Effect of Red Clover on Menopause Symptoms and Lipid Profile

NCT06209697 | Completed

• 1 other identifier: redclover*
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause

Keywords

menopause, hyperlipidemia, red clover

Outcome Measures

Primary Outcomes (1)

• 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).

  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

Study Arms (2)

red clover

ACTIVE COMPARATOR

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

placebo

PLACEBO COMPARATOR

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

Interventions

red clover DIETARY_SUPPLEMENT

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; red clover

Eligibility Criteria

• Age: 45 Years - 55 Years
• Gender Eligibility Details: The study evaluates women in the postmenopausal period.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Pendik /Istanbul, 34893, Turkey (Türkiye)

Location

Related Publications (5)

• Shakeri F, Taavoni S, Goushegir A, Haghani H. Effectiveness of red clover in alleviating menopausal symptoms: a 12-week randomized, controlled trial. Climacteric. 2015;18(4):568-73. doi: 10.3109/13697137.2014.999660. Epub 2015 Feb 24.

  PMID: 25581426 RESULT

• Kanadys W, Baranska A, Blaszczuk A, Polz-Dacewicz M, Drop B, Kanecki K, Malm M. Evaluation of Clinical Meaningfulness of Red Clover (Trifolium pratense L.) Extract to Relieve Hot Flushes and Menopausal Symptoms in Peri- and Post-Menopausal Women: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Nutrients. 2021 Apr 11;13(4):1258. doi: 10.3390/nu13041258.

  PMID: 33920485 RESULT

• Luis A, Domingues F, Pereira L. Effects of red clover on perimenopausal and postmenopausal women's blood lipid profile: A meta-analysis. Climacteric. 2018 Oct;21(5):446-453. doi: 10.1080/13697137.2018.1501673.

  PMID: 30269660 RESULT

• Hidalgo LA, Chedraui PA, Morocho N, Ross S, San Miguel G. The effect of red clover isoflavones on menopausal symptoms, lipids and vaginal cytology in menopausal women: a randomized, double-blind, placebo-controlled study. Gynecol Endocrinol. 2005 Nov;21(5):257-64. doi: 10.1080/09513590500361192.

  PMID: 16373244 RESULT

• Campbell MJ, Woodside JV, Honour JW, Morton MS, Leathem AJ. Effect of red clover-derived isoflavone supplementation on insulin-like growth factor, lipid and antioxidant status in healthy female volunteers: a pilot study. Eur J Clin Nutr. 2004 Jan;58(1):173-9. doi: 10.1038/sj.ejcn.1601764.

  PMID: 14679383 RESULT

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator / Asst. Prof. Dr.

Model Details: 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.

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: January 17, 2024
• Study Start: March 20, 2022
• Primary Completion: September 20, 2023
• Study Completion: September 20, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

TU (1)