Effect of Red Clover on Menopause Symptoms and Lipid Profile

January 15, 2024 updated by: Ece Yigit, Medipol University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Pendik /Istanbul
      • Istanbul, Pendik /Istanbul, Turkey, 34893
        • Istanbul Medipol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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. 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)].
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.
Placebo Comparator: placebo
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medipol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2022

Primary Completion (Actual)

September 20, 2023

Study Completion (Actual)

September 20, 2023

Study Registration Dates

First Submitted

December 14, 2023

First Submitted That Met QC Criteria

January 15, 2024

First Posted (Actual)

January 17, 2024

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 15, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • redclover*

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

MRS results and laboratory data can be shared while protecting patients' personal data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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