Extended data table 4. Safety parameters measured in all groups at baseline and at the end of the intervention.
| Placebo | Pasteurized Akk -1010 | Alive Akk -1010 | ||||
|---|---|---|---|---|---|---|
| Safety parameters | Baseline | 12 weeks | Baseline | 12 weeks | Baseline | 12 weeks |
| Systolic blood pressure (mm Hg) | 146,7 ± 15,60 | 129,00 ± 18,43* | 151,08 ± 12,81 | 132,67 ± 11,79* | 133,38 ± 12,41 | 124,63 ± 16,72* |
| Diastolic blood pressure (mm Hg) | 91,00 ± 9,08 | 81,70 ± 9,04* | 102,08 ± 11,77 | 83,92 ±10,38* | 92,25 ± 9,51 | 78,50 ± 13,03* |
| HbA1c (%) | 5,53 ± 0,36 | 5,61 ± 0,30 | 5,77 ± 0,42 | 5,72 ± 0,37 | 5,63 ± 0,35 | 5,62 ± 0,33 |
| C-reactive protein (mg/dl) | 5,00 ± 5,51 | 5,31 ± 6,10 | 8,08 ± 9,45 | 8,84 ± 10,71 | 3,89 ± 4,08 | 3,78 ± 3,77 |
| White Blood cells (103/μl) | 6,14 ± 1,13 | 6,87 ± 1,81* | 6,37 ± 2,43 | 6,24 ± 1,56 | 6,52 ± 2,40 | 6,74 ± 2,46 |
| Prothrombin time (sec) | 11,61 ± 0,69 | 11,37 ± 0,71 | 11,64 ± 4,61 | 11,61 ± 3,42 | 11,5 ± 0,73 | 11,61 ± 0,69 |
| Alanine aminotransferase activity (U/L) | 24 ± 11,26 | 23,36 ± 6,76 | 46,75 ± 39,56 | 39,92 ± 39,76 | 30,78 ± 13,84 | 30,89 ± 15,11 |
| Aspartate aminotransferase activity (U/L) | 18,82 ± 6,32 | 19,27 ± 3,64 | 33,33 ± 32,82 | 27,92 ± 26,21* | 20,33 ± 5,66 | 20,33 ± 7,75 |
| γ-Glutamyltransferase activity (U/L) | 26,18 ± 17,93 | 29,55 ± 20,20 | 50,83 ± 34,39 | 42,33 ± 22,58* | 34,11 ± 21,22 | 35,44 ± 33,00 |
| Urea (mg/dl) | 32,73 ± 7,99 | 32,36 ± 7,47 | 30,42 ± 3,23 | 33,42 ± 6,46 | 32,44 ± 6,58 | 33,56 ± 8,43 |
| Creatinine (mg/dl) | 0,84 ± 0,16 | 0,84 ± 0,18 | 0,81 ± 0,13 | 0,78 ± 0,09 | 0,83 ± 0,13 | 0,88 ± 0,11 |
| Glomerular filtration rate (ml min-1 1,73m-2) | 86,27 ± 16,69 | 87,36 ± 18,50 | 84,00 ± 13,31 | 88,67 ± 11,60 | 91,44 ± 14,48 | 86,33 ± 12,99 |
| Creatine kinase activity (U/L) | 106,36 ± 48,71 | 110,09 ± 48,00 | 133,54 ± 85,66 | 106,09 ± 72,75* | 117,89 ± 35,11 | 131,56 ± 70,39 |
| Lactate dehydrogenase activity (Ul/L) | 173,46 ± 20,90 | 177,00 ± 38,99 | 197,17 ± 25,43 | 176,67 ± 27,13* | 184,00 ± 24,98 | 176,78 ± 18,69 |
This table includes all participants that completed the study: Placebo n=11, Pasteurized n=12, Alive n=9. Data are expressed as mean ± SD. Non-parametric two-tailed Wilcoxon matched-pairs signed ranks tests were performed to verify changes from baseline in each group.
*
Significant difference from baseline value (P < 0.05)