Table 3.
Changing of patient’s characteristics: comparison of values before and after dietary intervention
| Verum (n = 18) | Placebo (n = 14) | V vs. P | |||||
|---|---|---|---|---|---|---|---|
| ± SD | ± SD | week 12 | |||||
| Baseline | Week 12 a | Diff | Baseline | Week 12 a | Diff | p b | |
| Weight (kg) | 83.4 ± 16.5 | 84.5 ± 17.1* | 1.1 ± 1.7 | 81.7 ± 19.9 | 82.2 ± 19.5 | 0.4 ± 1.2 | 0.722 |
| BMI (kg/m2) | 28.0 ± 4.4 | 28.4 ± 4.6* | 0.4 ± 0.5 | 28.8 ± 4.9 | 29.0 ± 4.7 | 0.2 ± 0.4 | 0.750 |
| WC (cm) f | 88 ± 11 | 89 ± 11 | 1 ± 2 | 83 ± 11 | 84 ± 12 | 1 ± 2 | 0.218 |
| Female ≥ 88 cm (%n)+ | 7 (70%) | 7 (70%) | 0 | 2 (20%) | 4 (40%) | 2 | 0.123 |
| WC (cm) m | 100 ± 11 | 101 ± 11 | 1 ± 2 | 109 ± 11 | 108 ± 12 | −1 ± 1 | 0.368 |
| Male ≥ 102 cm (%n)+ | 4 (50%) | 4 (50%) | 0 | 3 (75%) | 4 (100%) | 1 | 0.279 |
| BP systolic (mmHg) | 135 ± 10 | 133 ± 13 | −2 ± 11 | 130 ± 14 | 132 ± 17 | 2 ± 12 | 0.955 |
| ≥130 mmHg (%n) | 14 (78%) | 10 (56%) | −4 | 5 (36%) | 10 (71%) | 5 | 0.681 |
| BP diastolic (mmHg) | 85 ± 10 | 85 ± 9 | 0 ± 8 | 83 ± 8 | 84 ± 10 | 0 ± 10 | 0.512 |
| Pulse pressure | 51 ± 9 | 50 ± 7 | −1 ± 11 | 46 ± 10 | 49 ± 11 | 3 ± 8 | 0.357 |
| rHr (1/min) | 69 ± 10 | 72 ± 9 | 3 ± 6 | 73 ± 10 | 72 ± 12 | −1 ± 9 | 0.808 |
| PNF | 41 ± 5 | 33 ± 8* | −8 ± 9 | 39 ± 6 | 22 ± 9* | −17 ± 12 | 0.003 |
| PN | 16 ± 3 | 12 ± 4* | −3 ± 3 | 16 ± 3 | 10 ± 5* | −7 ± 5 | 0.168 |
| Cortisol_m (ng/ml)c | 7.5 ± 4.4 | 6.6 ± 4.1 | −0.5 ± 3.6 | 6.0 ± 3.4 | 5.3 ± 3.4 | −0.7 ± 3.4 | 0.425 |
| Cortisol_e (ng/ml)c | 1.2 ± 1.5 | 1.5 ± 1.6 | 0.6 ± 1.7 | 1.2 ± 1.2 | 0.9 ± 0.9 | −0.3 ± 0.8 | 0.533 |
| ΔCortisol (ng/ml)c | 6.3 ± 5.0 | 5.6 ± 4.8 | −0.6 ± 4.1 | 4.8 ± 3.9 | 4.4 ± 3.5 | −0.4 ± 3.5 | 0.454 |
| Serotonin (μg/l)c | 171 ± 90 | 185 ± 100 | 5 ± 34 | 180 ± 50 | 190 ± 64 | 11 ± 30 | 0.356 |
| CRP sensitive (mg/l) | 2.9 ± 3.1 | 2.4 ± 2.6 | −0.7 ± 2.9 | 7.1 ± 8.0 | 6.0 ± 7.8 | −1.0 ± 2.5 | 0.120 |
| GGT (U/l) | 45 ± 48 | 58 ± 71* | 13 ± 25 | 23 ± 11 | 24 ± 14 | 1.6 ± 4.8 | 0.180 |
| TC (mg/dl) | 219 ± 36 | 211 ± 40 | −8 ± 22 | 217 ± 43 | 216 ± 36 | −1 ± 20 | 0.561 |
| HDL-C (mg/dl) | 59 ± 27 | 59 ± 26 | 0 ± 6 | 62 ± 19 | 61 ± 14 | −0.8 ± 9.3 | 0.301 |
| LDL-C (mg/dl) | 133 ± 34 | 125 ± 36 | −8 ± 19 | 132 ± 44 | 132 ± 32 | 0 ± 21 | 0.561 |
| LDL-C/HDL-C | 2.6 ± 1.0 | 10.1 ± 32.9 | −0.4 ± 0.8 | 2.3 ± 0.9 | 2.3 ± 1.0 | 0 ± 0.5 | 0.561 |
| TG (mg/dl) | 162 ± 88 | 153 ± 87 | −9 ± 39 | 145 ± 61 | 136 ± 39 | −10 ± 42 | 0.808 |
| TG/HDL-C | 3.4 ± 2.6 | 6.0 ± 11.9 | 2.6 ± 11.6 | 2.9 ± 2.0 | 2.5 ± 1.2 | −0.4 ± 1.1 | 0.536 |
| FPG (mg/dl) | 99 ± 28 | 102 ± 44 | 3 ± 17 | 97 ± 17 | 92 ± 10 | −5 ± 18 | 0.891 |
| HbA1c (%) | 5.8 ± 0.9 | 5.8 ± 0.9 | 0.1 ± 0,2 | 5.7 ± 0.3 | 5.7 ± 0.3 | 0 ± 0.3 | 0.750 |
| HOMA-Index | 3.2 ± 3.3 | 3.6 ± 3.7 | 0.4 ± 2.6 | 2.2 ± 1.2 | 2.5 ± 1.9 | 0.3 ± 1.8 | 0.488 |
| Insulin-ECLIA (μU/ml) | 11.9 ± 8.1 | 2.3 ± 1.0 | −1.3 ± 6.1 | 8.8 ± 4.0 | 10.5 ± 7.5 | 1.8 ± 6.5 | 0.955 |
abbreviations used: BP, blood pressure; BMI, body mass index; Cortisol: _m, morning; _e, evening; ΔCortisol, cortisol difference morning-evening; CRP sensitive, C-reactive protein sensitive; Diff, difference; ECLIA, Enhanced Chemiluminescent Immunoassay; FPG, fasting plasma glucose; GGT, gamma-glutamyltransferase; HbA1c, glycated haemoglobin A1c; HDL-C, HDL cholesterol; HOMA-Index, Homeostasis Model Assessment-Index; LDL-C, LDL cholesterol; PNF, Psychological Neurological Questionnaire; PN, psycho-neurovegetative stability; rHR, resting heart rate; TC, total cholesterol; TG, triglycerides; WC, waist circumference.
p-value: aWilcoxon-test within groups, bMann–Whitney-U test: *p < 0.05.
cdata not available for all patients (numbers listed in Additional file 2).
+Verum: women n = 10, men n = 8; Placebo: women n = 10, men n = 4.