Alternative Treatments for Menopausal Women
Primary Purpose
Menopause, Hot Flushes, Osteoporosis
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Placebo
Red Clover extract
Sponsored by
About this trial
This is an interventional treatment trial for Menopause focused on measuring red clover, menopause, bioactive compounds, isoflavones, phytoestrogen
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
Sites / Locations
- Center for Clinical Research, Hospital Vendsyssel
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Red Clover extract
Placebo
Arm Description
150 ml/d Red Clover extract
150 ml/d sweetened and coloured water
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02028702
First Posted
July 12, 2012
Last Updated
February 5, 2015
Sponsor
Aarhus University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02028702
Brief Title
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
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
Menopausal women receiving RC treatment - 150ml/d Red Clover (80mg/d of isoflavones as aglycone)
Menopausal women receiving placebo - 150ml placebo
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopause, Hot Flushes, Osteoporosis, Dyslipidemia
Keywords
red clover, menopause, bioactive compounds, isoflavones, phytoestrogen
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Red Clover extract
Arm Type
Active Comparator
Arm Description
150 ml/d Red Clover extract
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
150 ml/d sweetened and coloured water
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
water with color
Intervention Type
Dietary Supplement
Intervention Name(s)
Red Clover extract
Other Intervention Name(s)
fermentated Red Clover extract
Intervention Description
Red Clover extract containing 80 mg Isoflavones. Dosage: 2 X 75 ml/day
Primary Outcome Measure Information:
Title
Primary Menopause-related symptoms
Description
To examine the extent to which red clover extract can reduce the frequency and intensity of hot flashes, sleep disturbances and flush related sweats.
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per B Jeppesen, Prof
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Clinical Research, Hospital Vendsyssel
City
Hjorring
State/Province
Nordjylland
ZIP/Postal Code
9800
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
28591133
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.
Results Reference
derived
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Alternative Treatments for Menopausal Women
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