TABLE 3.
Mixed‐effects linear regression analysis for change from baseline in outcome measures according to randomized intervention groups and APOE ε4 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 APOE ε4 carrier vs. non‐carrier | |||||
|---|---|---|---|---|---|---|---|
| Nutritional blend | Placebo | Nutritional blend vs. placebo | |||||
| APOE ε4 non‐carrier | APOE ε4 carrier b | APOE ε4 non‐carrier | APOE ε4 carrier b | APOE ε4 non‐carrier | APOE ε4 carrier b | ||
| Biomarkers | |||||||
| Plasma homocysteine (µmol/L) | −2.40 (−3.05, −1.75); <.0001 | −2.01 (−3.23, −0.79); .001 | 1.11 (0.43, 1.79); .001 | 0.15 (−0.97, 1.28); .789 | −3.51 (−4.45, −2.57); <.0001 | −2.16 (−3.82, −0.50); .011 | 1.35 (−0.56, 3.26); .164 |
| ω‐3 index c (%) | 1.51 (1.20, 1.83); <.0001 | 1.87 (1.25, 2.49); <.0001 | −1.15 (−1.47, −0.82); <.0001 | −1.04 (−1.60, −0.48); .0003 | 2.66 (2.21, 3.11); <.0001 | 2.91 (2.08, 3.75); <.0001 | 0.25 (−0.70, 1.20); 0.601 |
| Cognitive tests | |||||||
| PROMIS T‐score d (8 items) | 0.13 (−0.73, 0.98); .770 | −0.26 (−1.76, 1.25); .737 | 1.37 (0.48, 2.26); .003 | 0.78 (−0.66, 2.21); .287 | −1.25 (−2.48, −0.01); .048 | −1.03 (−3.11, 1.04); .328 | 0.21 (−2.20, 2.63); .861 |
| Composite cognitive score e | −0.09 (−0.19, 0.01); .069 | −0.15 (−0.33, 0.04); .114 | −0.11 (−0.21, −0.01); .035 | −0.10 (−0.27, 0.07); .234 | 0.02 (−0.12, 0.16); .782 | −0.05 (−0.29, 0.20); .719 | −0.07 (−0.35, 0.22); .653 |
| CFI self‐assessment score | −0.58 (−0.92, −0.24); .001 | −0.25 (−0.90, 0.40); .449 | −0.35 (−0.71, 0.01); .055 | −0.61 (−1.24, 0.02); .056 | −0.23 (−0.72, 0.27); .369 | 0.36 (−0.54, 1.27); .430 | 0.59 (−0.44, 1.62); .262 |
| CFI study partner score | −0.42 (−0.79, −0.04); .030 | −0.77 (−1.49, −0.04); .038 | 0.10 (−0.30, 0.50); .624 | −0.28 (−0.98, 0.42); .431 | −0.52 (−1.07, 0.03); .066 | −0.49 (−1.49, 0.52); .343 | 0.03 (−1.11, 1.18); .959 |
Abbreviations: CFI, Cognitive Function Instrument; PROMIS, Patient‐Reported Outcomes Measurement Information System.
Estimated with the mean at baseline.
Defined as presenting at least one ε4 allele.
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.