Table 5.
The change in muscle strength, physical performance, and IGF-1 over time and the difference between the groups at baseline and after 12-month follow-up (per protocol based analysis)1.
| Variables | Placebo | Low-dose pRJ | High-dose pRJ | P values2 | P for trend2 | P values3 | P for trend3 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| (n = 48) | (n = 55) | (n = 47) | |||||||||||
| Baseline | At 12 Months | Changes | Baseline | At 12 Months | Changes | Baseline | At 12 Months | Changes | |||||
| Handgrip strength (kg) | 23.5 (20.7, 26.3)4 | 22.5 (19.8, 25.3) | −0.96 (−2.04, 0.11) | 22.6 (20.2, 25.0) | 23.2 (20.7, 25.8) | 0.61 (−0.63, 1.84) | 21.4 (18.8, 24.1) | 22.6 (19.7, 25.6) | 1.21 (−0.31, 2.74)5 | 0.06 | 0.02 | 0.048 | 0.02 |
| 6MWT (m) | 344.7 (312.4, 377.0) | 339.6 (306.3, 372.8) | −5.10 (−22.5, 12.2) | 345.5 (310.3, 380.7) | 323.8 (292.2, 355.3) | −21.7 (−44.0, 0.50) | 349.0 (312.6, 385.3) | 335.9 (300.9, 370.8) | −13.1 (−31.2, 5.00) | 0.48 | 0.58 | 0.48 | 0.57 |
| TUGT (sec) | 10.4 (8.90, 11.9) | 11.5 (9.40, 13.6) | 1.10 (−0.15, 2.34) | 12.0 (10.2, 13.9) | 12.9 (10.7, 15.0) | 0.81 (0.04, 1.59) | 13.3 (10.3, 16.2) | 13.5 (9.90, 17.0) | 0.19 (−1.82, 2.20) | 0.64 | 0.35 | 0.63 | 0.34 |
| Standing on one leg with eyes closed (sec) | |||||||||||||
| right leg | 4.17 (2.52, 5.81) | 3.32 (2.46, 4.19) | −0.84 (−2.50, 0.81) | 5.23 (2.84, 7.61) | 4.55 (2.62, 6.48) | −0.68 (−3.39, 2.03) | 3.50 (2.36, 4.63) | 3.01 (2.09, 3.93) | −0.49 (−1.67, 0.70) | 0.97 | 0.81 | 0.98 | 0.86 |
| left leg | 3.83 (3.00, 4.67) | 4.47 (3.12, 5.82) | 0.63 (−0.79, 2.06) | 4.80 (2.62, 6.98) | 5.25 (3.38, 7.12) | 0.45 (−0.79, 1.69) | 4.47 (3.02, 5.92) | 3.57 (2.45, 4.70) | −0.90 (−2.32, 0.53) | 0.24 | 0.12 | 0.20 | 0.11 |
| IGF-1 (ng/ml) | 102.9 (77.7, 128.0) | 81.6 (73.0, 90.1) | −21.3 (−47.7, 5.14) | 88.0 (79.1, 96.9) | 91.0 (81.5, 100.5) | 3.02 (−7.79, 13.8) | 87.0 (75.3, 98.8) | 90.9 (81.7, 100.1) | 3.90 (−10.5, 18.3) | 0.08 | 0.06 | 0.12 | 0.09 |
1IGF-1, insulin-like growth factor-1; pRJ, protease-treated royal jelly; 6MWT: six minute walk test; TUGT, timed up and go test.
2 P values for differences between the groups over the 12-month study period.
3Adjusted for nursing home.
4Mean (95% confidence interval).
5 P < 0.05 compared with placebo group.