Menopausal Women, Menopause, Quality of Life, Soy Isoflavone Effect
Conditions
Keywords
menopause, Menopausal Women, Soy isoflavone effect, Quality of life
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.
Interventions
DIETARY_SUPPLEMENTSoy isoflavone supplement
2 capsules containing 10 mg natural tocotrienols, 40 mg soy isoflavonoids, 540 mg calcium, vitamin D IU.
OTHERControl (placebo) group
2 placebo capsules containing a multivitamin compound.
Sponsors
Universidad Nacional Autonoma de Honduras
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
To eliminate researcher bias, a third research participant will place the capsules containing the soy isoflavonate in one bottle and the placebo in another bottle. The bottles will be labeled as group A and group B, but the researchers will not know which is in which group, to ensure that the study intervention and the control/placebo are as indistinguishable as possible to the participants.
Intervention model description
double-blind, efficacy, parallel-group, superiority, randomized clinical trial.
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MENCAV | One month from the first intervention until 6 months | Change in MENCAV questionnaire scores, with 37 items likert type scale, the lowest point is zero and the maximun is 259 points |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| D-dimer | One month from the first intervention until 6 months | Changes in D-dimer values |
| side effects | One month from the first intervention until 6 months | incidence of side effects of soy isoflavones. |
Countries
Honduras
Outcome results
None listed