TABLE 4.

Mixed‐effects linear regression analysis for change from baseline in outcome measures according to randomized intervention groups and omega‐3 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 low vs. normal ω‐3
	Nutritional blend		Placebo		Nutritional blend vs. placebo
	Normal ω‐3 index	Low ω‐3 index b	Normal ω‐3 index	Low ω‐3 index b	Normal ω‐3 index	Low ω‐3 index b
Biomarkers
Plasma homocysteine (µmol/L)	−2.34 (−3.03, −1.66); <.0001	−1.65 (−2.82, −0.48); .006	0.68 (−0.03, 1.39); .060	1.93 (0.79, 3.07); .001	−3.03 (−4.01, −2.04); <.0001	−3.58 (−5.21, −1.94); <.0001	−0.55 (−2.46, 1.36); .572
ω‐3 index c (%)	1.47 (1.14, 1.80); <.0001	1.69 (1.10, 2.29); <.0001	−1.04 (−1.38, −0.70); <.0001	−1.37 (−1.96, −0.78); <.0001	2.51 (2.06, 2.96); <.0001	3.06 (2.32, 3.81); <.0001	0.56 (−0.32, 1.43); .213
Cognitive tests
PROMIS T‐score d (8 items)	−0.30 (−1.19, 0.59); .509	0.81 (−0.73, 2.36); .301	0.97 (0.04, 1.89); .040	1.65 (0.09, 3.21); .038	−1.27 (−2.55, 0.02); .053	−0.84 (−3.03, 1.36); .453	0.43 (−2.11, 2.97); .740
Composite cognitive score e	−0.06 (−0.16, 0.04); .235	−0.18 (−0.35, −0.01); .041	−0.11 (−0.21, 0.00); .041	−0.04 (−0.20, 0.13); .653	0.05 (−0.10, 0.19); .513	−0.14 (−0.38, 0.10); .248	−0.19 (−0.47, 0.09); .184
CFI self‐assessment score	−0.54 (−0.90, −0.18); .003	−0.47(−1.09, 0.15); .136	−0.34 (−0.72, 0.04); .075	−0.43 (−1.03, 0.18); .168	−0.20 (−0.72, 0.32); .456	−0.05 (−0.91, 0.82); .916	0.15 (−0.86, 1.16); .770
CFI study partner score	−0.48 (−0.89, −0.07); .021	−0.66(−1.34, 0.02); .058	0.00 (−0.43, 0.43); .998	−0.20 (−0.88, 0.48); .566	−0.48 (−1.07, 0.11); .112	−0.46 (−1.42, 0.50); .349	0.02 (−1.11, 1.15); .970

Abbreviations: CFI, Cognitive Function Instrument; PROMIS, Patient‐Reported Outcomes Measurement Information System.

^a Estimated with the mean at baseline.

^b ω‐3 index ≤5.69%.

^c Calculated as the sum of % docosahexaenoic acid and % eicosapentaenoic acid, expressed as the percentage of total erythrocyte membrane fatty acids.

^d After 1 month, and all other outcomes after 12 months.

^e 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.