Clinical trial NCT06759350: Soy Isoflavonates Versus Placebo on Quality of Life in Menopausal Women
Official title: Soy Isoflavonates Versus Placebo on Quality of Life in Menopausal Women: Randomized Double-blind Clinical Trial: FLAVOCAV TRIAL
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Menopause
Menopausal Women
Soy Isoflavone Effect
Quality of Life
Keywords: menopause
Menopausal Women
Soy isoflavone effect
Quality of life
Lead sponsor: Universidad Nacional Autonoma de Honduras
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 100
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double-blind, efficacy, parallel-group, superiority, randomized clinical trial.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: MENCAV
timeFrame: One month from the first intervention until 6 months
Secondary outcomes:
measure: D-dimer
timeFrame: One month from the first intervention until 6 months
measure: side effects
timeFrame: One month from the first intervention until 6 months
Other outcomes:
Locations:
city: Tegucigalpa
country: Honduras
facility: Hospital Escuela
state: FM
Study officials:
affiliation: Universidad Nacional Autonoma de Honduras
name: Ricardo A. Gutierrez Ramirez, MD, MSc
role: STUDY_DIRECTOR
References:
citation: 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.