Table 5.

Plasma choline, serum B vitamins and liver enzymes in placebo and LYM–X–SORB^™ (LXS) groups at baseline, 3, and 12 months.

Variable	n	Baseline	n	3 months	n	12 months	P_0–3	P_0–3–12
Plasma Choline
Choline (μmol/L)
Placebo	56	6.9 (4.2 – 12.8) ^a	46	7.1 (5.0 – 11.5)	39	6.6 (3.6 – 11.4)^**	0.011	0.037
LXS	52	7.6 (4.6 – 12.2)	40	9.3 (3.9 – 15.6)^**	31	7.9 (4.1 – 12.8)
Serum B Vitamins
B₆ (ng/mL)
Placebo	56	17.4 (5.2 – 91.7)	46	16.1 (4.7 – 93.8)	38	18.7 (5.8 – 74.4)	0.89	0.39
LXS	50	16.9 (5.0 – 55.5)	38	17.2 (3.2 – 77.8)	31	18.1 (4.2 – 72.9)
RBC folate (ng/mL)
Placebo	53	507 ± 157 ^b	46	515 ± 167	39	479 ± 152	0.84	0.85
LXS	47	534 ± 181	37	546 ± 145	31	482 ± 182
B₁₂ (pg/mL)
Placebo	55	1142 (387 – 2861)	46	1259 (387 – 2861)	39	1296 (387 – 2861)^*	0.22	0.26
LXS	51	1040 (371 – 3455)	39	1073 (457 – 3455)	31	1099 (457 – 2257)
Liver Enzymes
ALT (U/L)
Placebo	56	41 ± 25	46	42 ± 29	39	46 ± 60	0.59	0.86
LXS	54	37 ± 17	40	35 ± 15	31	44 ± 69
AST (U/L)
Placebo	56	44 ± 26	46	49 ± 51	39	47 ± 45	0.47	0.57
LXS	54	41 ± 18	40	40 ± 17	31	57 ± 116
GGT (U/L)
Placebo	56	29 ± 23	46	33 ± 38	39	31 ± 25	0.39	0.68
LXS	54	24 ± 15	40	24 ± 17	31	28 ± 28

ALT, alanine aminotransferase; AST, aspartate aminotransferase; GGT, gamma-glutamyl transferase;

Log transformation was applied for skewed variables in the mixed models.

P_0–3 is testing for partial randomization group x time interaction between baseline and 3 month from a mixed effects linear regression model that included baseline, 3, and 12 months data (i. randomization group x time interaction was used).

P_0–3–12 is testing for randomization group x time interaction between baseline and 3 and 12 month.

(P≤0.05)

^**

(P≤0.01) difference from baseline within randomization groups.

Continuous variables with significant skewness are given as medians (range)

Continuous normally distributed variables given as means ± SD