NCT06209697

Effect of Red Clover on Menopause Symptoms and Lipid Profile

Isoflavones Obtained From Red Clover Improves Both Dyslipidemia and Menopausal Symptoms in Menopausal Women: a Prospective Randomized Placebo-controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Medipol University · Academic / Other
• Sex: Female
• Age: 45 Years – 55 Years
• Healthy volunteers: Accepted

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 \[red clover (n = 39), placebo (n = 36)\].

Conditions

• Menopause

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	red 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.

Timeline

• Start date: 2022-03-20
• Primary completion: 2023-09-20
• Completion: 2023-09-20
• First posted: 2024-01-17
• Last updated: 2024-01-17

Locations

1 site across 1 country: Turkey (Türkiye)