Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
61 participants
INTERVENTIONAL
2012-06-30
2014-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Use of Black Cohosh and Red Clover for the Relief of Menopausal Symptoms
NCT00066144
Effect of Red Clover on Menopause Symptoms and Lipid Profile
NCT06209697
Single-Dose Study of Black Cohosh and Red Clover
NCT00010959
Diet, Cardiometabolic Risk (CM) and Menopause Symptoms
NCT05764473
Dose Finding Evaluation of Kudzu Root Extract in Women With Menopause Symptoms
NCT04552106
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Red Clover extract
150 ml/d Red Clover extract
Red Clover extract
Red Clover extract containing 80 mg Isoflavones. Dosage: 2 X 75 ml/day
Placebo
150 ml/d sweetened and coloured water
Placebo
water with color
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
water with color
Red Clover extract
Red Clover extract containing 80 mg Isoflavones. Dosage: 2 X 75 ml/day
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Experiencing daily hot flushes
* Body Mass Index (BMI) between 20-40
* Irregular menstrual bleeding
* FSH levels above the normal range
Exclusion Criteria
* Severe cardiovascular, psychiatric, neurological, and/or kidney disease.
* Alcohol or drug abuse and acute illness.
* Blood pressure \> 160/110
* Pregnant and lactating women
45 Years
65 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Aarhus University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Per Bendix Jeppesen
Associate Prof., PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Per B Jeppesen, Prof
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Center for Clinical Research, Hospital Vendsyssel
Hjørring, North Denmark, Denmark
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Mntl-1877
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.