Objectives: The objective of this study is to evaluate the effects of a soy drink with a high concentration of isoflavones (ViveSoy®) on climacteric symptoms.
Methods: An open-label, controlled, crossover clinical trial was conducted in 147 peri- and postmenopausal women. Eligible women were recruited from 13 Spanish health centers and randomly assigned to one of the two sequence groups (control or ViveSoy®, 500 mL per day, 15 g of protein and 50 mg of isoflavones). Each intervention phase lasted for 12 weeks with a 6-week washout period. Changes on the Menopause Rating Scale and quality of life questionnaires, as well as lipid profile, cardiovascular risk and carbohydrate and bone metabolism were assessed. Statistical analysis was performed using a mixed-effects model.
Results: A sample of 147 female volunteers was recruited of which 90 were evaluable. In both sequence groups, adherence to the intervention was high. Regular consumption of ViveSoy® reduced climacteric symptoms by 20.4% (p = 0.001) and symptoms in the urogenital domain by 21.3% (p < 0.05). It also improved health-related quality life by 18.1%, as per the MRS questionnaire (p <0.05).
Conclusion: Regular consumption of ViveSoy® improves both the somatic and urogenital domain symptoms of menopause, as well as health-related quality of life in peri- and postmenopausal women.
研究目的：本研究的目的是评价含有高浓度异黄酮(ViveSoy®)的大豆饮料对更年期症状的影响。
研究方法：对147名围绝经及绝经后妇女进行开放、对照、交叉临床试验。从13个西班牙医疗中心招募符合条件的女性受试者进行随机分配(对照组或ViveSoy®组，每天500毫升ViveSoy摄入，其中含有15g的蛋白质和50mg的异黄酮)。每个干预阶段持续12周其中包括6周的洗脱期。填写更年期评定量表和生活质量调查问卷,并且评估血脂高低、心血管疾病患病风险和碳水化合物和骨质新陈代谢情况。依据混合效应模型进行统计分析。
研究结果：147名女性志愿者中90人是可评价的。这两组成员的依从性都较高。经常食用ViveSoy®的小组成员更年期的症状减少了20.4%(p = 0.001)，泌尿生殖系统症状减少了21.3%(p<0.05)。依据更年期评定量表问卷健康相关生活质量提高了18.1%(p<0.05)。
研究结论：规律食用ViveSoy®可以减轻躯体和泌尿生殖系统的更年期的症状,提高围绝经期和绝经期妇女的健康相关生活质量。
Keywords: Estrogens; menopause; urogenital system.