Study title	GLP 3‐week study on 3‐FL in neonatal piglets (Unpublished study report, 2019c)
Tested system	Domestic Landrace crossbred swine
Test material	The novel food, a unique batch (purity 95% of 3‐FL)
Dose/concentration (route of administration)	Control group: 0 (standard milk replacer), 6 animals/sex Comparative control group: 2 g fructo‐oligosaccharides (FOS)/L standard milk replacer, 6 animals/sex Dose group: 1 and 2 g 3‐FL/L standard milk replacer, 6 animals/sex
Method	U.S. FDA Guidance for Industry: Nonclinical Safety Evaluation of Pediatric Drug Products, 2006
Key results
Parameters	Sex	Dose groups (expressed in g/L reconstituted milk)
		0 (control, G1); mean ± SD	2 g/L FOS (comparative control, G2); mean ± SD	1 g/L (low dose, G3); mean ± SD	2 g/L (high dose, G4); mean ± SD
Haematology
Mean corpuscular volume (MCV) fL (Day 22)	M	58.2 ± 1.6	58.0 ± 2.2	59.4 ± 1.8	54.5 ± 1.2*
	F	59.0 ± 2.1	58.5 ± 1.9	58.0 ± 3.0	58.9 ± 2.0
Haemoglobin (Hb) g/dL (Day 7)	M	10.4 ± 1.2	10.7 ± 0.5	10.6 ± 0.6	10.4 ± 0.9
	F	10.4 ± 1.5	10.4 ± 0.4	11.6 ± 1.0	11.6 ± 0.8**
Clinical chemistry
Alkaline phosphatase (ALP) U/L (Day 7)	M	875 ± 242	769 ± 96	953 ± 201	695 ± 61
	F	1112 ± 213	869 ± 237	845 ± 149	930 ± 183
Alkaline phosphatase (ALP) U/L (Day 22)	M	818 ± 210	521 ± 116	788 ± 132	557 ± 97**
	F	802 ± 216	494 ± 58	653 ± 127	560 ± 109
Globulin g/dL (Day 22)	M	1.6 ± 0.1	1.7 ± 0.1	1.5 ± 0.1	1.5 ± 0.1.**
	F	1.7 ± 0.2	1.7 ± 0.2	1.6 ± 0.1	1.6 ± 0.2
Organ weight values
Brain (g)	M	48.6 ± 1.8	50.1 ± 1.5	49.1 ± 1.7	46.7 ± 1.8**
	F	49.1 ± 2.5	49.4 ± 3.5	50.0 ± 3.1	49.3 ± 1.8
Large intestine, colon/bw (%)	M	0.52 ± 0.07	0.68 ± 0.06	0.67 ± 0.10	0.64 ± 0.06**
	F	0.12 ± 0.03	0.15 ± 0.05	0.16 ± 0.04	0.17 ± 0.05
Spleen (g)	M	17.2 ± 3.4	21.4 ± 5.7	22.2 ± 6.2	14.3 ± 5.7
	F	17.8 ± 1.9	22.0 ± 6.0	24.9 ± 4.7**	17.9 ± 3.4
Thyroid (g)	M	0.73 ± 0.14	0.96 ± 0.18	0.77 ± 0.22	0.66 ± 0.10***
	F	1.7 ± 0.2	1.7 ± 0.2	1.6 ± 0.1	1.6 ± 0.2

* ANOVA p < 0.01; ** ANOVA p < 0.05; *** p < 0.05 vs FOS.