Table 3.
Lipid profile of participants at baseline (Day 0), day 30, and day 60 in the ITT population (N = 118)
| Placebo | NRPT 1X | NRPT 2X | Between group | |
|---|---|---|---|---|
| Mean ±SD (n) | Mean ±SD (n) | Mean ±SD (n) | p-value | |
| Triglyceride concentration (mmol/L) | ||||
| Day 0 Baseline | 1.24 ± 0.72 (38) | 1.33 ± 0.71 (39) | 1.03 ± 0.38 (36) | 0.145a,b |
| Day 30 | 1.15 ± 0.60 (40) | 1.42 ± 0.93 (40) | 1.03 ± 0.39 (38) | 0.038a,b |
| Day 60 End of Study | 1.11 ± 0.67 (40) | 1.48 ± 0.93 (40) | 1.08 ± 0.45 (38) | 0.018a,b |
| Change from Day 0 to Day 30 | −0.09 ± 0.40 (38) | 0.01 ± 0.45 (39) | 0.01 ± 0.27 (36) | 0.427a,c |
| Change from Day 0 to Day 60 | −0.12 ± 0.38 (38)d | 0.11 ± 0.49 (39)e | 0.07 ± 0.30 (36) | 0.023a,c |
| Total cholesterol concentration (mmol/L) | ||||
| Day 0 Baseline | 5.09 ± 0.84 (38) | 5.58 ± 0.81 (39)e | 5.21 ± 0.84 (36) | 0.029a,b |
| Day 30 | 5.10 ± 0.89 (40) | 5.78 ± 0.87 (40) | 5.52 ± 0.84 (38) | 0.002a,b |
| Day 60 End of Study | 5.15 ± 0.92 (40) | 5.86 ± 0.85 (40) | 5.70 ± 0.94 (38) | <0.001a,b |
| Change from Day 0 to Day 30 | −0.02 ± 0.39 (38) | 0.13 ± 0.52 (39) | 0.32 ± 0.40 (36)e | 0.002a,c |
| Change from Day 0 to Day 60 | 0.05 ± 0.53 (38) | 0.22 ± 0.57 (39) | 0.51 ± 0.48 (36)e | <0.001a,c |
| High-density lipoprotein concentration (mmol/L) | ||||
| Day 0 Baseline | 1.71 ± 0.54 (38) | 1.61 ± 0.44 (39) | 1.73 ± 0.51 (36) | 0.589a,b |
| Day 30 | 1.68 ± 0.53 (40) | 1.58 ± 0.42 (40) | 1.74 ± 0.49 (38) | 0.389a,b |
| Day 60 End of Study | 1.72 ± 0.56 (40) | 1.53 ±0.41 (40) | 1.74 ± 0.49 (38) | 0.157a,b |
| Change from Day 0 to Day 30 | −0.020 ± 0.232 (38) | −0.017 ± 0.153 (39) | −0.003 ± 0.140 (36) | 0.879a,c |
| Change from Day 0 to Day 60 | 0.010 ± 0.209 (38) | −0.070 ± 0.194 (39) | −0.009 ± 0.138 (36) | 0.113a,c |
| Low-density lipoprotein concentration (mmol/L) | ||||
| Day 0 Baseline | 2.81 ± 0.81 (38) | 3.37 ± 0.67 (39)e | 3.01 ± 0.80 (36) | 0.004a,b |
| Day 30 | 2.90 ± 0.81 (40) | 3.56 ± 0.73 (40) | 3.31 ± 0.78 (38) | <0.001a,b |
| Day 60 End of Study | 2.93 ± 0.80 (40) | 3.65 ± 0.72 (40) | 3.47 ± 0.84 (38) | <0.001a,b |
| Change from Day 0 to Day 30 | 0.04 ± 0.36 (38) | 0.15 ± 0.44 (39) | 0.32 ± 0.35 (36)e | 0.004a,c |
| Change from Day 0 to Day 60 | 0.10 ± 0.38 (38) | 0.24 ± 0.43 (39)e | 0.48 ± 0.40 (36)e | <0.001a,c |
Probability values p ≤ 0.05 are statistically significant
a The logarithmic transformation was required to achieve normality
b Between group comparisons were made using ANOVA (no adjustment for baseline)
c Between group comparisons were made using ANCOVA adjusting for baseline
d Denotes significant within-group comparisons were made using the paired Student t-test
e Denotes significant difference compared to placebo as assessed by the Tukey-Kramer post-hoc test