Table 2.
Summary of patient characteristics, primary and secondary endpoints
| AP | Placebo | ||||||||
| Baseline | 18-wk | Within-group difference vs baseline (P) | Baseline | 18-wk | Within-group difference vs baseline (P) | Δ from baseline AP | Δ from baseline placebo | Between-group comparison of Δ (P) | |
| Number (M/F) | 29 (20/9) | 30 (18/12) | |||||||
| Age | 53 ± 7 | 50 ± 11.9 | |||||||
| Smoker | 3/29 | 3/30 | |||||||
| Weight (kg) | 90 ± 13 | 88 ± 12 | 0.008 | 96 ± 18 | 95 ± 18 | 0.011 | -1.6 ± 3.1 | -1.3 ± 2.6 | 0.657 |
| BMI (kg/m2) | 32.2 ± 4.6 | 31.7 ± 4.4 | 0.013 | 34.7 ± 5.1 | 34.2 ± 5.1 | 0.008 | -0.5 ± 1.1 | -0.5 ± 0.9 | 0.805 |
| Waist circumference (cm) | 110 ± 9 | 107 ± 9 | 0.018 | 115 ± 13 | 114 ± 13 | 0.087 | -2.4 ± 5.1 | -1.2 ± 3.6 | 0.301 |
| Systolic blood pressure (mmHg) | 125 ± 13 | 120 ± 9 | 0.037 | 125 ± 14 | 126 ± 12 | 0.585 | -5 ± 14 | 1 ± 12 | 0.047 |
| Diastolic blood pressure (mmHg) | 78 ± 8 | 75 ± 8 | 0.087 | 81 ± 8 | 78 ± 7 | 0.084 | -3 ± 8 | -3 ± 10 | 0.753 |
| Fasting glucose (mmol/L) | 5.72 ± 1.22 | 5.28 ± 1.11 | 0.006 | 4.72 ± 0.67 | 4.55 ± 0.67 | 0.006 | -0.44 ± 0.78 | -0.22 ± 0.39 | 0.186 |
| Fasting Insulin (pmol/L) | 90 ± 42 | 76 ± 42 | 0.165 | 90 ± 69 | 111 ± 90 | 0.119 | -14 ± 35 | 21 ± 57 | 0.042 |
| HOMA-IR | 3.2 ± 1.5 | 2.6 ± 1.3 | 0.019 | 2.8 ± 2.2 | 3.2 ± 2.6 | 0.259 | -0.6 ± 1.2 | 0.4 ± 1.9 | 0.023 |
| Mean postprandial glucose (mmol/L) | 7.00 ± 1.89 | 6.67 ± 1.61 | 0.085 | 5.89 ± 1.33 | 6.05 ± 0.89 | 0.309 | -0.33 ± 1.00 | 0.16 ± 0.78 | 0.046 |
| Mean postprandial Insulin (pmol/L) | 306 ± 125 | 298 ± 159 | 0.793 | 409 ± 194 | 507 ± 347 | 0.017 | -7 ± 115 | 100 ± 215 | 0.023 |
| OGTT Glucose at 2 h (mmol/L) | 8.89 ± 3.44 | 8.33 ± 3.00 | 0.216 | 6.94 ± 1.94 | 7.17 ± 1.89 | 0.478 | -10 ± 47 | 4 ± 25 | 0.153 |
| Triglycerides (mmol/L) | 1.76 ± 0.86 | 1.73 ± 0.85 | 0.933 | 1.92 ± 0.83 | 2.07 ± 1.28 | 0.375 | -0.01 ± 0.89 | 0.17 ± 1.03 | 0.467 |
| Total cholesterol (mmol/L) | 5.40 ± 1.00 | 4.60 ± 0.59 | < 0.001 | 5.09 ± 1.03 | 5.08 ± 0.82 | 0.253 | -0.82 ± 0.76 | -0.13 ± 0.60 | < 0.001 |
| HDL cholesterol (mmol/L) | 1.08 ± 0.26 | 1.08 ± 0.23 | 0.757 | 1.18 ± 0.35 | 1.1 ± 0.28 | 0.054 | 0.00 ± 0.13 | -0.08 ± 0.21 | 0.074 |
| LDL cholesterol (mmol/L) | 3.49 ± 0.19 | 2.69 ± 0.54 | < 0.001 | 3.05 ± 1 | 2.93 ± 0.99 | 0.200 | -0.82 ± 0.68 | -0.13 ± 0.55 | < 0.001 |
| Flow mediated dilation (%) | 6.8 ± 3.1 | 8.7 ± 3.3 | 0.021 | 6.8 ± 1.9 | 6.8 ± 2.1 | 0.982 | 1.9 ± 4.2 | 0 ± 1.9 | 0.032 |
AP: Neutraceutical consisting of berberine, policosanol and red yeast rice; OGTT: Oral glucose tolerance test; HOMA-IR: Homeostasis model assessment of insulin resistance; BMI: Body mass index; HDL: High density lipoprotein; LDL: Low density lipoprotein.