TABLE 4.
Secondary outcome measures of the two groups.
| FO group |
Placebo group |
Adjusted difference of FO vs. placebo over 12 weeks | pa | |||
| Baseline | 12 week | Baseline | 12 week | |||
| Intention to treat (n = 54) | ||||||
| Handgrip (right), kg | 59.3 ± 13.4 | 58.2 ± 14.5 | 63.0 ± 16.6 | 61.3 ± 21.0 | −0.53 (−9.41, 8.35) | 0.730 |
| Handgrip (left), kg | 56.0 ± 13.2 | 54.5 ± 12.2 | 59.9 ± 15.2 | 58.9 ± 18.8 | −0.32 (−9.01, 8.37) | 0.810 |
| ALM/heightb, kg/m2 | 5.4 ± 0.6 | 5.5 ± 0.8 | 5.7 ± 1.0 | 5.6 ± 1.1 | 0.19 (−0.30, 0.67) | 0.479 |
| ALM/weight × 100 | 23.4 ± 3.2 | 23.5 ± 3.7 | 24.3 ± 3.1 | 23.9 ± 3.9 | 1.03 (−0.88, 2.94) | 0.305 |
| Total fat percent, % | 39.6 ± 6.4 | 39.2 ± 6.1 | 37.9 ± 5.3 | 38.7 ± 6.5 | −1.15 (−3.63, 1.32) | 0.424 |
| Trunk fat percent, % | 40.7 ± 6.7 | 40.5 ± 6.9 | 39.7 ± 5.0 | 40.6 ± 7.1 | 1.10 (−4.04, 1.84) | 0.521 |
| Creatinine, mg/dl | 0.69 ± 0.12 | 0.69 ± 0.15 | 0.67 ± 0.20 | 0.70 ± 0.17 | 0.01 (−0.07, 0.10) | 0.738 |
| Pyruvate, μM | 21.9 [17.2−27.7] | 28.1 [21.0−32.1] | 21.1 [18.3−32.2] | 28.6 [16.2−39.8] | − | 0.741 |
| Lactate, mmol/L | 1.20 ± 0.41 | 1.28 ± 0.55 | 1.25 ± 0.57 | 1.17 ± 0.67 | −0.14 (−0.55, 0.27) | 0.330 |
| EQ-5D-3L | 0.903 ± 0.119 | 0.945 ± 0.088 | 0.927 ± 0.080 | 0.909 ± 0.138 | 0.03 (−0.05, 0.11) | 0.448 |
| EQ-VAS | 76.7 ± 16.3 | 75.5 ± 18.3 | 77.0 ± 13.4 | 73.6 ± 18.3 | 1.34 (−8.13, 10.81) | 0.775 |
| Per protocol (n = 49) | ||||||
| Handgrip (right), kg | 59.6 ± 13.6 | 56.0 ± 13.5 | 63.4 ± 16.9 | 64.9 ± 16.5 | −5.09 (−11.14, 0.97) | 0.098 |
| Handgrip (left), kg | 56.0 ± 13.4 | 55.1 ± 10.2 | 59.8 ± 15.6 | 61.3 ± 15.5 | −3.38 (−8.03, 1.27) | 0.150 |
| ALM/heightb, kg/m2 | 5.46 ± 0.62 | 5.54 ± 0.62b | 5.67 ± 1.00 | 5.66 ± 1.08 | 0.12 (−0.25, 0.50) | 0.504 |
| ALM/weight x 100 | 23.6 ± 2.9 | 23.8 ± 2.9 | 24.2 ± 3.2 | 24.1 ± 3.7 | 0.81 (−0.63, 2.25) | 0.263 |
| Total fat percent,% | 39.0 ± 5.9 | 38.9 ± 5.8 | 37.8 ± 5.3 | 37.7 ± 5.6 | 0.07 (−0.99, 1.13) | 0.896 |
| Trunk fat percent, % | 40.2 ± 6.2 | 39.9 ± 6.0 | 39.6 ± 5.1 | 39.2 ± 5.4 | 0.29 (−1.14, 1.71) | 0.686 |
| Creatinine, mg/dl | 0.70 ± 0.12 | 0.70 ± 0.14 | 0.68 ± 0.21 | 0.72 ± 0.16 | 0.01 (−0.06, 0.08) | 0.874 |
| Pyruvate, μM | 21.9 (17.2−27.7) | 27.5 (21.0−32.1) | 25.0 (18.7−33.4) | 28.6 (19.7−38.7) | − | 0.899 |
| Lactate, mmol/L | 1.20 ± 0.42 | 1.27 ± 0.51 | 1.26 ± 0.57 | 1.23 ± 0.51 | −0.23 (−0.58, 0.12) | 0.195 |
| EQ-5D-3L | 0.906 ± 0.121 | 0.954 ± 0.070 | 0.934 ± 0.073 | 0.941 ± 0.096 | 0.02 (−0.05, 0.08) | 0.568 |
| EQ-VAS | 77.1 ± 16.4 | 77.0 ± 14.5 | 78.0 ± 13.0 | 77.8 ± 13.0 | −0.55 (−7.92, 6.82) | 0.880 |
Values are mean ± SD, median [IQR], or mean (95% CI) unless otherwise indicated. FO, Fermented Oyster Extract; ALM, appendicular lean mass; EQ-5D-3L, EuroQol-5 dimensions-3-levels; VAS, visual analog scale. 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 by paired t-test or Wilcoxon signed-rank test within each group.