TABLE 2.
Within group pre–post supplementation difference for primary and secondary endpoints using piecewise mixed effect linear regression. At each time point, mean ± SD are reported
| Group | Mean (SD) T1 | Mean (SD) T2 | Mean (SD) T3 | Mean (SD) T4 | Effect | Estimate | SE | p Value* | |
|---|---|---|---|---|---|---|---|---|---|
| Primary endpoint | |||||||||
| VAT (g) | Supplement | 1,042.55 (629.56) | 913.12 (635.59) | 889.36 (623.74) | 890.88 (630.87) |
time T1‐T2 time T2‐T4 |
−130.08 −11.12 |
23.67 16.21 |
<.0001 .49 |
| Placebo | 1,095.32 (610.56) | 1,070.77 (653.26) | 1,029.81 (643.92) | 1,060.03 (626.53) |
time T1‐T2 time T2‐T4 |
−29.75 −5.37 |
26.93 15.92 |
.27 .74 |
|
| Secondary endpoints | |||||||||
| Total cholesterol (mg/dl) | Supplement | 245.09 (21.32) | 226.73 (18.18) | 229.79 (21.65) | 227.30 (22.79) |
time T1‐T2 time T2‐T4 |
−18.06 0.29 |
2.38 1.59 |
<.0001 .86 |
| Placebo | 237.29 (18.97) | 242.87 (25.77) | 237.39 (23.96) | 245.52 (22.60) |
time T1‐T2 time T2‐T4 |
2.07 1.32 |
4.90 1.68 |
.67 .43 |
|
| LDL (mg/dl) | Supplement | 156.30 (28.70) | 147.79 (26.41) | 148.15 (27.58) | 146.36 (30.99) |
time T1‐T2 time T2‐T4 |
−8.16 −0.71 |
2.35 1.62 |
.0008 .66 |
| Placebo | 161.19 (25.60) | 169.19 (31.01) | 161.94 (28.55) | 170.61 (28.32) |
time T1‐T2 time T2‐T4 |
3.66 0.71 |
3.73 1.60 |
.33 .66 |
|
| HDL (mg/dl) | Supplement | 61.12 (18.46) | 59.58 (16.44) | 59.00 (17.10) | 61.06 (16.49) |
time T1‐T3 time T3‐T4 |
−2.06 0.74 |
0.95 0.45 |
.03 .10 |
| Placebo | 60.77 (19.22) | 59.10 (17.72) | 57.87 (17.64) | 59.23 (17.77) |
time T1‐T3 time T3‐T4 |
−2.41 0.06 |
1.16 0.66 |
.04 .92 |
|
| Glycemia (mg/dl) | Supplement | 87.12 (8.02) | 86.15 (11.97) | 88.12 (19.77) | 88.09 (20.90) |
time T1‐T2 time T2‐T4 |
−0.81 0.97 |
1.71 1.21 |
.64 .42 |
| Placebo | 87.06 (7.05) | 85.00 (7.74) | 84.35 (7.41) | 85.48 (7.81) |
time T1‐T2 time T2‐T4 |
−2.33 0.24 |
1.19 0.63 |
.05 .70 |
|
| ApoB (mg/dl) | Supplement | 133.21 (23.54) | 127.94 (22.50) | 128.15 (20.71) | 129.21 (24.20) |
time T1‐T2 time T2‐T4 |
−5.39 0.64 |
2.60 1.85 |
.04 .73 |
| Placebo | 133.77 (18.55) | 136.29 (21.75) | 131.13 (19.94) | 136.81 (21.99) |
time T1‐T2 time T2‐T4 |
−0.45 0.26 |
2.44 1.27 |
.85 .84 |
|
| Creatinine (mg/dl) | Supplement | 0.80 (0.14) | 0.81 (0.14) | 0.81 (0.13) | 0.80 (0.15) |
time T1‐T3 time T3‐T4 |
0.01 −0.007 |
0.01 0.007 |
.45 .30 |
| Placebo | 0.82 (0.11) | 0.81 (0.13) | 0.82 (0.14) | 0.80 (0.12) |
time T1‐T3 time T3‐T4 |
−0.003 −0.008 |
0.01 0.007 |
.83 .22 |
|
| Lean mass (g) | Supplement | 42,324.30 (7,710.22) | 42,032.73 (7,673.63) | 42,291.18 (7,754.14) | 42,011.15 (7,548.28) |
time T1‐T3 time T3‐T4 |
−218.11 −10.79 |
193.97 105.11 |
.26 .92 |
| Placebo | 43,299.29 (7,520.21) | 42,911.74 (7,167.12) | 43,129.55 (7,356.75) | 40,945.29 (12,307.01) |
time T1‐T3 time T3‐T4 |
717.57 −983.23 |
760.04 770.27 |
.35 .20 |
|
| ApoA/HDL | Supplement | 2.79 (0.34) | 2.91 (0.37) | 2.92 (0.40) | 2.85 (0.40) |
time T1‐T3 time T3‐T4 |
0.12 −0.03 |
0.04 0.02 |
.001 .23 |
| Placebo | 2.78 (0.35) | 2.81 (0.31) | 2.84 (0.33) | 2.78 (0.28) |
time T1‐T3 time T3‐T4 |
0.05 −0.01 |
0.04 0.02 |
.14 .49 |
|
Note: The last four columns of the table report the estimate of the effect, its SE and the p‐value of the null hypothesis of a no effect. time x‐y refers to the x–y days interval as set by the breaking point or knot. All models were adjusted for age and sex. Significance level (two‐sided p‐value) of the null hypothesis of a no effect for the within group pre–post supplementation difference was obtained using piecewise linear model to accommodate for nonlinear trend. All models were adjusted for age, sex, and BMI.