MenopauseNCT02028702
Alternative Treatments for Menopausal Women
A study testing Red Clover extract in people with Menopause and Hot Flushes, run by Aarhus University Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Hot Flushes, Osteoporosis
- What is being tested?
- Red Clover extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Clinical Research, Hospital Vendsyssel
Hjørring, North Denmark, 9800
About this study
Official title: 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.
Read the 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
- Conditions
- Menopause, Hot Flushes, Osteoporosis, Dyslipidemia
- Being tested
- Placebo, Red Clover extract
- Keywords
- red clover, menopause, bioactive compounds, isoflavones, phytoestrogen
- Medical subject headings
- Hot Flashes, Osteoporosis, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
water with color
Red Clover extractDietary supplement
Also called fermentated Red Clover extract
Red Clover extract containing 80 mg Isoflavones. Dosage: 2 X 75 ml/day
| Study group | Role | What they receive |
|---|---|---|
| Red Clover extract | Active comparator | 150 ml/d Red Clover extract Receives: Dietary Supplement: Red Clover extract |
| Placebo | Placebo comparator | 150 ml/d sweetened and coloured water Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startJun 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Bendix Jeppesen, Aarhus University Hospital
- Investigators
- Per B Jeppesen, Prof, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02028702
- Sponsor's protocol ID
- Mntl-1877
- Status last verified
- Feb 2015
- First submitted
- 12 Jul 2012
- Last updated
- 6 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 28591133
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alternative Treatments for Menopausal Women: The Efficacy of a Novel Red Clover Treatment on Menopausal Women.
- ClinicalTrials.gov ID
- NCT02028702
- Acronym / sponsor ID
- Mntl-1877
- Conditions
- Menopause, Hot Flushes, Osteoporosis, Dyslipidemia
- Keywords
- red clover, menopause, bioactive compounds, isoflavones, phytoestrogen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 7 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Red Clover extract | Active comparator | Dietary Supplement: Red Clover extract150 ml/d Red Clover extract |
| Placebo | Placebo comparator | Dietary Supplement: Placebo150 ml/d sweetened and coloured water |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebowater with color | Dietary supplement | Placebo |
| Red Clover extractAlso: fermentated Red Clover extractRed Clover extract containing 80 mg Isoflavones. Dosage: 2 X 75 ml/day | Dietary supplement | Red Clover extract |
Primary outcome
Primary Menopause-related symptoms
Time frame: 3 months
To examine the extent to which red clover extract can reduce the frequency and intensity of hot flashes, sleep disturbances and flush related sweats.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2015.
- Derived from this study: PubMed 28591133Lambert 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per B Jeppesen, Prof principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red Clover extract in people with Menopause and Hot Flushes, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Menopause-related symptoms (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02028702, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2015.