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Alternative Treatments for Menopausal Women

Ainult registreeritud kasutajad saavad artikleid tõlkida
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Link salvestatakse lõikelauale
StaatusValmis
Sponsorid
Aarhus University Hospital

Märksõnad

Abstraktne

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.

Kirjeldus

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

Kuupäevad

Viimati kinnitatud: 01/31/2015
Esmalt esitatud: 07/11/2012
Hinnanguline registreerumine on esitatud: 01/05/2014
Esmalt postitatud: 01/06/2014
Viimane värskendus on esitatud: 02/04/2015
Viimati värskendus postitatud: 02/05/2015
Õppe tegelik alguskuupäev: 05/31/2012
Eeldatav esmane lõpetamise kuupäev: 11/30/2014
Eeldatav uuringu lõpetamise kuupäev: 11/30/2014

Seisund või haigus

Menopause
Hot Flushes
Osteoporosis
Dyslipidemia

Sekkumine / ravi

Dietary Supplement: Placebo

Dietary Supplement: Red Clover extract

Faas

-

Käerühmad

ArmSekkumine / ravi
Active Comparator: Red Clover extract
150 ml/d Red Clover extract
Dietary Supplement: Red Clover extract
Red Clover extract containing 80 mg Isoflavones. Dosage: 2 X 75 ml/day
Placebo Comparator: Placebo
150 ml/d sweetened and coloured water
Dietary Supplement: Placebo
water with color

Abikõlblikkuse kriteeriumid

Õppimiseks sobivad vanused 45 Years To 45 Years
Uuringuks kõlblikud soodFemale
Võtab vastu tervislikke vabatahtlikkeJah
Kriteeriumid

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

Tulemus

Esmased tulemusnäitajad

1. Primary Menopause-related symptoms [3 months]

To examine the extent to which red clover extract can reduce the frequency and intensity of hot flashes, sleep disturbances and flush related sweats.

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