Table 2.
Safety and tolerability of product consumption was assessed by monitoring evolution between visits of (A) liver enzymes (glutamyl oxaloacetic transaminase, GOT; glutamic-pyruvatetransaminase, GPT; gamma-glutamyltransferase, GGT; bilirubin; and alkaline phosphatase, AP) and creatinine; (B) vital constants (systolic blood pressure, SBP; diastolic blood pressure, DBP; and heart rate, HR); and (C) evolution of hematologic profile.
| (A) Liver Enzymes, Total Bilirubin, Creatinine | |||||||||
| CC (Control) | CR (Study) | Effect * | |||||||
| V1 | V2 | V3 | V1 | V2 | V3 | Visit | Group | Visit × Group | |
| GOT (UI/L) | 18.26 (0.73) | 18.26 (1.05) | 18.07 (0.75) | 19.7 (0.86) | 18.63 (0.84) | 20.57 (0.9) | 0.2416 | 0.1512 | 0.1512 |
| GPT (UI/L) | 17.74 (1.4) | 16.15 (1.21) | 15.7 (1.31) | 18.83 (1.47) | 16.2 (1.26) | 18.63 (1.42) | 0.0065 | 0.368 | 0.0794 |
| GGT (UI/L) | 17.99 (2.18) | 16.01 (1.5) | 15.24 (1.04) | 18.63 (1.3) | 17.46 (1.14) | 18.36 (1.21) | 0.0187 | 0.2867 | 0.1182 |
| AP (UI/L) | 57.07 (4.21) | 56.19 (3.39) | 57.07 (3.66) | 54.2 (3.37) | 54.83 (2.67) | 56.97 (2.89) | 0.2637 | 0.741 | 0.4248 |
| TBil (mg/dL) | 0.77 (0.08) | 0.7 (0.08) | 0.71 (0.08) | 0.79 (0.06) | 0.7 (0.06) | 0.65 (0.05) | 0.038 | 0.9484 | 0.4705 |
| Creatinine (mg/dL) | 0.79 (0.02) | - | 0.83 (0.02) | 0.8 (0.02) | - | 0.85 (0.02) | <0.001 | 0.5661 | 0.5346 |
| (B) Vital Constants | |||||||||
| CC (Control) | CR (Study) | Effect * | |||||||
| V1 | V3 | V1 | V3 | Visit | Group | Visit × Group | |||
| SBP (mmHg) | 115.85 (2.28) | 110.69 (2.31) | 118.03 (2.8) | 115.37 (2.63) | 0.0091 | 0.1588 | 0.3909 | ||
| DBP (mmHg) | 69 (1.21) | 69.88 (1.7) | 69.17 (1.65) | 69.28 (1.64) | 0.6083 | 0.9966 | 0.6844 | ||
| HR (beat/min) | 71.38 (2.46) | 70.08 (2.34) | 67.21 (2.59) | 66.1 (1.94) | 0.3559 | 0.1254 | 0.9132 | ||
| (C) Hematological Profile | |||||||||
| CC (Control) | CR (Study) | Effect * | |||||||
| V1 | V3 | V1 | V3 | Visit | Group | Visit × Group | |||
| Erythrocytes (10.6/µL) | 4.53 (0.07) | 4.42 (0.07) | 4.57(0.08) | 4.46 (0.08) | <0.001 | 0.5753 | 0.8106 | ||
| Erythrocytes (%) | 40.84 (0.57) | 39.73 (0.58) | 40.95 (0.7) | 39.94 (0.67) | <0.001 | 0.5927 | 0.8402 | ||
| Hemoglobin (g/dL) | 13.63 (0.23) | 13.47 (0.22) | 13.61 (0.26) | 13.52 (0.25) | 0.0792 | 0.7324 | 0.6625 | ||
| Leukocytes (10.3/µL) | 6.4 (0.32) | 6.01 (0.29) | 6.33 (0.33) | 6.5 (0.32) | 0.6178 | 0.6266 | 0.1667 | ||
| Lymphocytes (10.3/µL) | 2.15 (0.09) | 2.14 (0.1) | 2.2 (0.09) | 2.3 (0.14) | 0.408 | 0.4449 | 0.3247 | ||
| Neutrophils (10.3/µL) | 3.53 (0.28) | 3.2 (0.22) | 3.41 (0.28) | 3.47 (0.23) | 0.4645 | 0.8303 | 0.2574 | ||
| Monocytes (10.3/µL) | 0.53 (0.03) | 0.5 (0.03) | 0.51 (0.02) | 0.5 (0.02) | 0.2564 | 0.7444 | 0.4594 | ||
| Basophils (10.3/µL) | 0.06 (0) | 0.05 (0) | 0.07 (0) | 0.06 (0) | <0.001 | 0.0962 | 0.9151 | ||
| Platelets (10.3/µL) | 231.33 (8.3) | 217.59 (7.78) | 236.1 (8.65) | 228.67 (8.26) | 0.0048 | 0.4715 | 0.3886 | ||
* Effect: Visit indicates evolution in the same group from V1 to V3; group indicates the differences between groups (CC: control capsules), CR: intervention capsules) regardless of time; and visit × group indicates the differences in evolution (V1 to V3) between groups as a result of the treatment (CC, CR). The p-value of the interaction was adjusted by sex, age, and BMI. Data expressed as mean (SEM). A p-value > 0.05 was considered non-significant.