Table 2.
Total daily energy, macronutrients, choline, betaine and B vitamin intake in placebo and LYM–X–SORB™ (LXS) groups at baseline, 3, and 12 months.
| Nutrient | n | Baseline | n | 3 months | n | 12 months | P0–3 | P0–3–12 |
|---|---|---|---|---|---|---|---|---|
| Energy (kcal) | ||||||||
| Placebo | 54 | 2438 ± 798 a | 37 | 2609 ± 563 | 35 | 2618 ± 667 | 0.76 | 0.95 |
| LXS | 44 | 2423 ± 618 | 31 | 2567 ± 580 | 23 | 2704 ±643 | ||
| Protein (gm/kg) | ||||||||
| Placebo | 54 | 2.7 ± 1.0 | 37 | 2.6 ± 1.0* | 35 | 2.5 ± 1.0** | 0.92 | 0.86 |
| LXS | 44 | 2.6 ± 0.8 | 31 | 2.4 ± 0.7 | 23 | 2.5 ± 0.8 | ||
| Protein as % RDA | ||||||||
| Placebo | 54 | 282 ± 108 | 37 | 273 ± 108* | 35 | 265 ± 109** | 0.97 | 0.83 |
| LXS | 44 | 274 ± 79 | 31 | 260 ± 76 | 23 | 265 ± 89 | ||
| Protein as % kcal | ||||||||
| Placebo | 54 | 13.6 ± 2.9 | 37 | 12.9 ± 2.6* | 35 | 12.9 ± 3.1 | 0.77 | 0.78 |
| LXS | 44 | 13.3 ± 2.6 | 31 | 12.5 ± 2.2* | 23 | 13.0 ± 2.3 | ||
| Fat as % kcal | ||||||||
| Placebo | 54 | 35.9 ± 6.1 | 37 | 34.9 ± 5.8 | 35 | 36.3 ± 4.5 | 0.79 | 0.36 |
| LXS | 44 | 36.1 ± 4.6 | 31 | 34.4 ± 6.9 | 23 | 34.6 ± 5.1 | ||
| Carbohydrate as % kcal | ||||||||
| Placebo | 54 | 51.8 ± 7.2 | 37 | 52.6 ± 6.2 | 35 | 51.1 ± 5.3 | 0.59 | 0.44 |
| LXS | 44 | 52.7 ± 6.0 | 31 | 53.5 ± 8.2* | 23 | 53.0 ± 6.4 | ||
| Choline (mg/day) | ||||||||
| Placebo | 54 | 308 (144 – 736) b | 37 | 358 (193 – 773)*** | 35 | 361 (183 – 765)*** | <0.001 | <0.001 |
| LXS | 44 | 291 (129 – 735) | 31 | 831 (444 – 1691)*** | 23 | 812 (244 – 1727)*** | ||
| Choline as % AI | ||||||||
| Placebo | 54 | 88 (37 – 288) | 37 | 92 (52 – 309)** | 35 | 108 (49 – 292)** | <0.001 | <0.001 |
| LXS | 44 | 87 (34 – 221) | 31 | 248 (134 – 524)*** | 23 | 235 (61 – 350)*** | ||
| Betaine (mg/day) | ||||||||
| Placebo | 54 | 135 (25 – 359) | 37 | 124 (73 – 339) | 35 | 112 (31 – 734) | 0.006 | 0.021 |
| LXS | 44 | 135 (47 – 344) | 31 | 106 (9 – 300)*** | 23 | 121 (15 – 392)* | ||
| Total B6 (μg/day) | ||||||||
| Placebo | 54 | 4.6 (1.9 – 32.4) | 37 | 5.5 (1.4 – 40.7) | 35 | 4.5 (1.1 – 8.9) | 0.29 | 0.38 |
| LXS | 44 | 4.7 (2.4 – 78.2) | 31 | 5.0 (1.9 – 12.0) | 23 | 4.6 (2.6 – 11.5) | ||
| Total B6 as % RDA | ||||||||
| Placebo | 54 | 554 (291 – 2496) | 37 | 572 (228 – 4073) | 35 | 529 (148 – 1221)* | 0.37 | 0.64 |
| LXS | 44 | 542 (243 – 7827) | 31 | 547 (188 – 1526) | 23 | 497 (265 – 945) | ||
| Total folic acid (ug/day) | ||||||||
| Placebo | 54 | 800 (340 – 1872) | 37 | 744 (250 – 1954) | 35 | 631 (230 – 1307)** | 0.96 | 0.78 |
| LXS | 44 | 747 (335 – 1684) | 31 | 738 (262 – 1546) | 23 | 681 (338 – 1471) | ||
| Total folic acid as % RDA | ||||||||
| Placebo | 54 | 280 (113 – 840) | 37 | 251 (99 – 800)* | 35 | 227 (106 – 497)*** | 0.73 | 0.94 |
| LXS | 44 | 286 (128 – 562) | 31 | 263 (97 – 674) | 23 | 247 (118 – 423)** | ||
| Total B12 (μg/day) | ||||||||
| Placebo | 54 | 18.7 (5.3 – 109.8) | 37 | 19.3 (6.1 – 111.6) | 35 | 15.2 (3.0 – 36.4)*** | 0.62 | 0.37 |
| LXS | 44 | 17.4 (5.6 – 158.9) | 31 | 18.6 (4.7 – 40.3) | 23 | 17.4 (9.1 – 36.8) | ||
| Total B12 as % RDA | ||||||||
| Placebo | 54 | 1163 (442 – 4575) | 37 | 1093 (354 – 4649) | 35 | 893 (250 – 2271)*** | 0.73 | 0.63 |
| LXS | 44 | 1168 (310 – 8826) | 31 | 1035 (319 – 2519) | 23 | 966 (508 – 2043) | ||
AI: adequate intake. RDA: recommended dietary intake
P0–3 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).
P0–3–12 is testing for randomization group x time interaction between baseline and 3 and 12 month.
(P≤0.05)
(P≤0.01)
(P≤0.001) difference from baseline within randomization groups.
Continuous normally distributed variables given as means ± SD
Continuous variables with significant skewness are given as medians (range). Log transformation was applied for skewed variables in the mixed models.