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

Universidad Nacional Autonoma de Honduras

Status: Completed

Conditions: Menopausal Women; Quality of Life; Menopause; Soy Isoflavone Effect

Treatments: Dietary Supplement: Soy isoflavone supplement; Other: Control (placebo) group

Study type: Interventional

Funder types: Other

Identifiers

NCT06759350

PGO-UNAH-48-3-2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

100 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

2 capsules containing 10 mg natural tocotrienols, 40 mg soy isoflavonoids, 540 mg calcium, vitamin D IU.

Treatment:

Dietary Supplement: Soy isoflavone supplement

control

Placebo Comparator group

Description:

2 placebo capsules containing a multivitamin compound.

Treatment:

Other: Control (placebo) group