TABLE 5.
Mixed‐effects linear regression analysis for change from baseline in outcome measures according to randomized intervention groups and homocysteine status among the modified intention‐to‐treat population of non‐demented, community‐dwelling older adults
| Estimated mean within‐group change from baseline a (95% CI); P‐value | Between‐group difference over time (95% CI); P‐value | Difference in between‐group differences over time for high vs. normal homocysteine | |||||
|---|---|---|---|---|---|---|---|
| Nutritional blend | Placebo | Nutritional blend vs. placebo | |||||
| Normal homocysteine | High homocysteine b | Normal homocysteine | High homocysteine b | Normal homocysteine | High homocysteine b | ||
| Biomarkers | |||||||
| Plasma homocysteine (µmol/L) | −2.37 (−3.06, −1.68); <.0001 | −1.82 (−3.18, −0.47); .008 | 0.44 (−0.24, 1.13); .207 | 2.64 (1.24, 4.03); .0002 | −2.82 (−3.73, −1.90); <.0001 | −4.46 (−6.10, −2.83); <.0001 | −1.65 (−3.52, 0.23); .085 |
| Omega‐3 index c (%) | 1.47 (1.16, 1.78); <.0001 | 1.71 (1.14, 2.29); <.0001 | −1.11 (−1.42, −0.79); <.0001 | −1.21 (−1.80, −0.62); <.0001 | 2.58 (2.14, 3.02); <.0001 | 2.92 (2.10, 3.75); <.0001 | 0.34 (−0.60, 1.28); .474 |
| Cognitive tests | |||||||
| PROMIS T‐score d (8 items) | 0.05 (−0.78, 0.89); .897 | −0.42 (−1.95, 1.12); .591 | 1.09 (0.25, 1.93); .011 | 1.31 (−0.28, 2.91); .106 | −1.03 (−2.22, 0.15); .086 | −1.73 (−3.95, 0.48); .125 | −0.70 (−3.21, 1.81); .584 |
| Composite cognitive score e | −0.04 (−0.13, 0.06); .437 | −0.30 (−0.45, −0.14); .0003 | −0.06 (−0.15, 0.04); .245 | −0.23 (−0.40, −0.06); .009 | 0.02 (−0.12, 0.15); .790 | −0.06 (−0.30, 0.17); .587 | −0.08 (−0.35, 0.19); .545 |
| CFI self‐assessment score | −0.59 (−0.93, −0.25); .001 | −0.26 (−0.85, 0.33); .385 | −0.58 (−0.92, −0.24); .001 | 0.42 (−0.24, 1.07); .210 | −0.01 (−0.49, 0.47); .970 | −0.68 (−1.56, 0.20); .131 | −0.67 (−1.67, 0.33); .190 |
| CFI study partner score | −0.37 (−0.76, 0.01); .057 | −0.81 (−1.46, −0.16); .014 | −0.10 (−0.49, 0.29); .612 | 0.34 (−0.40, 1.09); .362 | −0.27 (−0.82, 0.27); .328 | −1.16 (−2.15, −0.17); .022 | −0.88 (−2.01, 0.25); .125 |
Abbreviations: CFI, Cognitive Function Instrument; PROMIS, Patient‐Reported Outcomes Measurement Information System.
Estimated with the mean at baseline.
Homocysteine concentrations >14 µmol/L.
Calculated as the sum of % docosahexaenoic acid and % eicosapentaenoic acid, expressed as the percentage of total erythrocyte membrane fatty acids.
After 1 month, and all other outcomes after 12 months.
Based on four cognitive tests (free and total recall of the Free and Cued Selective Reminding test, 10 Mini‐Mental State Examination orientation items, Digit Symbol Substitution Test and Category Naming Test.