Effect of Omega-3 Fatty Acids, Lutein/Zeaxanthin, or other Nutrient Supplementation on Cognitive Function: The AREDS2 Randomized Clinical Trial
Abstract
Importance Observational data have shown high dietary intake of saturated fat and low intake of vegetable were associated with increased risk of Alzheimer disease. Objective To test the effects of oral supplementation with nutrients on cognitive function. Design, Setting and Participants In the double-masked (blinded) randomized controlled clinical trial, the Age-Related Eye Disease Study 2, retinal specialists in 82 academic and community medical centers in the United States enrolled and followed participants who were at risk for developing late age-related macular degeneration (AMD) from October 2006 to December 2012. In addition to annual eye examinations, several validated cognitive function tests were administered via telephone by trained personnel at baseline and every 2 years during the 5 year study. Interventions Long-chain polyunsaturated fatty acids (LCPUFAs) (1 g) and/or lutein (10 mg)/zeaxanthin (2 mg) versus placebo were tested. All participants were also given varying combination of vitamins C, E, beta-carotene, and zinc, known as the Age-Related Eye Disease Study supplement. Main Outcomes and Measures The main outcome was the yearly change in composite scores determined from a battery of cognitive function tests from baseline. The analyses, which were adjusted for baseline age, sex, race, history of hypertension, education, cognitive score and depression score, evaluated the differences in the composite score between the treated vs. untreated groups. The…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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