Menopause Not Applicable
Conditions
Interventions
Current interventions as of 11/05/2021:
All participants in the study are clinically examined and sign an informed consent to accept their participation in the study. Participants were
Sponsors
CIBER (Consorcio Centro de Investigación Biomédica en Red, M.P.)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 11/05/2021: Postmenopausal women between 45 and 70 years of age: 1. FSH 23-116 U/L 2. Estradiol (E2) 3 Miu/ml 2. Estradiol (E2) =30 pg/ml 3. Amenorrhea =12 months
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 28/05/2021: 1. Participants using estrogen therapy 2. Participants who received silicon or polyphenol supplements Previous exclusion criteria: 1. Patients with known diseases affecting bone metabolism (rheumatoid arthritis, hyperthyroidism, surgical menopause, hypercortisolism, renal bone disease, chronic liver disease, among others) 2. Use of drugs affecting bone metabolism (fluorides, bisphosphonates, calcitonin, teriparatide or parathormone, strontium ranelate, SERMs, estrogen therapy, anabolic steroids, chronic glucocorticoids (> 3 months), cytostatics, antiandrogens and antiepileptics) 3. Participants who received silicon or polyphenol supplements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Menopausal symptoms (hot flashes, sweating, palpitations, dizziness, vaginal dryness, mood swings, etc), measured using the Menopause Rating Scale at baseline, 1.5, 3 and 6 months 2. Calcium excretion, measured using liquid chromatography coupled mass spectrometry at baseline and 6 months 3. Menopausal-related hormone profile, measured using ELISA at baseline, 1.5, 3 and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 11/05/2021: 1. Dietary evaluation: nutrient intake and adherence to the dietary recommendations measured using a 7-day food record validated nutritional questionnaire at the baseline and at 6 months. In addition, the food frequency questionnaire and 14-point Mediterranean Diet Adherence questionnaire are recorded at baseline. 2. Physical activity is measured using the Minnesota Leisure Time Physical Activity questionnaire at baseline and 6 months 3. Bioavailability, identification and quantification of polyphenols in biological samples is measured using LTQ-Orbitrap Mass Spectrometry and HPLC-MS/MS at baseline and at the end of the intervention period 4. Changes in urine metabolites are measured using mass spectrometry and statistical analysis at baseline and at the end of the intervention period Previous secondary outcome measures: 1. Dietary evaluation: nutrient intake and adherence to the dietary recommendations are measured using a 7-day food record validated nutritional questionnaire and a Food Frequency Test at the baseline, 6 months, 1 year and 2 years 2. Physical activity is measured using the Minnesota Leisure Time Physical Activity questionnaire at baseline, 6 months, 1 year and 2 years 3. Bioavailability, identification and quantification of polyphenols in biological samples is measured using LTQ-Orbitrap Mass Spectrometry and HPLC-MS/MS at baseline and at the end of the intervention period 4. Changes in urine metabolites are measured using mass spectrometry and statistical analysis at baseline and at the end of the intervention period | — |
Countries
Spain
Outcome results
None listed