Table 3.
Baseline, and 3 Months Data of Patients During Nutraceutical Treatment and Placebo
| Parameters | Nutraceutical | Placebo | p-value Nutraceutical vs Placebo | ||||
|---|---|---|---|---|---|---|---|
| Baseline | 3 Months | p-value vs Baseline | Baseline | 3 Months | p-value vs Baseline | ||
| Patients | 73 | 70 | 75 | 70 | |||
| M/F | 35/38 | 32/38 | 38/37 | 36/34 | |||
| Age (years) | 55.8 ± 8.3 | - | 56.9 ± 8.7 | – | |||
| Smoking status (M/F) | 14/16 | 12/16 | 15/13 | 14/11 | |||
| Height (cm) | 1.68 ± 0.04 | 1.68 ± 0.04 | 0.142 | 1.69 ± 0.05 | 1.69 ± 0.05 | 0.145 | 0.139 |
| Weight (Kg) | 80.1 ± 9.7 | 79.5 ± 9.4 | 0.231 | 81.5 ± 9.9 | 81.9 ± 10.3 | 0.238 | 0.244 |
| BMI (Kg/m2) | 28.4 ± 2.3 | 28.2 ± 2.1 | 0.346 | 28.5 ± 2.4 | 28.7 ± 2.5 | 0.355 | 0.316 |
| WC (cm) | 89.4 ± 3.1 | 88.2 ± 2.8 | 0.397 | 89.9 ± 3.4 | 90.6 ± 3.8 | 0.403 | 0.453 |
| HC (cm) | 86.3 ± 2.4 | 86.1 ± 2.2 | 0.374 | 86.7 ± 2.6 | 87.8 ± 3.1 | 0.382 | 0.393 |
| AC (cm) | 97.1 ± 3.0 | 96.3 ± 2.7 | 0.426 | 98.1 ± 3.3 | 98.9 ± 3.7 | 0.431 | 0.433 |
| FPG (mg/dl) | 117.4 ± 7.7 | 102.4 ± 7.0*,^ | 0.041 | 114.3 ± 7.1 | 116.5 ± 11.4 | 0.376 | 0.048 |
| PPG (mg/dl) | 128.2 ± 13.6 | 118.5 ± 7.2*,^ | 0.037 | 129.1 ± 7.3 | 130.6 ± 7.7 | 0.326 | 0.042 |
| HbA1c (%) | 6.0 ± 0.4 | 5.6 ± 0.2*,^ | 0.035 | 5.9 ± 0.3 | 5.8 ± 0.3 | 0.416 | 0.045 |
| FPI (μU/mL) | 8.9 ± 5.1 | 9.5± 5.3*,^ | 0.032 | 9.0 ± 5.2 | 8.9 ± 5.1 | 0.459 | 0.037 |
| Homa index | 2.57 ± 0.8 | 2.39 ± 0.7*,^ | 0.037 | 2.56 ± 0.7 | 2.51 ± 0.5 | 0.363 | 0.032 |
| TC (mg/dl) | 215.1 ± 18.3 | 202.6 ± 17.2* | 0.042 | 213.6 ± 17.9 | 209.4 ± 16.9 | 0.248 | 0.074 |
| LDL-C (mg/dl) | 144.3 ± 17.4 | 134.3 ± 14.2 | 0.076 | 143.1 ± 16.8 | 138.7 ± 15.8 | 0.252 | 0.091 |
| HDL-C (mg/dl) | 45.1 ± 4.8 | 46.3 ± 5.1 | 0.178 | 45.5 ± 4.9 | 44.2 ± 4.5 | 0.293 | 0.141 |
| Tg (mg/dl) | 128.3 ± 36.3 | 110.2 ± 31.4*,^ | 0.034 | 125.2 ± 35.9 | 132.4 ± 37.1 | 0.167 | 0.039 |
| AST (UI/l) | 18.4 ± 8.3 | 17.8 ± 8.1 | 0.189 | 18.5 ± 8.6 | 18.1 ± 9.2 | 0.293 | 0.161 |
| ALT (UI/l) | 23.2 ± 13.6 | 21.9 ± 12.1 | 0.157 | 22.1 ± 12.5 | 23.6 ± 13.9 | 0.187 | 0.173 |
| Hs-CRP (mg/l) | 1.2 ± 0.7 | 0.9 ± 0.6 | 0.069 | 1.0 ± 0.5 | 1.2 ± 0.7 | 0.163 | 0.082 |
Notes: Data are expressed as mean ± standard deviation. *p < 0.05 vs baseline; ^p < 0.05 vs placebo.
Abbreviations: M, males; F, females; BMI, body mass index; WC, waist circumference; HC, hip circumference; AC, abdominal circumference; FPG, fasting plasma glucose; PPG, postprandial glucose; HbA1c, glycated hemoglobin; FPI, fasting plasma insulin; TC, total cholesterol; LDL-C, low-density lipoprotein-cholesterol; HDL-C, high-density lipoprotein-cholesterol; Tg, triglycerides; AST, aspartate aminotransferase; ALT, alanine aminotransferase; Hs-CRP, high-sensitivity C-reactive protein.