Table 3.
Variable | Visit | PED arm | MED arm | P value2 (Difference between arm) | Adjusted P value3 | ||
Value (mean ± SE) | Mean % change from baseline | Value (mean ± SE) | Mean % change from baseline | ||||
Cholesterol (mmol/L) | Baseline | 6.57 ± 0.15 | 6.67 ± 0.20 | ||||
8 weeks | 5.67 ± 0.22** | -13.8% | 6.09 ± 0.25** | -8.7% | 0.13 | 0.04 | |
12 weeks | 5.59 ± 0.14** | -14.5% | 6.27 ± 0.22* | -6.3% | 0.03 | 0.04 | |
TG (mmol/L) | Baseline | 2.78 ± 0.22 | 2.37 ± 0.23 | ||||
8 weeks | 2.02 ± 0.25** | -27.2% | 1.84 ± 0.17** | -22.3% | 0.27 | 0.05 | |
12 weeks | 1.86 ± 0.12** | -35.2% | 2.09 ± 0.19 | -14.3% | 0.03 | 0.01 | |
HDL (mmol/L) | Baseline | 0.98 ± 0.05 | 1.02 ± 0.05 | ||||
8 weeks | 0.99 ± 0.05 | 0.7% | 1.00 ± 0.04 | -1.6% | 0.34 | 0.45 | |
12 weeks | 1.05 ± 0.05* | 7.0% | 1.04 ± 0.05 | 2.7% | 0.18 | 0.21 | |
LDL (mmol/L) | Baseline | 4.39 ± 0.17 | 4.64 ± 0.20 | ||||
8 weeks | 3.78 ± 0.19** | -16.8% | 4.24 ± 0.20** | -9.8% | 0.11 | 0.19 | |
12 weeks | 3.69 ± 0.12** | -17.3% | 4.28 ± 0.17* | -8.4% | 0.11 | 0.18 | |
Non-HDL cholesterol (mmol/L) | Baseline | 5.59 ± 0.14 | 5.65 ± 0.19 | ||||
8 weeks | 4.67 ± 0.20** | -16.4% | 5.09 ± 0.25** | 10.0% | 0.19 | 0.03 | |
12 weeks | 4.54 ± 0.14** | -18.2% | 5.23 ± 0.22* | -8.0% | 0.02 | 0.03 | |
LDL particle number (nmol/L) | Baseline | 1634 ± 57 | 1733 ± 84 | ||||
8 weeks | 1453 ± 63* | -11.9% | 1618 ± 108 | -6.6% | 0.24 | 0.19 | |
12 weeks | 1455 ± 63* | -11.9% | 1629 ± 109* | -7.0% | 0.26 | 0.31 | |
Chol/HDL | Baseline | 6.9 ± 0.3 | 6.8 ± 0.3 | ||||
8 weeks | 5.9 ± 0.3** | -14.3% | 6.2 ± 0.3** | -9.0% | 0.13 | 0.09 | |
12 weeks | 5.6 ± 0.3** | -19.5% | 6.3 ± 0.4** | -8.9% | 0.01 | 0.02 | |
TG/HDL | Baseline | 3.1 ± 1.7 | 2.5 ± 1.4 | ||||
8 weeks | 2.1 ± 1.3** | -30.6% | 1.9 ± 0.9** | -23.2% | 0.20 | 0.07 | |
12 weeks | 1.9 ± 0.7** | -42.7% | 2.1 ± 1.1 | -17.6% | 0.02 | 0.01 | |
apo A-I (g/L) | Baseline | 1.94 ± 0.06 | 1.96 ± 0.07 | ||||
8 weeks | 1.89 ± 0.05 | -2.5% | 1.88 ± 0.06 | -3.9% | 0.32 | 0.30 | |
12 weeks | 1.90 ± 0.06 | -2.1% | 1.87 ± 0.06 | -4.3% | 0.24 | 0.16 | |
apo B (g/L) | Baseline | 1.48 ± 0.05 | 1.50 ± 0.06 | ||||
8 weeks | 1.30 ± 0.05** | -12.1% | 1.36 ± 0.06** | -9.9% | 0.32 | 0.21 | |
12 weeks | 1.21 ± 0.04** | -17.5% | 1.36 ± 0.06** | -9.9% | 0.09 | 0.14 | |
apoB/apoA-I | Baseline | 0.78 ± 0.03 | 0.78 ± 0.04 | ||||
8 weeks | 0.70 ± 0.03* | -10.3% | 0.73 ± 0.04* | -6.4% | 0.26 | 0.13 | |
12 weeks | 0.66 ± 0.03** | -15.4% | 0.75 ± 0.05* | -6.3% | 0.07 | 0.08 | |
Fasting Glucose (mmol/L) | Baseline | 5.49 ± 0.10 | 5.63 ± 0.11 | ||||
8 weeks | 5.31 ± 0.11 | -3.3% | 5.46 ± 0.10 | -2.9% | 0.45 | 0.42 | |
12 weeks | 5.39 ± 0.10 | -2.2% | 5.41 ± 0.12* | -4.8% | 0.85 | 0.92 | |
Fasting Insulin (pmol/L) | Baseline | 82.65 ± 8.33 | 110.43 ± 13.13 | ||||
8 weeks | 53.48 ± 4.58** | -35.2% | 75.70 ± 10.42* | -31.0% | 0.66 | 0.82 | |
12 weeks | 60.42 ± 5.69** | -26.8% | 88.90 ± 11.74* | -22.3% | 0.59 | 0.74 | |
HOMA1 | Baseline | 3.0 ± 0.4 | 4.1 ± 0.6 | ||||
8 weeks | 1.8 ± 0.2** | -38.9% | 2.7 ± 0.4* | -32.6% | 0.63 | 0.81 | |
12 weeks | 2.0 ± 0.2* | -29.7% | 3.0 ± 0.5 | -24.9% | 0.61 | 0.76 | |
HbA1c % | Baseline | 5.7 ± 0.1 | 6.0 ± 0.1 | ||||
8 weeks | 5.6 ± 0.1* | -1.9% | 5.9 ± 0.1** | -2.7% | 0.77 | 0.72 | |
12 weeks | 5.6 ± 0.1** | -2.6% | 5.8 ± 0.1** | -3.8% | 0.82 | 0.87 |
*Different from baseline, P < 0.05
**Different from baseline, P < 0.01
1HOMA score calculated as follows: [(insulin (pmol/L)*glucose (mmol/L))/135].
2Comparing the values between arms using 1-sided unpaired t-test
3Adjusted for body weight, caloric intake, and carbohydrate intake