Daidzein-rich Isoflavone-aglycones for Menopausal Symptoms
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Hot flash frequency and severity
研究概览
简要总结
Hot flashes occur in three quarters of menopausal women, and can negatively impact quality of life. Interest has arisen in isoflavones, found in rich supply in soy products, as therapy for hot flashes. The study examines the effect of a new soy supplement, as compared to a placebo, in menopausal women on hot flash symptoms.
详细描述
Hot flashes occur in 75% of menopausal women and impact quality of life. Interest has arisen in isoflavones, found in rich supply in soy products, as therapy for hot flashes. The effect of a daidzein-rich isoflavone-aglycone supplement from soy germ fermentation with Koji fungus, on the severity and frequency of hot flashes in postmenopausal women is being examined in a randomized, placebo controlled, double-blinded clinical trial. The study is a 13 week trial in which subjects record their hot flash frequency and severity in a diary. Subjects are given 40 mg or 60 mg of isoflavones (or placebo) once a day. This isoflavone-aglycone extract (Agly-Max TM, Nichimo, Shinagawa, Tokyo, Japan) is a product prepared from soybean germ fermentation with Koji fungus (Aspergliius awamori) producing ß-glycosidase efficiency, followed by ethanol and water extraction and purification by using a proprietary extraction procedure. The product is rich in daidzein (70% daidzein, 10% genistein, and 20% glycitein).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 38 Years 至 65 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •No menstrual period for at least six months, Hot flashes at least four t imes per day, Ages 38-65
排除标准
- •Pregnant, BMI>45, History of breast cancer or other estrogen dependent tumors, Abnormal uterine bleeding, Heart, renal, or liver disease, Diabetes, Women taking hormone replacement therapy or serotonin reuptake inhibitors, Women taking any dietary supplements for the treatment of hot flashes (ex. soy supplements, vitamin E, flaxseed, red clover extract) within the past 30 days
结局指标
主要结局
Hot flash frequency and severity
次要结局
- Menopausal quality of life
研究者
Hope Ricciotti
Associate Professor of Obstetrics, Gynecology and Reproductive Biology
Beth Israel Deaconess Medical Center
