TABLE 5.
Laboratory findings evaluating adverse effects and additional benefits profile.
| FO group |
Placebo group |
Adjusted difference of FO vs. placebo 12 weeks | pa | |||
| Baseline | 12 week | Baseline | 12 week | |||
| Intention to treat (n = 54) | ||||||
| Systolic BP, mmHg | 124.4 ± 13.9 | 124.9 ± 14.0 | 126.9 ± 14.0 | 123.5 ± 14.2 | 1.53 (−7.48, 10.53) | 0.619 |
| Diastolic BP, mmHg | 78.5.4 ± 10.2 | 79.3 ± 8.9 | 82.4 ± 10.3 | 80.8 ± 9.7 | −0.23 (−5.74, 5.28) | 0.754 |
| AST, IU/L | 22.9 ± 4.4 | 23.1 ± 7.0 | 25.3 ± 4.0b | 24.6 ± 5.0 | 2.08 (−2.33, 6.48) | 0.367 |
| ALT, IU/L | 16.6 ± 4.7 | 19.6 ± 13.6 | 20.7 ± 7.8b | 18.6 ± 11.1 | 6.95 (−2.39, 16.29) | 0.190 |
| Glucose, mg/dL | 94.0 [87.0−97.0] | 92.0 [83.0−101.0] | 92.0 [83.0−101.0] | 92.0 [87.0−99.0] | − | 0.246 |
| Insulin, μU/mL | 4.8 [3.8−6.8] | 5.1 [4.1−6.4] | 4.1 [2.4−7.0] | 4.9 [2.8−7.4] | − | 0.464 |
| HOMA-IR | 1.13 [0.89−1.44] | 1.15 [0.95−1.71] | 0.98 [0.53−1.59] | 1.12 [0.67−1.71] | − | 0.380 |
| hs-CRP, mg/dl | 0.05 [0.03−0.07] | 0.04 [0.03−0.08] | 0.04 [0.03−0.10] | 0.04 [0.02−0.08] | − | 0.644 |
| FFA, mg/dL | 311.7 ± 131.0 | 338.2 ± 173.2 | 357.9 ± 162.6 | 312.9 ± 204.9 | 100.25 (−41.13, 241.62) | 0.165 |
| Creatine kinase, U/L | 25.1 ± 13.8 | 24.9 ± 17.4 | 27.0 ± 15.8 | 26.0 ± 13.2 | −0.25 (−10.91, 10.33) | 0.823 |
| Malondialdehyde, μM | 3.11 ± 0.78 | 3.19 ± 0.72 | 3.23 ± 0.82 | 3.15 ± 0.78 | −0.02 (−0.53, 0.49) | 0.810 |
| Per protocol (n = 49) | ||||||
| Systolic BP, mmHg | 124.4 ± 14.2 | 124.4 ± 13.8 | 126.6 ± 15.1 | 124.0 ± 14.2 | 0.60 (−7.99, 9.18) | 0.889 |
| Diastolic BP, mmHg | 78.2 ± 10.2 | 78.9 ± 8.5 | 82.3 ± 11.1 | 81.3 ± 9.1 | −1.34 (−6.07, 3.38) | 0.569 |
| AST, IU/L | 23.0 ± 4.3 | 23.2 ± 7.0 | 25.2 ± 4.3 | 25.6 ± 3.7 | 1.15 (−2.91, 5.21) | 0.571 |
| ALT, IU/L | 16.1 ± 4.0 | 19.6 ± 13.6 | 21.6 ± 7.9c | 21.1 ± 5.8 | 4.23 (−4.18, 12.64) | 0.316 |
| Glucose, mg/dL | 94.0 [87.0−97.0] | 92.5 [83.0−101.0) | 92.0 (83.0−101.0) | 93.0 (84.0−99.8) | − | 0.270 |
| Insulin, μU/mL | 4.7 [3.8−6.6] | 5.1 [4.1−6.4] | 4.1 [2.5−7.0] | 4.9 [2.8−6.6] | − | 0.357 |
| HOMA-IR | 1.12 [0.89−1.37] | 1.17 [0.95−1.71] | 0.98 [0.53−1.88] | 1.08 [0.67−1.64] | − | 0.281 |
| hs-CRP, mg/dl | 0.04 [0.02−0.09] | 0.04 [0.03−0.08] | 0.05 [0.03−0.07] | 0.03 [0.02−0.08] | − | 0.532 |
| FFA, mg/dL | 311.7 ± 131.9 | 335.9 ± 173.0 | 362.3 ± 161.0 | 351.4 ± 170.2 | 61.44 (−63.84, 186.73) | 0.328 |
| Creatine kinase, U/L | 25.8 ± 13.5 | 25.3 ± 16.5 | 28.0 ± 16.7 | 26.8 ± 11.5 | −0.99 (−10.73, 8.75) | 0.838 |
| Malondialdehyde, μM | 3.08 ± 0.78 | 3.19 ± 0.70 | 3.24 ± 0.88 | 3.14 ± 0.76 | −0.04 (−0.51, 0.43) | 0.810 |
Values are mean ± SD, median [IQR] or mean (95% CI) unless otherwise indicated. FO, Fermented Oyster Extract; BP, blood pressure; AST, aspartate aminotransferase; ALT, alanine aminotransferase; HOMA-IR, Homeostatic Model Assessment for Insulin Resistance; hs-CRP, high-sensitivity C-reactive protein; FFA, free fatty acids. aANCOVA or ranked ANCOVA adjusted for age, sex, each baseline value, and the changes from baseline in dietary total caloric intake and protein intake as covariates over the 12-week period. bP < 0.05. cP < 0.005 by paired t-test or Wilcoxon signed-rank test within each group.