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Alternative Treatments for Menopausal Women

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02028702
Enrollment
61
Registered
2014-01-07
Start date
2012-06-30
Completion date
2014-12-31
Last updated
2015-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia, Hot Flushes, Menopause, Osteoporosis

Keywords

red clover, menopause, bioactive compounds, isoflavones, phytoestrogen

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

Interventions

DIETARY_SUPPLEMENTPlacebo

water with color

DIETARY_SUPPLEMENTRed Clover extract

Red Clover extract containing 80 mg Isoflavones. Dosage: 2 X 75 ml/day

Sponsors

Aarhus University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Primary Menopause-related symptoms3 monthsTo examine the extent to which red clover extract can reduce the frequency and intensity of hot flashes, sleep disturbances and flush related sweats.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026