D-Chiro inositol (Caronositol®) is a natural inositol isomer extracted from the Carob tree which has shown a beneficial effect on the physiological balance in women with PCOS. Banaba extract is traditionally used for the treatment of hyperglycemia and, for that, also known as “phyto-insulin”. The active principles of Banaba extract facilitate the active carriage of glucose from the blood to inside the cells, particularly the ones of the striated muscles, for a sensitisation or re-sensitisation to insulin.
Chromium is a very important oligoelement for regulatinginsulin secretion and contributes to maintenance of normal blood glucose levels.
Vitamin E has a marked anti-oxidant action, which protects human cells from oxidative stress.
The combination of these substances in a unique formulation is very promising from pathophysiological point of view in controlling the disorder of PCOS and, particularly, Insuline Resistance.
The polycystic ovary syndrome (PCOS) is one of the most common endocrinological troubles in fertile age women, is the most frequent cause of infertility linked to chronic anovulation (Lagana 2016). The recurrent miscarriage is more observed in women with PCOS. Furthermore, insulin-resistance (IR) associated to PCOS in more than 80% of obese patients is an important cause of non insulin-dependent diabetes.
Currently, many food supplements based on inositol or other substances that showed to be active in reducing the IR severity are available on the market.
New natural substances, still commercially unknown, have evidenced an insulin sensitizing action, that could be exploited to potentiate the clinical activity of a food supplement indicated for PCOS.
Among these ones, Banaba is characterized by interesting properties in the treatment of hyperglycemia and in reducing the severity of insulin resistance.
POLIGEN® is a food supplement available in orally disintegrating granules (odg in stick) and soluble granules (in sachet), useful for the wellness of women with PCOS and in case of increased need of those nutrients. It contributes to keep glucose-insulin metabolism in normal range and to regulate body weight. It favours a normal carbohydrate, lipid and protein metabolism.
HOW TO USE
1 sachet or stick per day is recommended.
The odg should be dissolved directly in the mouth.
The soluble granules should be dissolved in a glass of water.
- gluten free
- lactose free
- sugar free
|D-chiro inositol**||25 mg|
|Banaba (Lagerstroemia speciosa L.)
leaf dry extract (min 1% corosolic acid)
|Vitamin E||36 mg||300%|
|Folic acid||400 µg||200%|
(*) % Reference Nutrient Values - (**) Caronositol®
Efficacy and safety of POLIGEN® are under evaluation in a long term, preliminary, observational clinical study, in which women presenting troubles of the polycystic ovary syndrome, irregular cycles with anovulatory cycles, not so severe to require pharmacologic therapy, were recruited.
The women included, aged between 18 and 30 years, undergo a clinical and echographical evaluation just after admission to the study. [De Leo et al. 2017]
POLIGEN® is administered orally at the dose of 1 sachet/day for 6 months.
At baseline, 2 and 6 months of treatment, the following exams are performed in all the women in early follicular phase of the spontaneous cycle and induced by a progestin:
- baseline blood sampling to determine fasting levels of glucose and insulin, and calculate HOMA index (glycaemia x insulinemia) / 22.5 where glycaemia is expressed in mmol/L and insulin in mU/L);
- Oral Glucose Tolerance Test (OGTT 75 g times 0, 30, 60, 90 and 120 min) to determine glycaemia and insulin in all samplings.
- acne and hirsutism evaluated by Ferriman-Gallwey score where 0=absent; 812=mild; 13-16=moderate; >16=marked (>16)
- regularity of menstrual cycle: number of menstruations in the previous 3 months (calculation of the expected cycles; in pretreatment, calculation is: no. of cycles in the last 12 months/12
- pelvic echography (ovary volume, antral follicles)
- BMI evaluation
- total cholesterol and triglycerides
At the end of the treatment, the physician’s overall judgement on the treatment and the woman’s evaluation of the acceptability of the treatment are expressed by a semi quantitative scale where the score are: 0 = nil; 1 = poor; 2 = moderate; 3 = good; 4 = very good.
Phytosurveillance: any adverse reaction or unwanted event is recorded in the Case report form, specifying severity, duration, onset time, relationship with the treatment and the action taken.