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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 2 capsules containing 10 mg natural tocotrienols, 40 mg soy isoflavonoids, 540 mg calcium, vitamin D IU. |
|
| control | Placebo Comparator | 2 placebo capsules containing a multivitamin compound. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soy isoflavone supplement | Dietary Supplement | 2 capsules containing 10 mg natural tocotrienols, 40 mg soy isoflavonoids, 540 mg calcium, vitamin D IU. |
|
| 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 |
| 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. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ricardo A. Gutierrez Ramirez, MD, MSc | Universidad Nacional Autonoma de Honduras | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Escuela | Tegucigalpa | FM | 11101 | Honduras |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33809928 | Background | 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. |
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It is not necessary, none of the 18 HIPAA identifiers will be placed
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| ID | Term |
|---|---|
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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double-blind, efficacy, parallel-group, superiority, randomized clinical trial.
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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.
| Control (placebo) group | Other | 2 placebo capsules containing a multivitamin compound. |
|
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| One month from the first intervention until 6 months |