Table 4.
Safety assessment before and after 12 weeks of MED-01 and placebo intake.
| Variable | MED-01 (n = 50) | Placebo (n = 51) | p-Value | ||
|---|---|---|---|---|---|
| Baseline | 12 Weeks | Baseline | 12 Weeks | ||
| Hematology | |||||
| RBC (1012/L) | 4.26 ± 0.29 | 4.30 ± 0.28 | 4.30 ± 0.31 | 4.25 ± 0.25 | 0.134 T |
| Hb (g/dL) | 12.64 ± 1.10 | 12.80 ± 1.09 | 12.83 ± 1.18 | 12.74 ± 1.32 | 0.075 W |
| Hct (%) | 38.15 ± 2.73 | 38.46 ± 2.63 | 38.66 ± 3.06 | 38.43 ± 3.30 | 0.229 T |
| WBC (109/L) | 5.69 ± 1.54 | 5.83 ± 1.81 | 5.98 ± 1.75 | 5.89 ± 1.88 | 0.809 W |
| Platelet (103/µL) | 242.92 ± 50.67 | 251.71 ± 54.35 | 269.63 ± 66.38 | 269.48 ± 62.27 | 0.215 T |
| Neutrophil (%) | 56.23 ± 7.44 | 56.35 ± 8.65 | 58.49 ± 9.86 | 56.54 ± 8.97 | 0.787 W |
| Lymphocyte (%) | 33.46 ± 6.89 | 33.52 ± 7.80 | 31.48 ± 8.69 | 32.84 ± 8.60 | 0.490 T |
| Monocyte (%) | 6.60 ± 1.81 | 6.45 ± 1.88 | 6.45 ± 2.09 | 6.75 ± 2.18 | 0.234 T |
| Eosinophil (%) | 2.40 ± 1.61 | 2.37 ± 1.66 | 2.24 ± 1.64 | 2.54 ± 2.20 | 0.204 W |
| Basophil (%) | 0.69 ± 0.34 | 0.59 ± 0.36 | 0.64 ± 0.31 | 0.58 ± 0.29 | 0.934 W |
| MCV (fL) | 89.74 ± 4.83 | 89.44 ± 4.95 | 90.02 ± 5.31 | 90.43 ± 6.19 | 0.819 T |
| Blood chemistry | |||||
| AST (IU/L) | 20.48 ± 8.54 | 20.56 ± 6.21 | 19.10 ± 4.98 | 19.28 ± 5.26 | 0.811 W |
| ALT (IU/L) | 15.48 ± 7.98 | 16.69 ± 9.01 | 14.76 ± 8.84 | 14.61 ± 9.29 | 0.630 W |
| Protein (g/dL) | 7.21 ± 0.34 | 7.23 ± 0.38 | 7.25 ± 0.35 | 7.25 ± 0.43 | 0.936 T |
| Albumin (g/dL) | 4.40 ± 0.26 | 4.43 ± 0.24 | 4.50 ± 0.27 | 4.43 ± 0.28 | 0.132 W |
| Total bilirubin (mg/dL) | 0.61 ± 0.26 | 0.64 ± 0.28 | 0.65 ± 0.31 | 0.60 ± 0.27 | 0.087 W |
| ALP (IU/L) | 54.62 ± 13.93 | 55.98 ± 12.73 | 53.27 ± 13.85 | 54.54 ± 13.17 | 0.371 T |
| Creatinine (mg/dL) | 0.67 ± 0.10 | 0.66 ± 0.10 | 0.64 ± 0.09 | 0.64 ± 0.09 | 0.678 T |
| BUN (mg/dL) | 12.40 ± 2.90 | 12.44 ± 2.77 | 11.16 ± 2.63 | 11.00 ± 2.54 | 0.991 W |
| Uric acid (mg/dL) | 4.20 ± 0.92 | 4.39 ± 1.20 | 4.25 ± 0.94 | 4.20 ± 1.00 | 0.169 W |
| γ-GTP | 15.32 ± 11.89 | 16.02 ± 10.56 | 17.37 ± 12.79 | 16.74 ± 10.95 | 0.767 W |
| Anthropometry | |||||
| Systolic blood pressure (mmHg) |
114.38 ± 13.73 | 118.47 ± 14.93 | 114.43 ± 12.73 | 113.35 ± 12.77 | 0.072 T |
| Diastolic blood pressure (mmHg) |
70.60 ± 11.29 | 71.36 ± 13.70 | 71.08 ± 8.79 | 70.11 ± 8.93 | 0.338 T |
| Pulse (times/min) | 78.10 ± 9.63 | 81.20 ± 10.83 | 81.96 ± 10.78 | 81.37 ± 9.03 | 0.112 T |
| Body weight (kg) | 58.08 ± 8.12 | 58.23 ± 8.49 | 57.20 ± 7.30 | 56.67 ± 7.20 | 0.605 T |
Safety assessments were performed on all participants in randomization (safety set, n = 101). Values are presented as mean ± SD. p-values were analyzed by T two-sample t-test or W Wilcoxon rank sum test between the groups. RBC, red blood cell; Hb, hemoglobin; Hct, hematocrit; WBC, white blood cell; MCV, mean corpuscular volume; AST, aspartate aminotransferase; ALT, alanine aminotransferase; ALP, alkaline phosphatase; BUN, blood urea nitrogen; γ-GTP, gamma-glutamic transpeptidase.