Effects of a New Botanical Extracts Combination on Quality of Life in Menopausal Spanish Women

Study on the Effect of a Nutritional Supplement With Isoflavones on the Symptoms of Climacteric in Healthy Women

This study was designed to evaluate the beneficial effects and safety of a standardised botanical extract combination containing soy isoflavone extract, grains of paradise seed dry extract and pomegranate skin dry extract on health-related Quality of Life in healthy Spanish menopausal women with hot flashes, anxiety, and depressive symptoms using the self reported and validated Cervantes Scale.

Fifty-seven outpatient women (45-65 years) with menstrual problems associated with climacteric syndrome were enrolled from April 2018 to April 2019 in the context of a prospective, placebo-controlled, double-blind study. Women were randomized to receive treatment with either the botanical combination (250 mg daily divided into two doses) or placebo for eight weeks. At the beginning and end of the study, health-related Quality of Life was assessed using the Cervantes Scale.

Inclusion Criteria:

• Women in the Climacteric Phase under medical criteria based on Health questionnaire, Blood and urine test.
• Informed consent to participate in the study.

Exclusion Criteria:

• Hormone-related pathologies.
• Menopause from surgery origin.
• Family or personal history of endocrine cancer.
• Known hypersensitivity to gluten, soybeans, soy protein, dairy products, pomegranate or grains of paradise.
• Vegetarian diet or daily consumption of soya rich-products during the last year.
• Anovulatory treatment.
• Hormone replacement treatment.