Soy Isoflavonates Versus Placebo on Quality of Life in Menopausal Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2025-08-01

Brief Summary

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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.

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Detailed Description

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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

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Menopause Menopausal Women Soy Isoflavone Effect Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

double-blind, efficacy, parallel-group, superiority, randomized clinical trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Soy isoflavone supplement

Intervention Type DIETARY_SUPPLEMENT

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

control

2 placebo capsules containing a multivitamin compound.

Group Type PLACEBO_COMPARATOR

Control (placebo) group

Intervention Type OTHER

2 placebo capsules containing a multivitamin compound.

Interventions

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Soy isoflavone supplement

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

Intervention Type DIETARY_SUPPLEMENT

Control (placebo) group

2 placebo capsules containing a multivitamin compound.

Intervention Type OTHER

Other Intervention Names

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Multivitamin compound

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes