.efsa.2023.8239. eCollection 2023 Oct.
Following an application from Greenleaf Medical AB, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Sweden, 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 Appethyl® and reduction of body weight. Appethyl® is an aqueous extract from spinach leaves standardised by the manufacturing process and its lipase/colipase inhibition capacity . The Panel considers that the food is sufficiently characterised. A reduction in body weight is a beneficial physiological effect for overweight/obese individuals. The applicant identified a total of three human intervention studies that investigated the effects of Appethyl® on body weight as being pertinent to the claim. In weighing the evidence, the Panel took into account that Appethyl® (5 g/day for 12 weeks) had no effect on body weight as compared to placebo under minimal dietary counselling and moderate physical activity, and that no beneficial physiological effects are to be expected for the target population of overweight/obese individuals from the weight loss that could be attributed to the intervention with Appethyl® under predefined energy restriction and moderate physical activity. The Panel also considered that the effect of Appethyl® (5 g/day for 24 weeks) on body weight maintenance after initial weight loss shown in one study has not been replicated in different settings, which questions the external validity of the results, and that no evidence was provided for a plausible mechanism by which daily consumption of Appethyl® could exert a sustained effect on body weight in humans. The Panel concludes that a cause-and-effect relationship has not been established between the consumption of Appethyl® and a reduction of body weight under the conditions of use proposed by the applicant.
绿叶医疗股份公司（Greenleaf Medical AB）依据欧盟第1924/2006号法规第13(5)条，通过瑞典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（EFSA）营养、新型食品及食品过敏原专家委员会（NDA）被要求就与Appethyl®及体重减轻相关的健康声称的科学依据发表意见。Appethyl®是一种经制造工艺标准化的菠菜叶水提取物，具有脂肪酶/共脂肪酶抑制能力。专家委员会认为该食品具有充分的特征描述。体重减轻对超重/肥胖个体而言是一种有益的生理效应。申请人共确定了三项人体干预研究，认为这些研究调查了Appethyl®对体重的影响，与该声称相关。在权衡证据时，专家委员会考虑到，在最低限度饮食咨询和适度体育活动的情况下，与安慰剂相比，Appethyl®（每天5克，持续12周）对体重没有影响，而且在预先设定的能量限制和适度体育活动下，对于超重/肥胖个体这一目标人群而言，无法预期Appethyl®干预带来的体重减轻会产生任何有益的生理效应。专家委员会还认为，一项研究中显示的Appethyl®（每天5克，持续24周）对初始体重减轻后体重维持的影响，在不同环境中未得到重复验证，这对结果的外部有效性提出了质疑，而且没有提供证据证明每日食用Appethyl®能对人体体重产生持续影响的合理机制。专家委员会得出结论，在申请人提议的使用条件下，食用Appethyl®与体重减轻之间尚未建立因果关系。
