Blood tests
nutritional ketosis
No significant variation in renal function (plasma creatinine and uric acid) were observed in subjects that followed VLCKD or HBD. GGT serum leves were significantly decreased in VLCKD group during the study. On the other hand, a significant reduction of ALT was found in HBD group, confirming the safety of both nutritional protocols. Importantly, white blood cell (WBC), platelets (PLT), neutrophils and monocytes were significantly reduced in the VLCKD group at week 8 (p = 0.001, p = 0.004, p = 0.002, p < 0.001, respectively) and week 12 (p < 0.05) (Fig. Box blot of mean change in WBC (Biochemical parameters (mean ± SD) at enrolling visit (week -4) and week 8 in VLCKD and HBD groupBiochemical parameters (mean ± SD) at enrolling visit (week -4) and week 12 in VLCKD and HBD groupChanges in Treg/Th17 ratio at week 4 and week 8 in VLCKD group and HBD groupAt week 8 blood ketone levels was 0.86 ± 0.56 mmol/L, confirming the efficacy of VLCKD as well as patients adherence (the threshold value for nutritional ketosis was set at 0.5 mmol/L) [Importantly, the reduction in glucose levels at week 12 was significantly higher in VLCKD group compared to HBD group (p = 0.003) (Table Aldosterone plasma level were significantly increased in both groups at week 8 (p = 0.003 in VLCKD group, p = 0.021 in HBD group—Fig. Box blot of mean change in serum aldosterone at baseline (week 0), week 8 and week 12 in VLCKD group (Electrolyte and hormonal profile at enrolling visit (week -4), week 8 and 12 in VLCKD and HBD groupFigure 