Table III.
Trend in laboratory parameters during the trial in the different treatment groups
| Parameter | Placebo arm (n = 30; F = 14, M = 16) | Low-dose arm (n = 30; F = 15, M = 15) | High-dose arm (n = 30; F = 14, M = 16) | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline | Week-6 follow-up | Week-12 follow-up | Baseline | Week-6 follow-up | Week-12 follow-up | Baseline | Week-6 follow-up | Week-12 follow-up | |
| TC [mg/dl] | 248 ±14 | 244 ±11 | 243 ±12 | 244 ±12 | 233 ±11 | 228 ±9*° | 250 ±13 | 223 ±10*° | 217 ±9*° |
| LDL-C [mg/l | 164 ±9 | 163 ±9 | 163 ±10 | 162 ±9 | 154 ±7* | 158 ±6 | 169 ±9 | 145 ±8*° | 139 ±7*° |
| HDL-C [mg/dl] | 45 ±4 | 46 ±3 | 44 ±3 | 44 ±2 | 45 ±3 | 46 ±3 | 45 ±3 | 47 ±3 | 48 ±4* |
| Non HDL-C [mg/dl] | 203 ±11 | 198 ±10 | 199 ±10 | 200 ±11 | 188 ±10 | 182 ±10*° | 205 ±12 | 176 ±11*° | 169 ±9*° |
| TG [mg/dl] | 195 ±12 | 177 ±13* | 179 ±11* | 189 ±13 | 170 ±14* | 167 ±13*° | 181 ±14 | 156 ±15*° | 151 ±13*° |
| TG/HDL-C | 4.3 ±1.1 | 3.8 ±1.2* | 4.1 ±1.0 | 4.3 ±1.2 | 3.8 ±1.3* | 3.6 ±1.2*° | 4.0 ±1.3 | 3.3 ±1.4*° | 3.1 ±1.2*° |
| FPG [mg/dl] | 90 ±8 | 88 ±6 | 87 ±7 | 87 ±5 | 85 ±4 | 84 ±4 | 90 ±7 | 87 ±5 | 85 ±5* |
| FPI [µU/ml] | 18.1 ±3.2 | 17.7 ±2.8 | 17.5 ±2.9 | 18.5 ±3.6 | 18.3 ±3.4 | 17.3 ±3.6 | 18.4 ±3.5 | 17.8 ±3.0 | 16.4 ±2.4* |
| HOMA-IR | 4.1 ±0.8 | 3.9 ±0.7 | 3.9 ±0.6 | 3.9 ±0.9 | 3.8 ±0.7 | 3.5 ±0.6*° | 4.1 ±0.7 | 3.9 ±0.8 | 3.6 ±0.7*° |
| AST [U/l] | 22 ±5 | 23 ±4 | 22 ±4 | 19 ±5 | 18 ±3 | 18 ±4 | 22 ±6 | 20 ±4 | 21 ±4 |
| ALT [U/l] | 24 ±6 | 24 ±5 | 23 ±6 | 22 ±4 | 21 ±4 | 21 ±5 | 23 ±5 | 22 ±4 | 23 ±5 |
| γ-GT [U/l] | 29 ±7 | 27 ±7 | 26 ±8 | 26 ±6 | 23 ±5 | 25 ±5 | 27 ±8 | 22 ±6* | 21 ±4*° |
| FLI | 58 ±10 | 57 ±9 | 56 ±9 | 56 ±8 | 54 ±7 | 54 ±8 | 58 ±10 | 54 ±8 | 53 ±8* |
| SUA [mg/dl] | 5.3 ±0.8 | 5.1 ±0.9 | 5.3 ±0.7 | 5.2 ±0.8 | 5.3 ±0.8 | 5.1 ±0.7 | 5.1 ±1.0 | 5.2 ±1.0 | 5.0 ±0.8 |
| CK [U/l] | 131 ±22 | 141 ±38 | 157 ±36 | 144 ±41 | 124 ±36 | 137 ±29 | 139 ±36 | 141 ±38 | 143 ±22 |
| hs-CRP [mg/l] | 2.86 ±0.13 | 2.84 ±0.19 | 2.88 ±0.15 | 2.80 ±0.15 | 2.66 ±0.11 | 2.61 ±0.13 | 2.91 ±0.12 | 2.61 ±0.09* | 2.39 ±0.08*° |
*
P < 0.05 vs. baseline;
°
p < 0.05 vs. placebo. ALT – alanine aminotransferase, AST – aspartate aminotransferase, CK – creatine kinase, FPG – fasting plasma glucose, FLI – fatty liver index, FPI – fasting plasma insulin, γ-GT – γ-glutamyl transferase, HDL-C – high-density lipoprotein cholesterol, HOMA-IR – homeostatic model assessment for insulin resistance, hs-CRP – high-sensitivity C-reactive protein, LDL-C – low-density lipoprotein cholesterol, SUA – serum uric acid, TC – total cholesterol, TG – triglycerides.