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. 2018 Nov 30;2018(11):CD003177. doi: 10.1002/14651858.CD003177.pub4

EPOCH 2014.

Methods Older People, Omega‐3 and Cognitive Health (EPOCH)
RCT, parallel (n‐3 EPA + DHA vs MUFA), 18 months
Summary risk of bias: low
Participants Healthy older adults with no cognitive impairment
N: 195 intervention, 196 control (reported by author)
Level of risk for CVD: low
Men: not reported
Mean age in years (SD): not reported
Age range: not reported, but 65‐90 recruited
Smokers: not reported
Hypertension: not reported
Medications taken by at least 50% of those in the control group: not reported
Medications taken by 20%‐49% of those in the control group: not reported
Medications taken by some, but less than 20% of the control group: not reported
Location: Australia
Ethnicity: not reported
Interventions Type: supplement (fish oil capsules)
Comparison: EPA + DHA vs MUFA
Intervention: 4 capsules/d (1.72 g/d DHA and 0.60 g/d EPA). Dose: 2.32 g/d EPA + DHA
Control: 4 capsules/d (3.960 g/d olive oil and 40 mg/d fish oil)
Compliance: count of all unused supplements returned at three‐monthly intervals, plus self‐report calendars, mailed back on a monthly basis. If compliance fell below 85% (re calendars), they were contacted by a researcher who noted the reasons. Compliance also assessed by erythrocyte membrane n‐3 LC PUFA status
Length of intervention: 18 months
Outcomes Main study outcome: change in cognitive performance
Dropouts: not reported
Available outcomes: mortality (nil), MI, stroke, revascularisation, arrhythmias, CV events
Response to contact: yes (data provided)
Notes Authors reported some events, but don't appear to be published.
Study funding: EPAX donated the Omega‐3 concentrate and Blackmores Pty Ltd donated the placebo and packaging of the Omega‐3 concentrate. The trial was supported by the Brailsford Robertson Award 2007‐2008 (University of Adelaide and CSIRO Food and Nutritional Sciences), and is funded by a National Health and Medical Research Project Grant (#578800).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Age‐stratified, permuted‐block randomisation, with mixed block‐sizes (2‐8, size unknown to study investigators), 1:1 allocation. Computer‐generated randomisation schedule
Allocation concealment (selection bias) Low risk An independent researcher prepared allocation to treatment
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk The researchers, project staff, and participants remained blinded to treatment allocation until the trial was completed and the database locked. However, no information provided on capsules appearance, taste or smell
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk As above
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk No data for each group presented, and no attrition data presented
Selective reporting (reporting bias) High risk Only cognitive functions reported for whole population (not by arm). No secondary outcomes reported (MMSE; perceived health status, depressive symptoms, positive and negative affect, life satisfaction, self‐reported cognitive functioning, and functional capacity; blood pressure; biomarkers of glucose, glycated haemoglobin, triglycerides, total cholesterol, HDL, LDL, homocysteine, CRP, MDA, and telomere length)
Attention Low risk All had the same contact and attention
Compliance Unclear risk Count of all unused supplements returned at 3‐monthly intervals, plus self‐report calendars, mailed back on a monthly basis. If compliance fell below 85% (re calendars), they were contacted by a researcher who noted the reasons. Compliance also assessed by erythrocyte membrane n‐3 LC PUFA status but results not reported
Other bias Low risk None noted
HHS Vulnerability Disclosure