Table 3.
Measurement | Mean ± SD Phase 1 | Mean ± SD Phase 2 | Mean ± SD Phase 3 | Mean difference Phase 1 to 2 | Mean difference Phase 2 to 3 | Mean difference Phase 1 to 3 |
Clinical outcome | ||||||
Weight (kg) | 100.6 ± 21.7 | 99.2 ± 21.3 | 99.5 ± 21.5 | -1.4 (P = 0.009) | +0.28 (P = 1.0) | -1.12 (P = 0.08) |
BMI (kg/m2) | 36.9 ± 8.3 | 36.4 ± 8.1 | 36.5 ± 8.1 | -0.52 (P = 0.01) | +0.1 (P = 1.0) | -0.42 (P = 0.09) |
Waist circumference (cm) | 109.6 ± 11.1 | 107.8 ± 11.1 | 107.5 ± 10.9 | -1.75 (P = 0.086) | -0.30 (P = 1.0) | -2.05 (P = 0.24) |
Systolic BP (mmHg) | 130.0 ± 17.8 | 127.0 ± 21.4 | 128.5 ± 14.3 | -3 (P = 0.83) | +1.5 (P = 1.0) | -1.5 (P = 1.0) |
Diastolic BP (mmHg) | 80.5 ± 13.2 | 79.8 ± 15.7 | 81.7 ± 12.2 | -0.72 (P = 1.0) | +1.9 (P = 0.76) | +1.2 (P = 1.0) |
Daily hours fasted | 11.6 ± 1.9 | 16.8 ± 1.2 | 11.5 ± 2.0 | +5.2 (P < 0.005) | -5.3 (P < 0.005) | -0.09 (P = 1.0) |
Biochemical outcome | ||||||
C-reactive protein (mg/L) | 4.3 ± 3.8 | 4.0 ± 3.7 | 4.1 ± 3.5 | -0.3 (P = 0.9) | +0.09 (P = 1.0) | -0.25 (P = 1.0) |
HOMA-IR | 6.9 ± 3.0 | 6.5 ± 2.4 | 6.6 ± 3.0 | -0.46 (P = 1.0) | +0.11 (P = 1.0) | -0.35 (P = 1.0) |
HOMA-IR: Homeostasis Model Assessment; BMI: Body mass index; BP: Blood pressure.