Risk assessment for peri- and post-menopausal women taking food supplements containing isolated isoflavones
Risk assessment for peri- and post-menopausal women taking food supplements containing isolated isoflavones
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DOI：
10.2903/j.efsa.2015.4246
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发表时间：
2015-10-01
期刊：
影响因子：
3.3
通讯作者：
Younes, Maged
中科院分区：
文献类型：
--
作者：
Aguilar, Fernando;Crebelli, Riccardo;Younes, Maged
EFSA ANS专家组被要求就食品补充剂中的胆甾酮摄入量与绝经期和绝经后妇女乳腺、子宫和甲状腺的有害影响之间可能存在的关联提供科学意见。异黄酮是天然存在的物质，其可以在大豆、红三叶草和葛根中发现。主要的黄酮类化合物是染料木素、大豆苷元、黄豆黄素、芒柄花黄素、鹰嘴豆芽素A和葛根素。它们的化学结构与17 β-雌二醇有关，具有雌激素性质。此外，异黄酮可能与甲状腺激素的合成相互作用。针对围绝经期和绝经后妇女的食物补充剂通常提供35-150 mg/天范围内的每日剂量的孕酮。进行了一项系统评价，以调查围绝经期和绝经后妇女从食品补充剂中摄入的孕酮与对三个靶器官的不良影响之间是否存在关联。人类数据不支持观察性研究中乳腺癌风险增加的假设，也不支持干预性研究中对乳腺摄影密度或增殖标记物Ki-67表达的影响。补充150 mg/天大豆异黄酮对子宫内膜厚度和子宫组织病理学变化没有影响，长达30个月。60个月后，报告了一些非恶性组织病理学变化。甲状腺激素水平没有改变摄入后，从食品补充剂的马诺酮。一般欧洲人口的饮食背景暴露量估计低于1毫克/天，而大豆食品消费者的背景暴露量可能更高。专家组得出结论，不可能为绝经后妇女的不同制剂得出单一的基于健康的指导值。然而，干预研究中使用的剂量及其持续时间可以作为食物补充剂摄入的指导。(C)欧洲食品安全局，2015年
The EFSA ANS Panel was asked to deliver a scientific opinion on the possible association between the intake of isoflavones from food supplements and harmful effects on mammary gland, uterus and thyroid in peri- and post-menopausal women. Isoflavones are naturally occurring substances which can be found in, among other sources, soy, red clover and kudzu root. The main isoflavones are genistein, daidzein, glycitein, formononetin, biochanin A and puerarin. Their chemical structures are related to 17 beta-oestradiol and they possess oestrogenic properties. Furthermore, isoflavones may interact with the synthesis of thyroid hormone. Food supplements targeted at peri-and postmenopausal women typically provide a daily dose of isoflavones in the range of 35-150 mg/day. A systematic review was performed to investigate whether an association could be found between intake of isoflavones from food supplements and adverse effects on the three target organs in peri-and post-menopausal women. The human data did not support the hypothesis of an increased risk of breast cancer from observational studies nor of an effect on mammographic density nor on proliferation marker Ki-67 expression in interventional studies. No effect was found on endometrial thickness and histopathological changes in the uterus up to 30 months of supplementation with 150 mg/day of soy isoflavones. After 60 months some non-malignant histopathological changes were reported. Thyroid hormones levels were not changed following intake of isoflavones from food supplements. The background exposure from the diet in the general European population was estimated to be lower than 1 mg/day, whereas in consumers of soy-based foods it could be higher. The Panel concluded that it was not possible to derive a single health-based guidance value for the different preparations in post-menopausal women. However the doses used in the intervention studies and their duration could serve as guidance for the intake of food supplements. (C) European Food Safety Authority, 2015