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 |
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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 |
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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 |
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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) |
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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). |
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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 |