Menopause and bone turnover Nutritional, Metabolic, Endocrine
Conditions
Interventions
Treatment allocation is randomized according to a computer generated restricted randomization list.
The active product was named “Integratore menopausa Lot. FH226” while the placebo product was named
Sponsors
Paladin Pharma S.p.A.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Healthy female subjects; Age: between 50 and 55 years old 2. Caucasian ethnicity 3. Body mass index between 20 and 25 4. Slightly overweight (10-20% than ideal weight) 5. Menopause onset (date of last menstrual cycle) not longer than 1 year from the date of study entry 6. Case history characterized by menopausal syndrome psychological complaints (anxiety, emotional instability, depression), hot flush, localized fat and body fat percentage increase 7. No participation in similar trials 8. Absence of disease 9. Agreement not to make any changes to the normal everyday routine 10. Agreement not to use during the study products with activity similar such than the tested product 11. Agreement not to make any changes to eating habits 12. Subjects informed of the trial procedures who have signed an informed consent form
Exclusion criteria
Exclusion criteria: 1. Subjects not satisfying the inclusion criteria 2. Subjects under local or systemic pharmacological treatment 3. Subjects who do not have endometrial hyperplasia in their case history 4. Hormone replacement therapy 5. Metabolic syndrome 6. Depressive syndrome not menopause related 7. Subjects with food intolerances
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Urinary Deoxypyridinoline (DPD) measured by means of high-performance liquid cromatography (HPLC), at baseline, and then 6 months and 12 months after treatment 2. Serum Acid phosphatase (AP) measured by means of electrophoresis on agarose gel according to the optimized method by D.G.K.C. at 37°C, at baseline, and then 6 months and 12 months after treatment 3. Serum Osteocalcin (OC) measured by means of electrochemiluminescence technique (ECLIA), at baseline, and then 6 months and 12 months after treatment 4. Serum Bone-specific alkaline phosphatase (BAP) measured by means of colorimetric-enzymatic technique, at baseline, and then 6 months and 12 months after treatment 5. Menopause syndrome by means of Menopause Rating Scale, assessed at baseline, 1 month and 3 months after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Bone mineral density (BMD), measured at baseline, and then 6 months and 12 months after treatment 2. Amelioration of depression associated to menopause 3. Amelioration of sleep | — |
Countries
Italy
Outcome results
None listed