Soy Isoflavonates Versus Placebo on Quality of Life in Menopausal Women

NCT06759350 | Completed DMC

• 1 other identifier: PGO-UNAH-48-3-2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

menopause; Menopausal Women; Soy isoflavone effect; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• D-dimer

  One month from the first intervention until 6 months

• side effects

  One month from the first intervention until 6 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Dietary Supplement: Soy isoflavone supplement

control

PLACEBO COMPARATOR

2 placebo capsules containing a multivitamin compound.

Other: Control (placebo) group

Interventions

Soy isoflavone supplement DIETARY_SUPPLEMENT

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

Intervention

Control (placebo) group OTHER

2 placebo capsules containing a multivitamin compound.

Also known as: Multivitamin compound

control

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Nacional Autonoma de Honduras: lead

Study Sites (1)

Hospital Escuela

Tegucigalpa, FM, 11101, Honduras

Location

Related Publications (1)

• 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.

  PMID: 33809928 BACKGROUND

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Ricardo A. Gutierrez Ramirez, MD, MSc

  Universidad Nacional Autonoma de Honduras

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Titular professor

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

Study Record Dates

• First Submitted: December 29, 2024
• First Posted: January 6, 2025
• Study Start: February 1, 2025
• Primary Completion: July 31, 2025
• Study Completion: August 1, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

HO (1)