Table 2.
Risk factor/Metabolic changes in subjects who completed the trial.
| Variable | Baseline n | Baseline mean ± SD | Evaluation n | Evaluation mean ± SD | Average difference | (95% CI) | Efficacy (p value) |
|---|---|---|---|---|---|---|---|
| Body weight (kg) | 35 | 98 (17) | 29 | 92 (15) | −3.8 | (−5.61, −1.97) | 0.0002 |
| BMI (kg/m2) | 32 | 32 (6.8) | 29 | 30 (5.6) | −1.2 | (−1.81, −0.67) | 0.0001 |
| Abdominal Circumference (cm) | 34 | 111 (12) | 29 | 105 (12) | −4.6 | (−6.87, −2.27) | 0.0003 |
| Systolic Blood Pressure (mmHg) | 35 | 138 (18) | 29 | 128 (18) | −9.5 | (−16.16, −2.88) | 0.0066 |
| Diastolic Blood Pressure (mmHg) | 35 | 81 (12) | 29 | 77 (11) | −4.5 | (−8.54, −0.43) | 0.0316 |
| Triglycerides (mg/dL) | 25 | 1.5 (0.67) | 19 | 1.3 (0.46) | −0.22 | (−0.52, 0.07) | 0.127 |
| Total Cholesterol (mg/dL) | 26 | 4.6 (0.85) | 20 | 4.5 (1.1) | −0.2 | (−0.42, 0.01) | 0.0634 |
| LDL Cholesterol (mg/dL) | 26 | 2.6 (0.65) | 20 | 2.6 (0.97) | −0.13 | (−0.37, 0.12) | 0.2887 |
| HDL Cholesterol (mg/dL) | 26 | 1.3 (0.28) | 19 | 1.4 (0.39) | 0.07 | (−0.02, 0.15) | 0.1178 |
| HbA1C | 19 | 41 (8.8) | 14 | 39 (11) | −4.4 | (−8.97, 0.26) | 0.0625 |
| PSA (ng/dL) | 26 | 2.3 (3.8) | 20 | 3.7 (7.5) | 0.39 | (0.1, 0.68) | 0.0112 |
CI confidence interval.