Isoflavones and Magnolia Extract in the 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

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-10-31

Brief Summary

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In menopause, the vasomotor symptomatology, accompanied or less by affective and behavioural symptoms, globally worsens the quality of daily life.

The improvement of the quality could be reached with adequate food supplements, named phytoestrogens, in particular Soy Isoflavones (SI), which are natural substances with estrogen-like and estrogen-antagonistic activity, which are active in the control of menopausal vasomotor symptoms. Besides, combined with magnolia extract it could improve the psychological symptomatology also improving the quality of life.

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Detailed Description

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Multicenter, observational, prospective, longitudinal study of clinical practice conducted in 10 gynecological centers.

The study will be conducted in patients with typical mild to moderate vasomotor symptoms and psycho symptoms such as mood disorders, or sleep, anxiety / depression, which do not require specific drug treatment.

Quality of life will be analyzed by the scale of Cervantes.

Conditions

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Menopause

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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isoflavones combined with magnolia

A food supplement containing soy isoflavones, lactobacillus sporogenous, Ca,vitamin D3, magnesium and magnolia extract will be administered once a day during 12 weeks.

isoflavones combined with magnolia

Intervention Type DIETARY_SUPPLEMENT

1 tablet/day duration: 12 weeks

Interventions

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isoflavones combined with magnolia

1 tablet/day duration: 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Estromineral Serena

Eligibility Criteria

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Inclusion Criteria

* Women with at least 12 months of amenorrhea
* Presence of 1 or more vasomotor symptoms as hot flushing, nocturnal sweating or palpitations
* One or more psychological symptoms as insomnia, irritability, anxiety, depressed mood. Also with concomitant symptoms of sexual area as reduction of libido and vaginal dryness.
* Women must give the informed consent

Exclusion Criteria

* clinical history of medical or surgical pathologies that could affect the results of the study, including serious cardiovascular, metabolic, kidney or liver diseases
* Patients with the habit of eating soy foods or dietary supplements with soy extract
* patients diagnosed with breast or uterine mass (neoplasia hormone sensitive)
* patients that were treated with estrogens (HRT or phytoestrogens)in the 2 months before the beginning of the study.
* patients with treatment with antibiotics, antidepressant and/or anxiolytic products

Minimum Eligible Age

45 Years

Maximum Eligible Age

59 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No