Alternative Treatments for Menopausal Women
Condition: Menopause; Hot Flushes; Osteoporosis; Dyslipidemia
MeSH terms: Osteoporosis; Dyslipidemias
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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
    

Intervention name(s): Placebo; Red Clover extract
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): water with color; Red Clover extract containing 80 mg Isoflavones. Dosage: 2 X 75 ml/day
Other intervention name(s): fermentated Red Clover extract
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: red clover; menopause; bioactive compounds; isoflavones; phytoestrogen