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

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN10128742
• Date of registration: 22/04/2016
• Prospective Registration: No
• Primary sponsor: Paladin Pharma S.p.A.
• Public title: Assessment of the efficacy of a food supplement in improving menopausal symptomatology.
• Scientific title: Assessment of the efficacy of a food supplement in improving bone turnover markers and menopause-related symptoms in post-menopausal women: a double blind, randomized clinical study of efficacy and safety.
• Date of first enrolment: 19/04/2011
• Target sample size: 120
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN10128742
• Study type: Interventional
• Study design: Monocentric, randomized, parallel group, interventional study (Quality of life)

Countries of recruitment

Italy

Contacts

• Name: Nobile Vincenzo

Key inclusion & exclusion 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: 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

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Menopause and bone turnover
Nutritional, Metabolic, Endocrine

Intervention(s)

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 “Integratore menopausa Lot. FH314”. The active and the placebo products were in tablet form and identical in appearance.

Product efficacy in modulating bone turnover markers was evaluated in 60 subjects (30 subjects per treatment arm) before and after 6 and 12 months treatment. The following markers were measured: deoxypyridinoline (DPD), acid phosphatase (AP), osteocalcin (OC), and bone-specific alkaline phosphatase (BAP). Bone mineral density (BMD) was assessed in a sub-group (n=15) of subjects. Product efficacy on ameliorating menopausal symptomatology was assessed in 60 subjects (30 subjects per treatment arm) before and after 1 and 3 months treatment by means of a validated questionnaire.

Primary Outcome(s)

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 Outcome(s)

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

Secondary ID(s)

SI.02.DS.L_2011/584+SI.02.DS.L_2011/585

Source(s) of Monetary Support

Paladin Pharma S.p.A.