A controlled study to investigate the effect of a food supplement (Femifert™) on polycystic ovarian syndrome and metabolic syndrome in women
| ISRCTN | ISRCTN32169940 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32169940 |
| Secondary identifying numbers | FMFRT01-IT |
- Submission date
- 15/04/2019
- Registration date
- 23/04/2019
- Last edited
- 24/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Polycystic ovarian syndrome (PCOS) is a very common condition affecting women. PCOS is a set of symptoms due to elevated androgens (male hormones) in females. Signs and symptoms of PCOS include irregular or no menstrual periods, heavy periods, excess body and facial hair, acne, pelvic pain, difficulty getting pregnant, and patches of thick, darker, velvety skin.
Recent research suggests that PCOS should no longer be considered purely a disorder of the reproductive organs. Although the origin of the condition is unknown, recent evidence suggests that affected women seem to have mild insulin resistance. Increased insulin production stimulates excess androgen production by the ovaries. Associated with the prevalent insulin resistance, these subjects exhibit high cholesterol and a predisposition to non-insulin dependent diabetes and cardiovascular disease in later life. Thus, PCOS seems to have many of the hallmarks of metabolic syndrome (a combination of diabetes, high blood pressure and obesity).
Although drug treatment represents the first-line treatment for PCOS according to recent guidelines, other insulin sensitizing compounds from food sources may play a crucial role in the treatment of this condition. For example, D-chiro-inositol may improve both hormone and metabolic disturbances and reduce the risk of vascular disease. Femifert™ is a dietary supplement containing D-chiro-inositol, flaxseed dry extract, Ipomea Batatas, Lagerstroemia Speciosa (Banaba), zinc gluconate, vitamin B12, and folic acid. All these compounds may be useful to better control insulin metabolism and reduce symptoms associated with ovarian abnormalities.
The aim of this study is to analyze the improvement of metabolic profiles, hormonal parameters and ovarian parameters in women with PCOS and/or metabolic syndrome before and after 6 months of therapy with Femifert™, in combination with pharmacological treatment and compare these data with a group only pharmacologically treated.
Who can participate?
Females aged 18-65 who have been diagnosed with PCOS and/or metabolic syndrome
What does the study involve?
Participants are randomly allocated to one of two groups: the active group or the control group. The active group take one tablet of Femifert™ every day in combination with metformin, spironolactone, and rosuvastatin. The control group take only metformin, spironolactone, and rosuvastatin. The investigator collect the clinical documentation and biological samples. After a follow-up of 6 months, all subjects will be re-evaluated regarding the anthropometric, biochemical and ultrasound parameters.
What are the possible benefits and risks of participating?
The benefits of participating in this study is that the subjects may improve their metabolic profiles, as well as hormonal parameters and ovarian parameters. There are no expected risks in participating in this trial. Previous studies have not shown any side effects of the single compounds present in Femifert™ at the doses we are using.
Where is the study run from?
Antonio Cardarelli Hospital, Campobasso, Italy
When is the study starting and how long is it expected to run for?
April 2019 to May 2019
Who is funding the study?
Claride Pharma srl, Italy
Who is the main contact?
Dr Sergio Davinelli, sergio.davinelli@unimol.it
Contact information
Scientific
Via de sanctis s.n.c.
Campobasso
86100
Italy
 ORCID ID |
0000-0003-2578-7199 |
|---|---|
| Phone | + 39 0874 404771 |
| sergio.davinelli@unimol.it |
Study information
| Study design | Single-center double-blind randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Efficacy and tolerability of Femifert™ in women with polycystic ovarian syndrome and metabolic syndrome: a double-blind, randomized controlled trial |
| Study acronym | Femifert-POS/MS |
| Study objectives | Femifert™, a combination of insulin-sensitizer compounds, would have beneficial effects on metabolic and hormonal abnormalities in women with polycystic ovary syndrome. |
| Ethics approval(s) | Approved 06/03/2019, Ethics and Technical Committee - Department of Medicine and Health Sciences "V. Tiberio" (Comitato Tecnico Scientifico - Università degli Studi del Molise - Dipartimento di Medicina e Science per la Salute “V. Tiberio” - Via De Sanctis snc, Campobasso, 86100, Italy; +39 874 404 886; ciro.costagliola@unimol.it) ref: Prot. n.13/2019. |
| Health condition(s) or problem(s) studied | Polycystic ovarian syndrome and/or metabolic syndrome |
| Intervention | The study consisted of two intervention treatments: 1. Active treatment (metformin, spironolactone, rosuvastatin, and Femifert™ dietary supplement) 2. Control treatment (metformin, spironolactone, and rosuvastatin) Femifert™ tablets were a gift from Healthspan (Claride Pharma srl, Italy). Femifert™ is a dietary supplement containing D-Chiro-inositol (100 mg) Flaxseed dry extract (80 mg; standardized to 20% lignans), Ipomea Batatas (80 mg), Lagerstroemia Speciosa (80 mg), Zinc gluconate (50.4 mg), Vitamin B12 (4.5), and Folic Acid (0.6 mg). The daily amount of Femifert™ consumed by participants will be 550 mg during the intervention period (550 mg/day; 1 pill). The study is a single-center, double-blind, randomized controlled trial. The intervention model will be a parallel assignment. At least 40 subjects will be randomized to a 24-week treatment period with a follow-up data collection (six months). Active Group: Subjects with polycystic ovarian syndrome and/or metabolic syndrome will receive oral pharmacological treatment with metformin, spironolactone, and rosuvastatin combined with Femifert™ supplementation (550 mg/day; 1 pill) Control Group: Subjects with metabolic syndrome will receive oral pharmacological treatment with metformin, spironolactone, and rosuvastatin. A randomization list will be created using PASS 2008 statistical software. The randomization sequence will be stratified using 10% maximum allowable% deviation with a 1:1 allocation ratio. |
| Intervention type | Supplement |
| Primary outcome measure | Timepoint measures: Baseline (T0); 8 weeks (T1); 16 weeks (T2); 24 weeks (T3): 1. Ovulatory dysfunction, menstrual frequency and variability of cycle length (amenorrhea; dysmenorrhea) measured using menstrual diary data. 2. The Ferriman–Gallwey score (hirsutism) measured using the Ferriman-Gallwey questionnaire. 3. Pelvic ultrasound to measure ovarian volume and number and volume of follicles. 4. Lipid profile (total cholesterol, LDL, HDL, and triglycerides) measured using traditional enzymatic methods. 5. Glycemic and insulinemic index curves. 6. Measurements of: 17-hydroxyprogesterone (17-OHP); sex hormone binding globulin (SHBG); dihydrotestosterone (DHT); 3 alpha-Androstanediol glucuronide (3 alpha diol-G); luteinizing hormone (LH); Follicle-stimulating hormone (FSH); prolactin (PRL); Dehydroepiandrosterone sulfate (DHEA-S); Thyroid-stimulating hormone (TSH) reflex measured using ELISA. |
| Secondary outcome measures | Timepoint measures: Baseline (T0); 8 weeks (T1); 16 weeks (T2); 24 weeks (T3): 1. Weight, BMI, waist-hip ratio. 2. Polycystic Ovary Syndrome Questionnaire. 3. Treatment safety: liver and kidney function tests and the frequency, severity and nature of adverse events. 4. Adherence to study protocol. 5. Reasons for loss to follow-up. |
| Overall study start date | 06/01/2019 |
| Completion date | 01/06/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Female |
| Target number of participants | 40 subjects (2 arms) |
| Key inclusion criteria | 1. Female 2. Age 18-65 3. Triglycerides ≥150 mg/dl 4. HDL <40 mg/dl and/or LDL <150 mg/dl 5. Fasting glucose <110mg/dl 6. Blood pressure 145/95 mmHg 7. Waist circumference >88cm 8. Index of Ferriman & Gallway score >6 9. Hyperandrogenemia and hyperinsulinemia 10. Presence of 12 or more follicles in each ovary measuring 2-9 mm in diameter, and increased ovarian volume (>10 ml) |
| Key exclusion criteria | 1. Suffer from other causes of hyperandrogenism (e.g. Cushing's syndrome, congenital adrenal hyperplasia, androgen secreting tumors 2. Are pregnant, or suspected to be pregnant 3. History of liver or kidney pathologies 4. History of psychotic illness 5. Present with current and major depression 6 History of cardiovascular diseases 7. Regular consumption of micronutrient and/or herbal and/or polyphenol supplements known to have an impact on insulin sensitivity/secretion and/or vascular/endothelial function |
| Date of first enrolment | 01/05/2019 |
| Date of final enrolment | 30/05/2019 |
Locations
Countries of recruitment
- Italy
Study participating centre
Campobasso
86100
Italy
Sponsor information
Industry
Via A. Albricci 8
Milano
20122
Italy
| Phone | +393496556591 |
|---|---|
| sonia.longo@claridepharma.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed high-impact journal is anticipated around 6 months following the end of the trial. This will be finalized following the end of the trial. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Editorial Notes
24/04/2019: Internal review.
23/04/2019: Trial’s existence confirmed by Ethics and Technical Committee - Department of Medicine and Health Sciences 'V. Tiberio', University of Molise, Italy.
