NCT06759350

Soy Isoflavonates Versus Placebo on Quality of Life in Menopausal Women

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Universidad Nacional Autonoma de Honduras · Academic / Other
• Sex: Female
• Age: 45 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Menopause
• Menopausal Women
• Soy Isoflavone Effect
• Quality of Life

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Soy isoflavone supplement	2 capsules containing 10 mg natural tocotrienols, 40 mg soy isoflavonoids, 540 mg calcium, vitamin D IU.
OTHER	Control (placebo) group	2 placebo capsules containing a multivitamin compound.

Timeline

• Start date: 2025-02-01
• Primary completion: 2025-07-31
• Completion: 2025-08-01
• First posted: 2025-01-06
• Last updated: 2025-08-28

Locations

1 site across 1 country: Honduras