Menopause
Conditions
Keywords
menopause, hyperlipidemia, red clover
Brief 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. 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 \[red clover (n = 39), placebo (n = 36)\].
Interventions
DIETARY_SUPPLEMENTred clover
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.
Sponsors
Medipol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
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
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed