Table 3.
Placebo | LU | B420 | LU + B420 | Overall P | Factorial P B420 | Factorial P LU | ||
---|---|---|---|---|---|---|---|---|
Outcome | Mean ± SD | Mean ± SD | Mean ± SD | Mean ± SD | ||||
n | 35–36 | 35–36 | 25 | 37 | ||||
Zonulin (ng/ml) | Baseline | 56.5 ± 12.6 | 55.5 ± 9.1 | 58.4 ± 11.4 | 64.6 ± 14.2 | |||
Month 6 | 59.7 ± 10.9 | 58.4 ± 12.0 | 57.1 ± 8.3 | 63.4 ± 13.0 | ||||
Δ (ng/ml) | + 3.5 ± 10.0 | + 2.8 ± 8.6 | − 1.2 ± 9.1 | − 1.2 ± 7.0 | 0.10 | 0.063 | 0.84 | |
ApoB-48 (μg/ml) | Baseline | 11.0 ± 7.2 | 9.5 ± 6.9 | 11.1 ± 5.5 | 9.8 ± 4.9 | |||
Month 6 | 11.0 ± 6.1 | 9.1 ± 5.4 | 12.6 ± 7.5 | 10.4 ± 5.7 | ||||
Δ (μg/ml) | + 0.07 ± 5.7 | − 0.44 ± 5.3 | + 1.53 ± 6.5 | + 0.56 ± 4.0 | 0.74a | 0.26a | 0.092a | |
hsCRP (mg/l) | Baseline | 1.73 ± 1.4 | 2.20 ± 2.3 | 2.78 ± 2.6 | 2.58 ± 2.6 | |||
Month 6 | 2.08 ± 1.3 | 2.43 ± 2.30 | 2.22 ± 2.6 | 2.56 ± 2.6 | ||||
Δ (mg/l) | + 0.35 ± 1.7 | + 0.23 ± 1.8 | − 0.56 ± 2.0 | − 0.02 ± 2.0 | 0.13a | 0.073a | 0.84a | |
LPS (EU/l) | Baseline | 65 ± 115 | 120 ± 206 | 43 ± 61 | 39 ± 43 | |||
Month 6 | 39 ± 26 | 101 ± 365 | 51 ± 76 | 48 ± 42 | ||||
Δ (EU/l) | − 26 ± 108 | − 13 ± 341 | + 7.1 ± 39 | + 9.1 ± 40⁎ | 0.007b | 0.094a | 0.22a | |
sCD14 (μg/ml) | Baseline | 1.62 ± 0.39 | 1.82 ± 0.43 | 1.80 ± 0.37 | 1.77 ± 0.49 | |||
Month 6 | 1.80 ± 0.61 | 1.87 ± 0.49 | 1.79 ± 0.54 | 1.75 ± 0.43 | ||||
Δ (μg/ml) | + 0.18 ± 0.6 | + 0.06 ± 0.5 | − 0.01 ± 0.5 | − 0.03 ± 0.5 | 0.43 | 0.24 | 0.78 | |
IL-6 (pg/ml) | Baseline | 10.5 ± 19 | 12.8 ± 20 | 9.0 ± 10 | 17.5 ± 54 | |||
Month 6 | 9.2 ± 16 | 12.3 ± 13 | 11.2 ± 13 | 8.0 ± 10 | ||||
Δ (pg/ml) | − 1.2 ± 10 | − 0.54 ± 15 | + 2.2 ± 13 | − 9.5 ± 47 | 0.72a | 0.42a | 0.64a |
Significant difference from Placebo, P < 0.05 (Dunnett's test, corrected for multiple comparisons). Only relative changes from baseline to month 6 were statistically compared between groups.
Analyses on log-transformed data.
Non-parametric analyses.