Alternative Treatments for Menopausal Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Aarhus University Hospital
Sponsor:
Information provided by (Responsible Party):
Per Bendix Jeppesen, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT02028702
First received: July 12, 2012
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

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 Intervention
Menopause
Hot Flushes
Osteoporosis
Dyslipidemia
Dietary Supplement: Placebo
Dietary Supplement: Red Clover extract

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Alternative Treatments for Menopausal Women: The Efficacy of a Novel Red Clover Treatment on Menopausal Women.

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:
  • Primary Menopause-related symptoms [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    To examine the extent to which red clover extract can reduce the frequency and intensity of hot flashes, sleep disturbances and flush related sweats.


Estimated Enrollment: 61
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02028702

Contacts
Contact: Per B Jeppesen, Prof +45 22896616 per.bendix.jeppesen@ki.au.dk
Contact: Anne C Thorup, MSc Phd Stud +45 22896616 anne.cathrine.thorup@ki.au.dk

Locations
Denmark
Center for Clinical Research, Hospital Vendsyssel Recruiting
Hjorring, Nordjylland, Denmark, 9800
Contact: Per B Jeppesen, Prof. PhD    +45 28151877    per.bendix.jeppesen@ki.au.dk   
Principal Investigator: Per B Jeppesen, prof., PhD         
Sub-Investigator: Anne C Thorup, PhD-stud         
Sub-Investigator: Max NT Lambert, PhD-stud         
Sponsors and Collaborators
Aarhus University Hospital
Investigators
Principal Investigator: Per B Jeppesen, Prof Aarhus University Hospital
  More Information

No publications provided

Responsible Party: Per Bendix Jeppesen, Associate Prof., PhD, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT02028702     History of Changes
Other Study ID Numbers: Mntl-1877
Study First Received: July 12, 2012
Last Updated: July 8, 2014
Health Authority: Denmark: Ethics Committee

Keywords provided by Aarhus University Hospital:
red clover
menopause
bioactive compounds
isoflavones
phytoestrogen

Additional relevant MeSH terms:
Osteoporosis
Dyslipidemias
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014