Dietary Supplements, Menopause, Quality of Life
Conditions
Keywords
Menopause, Hot flushes, Isoflavones, Aframomum melegueta extract, Punica granatum extract, Cervantes Scale
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTBotanical dry extracts combination
Aframomum melgueta dry extract (50mg), Glycine max bean dry extract (100mg) and Punica granatum skin extract (100mg)
DIETARY_SUPPLEMENTPlacebo
Filler agent
Sponsors
Clínica Barem
Nektium Pharma SL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline to Week 8 in the global score of quality of life using the validated Cervantes Scale | 8 weeks | To evaluate the improvement of quality of life after trial, a variable to quantify the percentage of reduction between after-treatment and before-treatment for global score (GS) in quality of life is generated: \[Variation%=100 x ((initial GS value-final GS value)/ initial GS value)\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline to Week 8 in the Menopause-health score of quality of life using the validated Cervantes Scale | 8 weeks | To evaluate the improvement of quality of life after trial, a variable to quantify the percentage of reduction between after-treatment and before-treatment for Menopause and health score (MHS) in quality of life is generated: \[Variation%=100 x ((initial MHS value-final MHS value)/ initial MHS value)\] |
| Change from Baseline to Week 8 in the psychic score of quality of life using the validated Cervantes Scale | 8 weeks | To evaluate the improvement of quality of life after trial, a variable to quantify the percentage of reduction between after-treatment and before-treatment for psychic score (PS) in quality of life is generated: \[Variation%=100 x ((initial PS value-final PS value)/ initial PS value)\] |
| Change from Baseline to Week 8 in the sexuality-couple score of quality of life using the validated Cervantes Scale. | 8 weeks | To evaluate the improvement of quality of life after trial, a variable to quantify the percentage of reduction between after-treatment and before-treatment for sexuality-couple score (SCS) in quality of life is generated: \[Variation%=100 x ((initial SCS value-final SCS value)/ initial SCS value)\] |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to week 8 in the bogy weight | 8 weeks | To evaluate the body weight reduccion, a variable to quantify the percentage of reduction between after-treatment and before-treatment in body weight (BW) is generated: \[Variation%=100 x ((initial BW value-final BW value)/ initial BW value)\] |
Countries
Spain
Outcome results
None listed