Alternative Treatments for Menopausal Women

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02028702
• Other study ID #: Mntl-1877
• Status: Completed
• Phase: N/A
• First received: July 12, 2012
• Last updated: February 5, 2015
• Start date: June 2012
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hot Flushes
• Menopause
• Osteoporosis

Intervention

Dietary Supplement:
• Placebo
water with color
• Red Clover extract
Red Clover extract containing 80 mg Isoflavones. Dosage: 2 X 75 ml/day

Locations

Country	Name	City	State
Denmark	Center for Clinical Research, Hospital Vendsyssel	Hjorring	Nordjylland

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No