Effects of the phytoestrogen genistein on some predictors of cardiovascular risk in osteopenic, postmenopausal women: A two-year randomized, double-blind, placebo-controlled study

Effects of the phytoestrogen genistein on some predictors of cardiovascular risk in osteopenic, postmenopausal women: A two-year randomized, double-blind, placebo-controlled study
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DOI:
10.1210/jc.2006-2295
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发表时间:
2007-08-01
影响因子:
5.8
通讯作者:
Squadrito, Francesco
Squadrito, Francesco
中科院分区:
医学2区
文献类型:
--
作者:
Atteritano, Marco;Marini, Herbert;Squadrito, Francesco

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背景:染料木黄酮,一种大豆异黄酮,由于其潜在的预防心血管疾病的作用,在过去几年中受到了广泛的关注。目的:我们的目的是评估染料木素给药(54 mg/d)对骨质减少、绝经后妇女心血管风险的一些预测因素的影响。设计与环境:我们在三所意大利大学医学中心进行了一项随机、双盲、安慰剂对照试验。干预:在标准的等热量、低脂饮食稳定4周后,参与者被随机分配接受染料木素(n = 198)或安慰剂(n = 191),持续24个月。干预和安慰剂都含有钙和维生素D-3。结果测量:在基线和治疗12个月和24个月后测量血脂、空腹血糖和胰岛素、胰岛素抵抗的稳态模型评估、纤维蛋白原、可溶性细胞间粘附分子-1、可溶性血管细胞粘附分子-1、f2 -异前列腺素和骨保护素。结果:与安慰剂相比,染料木素在治疗12个月和24个月后显著降低空腹血糖和胰岛素,以及胰岛素抵抗的稳态模型评估。相比之下,尽管24个月后纤维蛋白原、f2 -异前列腺素、可溶性细胞间黏附分子-1和可溶性血管细胞黏附分子-1与安慰剂相比显著降低,染料木素给药对血脂水平没有影响。染料木素组血清骨保护素高于安慰剂组。在24个月时,染料木素组与安慰剂组相比,子宫内膜厚度没有变化。大多数治疗相关不良事件为中度,由胃肠道副作用组成[染料木素,n = 37 (19%);安慰剂,n = 15(8%)]。结论:这些结果表明,54毫克染料木素加钙、维生素D3和健康的饮食对骨质减少、绝经后妇女的血糖控制和一些心血管风险指标都有良好的影响。
Context: Genistein, a soy isoflavone, has received wide attention over the last few years because of its potential preventive role for cardiovascular disease.Objective: Our objective was to assess the effects of genistein administration (54 mg/d) on some predictors of cardiovascular risk in osteopenic, postmenopausal women.Design and Setting: We conducted a randomized, double-blind, placebo-controlled trial at three Italian university medical centers. Intervention: After a 4- wk stabilization on a standard isocaloric, fat-reduced diet, participants were randomly assigned to receive genistein (n = 198) or placebo (n = 191) daily for 24 months. Both intervention and placebo contained calcium and vitamin D-3.Outcome Measures: Blood lipid profiles, fasting glucose and insulin, homeostasis model assessment for insulin resistance, fibrinogen, soluble intercellular adhesion molecule-1, soluble vascular cellular adhesion molecule-1, F2-isoprostanes, and osteoprotegerin at baseline and after 12 and 24 months of treatment were measured.Results: Compared with placebo, genistein significantly reduced fasting glucose and insulin as well as homeostasis model assessment for insulin resistance after both 12 and 24 months of treatment. By contrast, genistein administration did not affect blood lipid levels although fibrinogen, F2-isoprostanes, soluble intercellular adhesion molecule-1, and soluble vascular cellular adhesion molecule-1 decreased significantly compared with placebo after 24 months. Serum osteoprotegerin was higher in the genistein group compared with placebo. At 24 months, the genistein group showed no change in endometrial thickness compared with placebo. Most treatment-related adverse events were moderate and composed of gastrointestinal side effects [genistein, n = 37 (19%); placebo, n = 15 (8%)].Conclusions: These results suggest that 54 mg genistein plus calcium, vitamin D3, and a healthy diet was associated with favorable effects on both glycemic control and some cardiovascular risk markers in a cohort of osteopenic, postmenopausal women.