NCT02028702

Alternative Treatments for Menopausal Women

Alternative Treatments for Menopausal Women: The Efficacy of a Novel Red Clover Treatment on Menopausal Women.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Aarhus University Hospital · Academic / Other
• Sex: Female
• Age: 45 Years – 65 Years
• Healthy volunteers: Accepted

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

Conditions

• Menopause
• Hot Flushes
• Osteoporosis
• Dyslipidemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo	water with color
DIETARY_SUPPLEMENT	Red Clover extract	Red Clover extract containing 80 mg Isoflavones. Dosage: 2 X 75 ml/day

Timeline

• Start date: 2012-06-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-01-07
• Last updated: 2015-02-06

Locations

1 site across 1 country: Denmark