Table 2.
Subject data and biochemical parameters for assessment of safety of oral administration of ME. Blood and urine samples were collected from the subjects in 0, 1, 4, 12, 16, and 24 weeks after beginning oral administration of ME. The biochemical parameters were measured as tabulated. Body mass index and blood pressure were also determined. All parameters were collected and calculated from 11 healthy individuals.
| Test | Subject data and laboratory safety assessment, mean (SEM) | |||||
|---|---|---|---|---|---|---|
| Day 0 | 1 week | 4 weeks | 12 weeks | 16 weeks | 24 weeks | |
| Glucose (mg/dL) |
86.73 (1.64) | 85.00 (1.67) | 83.09 (1.45) | 81.45 (3.04) | 80.91 (1.46) | 85.00 (2.53) |
| Cholesterol (mg/dL) |
206.54 (13.10) | 196.00 (12.95) | 201.09 (14.32) | 193.45 (10.34) | 190.63 (13.61) | 192.45 (24.74) |
| Triglycerides (mg/dL) |
78.00 (11.15) | 77.18 (19.58) | 81,27 (20.11) | 87.18 (17.27) | 103.54 (30.80) | 92.27 (22.65) |
| HDL-CHOL (mg/dL) |
62.90 (2.94) | 60.45 (2.52) | 59.45 (2.13) | 59.72 (2.08) | 57.81 (2.26) | 59.45 (1.95) |
| LDL-calculated (mg/dL) |
128.03 (12.00) | 120.10 (10.62) | 125.38 (12.34) | 116.29 (8.95) | 112.10 (9.13) | 114.54 (10.80) |
| BUN (mg/dL) |
12.84 (1.63) | 11.26 (0.58) | 12.43 (1.03) | 11.82 (0.82) | 12.23 (0.88) | 12.17 (1.18) |
| Creatinine (mg/dL) |
0.86 (0.06) | 0.84 (0.04) | 0.81 (0.05) | 0.82 (0.04) | 0.82 (0.04) | 0.81 (0.04) |
| Sodium (mmol/L) |
141.27 (0.57) | 141.54 (0.89) | 141.36 (0.51) | 140.09 (0.47) | 141.09 (0.41) | 140.18 (0.38) |
| Potassium (mmol/L) |
3.75 (0.06) | 3.72 (0.09) | 3.75 (0.07) | 3.58 (0.08) | 3.56 (0.06) | 3.63 (0.08) |
| Chloride (mmol/L) |
102.79 (0.45) | 103.08 (0.56) | 102.50 (0.50) | 101.79 (0.71) | 103.23 (0.55) | 102.93 (0.36) |
| Bicarbonate (mmol/L) |
28.14 (0.85) | 24.92 (0.70) | 26.50 (1.04) | 25.43 (0.70) | 24.85 (1.01) | 24.14 (0.71) |
| Total bilirubin (mg/dL) |
0.63 (0.14) | 0.60 (0.11) | 0.49 (0.08) | 0.59 (0.11) | 0.60 (0.14) | 0.57 (0.10) |
| Direct bilirubin (mg/dL) |
0.21 (0.04) | 0.23 (0.03) | 0.20 (0.02) | 0.24 (0.04) | 0.24 (0.04) | 0.22 (0.03) |
| AST (SGOT) (U/L) |
20.81 (1.89) | 19.45 (2.07) | 30.54 (8.04) | 18.00 (1.80) | 19.09 (1.46) | 17.63 (2.83) |
| ALT (SGPT) (U/L) |
19.18 (4.12) | 17.00 (3.68) | 31.27 (10.40) | 18.45 (4.54) | 15.63 (2.61) | 20.45 (7.71) |
| ALP (U/L) |
60.72 (2.68) | 59.27 (3.14) | 63.63 (3.17) | 62.45 (2.05) | 64.09 (3.74) | 62.54 (3.14) |
| T3 (ng/dL) |
99.42 (3.27) | 104.62 (3.53) | 97.45 (3.16) | 97.35 (3.82) | 99.26 (6.33) | 92.62 (3.72) |
| TSH (μIU/mL) |
2.15 (0.32) | 2.01 (0.32) | 2.09 (0.42) | 2.03 (0.36) | 2.07 (0.28) | 2.16 (0.30) |
| FT4 (ng/dL) |
1.32 (0.05) | 1.28 (0.05) | 1.26 (0.05) | 1.22 (0.02) | 1.18 (0.03) | 1.22 (0.04) |
| Hemoglobin (g/dL) |
13.60 (0.31) | 13.25 (0.39) | 13.45 (0.31) | 13.55 (0.37) | 13.50 (0.40) | 13.50 (0.43) |
| Hematocrit (%) |
42.19 (1.00) | 40.91 (1.04) | 41.32 (1.05) | 41.43 (1.10) | 40.51 (1.25) | 40.64 (1.21) |
| WBC count (×103/μL) |
5.97 (0.36) | 5.77 (0.33) | 5.94 (0.26) | 6.44 (0.32) | 5.70 (0.37) | 5.43 (0.29) |
| Platelet count (×103/μL) |
246.27 (13.14) | 240.45 (14.30) | 255.36 (14.13) | 243.54 (12.65) | 238.27 (12.20) | 239.72 (10.64) |
| Absolute neutrophils (×103/μL) |
3.09 (0.23) | 3.19 (0.26) | 3.27 (0.14) | 3.88 (0.44) | 3.12 (0.28) | 2.84 (0.20) |
| PT (sec) |
12.14 (0.21) | 12.08 (0.21) | 11.99 (0.24) | 12.23 (0.19) | 12.48 (0.27) | 12.62 (0.22) |
| aPTT (sec) |
28.53 (0.60) | 28.19 (0.76) | 28.61 (0.69) | 28.97 (0.61) | 29.20 (0.81) | 29.70 (0.74) |
| Urine protein (Neg–trace) | 54.5% | 72.7% | 72.7% | 81.8% | 72.7% | 54.5% |
| Body mass index | 21.74 (1.12) | 21.86 (1.12) | 21.64 (1.07) | 22.07 (1.14) | 21.91 (1.12) | 21.89 (1.13) |
| Arterial blood pressure (mm Hg) |
117/72 | 117/76 | 117/77 | 119/73 | 118/72 | 113/73 |
HDL-CHOL, high-density lipoprotein cholesterol; LDL, low-density lipoprotein; BUN, blood urea nitrogen; AST (SGOT), aspartate aminotransferase (serum glutamic oxaloacetic transaminase); ALT (SGPT), alanine aminotransferase (serum glutamic pyruvic transaminase); ALP, alkaline phosphatase; T3, triiodothyronine; TSH, thyroid-stimulating hormone; FT4, free thyroxine; WBC, white blood cell; PT, prothrombin time; aPTT, activated partial thromboplastin time.