Assessment of the efficacy of a food supplement in improving menopausal symptomatology.

Not Applicable

Completed

Conditions: Menopause and bone turnover
Nutritional, Metabolic, Endocrine

Registration Number: ISRCTN10128742

Lead Sponsor: Paladin Pharma S.p.A.

Brief Summary: 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37569440/ (added 03/05/2024)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 60

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Urinary Deoxypyridinoline (DPD) measured by means of high-performance liquid cromatography (HPLC), at baseline, and then 6 months and 12 months after treatment<br>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<br>3. Serum Osteocalcin (OC) measured by means of electrochemiluminescence technique (ECLIA), at baseline, and then 6 months and 12 months after treatment<br>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<br>5. Menopause syndrome by means of Menopause Rating Scale, assessed at baseline, 1 month and 3 months after treatment

Secondary Outcome Measures

Name	Time	Method
1. Bone mineral density (BMD), measured at baseline, and then 6 months and 12 months after treatment<br>2. Amelioration of depression associated to menopause<br>3. Amelioration of sleep