Osteoporosis Clinical Trial
Official title:
Alternative Treatments for Menopausal Women: The Efficacy of a Novel Red Clover Treatment on Menopausal Women.
To investigate the reported health benefits (lipid profile, inflammatory factors, cardiovascular status and bone density) of a novel, phytoestrogen rich, Red Clover treatment on women suffering from both menopause related primary (hot flushes, night sweats, sleep disturbance and weight gain) and secondary (osteoporosis, cardiovascular and changes in lipid metabolism) symptoms.
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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