Table 3 Primary and secondary outcomes over the intervention in per-protocol seta
Outcome | Group | Pb | |||
|---|---|---|---|---|---|
LP group | PLA group | Group | Time | Group × Time | |
LDL-C, mmol/L | 0.995 | < 0.001 | 0.041 | ||
Week 0 | 3.937 (0.568) | 3.925 (0.625) | |||
Week 6 | 4.143 (0.602) | 4.033 (0.639) | |||
Week 12 | 3.828 (0.640) | 3.942 (0.624) | |||
ΔWeek 6 | 0.195 (0.542) | 0.111 (0.402) | |||
ΔWeek 12 | −0.100 (0.602) | 0.018 (0.416) | |||
TC, mmol/L | 0.981 | < 0.001 | 0.023 | ||
Week 0 | 5.808 (0.749) | 5.789 (0.763) | |||
Week 6 | 6.060 (0.764) | 5.931 (0.766) | |||
Week 12 | 5.688 (0.796) | 5.828 (0.739) | |||
ΔWeek 6 | 0.241 (0.624) | 0.152 (0.473) | |||
ΔWeek 12 | −0.117 (0.703) | 0.046 (0.510) | |||
TG, mmol/L | 0.424 | 0.006 | 0.394 | ||
Week 0 | 2.429 (0.807) | 2.614 (1.547) | |||
Week 6 | 2.726 (1.239) | 2.742 (1.449) | |||
Week 12 | 2.299 (0.896) | 2.510 (0.920) | |||
ΔWeek 6 | 0.286 (0.910) | 0.232 (1.521) | |||
ΔWeek 12 | −0.087 (0.858) | -0.061 (1.306) | |||
HDL-C, mmol/L | 0.500 | 0.250 | 0.800 | ||
Week 0 | 1.083 (0.213) | 1.072 (0.205) | |||
Week 6 | 1.102 (0.215) | 1.088 (0.189) | |||
Week 12 | 1.122 (0.208) | 1.090 (0.216) | |||
ΔWeek 6 | 0.014 (0.118) | 0.007 (0.126) | |||
ΔWeek 12 | 0.019 (0.123) | 0.022 (0.120) | |||
INS, μU/mL | 0.655 | 0.342 | 0.471 | ||
Week 0 | 12.121 (12.165) | 11.180 (4.854) | |||
Week 6 | 10.514 (7.268) | 11.289 (5.438) | |||
Week 12 | 11.161 (9.801) | 11.594 (5.586) | |||
ΔWeek 6 | −1.009 (5.283) | 0.060 (3.957) | |||
ΔWeek 12 | −0.799 (5.816) | 0.343 (4.330) | |||
GLU, mmol/L | 0.580 | 0.153 | 0.177 | ||
Week 0 | 5.037 (0.332) | 5.130 (0.518) | |||
Week 6 | 5.106 (0.543) | 5.129 (0.532) | |||
Week 12 | 5.012 (0.462) | 5.093 (0.548) | |||
ΔWeek 6 | 0.055 (0.426) | -0.001 (0.431) | |||
ΔWeek 12 | −0.047 (0.365) | 0.005 (0.422) | |||
BMI, kg/m2 | 0.280 | 0.821 | 0.751 | ||
Week 0 | 25.617 (4.483) | 24.786 (4.210) | |||
Week 6 | 25.873 (6.458) | 25.225 (5.106) | |||
Week 12 | 26.358 (5.246) | 24.995 (3.765) | |||
ΔWeek 6 | 0.019 (4.246) | 0.302 (3.923) | |||
ΔWeek 12 | 0.325 (4.241) | 0.032 (3.608) | |||