Alternative Treatments for Menopausal Women
关键词
抽象
描述
Menopausal symptoms are a common phenomenon causing discomfort to many middle aged women throughout the world. The core symptoms are experienced as hot flushes (HF), night sweats, vaginal dryness and sleep disturbance. Other secondary symptoms are sexual dysfunction, depression, anxiety, memory loss, fatigue, headache, joint pains and weight gain. Moreover there is increased risk of further complications such as osteoporosis, cardiovascular and negative changes in lipid profile associated with the reduction in oestrogen during and post menopause.
Trifolium Pratense or Red Clover (RC) has arisen as a popular source for women experiencing HF because it contains a variety of phytoestrogen's, namely isoflavones, lignans and coumestans. Phytoestrogens are shown to have positive effects on menopausal disorders such as breast cancer, cardiovascular risk factors, osteoporosis and have been shown to exert non-hormonal antioxidant effects. Additionally these isoflavones appear to reduce bone resorbtion, help maintain bone mineral density and improve lipid profile (reducing LDL: HDL, lipoprotein A, total cholesterol and may also reduce triglycerides).
RC is particularly high in estrogenic isoflavones biochanin A, formononetin and to a lesser degree genestein and diadzein, although the two former are precursors to genestein and diadzein. Asian populations with a high intake of soy (rich in genestein and diadzein) have long shown a lower reported incidence of the symptoms of menopause.
The study will be carried out as a 3-month parallel randomized control intervention study, consisting of 61 menopausal women. During summer 2012, 61 participants will be randomised into 2 groups (~30-31 in each group). The two groups are as follows:
1. Menopausal women receiving RC treatment - 150ml/d Red Clover (80mg/d of isoflavones as aglycone)
2. Menopausal women receiving placebo - 150ml placebo
日期
| 最后验证: | 01/31/2015 |
| 首次提交: | 07/11/2012 |
| 提交的预估入学人数: | 01/05/2014 |
| 首次发布: | 01/06/2014 |
| 上次提交的更新: | 02/04/2015 |
| 最近更新发布: | 02/05/2015 |
| 实际学习开始日期: | 05/31/2012 |
| 预计主要完成日期: | 11/30/2014 |
| 预计完成日期: | 11/30/2014 |
状况或疾病
干预/治疗
Dietary Supplement: Placebo
Dietary Supplement: Red Clover extract
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: Red Clover extract 150 ml/d Red Clover extract | Dietary Supplement: Red Clover extract Red Clover extract containing 80 mg Isoflavones. Dosage: 2 X 75 ml/day |
| Placebo Comparator: Placebo 150 ml/d sweetened and coloured water | Dietary Supplement: Placebo water with color |
资格标准
| 有资格学习的年龄 | 45 Years 至 45 Years |
| 有资格学习的性别 | Female |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Women aged 40-65 years - Experiencing daily hot flushes - Body Mass Index (BMI) between 20-40 - Irregular menstrual bleeding - FSH levels above the normal range Exclusion Criteria: - Simultaneous participation in other clinical trials within the last 3 months - Severe cardiovascular, psychiatric, neurological, and/or kidney disease. - Alcohol or drug abuse and acute illness. - Blood pressure > 160/110 - Pregnant and lactating women |
结果
主要结果指标
1. Primary Menopause-related symptoms [3 months]
