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目的 应用随机双盲安慰剂对照的临床干预试验 ,观察补充大豆蛋白对血压处于正常高限或第I期高血压者的降压效果。方法 将观察对象随机分为干预组和对照组 ,干预组以服用大豆蛋白饼干的形式每天补充大豆蛋白 4 0克 ,对照组则服用普通饼干 ,为期 12周。在试验的基线、中期和末期分别进行病史和服用饼干情况的询问、测血压、人体测量、2 4小时膳食调查、采血和尿标本收集 ,并检测血液和尿液的相关指标。结果 末期时 ,干预组比对照组的收缩压和舒张压净变化分别为 - 4 2 3mmHg和 - 3 0mmHg ,均达到统计学显著意义 (P <0 0 1)。同时 ,干预组比对照组的 2 4小时尿总氮值净增加 1 4 3克 (P <0 0 5 )。结论 补充大豆蛋白能够降低血压在正常高限或第Ⅰ期高血压(SBP 130～ 15 9mmHg和 /或DBP 80～ 94mmHg)的成年人的血压。
Objective To evaluate the antihypertensive efficacy of soy protein supplement in patients with hypertension or hypertension in a randomized double-blind placebo-controlled clinical trial. Methods Subjects were randomly divided into intervention group and control group. In the intervention group, 40 grams of soybean protein was daily supplemented with soybean protein biscuits. Normal control group was given ordinary biscuits for 12 weeks. At baseline, mid-term, and end-of-course, patients were asked about their medical history and taking biscuits, blood pressure readings, body measurements, 24-hour meal surveys, collection of blood and urine samples, and blood and urine tests. At the end of the trial, the net change in systolic and diastolic blood pressure in the intervention group was -432 mmHg and -3.0 mmHg, respectively, reaching statistical significance (P <0.01). At the same time, the total net nitrogen value of 24 hours in the intervention group was increased by 143 grams (P <0.05) than the control group. Conclusion Soy protein supplementation can lower blood pressure in adults with normal high limit or stage I hypertension (SBP 130-1599 mmHg and / or DBP 80-94 mmHg).