Soy Isoflavonates Versus Placebo on Quality of Life in Menopausal Women (FLAVOCAV)

Soy Isoflavonates Versus Placebo on Quality of Life in Menopausal Women: Randomized Double-blind Clinical Trial: FLAVOCAV TRIAL

Within the context of the proposed research study, the effect of soy isoflavonoid supplements on the quality of life and coagulation of menopausal women. It has been observed that menopause, as a physiological process, is associated with alterations in the physical, mental and sexual quality of life, making the use of hormone replacement therapy necessary; however, hormone therapy is associated with hypercoagulability, since it has been seen that women have higher levels of thrombogenic microvesicles such as: platelets with a greater probability of causing blood clotting were more likely to present a greater amount of white matter hyperintensities, which appear in the MRI scan.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Menopause; Menopausal Women; Soy Isoflavone Effect
• Intervention / Treatment: Dietary supplement: Soy isoflavone supplement; Other: Control (placebo) group

Detailed Description

The following study is aimed at clarifying the effects of soy isoflavonate supplements on the quality of life and markers of hypercoagulability in menopausal women. The reasons for conducting this research arise from the concern of minimizing side effects such as hypercoagulation caused by hormone replacement therapy, which is intended to be replaced with soy isoflavonates to evaluate its efficacy.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Honduras
  • FM
    • Tegucigalpa, FM, Honduras, 11101
      • Hospital Escuela

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Submission of a signed and dated informed consent form.
• Declared willingness to comply with all study procedures and availability for the duration of the study.
• Can read and write
• Female, age 45 to 65 years
• Female with more than 1 year of amenorrhea.
• No hormone replacement therapy or herbal medications in the 6 months prior to the investigation.
• Ability to take oral medication and willing to comply with the <study intervention regimen.
• Agreement to comply with Lifestyle Considerations for the duration of the study.
• Have a smartphone-type cell phone
• Residence in Francisco Morazán

Exclusion Criteria:

• Patient does not sign informed consent
• Patient does not wish to participate
• History of thrombo embolism
• History of cardiovascular disease
• Presence of estrogen-dependent neoplasm
• Presence of abnormal genital bleeding
• Uncontrolled metabolic diseases
• Smoking and drinking habits
• Use of anticoagulant or acetylsalicylic acid
• Known allergic reactions to soy isoflavonate components
• History of thrombophilias such as: Antithrombin deficiency, Protein C deficiency, Protein S deficiency, Factor V Leiden, Prothrombin G20210A, Hyperhomocysteinemia, Antiphospholipid syndrome, Acquired activated protein C resistance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 2 capsules containing 10 mg natural tocotrienols, 40 mg soy isoflavonoids, 540 mg calcium, vitamin D IU.	Dietary supplement: Soy isoflavone supplement; 2 capsules containing 10 mg natural tocotrienols, 40 mg soy isoflavonoids, 540 mg calcium, vitamin D IU.
Placebo Comparator: control; 2 placebo capsules containing a multivitamin compound.	Other: Control (placebo) group; 2 placebo capsules containing a multivitamin compound.; Other Names: Multivitamin compound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MENCAV	Change in MENCAV questionnaire scores, with 37 items likert type scale, the lowest point is zero and the maximun is 259 points	One month from the first intervention until 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
D-dimer	Changes in D-dimer values	One month from the first intervention until 6 months
side effects	incidence of side effects of soy isoflavones.	One month from the first intervention until 6 months

Collaborators and Investigators

• Sponsor: Universidad Nacional Autonoma de Honduras
• Investigators: Study Director: Ricardo A. Gutierrez Ramirez, MD, MSc, Universidad Nacional Autonoma de Honduras

Publications and helpful links

General Publications

• Chen LR, Chen KH. Utilization of Isoflavones in Soybeans for Women with Menopausal Syndrome: An Overview. Int J Mol Sci. 2021 Mar 22;22(6):3212. doi: 10.3390/ijms22063212.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Actual): July 31, 2025
• Study Completion (Actual): August 1, 2025

Study Registration Dates

• First Submitted: December 29, 2024
• First Submitted That Met QC Criteria: January 3, 2025
• First Posted (Actual): January 6, 2025

Study Record Updates

• Last Update Posted (Estimated): August 28, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: menopause; Quality of life; Menopausal Women; Soy isoflavone effect
• Additional Relevant MeSH Terms: Substandard Drugs; Pharmaceutical Preparations; Organizations; Health Care Economics and Organizations; Counterfeit Drugs; Social Group
• Other Study ID Numbers: PGO-UNAH-48-3-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It is not necessary, none of the 18 HIPAA identifiers will be placed

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No