Assessment of the efficacy of a food supplement in improving menopausal symptomatology.
| ISRCTN | ISRCTN10128742 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10128742 |
| Secondary identifying numbers | SI.02.DS.L_2011/584+SI.02.DS.L_2011/585 |
- Submission date
- 14/03/2016
- Registration date
- 22/04/2016
- Last edited
- 03/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
The menopause happens when a woman stops having periods and is no longer able to get pregnant naturally. Symptoms can include hot flushes, low mood or anxiety, reduced sex drive and problems with memory and concentration. It can also increase the risk of developing osteoporosis, a condition where the bones become weaker and more likely to break. This study investigates whether a food supplement can alleviate the symptoms of the menopause and reduce the likelihood of developing osteoporosis.
Who can participate?
Women aged between 50-55 and going through the menopause.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 are given the active food supplement. Those in group 2 are given a placebo (dummy pill). Markers that show whether the participant is at risk of developing osteoporosis are measured for all participats before treatment begins, 6 months after treatment and again after 12 months.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Farcoderm Srl, San Martino Siccomario (Italy)
When is the study starting and how long is it expected to run for?
April 2011 to May 2012
Who is funding the study?
Paladin Pharma S.p.A.
Who is the main contact?
Dr Nobile Vincenzo
vincenzo.nobile@farcoderm.com
Contact information
Scientific
Via Mons. Angelini, 21
San Martino Siccomario
27028
Italy
 ORCID ID |
0000-0001-9147-302X |
|---|---|
| Phone | 0039 0382 25504 |
| vincenzo.nobile@farcoderm.com |
Study information
| Study design | Monocentric randomized parallel-group interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Home |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| 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. |
| Study objectives | The study is aimed to assess the efficacy of the product in modulating the bone turnover markers and in improving the menopause-related symptoms in post-menopausal women. |
| Ethics approval(s) | Independent Ethical Committee for Non-Pharmacological Clinical trials’, 30/03/2011, ref: 2011/02) |
| Health condition(s) or problem(s) studied | Menopause and bone turnover |
| Intervention | 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. |
| Intervention type | Supplement |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 19/04/2011 |
| Completion date | 19/05/2012 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 50 Years |
| Upper age limit | 55 Years |
| Sex | Female |
| Target number of participants | 120 |
| Total final enrolment | 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 19/04/2011 |
| Date of final enrolment | 19/06/2011 |
Locations
Countries of recruitment
- Italy
Study participating centre
San Martino Siccomario
27028
Italy
Sponsor information
Industry
Via Vincenzo Monti, 12/A
Torino
10126
Italy
| Website | http://paladinpharma.it/ |
|---|---|
"ROR" |
https://ror.org/01x62am17 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/05/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Data (all the study data) will be published in an appropriate scientific journal in the field of menopause. The manuscript is under drafting and is planned to be submitted to the identified scientific journal by May 2016. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 27/07/2023 | 03/05/2024 | Yes | No |
Editorial Notes
03/05/2024: Publication reference and total final enrolment added.
