3.2. Clinical Activity
SECONDARY
The anthropometric variables significantly modified in the PG group were the BW and BMI. The main variable, BW, showed that the verum administration was significantly more effective than the placebo. Within 3 months, the reduction was 3.71 kg in the PG group and 1.12 kg in the PL group, respectively. Therefore, BW reduction was three times higher in the PG group than in the PL group. VAT reduction was more consistent with PG, although not significant due to the high variability of the baseline data.Concerning the secondary parameters on the efficacy, the insulin blood levels and HOMA were significantly reduced after 3 months of treatment. In the PG group, insulin blood levels decreased from 14.62 ± 1.05 mcU/mL at baseline to 11.43 ± 0.98 mcU/mL, whereas in the PL group, there was a slight increase from 13.15 ± 1.12 mcU/mL to 13.64 ± 0.66 mcU/mL (Lipid and glucose analysis in blood are reported in None of the vitamins were significantly reduced. However, in both groups, the average levels of vitamin DGlucosamine was not detectable (sensitivity of the method with a detection limit of 0.1 µg/mL). None of the other variables were significantly modified in the two groups.Concerning safety, blood laboratory analysis was performed and variables related to the organ functionality were collected. There was no significant change observed in the RBC, HB, HCT, PLT, and % Lym. The WBC, especially lymphocytes, increased significantly in the PL group, from 6.54 ± 0.21 × 10