Alternative Treatments for Menopausal Women

Study Overview
=================
Brief 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: Menopausal women receiving RC treatment - 150ml/d Red Clover (80mg/d of isoflavones as aglycone) Menopausal women receiving placebo - 150ml placebo

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

Conditions
-----------------
Menopause, Hot Flushes, Osteoporosis, Dyslipidemia

Intervention / Treatment
-----------------
* Dietary Supplement: Placebo
* Dietary Supplement: Red Clover extract


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Red Clover extract<br>150 ml/d Red Clover extract | Dietary Supplement: Red Clover extract<br>* Red Clover extract containing 80 mg Isoflavones. Dosage: 2 X 75 ml/day<br>* Other names: fermentated Red Clover extract;|
| Placebo Comparator: Placebo<br>150 ml/d sweetened and coloured water | Dietary Supplement: Placebo<br>* water with color<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Menopause-related symptoms | To examine the extent to which red clover extract can reduce the frequency and intensity of hot flashes, sleep disturbances and flush related sweats. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
red clover, menopause, bioactive compounds, isoflavones, phytoestrogen