Table 2.
Anthropometry, body composition, blood pressure, and biochemical outcomes at day 45 and day 90.
| Variables | Overall Days 45 and 90 |
By visit Day 45 |
By visit Day 90 |
||||||
|---|---|---|---|---|---|---|---|---|---|
| DSF (n = 112) | Control (n = 118) | p-value | DSF (n = 112) | Control (n = 118) | p-value | DSF (n = 111) | Control (n = 118) | p-value | |
| Anthropometry | |||||||||
| Body weight (kg) | 72.10 ± 0.15 | 72.93 ± 0.15 | <0.001 | 72.28 ± 0.14 | 72.97 ± 0.14 | <0.001 | 71.92 ± 0.18 | 72.88 ± 0.18 | <0.001 |
| BMI (kg/m2) | 27.77 ± 0.06 | 28.08 ± 0.06 | <0.001 | 27.84 ± 0.05 | 28.09 ± 0.05 | <0.001 | 27.70 ± 0.07 | 28.06 ± 0.07 | <0.001 |
| Hip circumference (cm) | 100.24 ± 0.21 | 101.03 ± 0.20 | 0.003 | 100.57 ± 0.19 | 101.11 ± 0.19 | 0.028 | 99.91 ± 0.24 | 100.95 ± 0.24 | 0.003 |
| Waist circumference (cm) | 94.00 ± 0.23 | 95.04 ± 0.22 | <0.001 | 94.28 ± 0.22 | 95.11 ± 0.22 | 0.003 | 93.72 ± 0.26 | 94.97 ± 0.25 | <0.001 |
| Body composition | |||||||||
| Fat mass (kg) | 25.91 ± 0.17 | 26.53 ± 0.17 | 0.004 | 26.19 ± 0.18 | 26.57 ± 0.17 | 0.092 | 25.64 ± 0.19 | 26.49 ± 0.19 | 0.002 |
| Fat mass (%) | 36.27 ± 0.21 | 36.70 ± 0.21 | 0.111 | 36.56 ± 0.23 | 36.71 ± 0.23 | 0.608 | 35.98 ± 0.25 | 36.70 ± 0.25 | 0.058 |
| Fat-free mass (kg) | 46.05 ± 0.17 | 46.09 ± 0.16 | 0.832 | 45.95 ± 0.19 | 46.10 ± 0.18 | 1.000 | 46.14 ± 0.20 | 46.08 ± 0.19 | 1.000 |
| Fat-free mass (%) | 63.73 ± 0.21 | 63.30 ± 0.21 | 0.111 | 63.44 ± 0.23 | 63.29 ± 0.23 | 0.606 | 64.02 ± 0.25 | 63.30 ± 0.25 | 0.058 |
| Visceral adipose tissue (L) | 2.97 ± 0.03 | 3.08 ± 0.03 | 0.002 | 3.00 ± 0.03 | 3.08 ± 0.03 | 0.037 | 2.93 ± 0.03 | 3.08 ± 0.03 | <0.001 |
| Total body water (%) | 47.11 ± 0.15 | 46.83 ± 0.15 | 0.156 | 46.89 ± 0.17 | 46.84 ± 0.16 | 0.821 | 47.33 ± 0.18 | 46.82 ± 0.18 | 0.061 |
| Phase angle (°) | 5.78 ± 0.03 | 5.74 ± 0.03 | 0.372 | 5.79 ± 0.03 | 5.73 ± 0.03 | 0.340 | 5.77 ± 0.04 | 5.75 ± 0.04 | 0.739 |
| Blood pressure | |||||||||
| Systolic blood pressure (mmHg) | 127.5 ± 0.9 | 129.6 ± 0.9 | 0.082 | 127.8 ± 1.0 | 128.6 ± 1.0 | 0.518 | 127.3 ± 1.1 | 130.5 ± 1.0 | 0.043 |
| Diastolic blood pressure (mmHg) | 76.9 ± 0.6 | 78.4 ± 0.6 | 0.045 | 76.5 ± 0.6 | 78.2 ± 0.6 | 0.101 | 77.3 ± 0.7 | 78.6 ± 0.7 | 0.159 |
| Biochemical outcomes | |||||||||
| HbA1c (%) | 7.45 ± 0.06 | 7.69 ± 0.06 | 0.003 | 7.50 ± 0.06 | 7.68 ± 0.06 | 0.015 | 7.41 ± 0.07 | 7.70 ± 0.07 | 0.004 |
| Blood glucose (mmol/L) | 7.63 ± 0.14 | 7.92 ± 0.14 | 0.117 | 7.80 ± 0.17 | 7.91 ± 0.16 | 0.609 | 7.45 ± 0.17 | 7.92 ± 0.16 | 0.066 |
| Insulin (μIU/mL) | 15.62 ± 0.72 | 14.80 ± 0.71 | 0.373 | 15.68 ± 0.85 | 15.22 ± 0.84 | 0.681 | 15.57 ± 0.78 | 14.38 ± 0.77 | 0.484 |
| HOMA-β | 97.62 ± 8.42 | 85.08 ± 8.27 | 0.248 | 93.74 ± 10.06 | 91.59 ± 9.84 | 0.871 | 101.50 ± 8.62 | 78.56 ± 8.46 | 0.082 |
| HOMA-IR | 5.20 ± 0.29 | 5.28 ± 0.28 | 0.829 | 5.38 ± 0.36 | 5.34 ± 0.35 | 1.000 | 5.01 ± 0.30 | 5.21 ± 0.30 | 1.000 |
| Total cholesterol (mmol/L) | 4.18 ± 0.06 | 4.26 ± 0.05 | 0.245 | 4.16 ± 0.07 | 4.25 ± 0.07 | 0.681 | 4.19 ± 0.06 | 4.27 ± 0.06 | 0.681 |
| Triglycerides (mmol/L) | 1.78 ± 0.07 | 1.89 ± 0.07 | 0.250 | 1.73 ± 0.08 | 1.87 ± 0.08 | 0.379 | 1.84 ± 0.08 | 1.91 ± 0.08 | 0.484 |
| HDL cholesterol (mmol/L) | 1.19 ± 0.01 | 1.20 ± 0.01 | 0.470 | 1.17 ± 0.02 | 1.20 ± 0.02 | 0.307 | 1.21 ± 0.02 | 1.21 ± 0.02 | 0.952 |
| LDL cholesterol (mmol/L) | 2.19 ± 0.05 | 2.23 ± 0.05 | 0.516 | 2.21 ± 0.06 | 2.24 ± 0.06 | 0.896 | 2.17 ± 0.05 | 2.22 ± 0.05 | 0.896 |
| Total cholesterol:HDL cholesterol ratio | 3.62 ± 0.07 | 3.76 ± 0.07 | 0.124 | 3.65 ± 0.08 | 3.76 ± 0.08 | 0.313 | 3.59 ± 0.08 | 3.76 ± 0.07 | 0.176 |
| IPAQ total physical activity (MET-min per week) | 3601.1 ± 342.9 | 3953.4 ± 346.8 | 0.421 | 3657.8 ± 367.4 | 4449.3 ± 367.4 | 0.191 | 3544.4 ± 416.7 | 3457.4 ± 424.9 | 0.875 |
Repeated measures ANCOVA, adjusting for treatment group, site, randomization strata HbA1c level and BMI, visit, treatment group by visit interaction, and baseline value for the specific outcome variable. Stepdown Bonferroni (Holm) p value adjustments were made to account for multiple comparisons. The “Overall” column shows the results from the treatment main effect and the “By visit” columns show the results of the treatment group by visit interaction effect. Both results were obtained from the same repeated measures ANCOVA. Values are LSM ± SE. Statistically significant findings (p < 0.05) are in bold. For some variables, sample sizes are smaller than the overall stated sample sizes. ANCOVA, analysis of covariance; BMI, body mass index; HbA1c, glycated hemoglobin; HDL, high-density lipoprotein; HOMA-β, homeostasis model assessment of β-cell function; HOMA-IR, homeostasis model assessment of insulin resistance; IPAQ, International Physical Activity Questionnaire; LDL, low-density lipoprotein; LSM, least square mean; MET, metabolic equivalent task; SE, standard error.