Effect of Red Clover on Menopause Symptoms and Lipid Profile

Medipol University

Status: Completed

Conditions: Menopause

Treatments: Dietary Supplement: red clover

Study type: Interventional

Funder types: Other

Identifiers

NCT06209697

redclover*

Details and patient eligibility

About

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.

Full 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)].

Enrollment: 82 patients

Sex: Female

Ages: 45 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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82 participants in 2 patient groups, including a placebo group

red clover

Active Comparator group

Description:

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 \[genistein (1 mg), daidzein (1 mg), biochanin A (23 mg) and biochanin B (formononetin, 15 mg)\].

Treatment:

Dietary Supplement: red clover

placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: red clover