Table 7.
Results of the clinical chemistry evaluation in the 90-day study.
| Group (mg/kg bw/day) | ALT | AST | ALP | TBIL | CREA | UREA | GLUC | CHOL | Pi | Ca++ | Na+ | K+ | Cl− | ALB | TPROT | A/G | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| [U/L] | [U/L] | [U/L] | [µmol/L] | [µmol/L] | [mmol/L] | [mmol/L] | [mmol/L] | [mmol/L] | [mmol/L] | [mmol/L] | [mmol/L] | [mmol/L] | [g/L] | [g/L] | |||
| Main study groups (n = 10†) | |||||||||||||||||
| Male | |||||||||||||||||
| 0 (Control) | Mean | 40.9 | 95.3 | 87.7 | 1.07 | 29.7 | 7.52 | 6.09 | 2.39 | 1.91 | 2.60 | 144.53 | 4.37 | 100.32 | 44.20 | 63.99 | 2.25 |
| (n = 10) | SD | 5.5 | 15.1 | 12.8 | 0.32 | 3.2 | 0.82 | 0.43 | 0.23 | 0.16 | 0.07 | 1.30 | 0.21 | 0.81 | 1.06 | 1.79 | 0.12 |
| 75 | Mean | 50.5 | 78.9 | 74.6 | 1.12 | 25.7 | 7.90 | 5.77 | 2.87 | 2.05 | 2.63 | 143.78 | 4.61 | 98.77 | 45.02 | 64.86 | 2.28 |
| (n = 10) | SD | 15.8 | 8.3 | 16.7 | 0.29 | 3.4 | 0.93 | 0.55 | 0.29 | 0.17 | 0.06 | 0.58 | 0.33 | 1.41 | 1.38 | 2.86 | 0.19 |
| SS | ∗∗ | ∗ | ∗ | ∗∗ | ∗ | ∗∗ | |||||||||||
| 112 | Mean | 40.9 | 87.7 | 69.3 | 1.11 | 29.8 | 7.94 | 5.48 | 3.27 | 2.14 | 2.66 | 143.80 | 4.58 | 97.83 | 45.05 | 65.78 | 2.20 |
| (n = 10) | SD | 3.8 | 15.2 | 10.0 | 0.31 | 4.6 | 1.00 | 0.65 | 0.35 | 0.19 | 0.09 | 2.29 | 0.23 | 2.74 | 1.36 | 2.18 | 0.26 |
| SS | ∗∗ | ∗∗ | ∗ | ∗ | |||||||||||||
| 150 | Mean | 47.5 | 89.9 | 68.5 | 0.95 | 30.0 | 7.24 | 5.68 | 3.67 | 2.27 | 2.71 | 144.10 | 4.35 | 97.70 | 44.81 | 64.05 | 2.36 |
| (n = 10) | SD | 9.3 | 7.4 | 13.1 | 0.21 | 3.3 | 0.99 | 0.82 | 0.39 | 0.06 | 0.09 | 0.84 | 0.20 | 0.96 | 2.19 | 3.12 | 0.27 |
| SS | ∗∗ | ∗∗ | ∗∗ | ∗∗ | ∗∗ | ||||||||||||
| 187 | Mean | 52.9 | 83.9 | 63.9 | 1.22 | 27.6 | 8.06 | 6.01 | 3.63 | 1.99 | 2.62 | 142.86 | 4.32 | 97.28 | 45.89 | 64.42 | 2.47 |
| (n = 10) | SD | 9.5 | 9.5 | 17.5 | 0.47 | 2.7 | 1.53 | 0.90 | 0.63 | 0.29 | 0.09 | 1.42 | 0.12 | 1.94 | 0.83 | 1.62 | 0.21 |
| SS | ∗∗ | ∗ | ∗∗ | ∗∗ | ∗ | ∗∗ | ∗ | ∗ | |||||||||
| 225 | Mean | 58.3 | 85.3 | 57.9 | 1.06 | 29.6 | 7.00 | 5.29 | 4.12 | 2.12 | 2.63 | 141.53 | 3.96 | 95.90 | 45.97 | 65.33 | 2.38 |
| (n = 10) | SD | 10.0 | 10.0 | 15.6 | 0.23 | 3.1 | 0.58 | 0.64 | 0.38 | 0.15 | 0.09 | 1.69 | 0.22 | 1.55 | 1.63 | 2.91 | 0.22 |
| SS | ∗∗ | ∗∗ | ∗ | ∗∗ | ∗∗ | ∗∗ | ∗∗ | ∗∗ | ∗ | ||||||||
| Test for significance | DN | DN | DN | NS | DN | NS | DN | DN | U | DN | U | DN | U | DN | NS | DN | |
| Historical control range | 26.0–70.0 | 65.0–131.0 | 62.0–209.0 | 0.4–2.5 | 20.0–35.0 | 3.3–8.9 | 4.7–9.2 | 1.4–3.1 | 1.5–2.3 | 2.4–2.9 | 141.2–148.4 | 4.1–5.2 | 96.8–103.2 | 40.1–47.3 | 59.9–70.1 | 1.5–2.6 | |
| Female | |||||||||||||||||
| 0 (Control) | Mean | 48.7 | 99.7 | 41.5 | 1.84 | 29.0 | 6.51 | 5.29 | 2.20 | 1.83 | 2.67 | 143.59 | 4.24 | 101.08 | 49.61 | 66.44 | 3.00 |
| (n = 10) | SD | 12.5 | 21.0 | 9.5 | 0.81 | 2.7 | 0.68 | 0.63 | 0.25 | 0.12 | 0.09 | 1.07 | 0.21 | 1.60 | 3.17 | 4.73 | 0.44 |
| 75 | Mean | 52.0 | 101.6 | 50.9 | 0.92 | 27.4 | 7.04 | 6.31 | 3.03 | 1.93 | 2.67 | 142.25 | 4.41 | 99.30 | 48.07 | 66.40 | 2.63 |
| (n = 10) | SD | 9.0 | 20.2 | 29.6 | 0.34 | 3.1 | 0.74 | 0.97 | 0.93 | 0.35 | 0.09 | 2.08 | 0.39 | 1.75 | 3.82 | 5.40 | 0.27 |
| SS | ∗∗ | ∗∗ | ∗ | ∗ | ∗ | ||||||||||||
| 112 | Mean | 46.0 | 84.6 | 37.8 | 1.15 | 26.1 | 6.79 | 6.15 | 3.53 | 1.94 | 2.68 | 141.86 | 4.16 | 97.77 | 48.40 | 67.56 | 2.53 |
| (n = 10) | SD | 10.8 | 22.8 | 14.0 | 0.40 | 3.1 | 0.94 | 1.08 | 0.59 | 0.36 | 0.10 | 1.21 | 0.31 | 1.28 | 2.99 | 4.82 | 0.21 |
| SS | ∗∗ | ∗ | ∗∗ | ∗∗ | ∗∗ | ∗ | |||||||||||
| 150 | Mean | 50.0 | 84.2 | 53.5 | 1.03 | 24.4 | 7.09 | 6.70 | 3.02 | 2.09 | 2.76 | 141.47 | 4.41 | 96.13 | 48.75 | 66.46 | 2.75 |
| (n = 10) | SD | 12.2 | 16.7 | 18.9 | 0.44 | 3.6 | 0.72 | 0.59 | 0.65 | 0.17 | 0.09 | 1.17 | 0.30 | 1.57 | 2.34 | 3.56 | 0.23 |
| SS | ∗∗ | ∗∗ | ∗∗ | ∗∗ | ∗∗ | ∗ | ∗∗ | ∗∗ | |||||||||
| 187 | Mean | 56.3 | 80.3 | 39.6 | 1.23 | 25.9 | 7.12 | 6.39 | 3.55 | 2.33 | 2.76 | 140.38 | 4.48 | 95.94 | 46.89 | 64.21 | 2.77 |
| (n = 9†) | SD | 7.3 | 6.2 | 7.8 | 0.40 | 3.1 | 1.59 | 0.62 | 1.02 | 0.19 | 0.10 | 1.03 | 0.19 | 2.09 | 2.89 | 4.49 | 0.38 |
| SS | ∗ | ∗ | ∗ | ∗∗ | ∗∗ | ∗∗ | ∗∗ | ∗∗ | |||||||||
| 225 | Mean | 50.2 | 76.6 | 36.4 | 1.24 | 25.0 | 6.73 | 6.18 | 3.45 | 2.29 | 2.77 | 140.89 | 4.42 | 95.69 | 48.25 | 65.56 | 2.79 |
| (n = 10) | SD | 13.4 | 8.9 | 10.3 | 0.37 | 3.0 | 1.25 | 0.51 | 0.83 | 0.14 | 0.09 | 0.75 | 0.26 | 1.58 | 1.65 | 2.37 | 0.20 |
| SS | ∗∗ | ∗∗ | ∗ | ∗ | ∗ | ∗∗ | ∗ | ∗∗ | ∗∗ | ||||||||
| Test for significance | NS | U | NS | DN | DN | NS | DN | U | U | DN | DN | NS | DN | NS | NS | DN | |
| Historical control range | 28.0–133.0 | 66.0–249.0 | 22.0–162.0 | 0.5–3.6 | 24.0–40.0 | 3.8–9.5 | 4.0–7.3 | 1.1–2.8 | 0.8–2.1 | 2.4–2.9 | 140.9–146.5 | 3.1–4.6 | 97.6–105.0 | 43.8–57.6 | 56.5–78.9 | 1.7–3.7 | |
| Recovery groups | |||||||||||||||||
| Male | |||||||||||||||||
| 0 (Control) | Mean | 46.80 | 96.60 | 83.60 | 1.66 | 28.60 | 7.60 | 6.09 | 2.20 | 2.11 | 2.67 | 144.66 | 4.63 | 100.30 | 42.96 | 62.88 | 2.18 |
| (n = 5) | SD | 6.38 | 22.70 | 17.29 | 0.40 | 3.36 | 1.30 | 1.00 | 0.15 | 0.09 | 0.04 | 1.41 | 0.21 | 1.36 | 0.97 | 2.00 | 0.28 |
| 225 | Mean | 40.20 | 72.60 | 71.60 | 1.46 | 27.60 | 6.64 | 5.36 | 2.45 | 2.23 | 2.68 | 143.64 | 4.68 | 99.22 | 43.16 | 62.54 | 2.24 |
| (n = 5) | SD | 2.39 | 8.26 | 11.01 | 0.29 | 1.14 | 0.31 | 0.25 | 0.36 | 0.11 | 0.02 | 0.34 | 0.11 | 0.57 | 1.37 | 0.90 | 0.23 |
| Test for significance | NS | NS | NS | NS | NS | NS | NS | NS | NS | NS | NS | NS | NS | NS | NS | NS | |
| Female | |||||||||||||||||
| 0 (Control) | Mean | 48.80 | 95.20 | 37.80 | 1.84 | 36.80 | 6.76 | 5.64 | 1.94 | 1.39 | 2.59 | 141.36 | 4.04 | 99.44 | 48.56 | 66.56 | 2.72 |
| (n = 5) | SD | 9.63 | 13.08 | 13.77 | 0.43 | 5.76 | 1.09 | 0.37 | 0.38 | 0.21 | 0.05 | 1.05 | 0.29 | 0.76 | 2.25 | 3.77 | 0.28 |
| 225 | Mean | 37.80 | 77.80 | 36.40 | 1.88 | 30.40 | 6.72 | 5.43 | 2.48 | 1.39 | 2.65 | 142.02 | 4.23 | 99.58 | 48.86 | 67.90 | 2.64 |
| (n = 5) | SD | 4.60 | 24.24 | 22.86 | 0.84 | 2.97 | 1.05 | 0.82 | 0.64 | 0.46 | 0.08 | 0.98 | 0.19 | 1.91 | 3.16 | 4.10 | 0.45 |
| Test for significance | NS | NS | NS | NS | NS | NS | NS | NS | NS | NS | NS | NS | NS | NS | NS | NS | |
Abbreviations: A/G, albumin to globulin ratio; ALB, albumin; ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; BAC, bile acids; Ca++, calcium; CHOL, cholesterol; Cl−, chloride; CREA, creatinine; DN, Duncan's multiple range test; GLUC, glucose; K+, potassium; Na+, sodium; NS, Not Significant; Pi, inorganic phosphorous; SD, standard deviation; SS, statistically significant compared to control; TBIL, total bilirubin; TPROT, total protein; U, Mann-Whitney U-test versus control. †Main group females at 187 mg/kg bw/day (n = 9; one animal died at collection due to over anesthesia). ∗p < 0.05, ∗∗p < 0.01.