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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
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menopause focused on measuring red clover, menopause, bioactive compounds, isoflavones, phytoestrogen

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

First Posted
July 12, 2012
Last Updated
February 5, 2015
Sponsor
Aarhus University Hospital
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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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