Liu Zhao-min, Ho Suzanne C, Chen Yu-ming, Xie Yao Jie, Huang Zhi-guan, Ling Wen-hua
Division of Family Medicine and Primary Care, The Jockey Club School of Public Health and Primary Care, the Chinese University of Hong Kong, Hong Kong, SAR.
Division of Epidemiology, The Jockey Club School of Public Health and Primary Care, the Chinese University of Hong Kong, Hong Kong, SAR.
BMC Complement Altern Med. 2016 Mar 1;16:89. doi: 10.1186/s12906-016-1065-5.
Although higher habitual soy intake is associated with lower blood pressure (BP) and stroke incidence, clinical trials using soy protein or isoflavones on cardiovascular risks yielded inconsistent results. The discrepancies are hypothesized to be due to the individuals' intestinal bacterial capacity to metabolite isoflavones daidzein into equol. Animal and in vitro studies have revealed that equol has stronger estrogen-like and anti-oxidative activity than isoflavones and possesses natriuretic and vasorelaxant properties which may play an important role in the prevention of hypertension. However, no clinical trial has examined the effect of equol on BP. We thus propose a 24-week randomized controlled trial to test the effectiveness of natural S-equol on BP and vascular function among equol non-producers.
METHODS/DESIGN: This will be a 6-month double-blind, randomized, placebo-controlled trial among 207 non-equol producing postmenopausal women with prehypertension or early untreated hypertension. Eligible participants who have completed a 2-week run-in will be randomized to either one of the 3 groups: placebo group, low-equol group (10 mg/d) and high equol group (20 mg/d). The outcome measures will be conducted at baseline and at the end of the trial including 24 h ambulatory BP, endothelial function (by ultrasound determined brachial flow mediated dilation), arterial stiffness (by pulse wave analysis) and other cardiovascular risk factors (lipid profile, glycemic control and inflammatory biomarkers). Urinary isoflavones will be tested for compliance assessment. One way analysis of variance will be applied to compare the 6-month changes in ambulatory BP or parameters of vascular function among the 3 treatment groups.
This study will be performed in community subjects. If the antihypertensive effect of equol is proven, the provision of natural equol to those high risk adults who are unable to produce equol will have enormous public health implications for the primary and secondary prevention of hypertension and cardiovascular diseases on a population basis. The research efforts will also have significant implications for industry in the provision of suitable soy products for the prevention of hypertension and its related complications.
The trial was registered in ClinicalTrials.gov with identifier of NCT02515682 .
尽管日常大豆摄入量较高与较低的血压（BP）及中风发病率相关，但使用大豆蛋白或异黄酮进行的心血管疾病风险临床试验结果并不一致。这些差异据推测是由于个体肠道细菌将异黄酮大豆苷元代谢为雌马酚的能力不同。动物和体外研究表明，雌马酚比异黄酮具有更强的雌激素样和抗氧化活性，并具有利钠和血管舒张特性，这可能在预防高血压中发挥重要作用。然而，尚无临床试验研究雌马酚对血压的影响。因此，我们提出一项为期24周的随机对照试验，以测试天然S-雌马酚对雌马酚非生产者的血压和血管功能的有效性。
方法/设计：这将是一项为期6个月的双盲、随机、安慰剂对照试验，对象为207名患有高血压前期或未经治疗的早期高血压的绝经后雌马酚非生产者。完成2周导入期的符合条件的参与者将被随机分为3组之一：安慰剂组、低剂量雌马酚组（10毫克/天）和高剂量雌马酚组（20毫克/天）。结局指标将在基线和试验结束时进行测量，包括24小时动态血压、内皮功能（通过超声测定肱动脉血流介导的舒张）、动脉僵硬度（通过脉搏波分析）以及其他心血管疾病风险因素（血脂谱、血糖控制和炎症生物标志物）。将检测尿异黄酮以进行依从性评估。将应用单因素方差分析来比较3个治疗组之间6个月动态血压或血管功能参数的变化。
本研究将在社区受试者中进行。如果雌马酚的降压作用得到证实，那么向那些无法产生雌马酚的高危成年人提供天然雌马酚，对于高血压和心血管疾病的一级和二级预防将具有巨大的公共卫生意义。这些研究工作对于行业提供适合预防高血压及其相关并发症的大豆产品也将具有重要意义。
该试验已在ClinicalTrials.gov上注册，标识符为NCT02515682。
