Alternative Treatments for Menopausal Women

Alternative Treatments for Menopausal Women: The Efficacy of a Novel Red Clover Treatment on Menopausal Women.

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.

Study Overview

• Status: Completed
• Conditions: Dyslipidemia; Menopause; Osteoporosis; Hot Flushes
• Intervention / Treatment: Dietary supplement: Red Clover extract; Dietary supplement: Placebo

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

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Nordjylland
    • Hjorring, Nordjylland, Denmark, 9800
      • Center for Clinical Research, Hospital Vendsyssel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: fermentated Red Clover extract
Placebo Comparator: Placebo; 150 ml/d sweetened and coloured water	Dietary supplement: Placebo; water with color

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Investigators: Principal Investigator: Per B Jeppesen, Prof, Aarhus University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: July 12, 2012
• First Submitted That Met QC Criteria: January 6, 2014
• First Posted (Estimate): January 7, 2014

Study Record Updates

• Last Update Posted (Estimate): February 6, 2015
• Last Update Submitted That Met QC Criteria: February 5, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: menopause; isoflavones; phytoestrogen; bioactive compounds; red clover
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Lipid Metabolism Disorders; Bone Diseases, Metabolic; Dyslipidemias; Osteoporosis
• Other Study ID Numbers: Mntl-1877