Clinical trial NCT02028702: Alternative Treatments for Menopausal Women
Official title: Alternative Treatments for Menopausal Women: The Efficacy of a Novel Red Clover Treatment on Menopausal Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Hot Flushes
Osteoporosis
Dyslipidemia
Keywords: red clover
menopause
bioactive compounds
isoflavones
phytoestrogen
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2014-01-07
Enrollment: 61
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

1. Menopausal women receiving RC treatment - 150ml/d Red Clover (80mg/d of isoflavones as aglycone)
2. Menopausal women receiving placebo - 150ml placebo

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

Primary outcomes:
measure: Primary Menopause-related symptoms
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hjorring
country: Denmark
facility: Center for Clinical Research, Hospital Vendsyssel
state: Nordjylland
Study officials:
affiliation: Aarhus University Hospital
name: Per B Jeppesen, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lambert MNT, Thorup AC, Hansen ESS, Jeppesen PB. Combined Red Clover isoflavones and probiotics potently reduce menopausal vasomotor symptoms. PLoS One. 2017 Jun 7;12(6):e0176590. doi: 10.1371/journal.pone.0176590. eCollection 2017.