MenopauseNCT06209697
Effect of Red Clover on Menopause Symptoms and Lipid Profile
A study testing red clover in people with Menopause, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to investigate the effects of red clover isoflavones on menopausal symptoms and lipid profile in menopausal females.This prospective randomized, double-blind, placebo-controlled study included postmenopausal women with dyslipidemia. Read more about this study
- Who is it for?
- Ages 45 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- red clover
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2022to 20 Sep 2023
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- History of amenorrhea for at least 12 months
- Being aged 45-55
- Having received a diagnosis of dyslipidemia (at the present admission or within the past 3 months)
- Not receiving treatment for dyslipidemia
- Absence of other chronic diseases
- Follicle stimulating hormone level of >40 pg/mL
- Body mass index (BMI) of <30 kg/m2
Who cannot join
- Currently or previously undergoing hormone replacement therapy (either in the past, immediately before, or during the study)
- Using any phytotherapeutic drug
- Diagnosed with diabetes
- Presence of anemia
- Presence of cardiovascular disease Presence of musculoskeletal disease
- Presence of asthma / chronic obstructive pulmonary disease
Show all 15Show fewer
- Presence of malignancy
- Prsence of genital or gynecological disease (excluding menopausal symptoms)
- Presence of neurological or psychiatric disease
- Conditions involving acute or chronic inflammation
- Experiencing acute or chronic infection
- Displaying abnormal liver, kidney, or thyroid function tests
- Engaging in smoking, alcohol consumption, or drug use
- Suffering from sexual dysfunction (except for menopause-related reasons)
- Unable to complete the study, or not attending 3-month or 6-month follow-up
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Pendik /Istanbul, 34893
About this study
Official title: Isoflavones Obtained From Red Clover Improves Both Dyslipidemia and Menopausal Symptoms in Menopausal Women: a Prospective Randomized Placebo-controlled Trial
The goal of this clinical trial is to investigate the effects of red clover isoflavones on menopausal symptoms and lipid profile in menopausal females.This prospective randomized, double-blind, placebo-controlled study included postmenopausal women with dyslipidemia. The red clover group received 40 mg isoflavone red clover capsule twice daily for 6 months, while placebo was 40 mg starch capsules, twice daily. Data were collected at baseline, 3 months and 6 months. The study was completed with 75 subjects [red clover (n = 39), placebo (n = 36)]. Menopause Rating Scale (MRS) was applied to calculate subdimension and total scores. Blood lipid profile, including total cholesterol, low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C) and triglyceride levels were measured.
Read the detailed description
The goal of this clinical trial is to investigate the effects of red clover isoflavones on menopausal symptoms and lipid profile in menopausal females. This was a prospective, randomized, double-blind, placebo-controlled study conducted between March 2022 and September 2023 in the Departments of Gynecology and Internal Medicine of Medipol University Hospital, Istanbul, Turkey. The subjects were divided into two groups: red clover and placebo groups. For the randomization process, patients were provided with slips of paper bearing numbers starting from 1, assigned based on the order of admission by the admitting physician. Subsequently, they were directed to the appropriate nurse. The outpatient clinic nurse assigned red clover treatment to subjects with an odd-numbered slip and placebo to those with an even-numbered slip. The nurse documented the medication assigned to each patient, while the researchers and subjects remained blinded to this information. Red clover (Promensil, PharmaCare Europe Ltd., UK) and placebo (starch capsules) were administered orally twice a day with an interval of 12 hours for a total period of 6 months. Red clover capsules contained 40 mg of standardized red clover isoflavones in each capsule [genistein (1 mg), daidzein (1 mg), biochanin A (23 mg) and biochanin B (formononetin, 15 mg)]. Placebo capsules were ordered to be prepared with the same color, taste and smell as the red cover capsules. The patients' total cholesterol, low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C) and triglyceride levels were measured using the enzymatic colorimetric method (Hitachi 747 autoanalyzer; Germany) from antecubital venous blood samples taken at 8 AM after a 12-hour overnight fast at baseline, at 3-month follow-up and at 6-month follow-up. The severity of menopausal symptoms was assessed utilizing the Menopause Rating Scale (MRS). Data were collected at baseline, 3 months and 6 months. The study was completed with 75 subjects [red clover (n = 39), placebo (n = 36)].
- Conditions
- Menopause
- Being tested
- red clover
- Keywords
- menopause, hyperlipidemia, red clover
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
red cloverDietary supplement
Red clover (Promensil, PharmaCare Europe Ltd., UK) and placebo (starch capsules) were administered orally twice a day with an interval of 12 hours for a total period of 6 months.
| Study group | Role | What they receive |
|---|---|---|
| red clover | Active comparator | Red clover (Promensil, PharmaCare Europe Ltd., UK) and placebo (starch capsules) were administered orally twice a day with an interval of 12 hours for a total period of 6 months. Red clover capsules contained 40 mg of standardized red clover isoflavones in each capsule [genistein (1 mg), daidzein (1 mg), biochanin A (23 mg) and biochanin B (formononetin, 15 mg)]. Receives: Dietary Supplement: red clover |
| placebo | Placebo comparator | Placebo capsules were ordered to be prepared with the same color, taste and smell as the red cover capsules. Placebo capsules were administered orally twice a day with an interval of 12 hours for a total period of 6 months. Receives: Dietary Supplement: red clover |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measures were to assess the differences in MRS scores (somatic, psychological, urogenital and total score) and lipid profile (total cholesterol, LDL-C, HDL-C and triglyceride levels).
The patients' total cholesterol, low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C) and triglyceride levels were measured using the enzymatic colorimetric method (Hitachi 747 autoanalyzer; Germany) from antecubital venous blood samples taken at 8 AM after a 12-hour overnight fast at baseline, at 3-month follow-up and at 6-month follow-up. Values of the lipid profile were measured in mg/dl. The severity of menopausal symptoms was assessed utilizing the Menopause Rating Scale (MRS). MRS is a questionnaire consisting of 11 questions under 3 main categories, namely, the somatic disorders, psychological disorders, urogenital disorders. Each question is scored as 0 (no complaints), 1 (mild), 2 (moderate), 3 (severe) and 4 (very severe) based on the perceived severity of respondents.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start20 Mar 2022
- Primary completion20 Sep 2023
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study included postmenopausal women who had naturally entered menopause and had applied to the outpatient clinics of Istanbul Medipol University Internal Medicine or Gynecology Departments with symptoms of menopause. Other inclusion criteria were: having a history of amenorrhea for at least 12 months, being aged 45-55, having received a diagnosis of dyslipidemia (at the present admission or within the past 3 months), not receiving treatment for dyslipidemia, absence of other chronic diseases, having a follicle stimulating hormone level of \>40 pg/mL and having a body mass index (BMI) of \<30 kg/m2.The subjects were divided into two groups: red clover and placebo groups.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ece Yigit, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209697
- Sponsor's protocol ID
- redclover*
- Status last verified
- Jan 2024
- First submitted
- 14 Dec 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: MRS results and laboratory data can be shared while protecting patients' personal data.
Publications
Shakeri F, Taavoni S, Goushegir A, Haghani H. Effectiveness of red clover in alleviating menopausal symptoms: a 12-week randomized, controlled trial. Climacteric. 2015;18(4):568-73. doi: 10.3109/13697137.2014.999660. Epub 2015 Feb 24.
PubMed 25581426Kanadys W, Baranska A, Blaszczuk A, Polz-Dacewicz M, Drop B, Kanecki K, Malm M. Evaluation of Clinical Meaningfulness of Red Clover (Trifolium pratense L.) Extract to Relieve Hot Flushes and Menopausal Symptoms in Peri- and Post-Menopausal Women: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Nutrients. 2021 Apr 11;13(4):1258. doi: 10.3390/nu13041258.
PubMed 33920485Luis A, Domingues F, Pereira L. Effects of red clover on perimenopausal and postmenopausal women's blood lipid profile: A meta-analysis. Climacteric. 2018 Oct;21(5):446-453. doi: 10.1080/13697137.2018.1501673.
PubMed 30269660Hidalgo LA, Chedraui PA, Morocho N, Ross S, San Miguel G. The effect of red clover isoflavones on menopausal symptoms, lipids and vaginal cytology in menopausal women: a randomized, double-blind, placebo-controlled study. Gynecol Endocrinol. 2005 Nov;21(5):257-64. doi: 10.1080/09513590500361192.
PubMed 16373244Campbell MJ, Woodside JV, Honour JW, Morton MS, Leathem AJ. Effect of red clover-derived isoflavone supplementation on insulin-like growth factor, lipid and antioxidant status in healthy female volunteers: a pilot study. Eur J Clin Nutr. 2004 Jan;58(1):173-9. doi: 10.1038/sj.ejcn.1601764.
PubMed 14679383Yigit E, Unsal S. Isoflavones obtained from red clover improve both dyslipidemia and menopausal symptoms in menopausal women: a prospective randomized placebo-controlled trial. Climacteric. 2024 Dec;27(6):548-554. doi: 10.1080/13697137.2024.2393121. Epub 2024 Sep 10.
PubMed 39254422
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isoflavones Obtained From Red Clover Improves Both Dyslipidemia and Menopausal Symptoms in Menopausal Women: a Prospective Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06209697
- Acronym / sponsor ID
- redclover*
- Conditions
- Menopause
- Keywords
- menopause, hyperlipidemia, red clover
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 20 Mar 2022 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 17 Jan 2024 (actual)
- 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.
The goal of this clinical trial is to investigate the effects of red clover isoflavones on menopausal symptoms and lipid profile in menopausal females.This prospective randomized, double-blind, placebo-controlled study included postmenopausal women with dyslipidemia. The red clover group received 40 mg isoflavone red clover capsule twice daily for 6 months, while placebo was 40 mg starch capsules, twice daily. Data were collected at baseline, 3 months and 6 months. The study was completed with 75 subjects [red clover (n = 39), placebo (n = 36)]. Menopause Rating Scale (MRS) was applied to calculate subdimension and total scores. Blood lipid profile, including total cholesterol, low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C) and triglyceride levels were measured.
Detailed description
The goal of this clinical trial is to investigate the effects of red clover isoflavones on menopausal symptoms and lipid profile in menopausal females. This was a prospective, randomized, double-blind, placebo-controlled study conducted between March 2022 and September 2023 in the Departments of Gynecology and Internal Medicine of Medipol University Hospital, Istanbul, Turkey. The subjects were divided into two groups: red clover and placebo groups. For the randomization process, patients were provided with slips of paper bearing numbers starting from 1, assigned based on the order of admission by the admitting physician. Subsequently, they were directed to the appropriate nurse. The outpatient clinic nurse assigned red clover treatment to subjects with an odd-numbered slip and placebo to those with an even-numbered slip. The nurse documented the medication assigned to each patient, while the researchers and subjects remained blinded to this information. Red clover (Promensil, PharmaCare Europe Ltd., UK) and placebo (starch capsules) were administered orally twice a day with an interval of 12 hours for a total period of 6 months. Red clover capsules contained 40 mg of standardized red clover isoflavones in each capsule [genistein (1 mg), daidzein (1 mg), biochanin A (23 mg) and biochanin B (formononetin, 15 mg)]. Placebo capsules were ordered to be prepared with the same color, taste and smell as the red cover capsules. The patients' total cholesterol, low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C) and triglyceride levels were measured using the enzymatic colorimetric method (Hitachi 747 autoanalyzer; Germany) from antecubital venous blood samples taken at 8 AM after a 12-hour overnight fast at baseline, at 3-month follow-up and at 6-month follow-up. The severity of menopausal symptoms was assessed utilizing the Menopause Rating Scale (MRS). Data were collected at baseline, 3 months and 6 months. The study was completed with 75 subjects [red clover (n = 39), placebo (n = 36)].
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study included postmenopausal women who had naturally entered menopause and had applied to the outpatient clinics of Istanbul Medipol University Internal Medicine or Gynecology Departments with symptoms of menopause. Other inclusion criteria were: having a history of amenorrhea for at least 12 months, being aged 45-55, having received a diagnosis of dyslipidemia (at the present admission or within the past 3 months), not receiving treatment for dyslipidemia, absence of other chronic diseases, having a follicle stimulating hormone level of >40 pg/mL and having a body mass index (BMI) of <30 kg/m2.The subjects were divided into two groups: red clover and placebo groups.
| Arm | Type | Receives |
|---|---|---|
| red clover | Active comparator | Dietary Supplement: red cloverRed clover (Promensil, PharmaCare Europe Ltd., UK) and placebo (starch capsules) were administered orally twice a day with an interval of 12 hours for a total period of 6 months. Red clover capsules contained 40 mg of standardized red clover isoflavones in each capsule [genistein (1 mg), daidzein (1 mg), biochanin A (23 mg) and biochanin B (formononetin, 15 mg)]. |
| placebo | Placebo comparator | Dietary Supplement: red cloverPlacebo capsules were ordered to be prepared with the same color, taste and smell as the red cover capsules. Placebo capsules were administered orally twice a day with an interval of 12 hours for a total period of 6 months. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- History of amenorrhea for at least 12 months
- Being aged 45-55
- Having received a diagnosis of dyslipidemia (at the present admission or within the past 3 months)
- Not receiving treatment for dyslipidemia
- Absence of other chronic diseases
Key exclusion criteria (15 listed)
- Currently or previously undergoing hormone replacement therapy (either in the past, immediately before, or during the study)
- Using any phytotherapeutic drug
- Diagnosed with diabetes
- Presence of anemia
- Presence of cardiovascular disease Presence of musculoskeletal disease
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 |
|---|---|---|
| red cloverRed clover (Promensil, PharmaCare Europe Ltd., UK) and placebo (starch capsules) were administered orally twice a day with an interval of 12 hours for a total period of 6 months. | Dietary supplement | placebo, red clover |
Primary outcome
The primary outcome measures were to assess the differences in MRS scores (somatic, psychological, urogenital and total score) and lipid profile (total cholesterol, LDL-C, HDL-C and triglyceride levels).
Time frame: 6 months
The patients' total cholesterol, low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C) and triglyceride levels were measured using the enzymatic colorimetric method (Hitachi 747 autoanalyzer; Germany) from antecubital venous blood samples taken at 8 AM after a 12-hour overnight fast at baseline, at 3-month follow-up and at 6-month follow-up. Values of the lipid profile were measured in mg/dl. The severity of menopausal symptoms was assessed utilizing the Menopause Rating Scale (MRS). MRS is a questionnaire consisting of 11 questions under 3 main categories, namely, the somatic disorders, psychological disorders, urogenital disorders. Each question is scored as 0 (no complaints), 1 (mild), 2 (moderate), 3 (severe) and 4 (very severe) based on the perceived severity of respondents.
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 17 Jan 2024.
- Results publication: PubMed 25581426Shakeri F, Taavoni S, Goushegir A, Haghani H. Effectiveness of red clover in alleviating menopausal symptoms: a 12-week randomized, controlled trial. Climacteric. 2015;18(4):568-73. doi: 10.3109/13697137.2014.999660. Epub 2015 Feb 24.
- Results publication: PubMed 33920485Kanadys W, Baranska A, Blaszczuk A, Polz-Dacewicz M, Drop B, Kanecki K, Malm M. Evaluation of Clinical Meaningfulness of Red Clover (Trifolium pratense L.) Extract to Relieve Hot Flushes and Menopausal Symptoms in Peri- and Post-Menopausal Women: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Nutrients. 2021 Apr 11;13(4):1258. doi: 10.3390/nu13041258.
- Results publication: PubMed 30269660Luis A, Domingues F, Pereira L. Effects of red clover on perimenopausal and postmenopausal women's blood lipid profile: A meta-analysis. Climacteric. 2018 Oct;21(5):446-453. doi: 10.1080/13697137.2018.1501673.
- Results publication: PubMed 16373244Hidalgo LA, Chedraui PA, Morocho N, Ross S, San Miguel G. The effect of red clover isoflavones on menopausal symptoms, lipids and vaginal cytology in menopausal women: a randomized, double-blind, placebo-controlled study. Gynecol Endocrinol. 2005 Nov;21(5):257-64. doi: 10.1080/09513590500361192.
- Results publication: PubMed 14679383Campbell MJ, Woodside JV, Honour JW, Morton MS, Leathem AJ. Effect of red clover-derived isoflavone supplementation on insulin-like growth factor, lipid and antioxidant status in healthy female volunteers: a pilot study. Eur J Clin Nutr. 2004 Jan;58(1):173-9. doi: 10.1038/sj.ejcn.1601764.
- Derived from this study: PubMed 39254422Yigit E, Unsal S. Isoflavones obtained from red clover improve both dyslipidemia and menopausal symptoms in menopausal women: a prospective randomized placebo-controlled trial. Climacteric. 2024 Dec;27(6):548-554. doi: 10.1080/13697137.2024.2393121. Epub 2024 Sep 10.
- Individual participant dataSharing planned: Yes. MRS results and laboratory data can be shared while protecting patients' personal data.
Related trials for Menopause
Recruiting
Hop Extract Versus Soy Isoflavone Extract for Menopausal Symptoms (HOPES)
Menopause, Perimenopause
Not yet recruiting
The Role of Diet Quality in Sleep Among Women in Postmenopause
Post Menopausal Women
Active, not recruitingPhase 3
Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
Infertility (IVF Patients)
Not yet recruiting
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
RecruitingObservational study
Observational Study of Bone Complications in People With Post-menopausal Breast Cancer Who Have Stopped Treatment With Denosumab and Aromatase Inhibitors
Breast Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Menopause, run by Medipol University at 1 site in Turkey (Türkiye).
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 7 inclusion and 15 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 17 Jan 2024. 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 Turkey (Türkiye). 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?
The primary outcome measures were to assess the differences in MRS scores (somatic, psychological, urogenital and total score) and lipid profile (total cholesterol, LDL-C, HDL-C and triglyceride levels). (time frame: 6 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 NCT06209697, which also lists 6 linked publications.
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 17 Jan 2024.