Table 4.
Arm 1 + 4 (placebo) | Arm 2 (3 tablets) | Arm 3 (6 tablets) | P-value | P-value | P-value | ||||
---|---|---|---|---|---|---|---|---|---|
Value | Change from baseline | Value | Change from baseline | Value | Change from baseline | (1+4 versus 2) | (1+4 versus 3) | (2 versus 3) | |
Weight (kg) | |||||||||
8 weeks | 96.6 ± 2.8 | −3.5 ± 0.5 † | 94.9 ± 2.4 | −3.1 ± 0.5 † | 100.2 ± 3.1 | −3.3 ± 0.5 † | .50 | .77 | .71 |
12 weeks | 96.2 ± 2.8 | −3.9 ± 0.6 † | 95.9 ± 2.4 | −3.2 ± 0.5 † | 98.9 ± 3.1 | −3.8 ± 0.6 † | .39 | .86 | .50 |
Waist (cm) | |||||||||
8 weeks | 105.9 ± 2.2 | −3.4 ± 0.7 † | 104.6 ± 2.0 | −2.6 ± 0.7 † | 107.7 ± 2.3 | −2.4 ± 0.7 † | .84 | .43 | .33 |
12 weeks | 105.4 ± 2.2 | −3.9 ± 0.7 † | 105.1 ± 2.1 | −3.4 ± 0.8 † | 107.0 ± 2.2 | −2.8 ± 0.7 † | .56 | .64 | .29 |
BMI (kg/m2) | |||||||||
8 weeks | 33.7 ± 0.7 | −1.2 ± 0.2 † | 33.7 ± 0.7 | −1.1 ± 0.2 † | 34.6 ± 0.8 | −1.2 ± 0.2 † | .60 | .77 | .83 |
12 weeks | 33.6 ± 0.8 | −1.4 ± 0.2 † | 34.1 ± 0.7 | −1.1 ± 0.2 † | 34.2 ± 0.8 | −1.3 ± 0.2 † | .43 | .83 | .58 |
BP-systolic (mmHg) | |||||||||
8 weeks | 126.9 ± 2.5 | −3.4 ± 1.3* | 124.7 ± 2.7 | −4.7 ± 1.5 † | 127.1 ± 2.5 | −2.0 ± 2.3 | .59 | .57 | .29 |
12 weeks | 127.9 ± 2.4 | −2.3 ± 1.4 | 127.9 ± 2.4 | −0.6 ± 1.9 | 128.1 ± 2.3 | −0.1 ± 3.1 | .58 | .47 | .87 |
BP-diastolic (mmHg) | |||||||||
8 weeks | 79.1 ± 1.4 | −4.9 ± 1.3 † | 80.3 ± 1.5 | −2.5 ± 1.0* | 82.8 ± 1.5 | −2.3 ± 1.2 | .17 | .13 | .88 |
12 weeks | 80.6 ± 1.6 | −3.4 ± 1.3* | 81.3 ± 1.6 | −2.0 ± 1.2 | 81.0 ± 2.0 | −3.3 ± 1.9 | .51 | .98 | .54 |
F. glucose (mmol/L) | |||||||||
8 weeks | 5.52 ± 0.09 | 0.16 ± 0.06 † | 5.55 ± 0.13 | 0.07 ± 0.09 | 5.64 ± 0.07 | 0.29 ± 0.08 † | .40 | .23 | .05 |
12 weeks | 5.54 ± 0.09 | 0.18 ± 0.07* | 5.52 ± 0.10 | 0.03 ± 0.08 | 5.62 ± 0.13 | 0.24 ± 0.09* | .19 | .59 | .08 |
Glucose 2pp (mmol/L) | |||||||||
8 weeks | 6.49 ± 0.29 | 0.43 ± 0.29 | 6.97 ± 0.36 | −0.13 ± 0.35 | 7.21 ± 0.41 | 0.47 ± 0.33 | .22 | .94 | .21 |
12 weeks | 6.57 ± 0.33 | 0.51 ± 0.34 | 6.81 ± 0.27 | −0.36 ± 0.32 | 6.81 ± 0.44 | 0.04 ± 0.34 | .07 | .32 | .41 |
F. insulin (pmol/L) | |||||||||
8 weeks | 86.3 ± 10.5 | −8.4 ± 6.7 | 93.8 ± 11.1 | −27.2 ± 9.4 † | 79.6 ± 5.4 | −20.6 ± 8.1* | .10 | .28 | .57 |
12 weeks | 87.0 ± 8.5 | −7.7 ± 6.5 | 107.0 ± 14.2 | −20.5 ± 9.8* | 96.4 ± 16.6 | −2.8 ± 11.3 | .32 | .71 | .19 |
Insulin 2pp (pmol/L) | |||||||||
8 weeks | 460.8 ± 77.5 | −114.7 ± 63.5 | 579.7 ± 89.1 | −213.9 ± 118.9 | 550.4 ± 101.7 | −57.5 ± 63.9 | .40 | .63 | .21 |
12 weeks | 705.8 ± 85.0 | 130.3 ± 61.2* | 863.0 ± 117.6 | 35.4 ± 72.6 | 655.9 ± 82.5 | 56.5 ± 61.0 | .30 | .42 | .82 |
Cholesterol (mmol/L) | |||||||||
8 weeks | 5.35 ± 0.20 | −0.13 ± 0.13 | 5.26 ± 0.19 | −0.19 ± 0.13 | 5.20 ± 0.24 | −0.26 ± 0.14 | .73 | .47 | .72 |
12 weeks | 5.16 ± 0.17 | −0.32 ± 0.12* | 5.17 ± 0.16 | −0.18 ± 0.11 | 5.30 ± 0.23 | −0.16 ± 0.13 | .42 | .35 | .90 |
LDL (mmol/L) | |||||||||
8 weeks | 3.24 ± 0.16 | −0.08 ± 0.12 | 3.15 ± 0.18 | 0.06 ± 0.12 | 3.23 ± 0.20 | −0.10 ± 0.11 | .40 | .91 | .35 |
12 weeks | 2.98 ± 0.14 | −0.24 ± 0.12 | 3.08 ± 0.15 | 0.10 ± 0.11 | 3.24 ± 0.17 | 0.02 ± 0.11 | .04 | .10 | .64 |
TG (mmol/L) | |||||||||
8 weeks | 2.60 ± 0.36 | −0.02 ± 0.39 | 2.37 ± 0.21 | −0.55 ± 0.14 † | 2.05 ± 0.19 | −0.50 ± 0.18* | .17 | .22 | .89 |
12 weeks | 2.41 ± 0.23 | −0.20 ± 0.19 | 2.28 ± 0.22 | −0.59 ± 0.12† | 2.27 ± 0.32 | −0.25 ± 0.24 | .14 | .87 | .21 |
HDL (mmol/L) | |||||||||
8 weeks | 1.07 ± 0.04 | 0.01 ± 0.02 | 1.06 ± 0.03 | −0.01 ± 0.02 | 1.05 ± 0.03 | −0.04 ± 0.02 | .56 | .13 | .36 |
12 weeks | 1.07 ± 0.04 | 0.00 ± 0.02 | 1.07 ± 0.03 | −0.00 ± 0.02 | 1.06 ± 0.04 | −0.03 ± 0.03 | .83 | .29 | .40 |
Chol/HDL | |||||||||
8 weeks | 5.1 ± 0.2 | −0.2 ± 0.1 | 5.0 ± 0.2 | −0.1 ± 0.1 | 5.0 ± 0.2 | −0.1 ± 0.1 | .90 | .59 | .69 |
12 weeks | 4.9 ± 0.2 | −0.3 ± 0.1* | 4.9 ± 0.2 | −0.2 ± 0.1 | 5.1 ± 0.2 | 0.0 ± 0.1 | .41 | .06 | .30 |
TG/HDL | |||||||||
8 weeks | 5.9 ± 1.0 | 0.1 ± 1.1 | 5.3 ± 0.6 | −1.1 ± 0.4 † | 4.6 ± 0.4 | −0.8 ± 0.4 | .24 | .37 | .79 |
12 weeks | 5.3 ± 0.5 | −0.5 ± 0.5 | 5.0 ± 0.5 | −1.3 ± 0.3 † | 5.1 ± 0.8 | −0.3 ± 0.6 | .23 | .76 | .15 |
HOMA | |||||||||
8 weeks | 3.0 ± 0.4 | −0.2 ± 0.3 | 3.3 ± 0.4 | −0.9 ± 0.4* | 2.8 ± 0.2 | −0.6 ± 0.3 | .12 | .37 | .51 |
12 weeks | 3.1 ± 0.3 | −0.1 ± 0.3 | 3.7 ± 0.5 | −0.7 ± 0.4 | 3.7 ± 0.9 | 0.3 ± 0.6 | .38 | .49 | .13 |
Data expressed as mean ± SE. *P < .05, † P < .01 compared to baseline.