TABLE 2.
Clinical laboratory test results for alanine aminotransferase (ALT), lipid profiles, and platelet function1
| Dose and time | ALT2 | LDL-C3 | Cholesterol4 | HDL-C5 | TGs6 | PFCT7 |
| 1 Capsule/d | ||||||
| 0 mo | 20.6 ± 7.7 | 114.2 ± 34.2 | 195.9 ± 41 | 55.8 ± 15.4 | 129.5 ± 69 | 93.4 ± 11.8 |
| 3 mo | 23.6 ± 9.3 | 114.8 ± 24.6 | 190.8 ± 20 | 58.8 ± 13.5 | 86.6 ± 50.2 | 99 ± 25.1 |
| 6 mo | 21.1 ± 8.5 | 126.8 ± 23.8 | 205.3 ± 24.6 | 57.6 ± 16.5 | 95.9 ± 49.8 | 103.4 ± 29.1 |
| 3 Capsules/d | ||||||
| 0 mo | 20.3 ± 7.3 | 133.3 ± 27 | 212.6 ± 30.5 | 57.4 ± 16.5 | 109.3 ± 70.9 | 103.3 ± 18.5 |
| 3 mo | 21.9 ± 6.3 | 139.8 ± 26.1 | 213.8 ± 28.5 | 57.5 ± 15.9 | 80.7 ± 51.1 | 106.4 ± 31.2 |
| 6 mo | 22.8 ± 8.6 | 135.8 ± 29.8 | 208.1 ± 30.4 | 56.4 ± 16.3 | 79.3 ± 46.1 | 95 ± 22.9 |
| 6 Capsules/d | ||||||
| 0 mo | 19.3 ± 3.8 | 135.6 ± 33.4 | 208.7 ± 33.2 | 56.8 ± 15.8 | 84.7 ± 47.7 | 120.8 ± 45.2 |
| 3 mo | 20.2 ± 7.6 | 130.1 ± 33.8 | 198.6 ± 32.9 | 54.9 ± 16.3 | 65.5 ± 27.5 | 93.8 ± 29.2 |
| 6 mo | 20.7 ± 6.0 | 136.8 ± 29.7 | 205 ± 27.5 | 55.8 ± 13.4 | 62.4 ± 31.2 | 106.2 ± 30.1 |
| 9 Capsules/d | ||||||
| 0 mo | 19.3 ± 4.8 | 113.3 ± 36.8 | 196.2 ± 34.1 | 66.3 ± 17.0 | 89.7 ± 49.3 | 109.8 ± 29.1 |
| 3 mo | 21.3 ± 7.9 | 104.4 ± 38.2 | 170.3 ± 42 | 56.5 ± 26.6 | 45.8 ± 24.4 | 109.8 ± 21.4 |
| 6 mo | 19.8 ± 5.2 | 111.2 ± 34.9 | 181.3 ± 34.9 | 60.7 ± 24.4 | 47.8 ± 16.7 | 99.5 ± 24.7 |
All values are means ± SDs; n = 12 subjects per treatment arm (total n = 48 subjects). LDL-C, LDL cholesterol; HDL-C, HDL cholesterol; TGs, triglycerides; PFCT, platelet function closure time. No significant differences were found by repeated-measures ANOVA.
Range of normal values for ALT = 8–35 U/L.
Reference interval for LDL-C: optimal, <100 mg/dL; near optimal, 100–129 mg/dL; borderline high, 130–159 mg/dL; high, 160–189 mg/dL; and very high, ≥190 mg/dL.
Reference interval: desirable, <200 mg/dL; borderline high risk, 200–239 mg/dL; and high risk, ≥240 mg/dL.
Reference interval for HDL-C: low, <40 mg/dL; and high, >60 mg/dL.
Reference interval for TGs: desirable, <150 mg/dL; borderline, 150–199 mg/dL; high, 200–499 mg/dL; and very high, >500 mg/dL.
Reference range for PFCT as determined by the time for in vitro platelet plug formation: 88–198 s for clotting on collagen-adrenaline membranes.