Menopause | Alternative Treatments for Menopausal Women
Menopause research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Dietary Supplement:Placebowater with color
Dietary Supplement:Red Clover extractRed Clover extract containing 80 mg Isoflavones. Dosage: 2 X 75 ml/day
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Red Clover extract150 ml/d Red Clover extract
Placebo150 ml/d sweetened and coloured water
Start Date: June 2012
Completed Date: December 2014
Primary Outcome: Primary Menopause-related symptoms
Study sponsors, principal investigator, and references
Principal Investigator: Per B Jeppesen, Prof
Lead Sponsor: Aarhus University Hospital