4. Discussion
overweight, weight loss
OBESE, INSULIN SENSITIVITY
The present study demonstrates the efficacy of a three-month-long administration with a medical device based on polyglucosamine L112 polymers on the anthropometric and metabolic profile in overweight and obese subjects. In particular, a statistically significant improvement in the primary endpoint was observed in the treated group; in fact, the BW, and consequently the BMI, were significantly reduced. Even the reduction of VAT was more consistent with PG, although the change was not statistically significant.The results of our study are in agreement with previous studies which have demonstrated that PG was effective for weight loss in combination with dietary interventions [Fiber intake is associated with BW reduction [In different terms, PG can be considered as a matrix for the slow release of fats, reducing the fat absorption in the upper part of the gut [The differences between the ITT and PP analysis were almost identical for both treatments. The main variable of BW reduction in the PG group was three times higher in the PL group (Furthermore, the results of the present study show the efficacy of the PG on insulin blood levels and HOMA, which were significantly reduced after 3 months of treatment in the PG group. This can indicate that the fat-binding capacity of PG can improve insulin sensitivity. This effect is known to be related to the reduction of lipid availability in the diet [In relation to total cholesterol levels, the number of cases showing a clinically relevant 10% reduction was significantly higher in the PG group than in the PL group. A previous study was conducted with a similar product, showing that the duration of the treatment is the more important variable to determine the effect on both BW and CH [Finally, a reduction in fat absorption could affect the bioavailability of fat-soluble vitamins. However, previous studies have shown that chitosan does not reduce the absorption of fat-soluble vitamins in obese subjects [Further studies are needed to examine the effects of PG on metabolic parameters and, moreover, studies with a larger sample of subjects need to be conducted. Finally, considering that PG is not absorbed, it would be interesting to evaluate PG use in the pediatric population.