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. 2019 Jun 11;17(6):e05717. doi: 10.2903/j.efsa.2019.5717
Parameters Exposure (day) Sex Control Low dose (1,000 mg/kg bw) Mid dose (3,000 mg/kg bw) High dose (5,000 mg/kg bw) Oligofructose control (5,000 mg/kg bw)
Body weight (g) 9 F 31.2 ± 3.26 32.2 ± 2.02 32.6 ± 1.09 33.5 ± 2.52* 30.8 ± 2.70
Ulna length (mm) 64 M 39.5 ± 0.83 38.3 ± 0.94** 38.6 ± 0.44 39.5 ± 1.04 39.1 ± 1.20
64 F 36.7 ± 0.90 35.7 ± 0.46* 35.6 ± 0.50* 36.3 ± 1.13* 36.4 ± 1.21
Arena observations
Activity count 90 M 17.5 ± 5.0 12.6 ± 5.8 13.2 ± 6.6 17.4 ± 5.6 12.3 ± 6.0^
F 23.8 ± 4.5 25.4 ± 6.0 25.0 ± 6.1 19.8 ± 5.1* 20.6 ± 4.3
Sexual maturation
Balano preputial separation (day of age) 90 M 43.7 ± 1.91 44.4 ± 1.17 45.3 ± 0.82 45.4 ± 2.23* 45.4 ± 2.59^
Haematology
Haematocrit (L/L) 90 M 0.39 ± 0.01 0.45 ± 0.02** 0.45 ± 0.01** 0.43 ± 0.04** 0.39 ± 0.01
F 0.38 ± 0.02 0.44 ± 0.02** 0.44 ± 0.02** 0.39 ± 0.04 0.38 ± 0.01
Haemoglobin (g/dL) 90 M 14.8 ± 0.35 15.4 ± 0.54* 15.2 ± 0.37* 15.3 ± 0.78* 14.8 ± 0.35
Erythrocytes (× 1012/L) 90 M 7.46 ± 0.33 8.32 ± 0.31** 8.04 ± 0.46** 8.04 ± 0.67** 7.36 ± 0.20
F 7.06 ± 0.34 7.80 ± 0.33** 7.83 ± 0.36** 7.08 ± 0.71 6.95 ± 0.27
MCH (pg) 90 M 19.8 ± 0.62 18.5 ± 0.55* 19.0 ± 0.93* 19.1 ± 1.21* 20.1 ± 0.48
F 20.8 ± 0.68 19.2 ± 0.78** 19.0 ± 0.70** 20.3 ± 1.34 21.3 ± 0.62
MCHC (g/dL) 90 M 37.6 ± 0.57 33.9 ± 0.63** 33.6 ± 0.51** 35.9 ± 2.50** 37.9 ± 0.4
F 38.6 ± 0.85 33.7 ± 0.86** 33.6 ± 0.95** 36.8 ± 2.85 39.3 ± 0.70
MCV 90 M 52.7 ± 1.46 54.5 ± 1.03* 56.5 ± 2.30** 53.3 ± 1.72 52.9 ± 0.9
F 53.9 ± 1.22 56.9 ± 1.38** 56.6 ± 1.41** 55.2 ± 0.90 54.1 ± 1.1
Red cell distribution width (%) 90 M 12.4 ± 0.59 11.7 ± 0.32* 11.6 ± 0.50* 12.3 ± 0.83 12.7 ± 0.40
Leucocytes (× 109/L) 90 F 10.29 ± 3.86 6.92 ± 0.93* 6.34 ± 1.37** 10.82 ± 5.44 10.64 ± 2.08
Lymphocytes (× 109/L) 90 F 8.80 ± 3.65 5.75 ± 0.87** 5.15 ± 1.14** 7.67 ± 1.23 8.80 ± 2.03
Eosinophils (× 109/L) 90 M 0.16 ± 0.06 0.11 ± 0.04 0.09 ± 0.02* 0.18 ± 0.11 0.17 ± 0.06
F 0.14 ± 0.04 0.08 ± 0.03* 0.09 ± 0.04* 0.09 ± 0.03* 0.11 ± 0.04
Basophils (× 109/L) 90 M 0.04 ± 0.01 0.08 ± 0.03** 0.08 ± 0.03** 0.07 ± 0.04** 0.06 ± 0.03^
F 0.03 ± 0.02 0.04 ± 0.02** 0.05 ± 0.02** 0.04 ± 0.02** 0.03 ± 0.01
Monocytes (× 109/L) 90 F 0.22 ± 0.05 0.15 ± 0.03** 0.12 ± 0.04** 0.17 ± 0.08** 0.24 ± 0.08
LUC (× 109/L) 90 M 0.03 ± 0.01 0.06 ± 0.01* 0.06 ± 0.02** 0.06 ± 0.03** 0.05 ± 0.02
Platelet count (× 109/L) 90 F 976 ± 105.2 907 ± 69.7 813 ± 116.6* 881 ± 137.9* 872 ± 113.6^
Prothrombin time (sec) 90 M 20.6 ± 1.5 23.1 ± 2.3* 23.6 ± 3.22* 22.2 ± 2.76* 22.9 ± 2.22^
End 4‐week recovery period M 24.0 ± 40.8 n.a. n.a. 23.2 ± 3.26 22.6 ± 3.33
Clinical chemistry parameters
AST (U/L) 90 M 74 ± 7.3 85 ± 11.8* 84 ± 7.6* 75 ± 4.8 78 ± 10
F 70 ± 11.6 86 ± 13.2* 82 ± 13.7 70 ± 11.8 69 ± 7.6
Albumin (g/L) 90 M 34 ± 1.1 33 ± 1.2 32 ± 1.7** 35 ± 1.8 35 ± 1.2
90 F 40 ± 1.8 37 ± 2.7* 37 ± 1.5* 39 ± 3.8* 38 ± 1.7
Urea (mmol/L) 90 F 5.69 ± 0.58 6.77 ± 0.76* 6.86 ± 1.16* 5.80 ± 1.09 5.94 ± 0.48
Creatinine (μmol/L) 90 M 27 ± 2.5 25 ± 3.1 25 ± 3.1 23 ± 2.1** 25 ± 2.5
Sodium (mmol/L) 90 M 144 ± 1.3 142 ±1.2 143 ± 1.2 143 ± 1.3 142 ± 1.0^^
F 142 ± 0.5 142 ± 1.6 141 ± 1.4 141 ± 1.2** 141 ± 1.0^
Chloride (mmol/L) 90 M 100 ± 0.8 99 ± 1.3 100 ± 1.0 99 ± 1.2* 98 ± 1.5^^
Calcium (mmol/L) 90 M 2.39 ± 0.06 2.42 ± 0.07 2.40 ± 0.06 2.45 ± 0.06 2.44 ± 0.07^
F 2.43 ± 0.08 2.51 ± 0.10 2.43 ± 0.05 2.54 ± 0.08** 2.41 ± 0.07
Inorganic phosphorus (mmol/L) 90 F 1.77 ± 0.23 1.83 ± 0.31 1.80 ± 0.21 2.03 ± 0.24** 1.77 ± 0.24
Urinalysis
pH 90 F 6.7 ± 0.4 6.8 ± 0.3 7.1 ± 0.5 7.4 ± 0.9** 6.8 ± 0.4
Total creatinine (μmol) 90 F 45.35 ± 6.69 42.45 ± 5.63 41.25 ± 8.27 36.08 ± 9.78* 42.45 ± 8.19
Organ weight
Kidneys relative 90 M 3.332 3.674** 3.387 3.393 3.153
Seminal vesicles relative 90 M 1.745 1.991* 1.893 1.660 1.673
Thymus relative 90 M 0.321 0.400* 0.387* 0.399* 0.331

NF: novel food; bw: body weight; AST: aspartate aminotransferase; LUC: large unstained cells; MCH: mean cell haemoglobin; MCV: mean cell volume; MCHC: mean cell haemoglobin concentration; RDW: red cell distribution width.

*

Significantly different from control (p < 0.05) (Vehicle control vs 2’‐FL/DFL mixture‐treated groups).

**

Significantly different from control (p < 0.01) (control vs 2’‐FL/DFL mixture‐treated groups).

^

Significantly different from control (p < 0.05) (control vs reference control).

^^

Significantly different from control (p < 0.01) (control vs reference control).