TABLE 2.
Mixed‐effects linear regression analysis for change from baseline in primary, secondary, and exploratory outcome measures according to randomized intervention groups 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 | ||
|---|---|---|---|
| Nutritional blend | Placebo | Nutritional blend vs. placebo | |
| Biomarkers | |||
| Homocysteine (µmol/L) | −2.24 (−2.81, −1.68; <0.0001 |
0.96 (0.38, 1.53); .001 |
−3.20 (−4.01, −2.39); <.0001 |
| ω‐3 index b (%) | 1.53 (1.25, 1.80); <.0001 | −1.13 (−1.41, −0.85); <.0001 | 2.66 (2.27, 3.05); <.0001 |
| Cognitive tests | |||
| PROMIS T‐score (8 items)* | −0.03 (−0.75, 0.70); .945 |
1.15 (0.41, 1.88); .002 |
−1.17 (−2.20, −0.14); .026 |
| Composite cognitive score c | −0.10 (−0.18, −0.02); .016 | −0.10 (−0.18, −0.01); .022 | 0.00 (−0.12, 0.11); .953 |
| CFI self‐assessment score | −0.49 (−0.79, −0.19); .001 | −0.38 (−0.69, −0.07); .015 | −0.11 (−0.54, 0.31); .606 |
| CFI study partner total score | −0.34 (−0.80, 0.12); .134 |
0.14 (−0.34, 0.62); .544 |
−0.48 (−0.95, −0.01); .044 |
| Brain imaging d | |||
| Hippocampal volume left (mm3) | −36.02 (−65.98, −6.06); .019 | −78.39 (−108.31, −48.46); <.0001 | 42.37 (−0.10, 84.83); .051 |
| Hippocampal volume right (mm3) | −40.93 (−71.86, −10.01); .010 | −55.71 (−86.63, −24.79); .001 | 14.78 (−29.04, 58.60); .507 |
| Total hippocampal volume (mm3) | −75.47 (−126.45, −24.49); .004 | −135.00 (−185.95, −84.04); <.0001 | 59.53 (−12.72, 131.78); .106 |
| AD signature CT e (mm) |
−0.01 (−0.02, 0.01); .357 |
−0.03 (−0.04, −0.01); 0.001 | 0.02 (0.00, 0.04); .088 |
Abbreviations: AD, Alzheimer's disease; CFI, Cognitive Function Instrument; CT, cortical thickness; PROMIS, Patient‐Reported Outcomes Measurement Information System Applied Cognition‐Abilities.
*Change after 1 month, and all other outcomes after 12 months of follow‐up.
Estimated with the mean at baseline.
ω‐3 index was calculated as the sum of % docosahexaenoic acid and % eicosapentaenoic acid, expressed as the percentage of total erythrocyte membrane fatty acids.
Based on four cognitive tests (free and total recall of the Free and Cued Selective Reminding test, ten Mini‐Mental State Examination orientation items, Digit Symbol Substitution Test and Category Naming Test.
Magnetic resonance imaging was performed in a subsample (in the present analysis, n = 177 for hippocampal volume and n = 145 for AD signature cortical thickness). Analyses on hippocampal volume and AD signature CT were adjusted for baseline total intracranial volume.
Alzheimer's disease signature cortical thickness was composed by the mean cortical thickness of left and right hemispheres of four different regions of interest: entorhinal, inferior temporal, middle temporal, and fusiform weighted by each region's volume.