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Alternative Treatments for Menopausal Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02028702
Recruitment Status : Completed
First Posted : January 7, 2014
Last Update Posted : February 6, 2015
Information provided by (Responsible Party):
Per Bendix Jeppesen, Aarhus University Hospital

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.

Condition or disease Intervention/treatment Phase
Menopause Hot Flushes Osteoporosis Dyslipidemia Dietary Supplement: Placebo Dietary Supplement: Red Clover extract Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Alternative Treatments for Menopausal Women: The Efficacy of a Novel Red Clover Treatment on Menopausal Women.
Study Start Date : June 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause
Drug Information available for: Red clover

Arm Intervention/treatment
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
Other Name: fermentated Red Clover extract

Placebo Comparator: Placebo
150 ml/d sweetened and coloured water
Dietary Supplement: Placebo
water with color

Primary Outcome Measures :
  1. Primary Menopause-related symptoms [ Time Frame: 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02028702

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Center for Clinical Research, Hospital Vendsyssel
Hjorring, Nordjylland, Denmark, 9800
Sponsors and Collaborators
Aarhus University Hospital
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Principal Investigator: Per B Jeppesen, Prof Aarhus University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Per Bendix Jeppesen, Associate Prof., PhD, Aarhus University Hospital Identifier: NCT02028702    
Other Study ID Numbers: Mntl-1877
First Posted: January 7, 2014    Key Record Dates
Last Update Posted: February 6, 2015
Last Verified: February 2015
Keywords provided by Per Bendix Jeppesen, Aarhus University Hospital:
red clover
bioactive compounds
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Lipid Metabolism Disorders