The older people, omega-3, and cognitive health (EPOCH) trial design and methodology: A randomised, double-blind, controlled trial investigating the effect of long-chain omega-3 fatty acids on cognitive ageing and wellbeing in cognitively healthy older adults

Carlene, Wilson; Ted, Nettelbeck; Burns Nicholas R; Vanessa, Danthiir; Gary, Wittert · 2011 · DOAJ

DOI: 10.1186/1475-2891-10-117

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Summary

This paper outlines the design and methodology of the Older People, Omega-3, and Cognitive Health (EPOCH) trial, a randomized, double-blind, placebo-controlled study investigating whether long-chain omega-3 polyunsaturated fatty acid (n-3 LC PUFA) supplementation slows cognitive decline in cognitively healthy older adults. The research was motivated by inconsistent findings in previous studies; while observational data often linked higher n-3 intake to better cognitive outcomes, only two prior randomized controlled trials (RCTs) had tested supplementation in healthy elderly populations, with conflicting results regarding overall efficacy and the potential moderating role of the Apolipoprotein E-ε4 (ApoE-ε4) allele. The primary objective was to comprehensively assess the efficacy of a DHA-rich fish-oil supplement on cognitive trajectories over 18 months, while also examining functional capacity, well-being, and biological mechanisms. The trial recruited 391 participants aged 65–90 years from metropolitan Adelaide, Australia, who were English-speaking and screened for normal cognitive function using the Mini-Mental State Examination (MMSE). Participants were randomly allocated in a 1:1 ratio to either an intervention group or a placebo group. The intervention group received daily capsules containing 1720 mg of docosahexaenoic acid (DHA) and 600 mg of eicosapentaenoic acid (EPA), while the placebo group received capsules containing olive oil with a minimal amount of fish oil to maintain blinding. Assessments were conducted at baseline and every six months for 18 months. The primary outcome was the rate of change in cognitive performance, measured via latent growth curve modeling of constructs including reasoning, working memory, short-term memory, retrieval fluency, inhibition, and various speed-of-processing tasks. Secondary outcomes included changes in MMSE scores, functional capacity, well-being measures (depression, mood, life satisfaction), blood pressure, and biomarkers related to glucose, lipid metabolism, inflammation, oxidative stress, and DNA damage. ApoE genotyping was performed to analyze differential effects based on allele carriage. Compliance was monitored through capsule counts, self-report calendars, and erythrocyte membrane fatty acid analysis. As a methodology paper, this study does not report results or findings. Instead, it details the rigorous protocols established to address gaps in existing literature, such as the need for comprehensive cognitive testing and the consideration of ApoE status. The significance of the EPOCH trial lies in its potential to clarify whether n-3 LC PUFA supplementation can mitigate age-related cognitive decline in non-demented older adults. By employing a comprehensive cognitive battery and analyzing biological mediators, the study aims to determine if benefits are universal or specific to certain genetic subgroups, thereby informing public health strategies for maintaining cognitive health and independence in aging populations.

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• cognitive capacity variation