Table 2.
Baseline and follow-up clinical characteristics of participants according to the treatments (Intention To Treat analysis).
| Placebo (n = 41) | BC (n = 45) | |||||||
|---|---|---|---|---|---|---|---|---|
| Variables | Basal | Follow-up |
p-value (paired t-test) |
Basal | Follow-up |
p-value (paired t-test) |
p-value (unpaired t-test between basal values) |
p-value (unpaired t-test between follow-up values) |
| Weight (Kg) | 80 ± 11 | 77 ± 11 | <0.001 | 80 ± 12 | 76 ± 12 | <0.001 | 0.87 | 0.64 |
| BMI (Kg/m2) | 28.7 ± 4 | 27.7 ± 4 | <0.001 | 29.2 ± 3 | 27.6 ± 3 | <0.001 | 0.53 | 0.76 |
| WC (cm) | 97 ± 8 | 93 ± 8 | <0.001 | 99 ± 10 | 95 ± 9 | <0.001 | 0.23 | 0.52 |
| HC (cm) | 107 ± 7 | 103 ± 6 | <0.001 | 106 ± 7 | 102 ± 7 | <0.001 | 0.52 | 0.50 |
| FM (Kg) | 25 ± 8 | 22 ± 8 | <0.001 | 25 ± 7 | 21 ± 7 | <0.001 | 0.93 | 0.54 |
| SBP (mmHg) | 111 ± 17 | 110 ± 13 | 0.73 | 111 ± 14 | 109 ± 12 | 0.31 | 0.97 | 0.70 |
| DBP (mmHg) | 71 ± 15 | 71 ± 9 | 0.91 | 73 ± 11 | 72 ± 10 | 0.58 | 0.48 | 0.90 |
| CAP score (dB/m) | 283 ± 40 | 256 ± 52 | <0.001 | 295 ± 38 | 247 ± 42 | <0.001 | 0.15 | 0.37 |
| Stiffness (kPa) | 5.1 ± 1.4 | 4.6 ± 1.2 | 0.046 | 5.0 ± 1.3 | 4.7 ± 1.2 | 0.18 | 0.68 | 0.74 |
| Glucose (mg/dL) | 92 ± 8 | 92 ± 8 | 0.95 | 93 ± 8 | 92 ± 13 | 0.85 | 0.35 | 0.95 |
| Insulin (mU/L) | 10.2 ± 4 | 8.9 ± 5 | 0.021 | 10.2 ± 5 | 8.3 ± 5 | 0.016 | 0.86 | 0.50 |
| HOMA-IR | 2.3 ± 1.1 | 2.1 ± 1.2 | 0.07 | 2.4 ± 1.3 | 2.0 ± 1.2 | 0.034 | 0.76 | 0.63 |
| TC (mg/dL) | 194 ± 40 | 189 ± 42 | 0.30 | 188 ± 34 | 177 ± 33 | 0.001 | 0.48 | 0.13 |
| TG (mg/dL) | 113 ± 48 | 110 ± 55 | 0.72 | 102 ± 47 | 101 ± 49 | 0.84 | 0.28 | 0.38 |
| HDL-C (mg/dL) | 50 ± 12 | 49 ± 11 | 0.55 | 52 ± 12 | 49 ± 13 | 0.002 | 0.38 | 0.99 |
| LDL-C (mg/dL) | 122 ± 35 | 117 ± 36 | 0.32 | 116 ± 32 | 107 ± 30 | 0.002 | 0.42 | 0.15 |
| Non-HDL-C (mg/dL) | 144 ± 38 | 139 ± 42 | 0.34 | 136 ± 36 | 127 ± 34 | 0.003 | 0.32 | 0.13 |
| AST (IU/L) | 21 ± 9 | 20 ± 5 | 0.37 | 21 ± 6 | 19 ± 4 | 0.015 | 0.71 | 0.76 |
| ALT (IU/L) | 28 ± 21 | 22 ± 9 | 0.007 | 24 ± 13 | 19 ± 8 | 0.001 | 0.29 | 0.14 |
| γGT (UI/L) | 27 ± 21 | 25 ± 22 | 0.07 | 26 ± 18 | 22 ± 18 | 0.011 | 0.76 | 0.56 |
| Creatinine (mg/dL) | 0.82 ± 0.1 | 0.85 ± 0.1 | 0.034 | 0.83 ± 0.1 | 0.83 ± 0.1 | 0.63 | 0.68 | 0.63 |
| Uric Acid (mg/dL) | 5.2 ± 1.1 | 5.3 ± 1.2 | 0.27 | 5.2 ± 1.1 | 5.1 ± 1.0 | 0.42 | 1 | 0.33 |
| Total bilirubin (mg/dL) | 0.62 ± 0.3 | 0.69 ± 0.4 | 0.046 | 0.64 ± 0.3 | 0.65 ± 0.4 | 0.88 | 0.82 | 0.85 |
| WBCs (x103/uL) | 6.3 ± 1.3 | 6.0 ± 1.1 | 0.06 | 6.4 ± 1.6 | 6.0 ± 1.5 | 0.07 | 0.91 | 0.89 |
| Lymphocyte (x103/uL) | 1.91 ± 0.4 | 1.96 ± 0.4 | 0.58 | 2.06 ± 0.6 | 1.98 ± 0.7 | 0.47 | 0.31 | 0.95 |
| Neutrophil (x103/uL) | 3.68 ± 1.3 | 3.37 ± 0.8 | 0.19 | 4.01 ± 1.1 | 3.90 ± 0.9 | 0.60 | 0.87 | 0.027 |
| Monocyte (x103/uL) | 0.37 ± 0.1 | 0.36 ± 0.1 | 0.80 | 0.39 ± 0.1 | 0.38 ± 0.1 | 0.78 | 0.75 | 0.63 |
| Cytokine evaluation | ||||||||
| IL-1β (pg/mL) | 3.08 ± 0.6 | 1.53 ± 0.8 | <0.001 | 3.11 ± 0.8 | 1.75 ± 0.8 | <0.001 | 0.85 | 0.24 |
| IL-6 (pg/mL) | 1.68 ± 0.8 | 2.57 ± 1.3 | <0.001 | 1.92 ± 0.9 | 3.03 ± 1.3 | <0.001 | 0.21 | 0.12 |
| TNF-α (pg/mL) | 3.08 ± 0.6 | 1.53 ± 0.8 | <0.001 | 3.56 ± 3.9 | 2.04 ± 2.4 | 0.002 | 0.55 | 0.16 |
BMI, body mass index; WC, waist circumference; HC, hip circumference; FM, fat mass; SBP, Systolic Blood Pressure; DBP, Diastolic Blood Pressure; CAP, controlled attenuation parameter; HOMA-IR, homeostatic model assessment of insulin resistance; TC, total cholesterol; TG, triglycerides; HDL-C, high density lipoprotein cholesterol; LDL-C, low density lipoprotein cholesterol; AST, aspartate aminotransferase; ALT, alanine aminotransferase; γGT, gamma glutamyltransferase; WBCs, white blood cells; IL-1β, interleukin-1β; IL-6, interleukin-6; TNF-α, tumor necrosis factor α.