Effect of Red Clover on Menopause Symptoms and Lipid Profile
Condition: Menopause
Study type: Interventional

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)].
    

Intervention name(s): red clover
Intervention type(s): Dietary Supplement
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: menopause, hyperlipidemia, red clover