Alternative Treatments for Menopausal Women
Sleutelwoorden
Abstract
Omschrijving
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
Datums
| Laatst geverifieerd: | 01/31/2015 |
| Eerste ingediend: | 07/11/2012 |
| Geschatte inschrijving ingediend: | 01/05/2014 |
| Eerst geplaatst: | 01/06/2014 |
| Laatste update ingediend: | 02/04/2015 |
| Laatste update geplaatst: | 02/05/2015 |
| Werkelijke startdatum van het onderzoek: | 05/31/2012 |
| Geschatte primaire voltooiingsdatum: | 11/30/2014 |
| Geschatte voltooiingsdatum van het onderzoek: | 11/30/2014 |
Conditie of ziekte
Interventie / behandeling
Dietary Supplement: Placebo
Dietary Supplement: Red Clover extract
Fase
Armgroepen
| Arm | Interventie / behandeling |
|---|---|
| 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 |
Geschiktheidscriteria
| Leeftijden die in aanmerking komen voor studie | 45 Years Naar 45 Years |
| Geslachten die in aanmerking komen voor studie | Female |
| Accepteert gezonde vrijwilligers | Ja |
| Criteria | 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 |
Resultaat
Primaire uitkomstmaten
1. Primary Menopause-related symptoms [3 months]
