Deslypere 1992

Methods	RCT 4 arms, ( n‐3 EPA + DHA (3 different doses) vs MUFA), 12 months Summary risk of bias: moderate or high
Participants	Healthy monks N: 14 high, 15 medium, 15 low dose intervention, 14 control Level of risk for CVD: low Men: 100% Mean age in years (SD): 56.2 (16.5) (not reported by arm) Age range: 21‐87 Smokers: none 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 (no medications influencing lipid metabolism or non‐steroidal anti‐inflammatory drugs were allowed) Location: the Netherlands Ethnicity: not reported
Interventions	Type: capsules Comparsion: LCn3 vs MUFA Intervention 9 capsules (9 g vol.) per day, of which 3, 6 or 9 were fish oil (Labaz, Brussels, Belgium) and any remainder were placebo (providing respectively 1.12; 2.24 or 3.37 g n‐3 FA/day). Dose: 1.12 g/d; 2.24 g/d or 3.37 g/d EPA + DHA) Control: 9 placebo capsules made up of olive oil (Puget Marseille, France) and Palmoil (Loders‐Kroklaan Wormerveen, the Netherlands) with the same SFA, cholesterol and vitamin E as the fish oil capsules. Compliance: assessed by counting remaining capsules every 2 months and by measuring EPA concentration. Excellent compliance reported and shown by the EPA concentration results Length of intervention: 12 months
Outcomes	Main study outcome: effect on coronary risk factors Dropouts: none Available outcomes: deaths (nil), CVD events (nil), lipids, BP, HbA1c, weight (measured but only text suggests "no significant changes in the anthropometric parameters (weight, length, waist, hip and thigh circumferences) during the study"), IL‐6, TNF‐alpha and several IL‐1s (IL‐6 reported as below detection range, for the others there was "no significant difference between the two treatment groups at any point in time") Response to contact: yes
Notes	Study funding: capsules supplied by Labaz (Brussels Belgium). The placebo capsules contained olive oil (Puget) and palm oil (Loders‐Kroklaan, Wormerveer). Financial support by Sanofi‐Labaz. Data entered for high fish oil versus placebo groups
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote (author correspondence): "The manufacturer provided envelopes containing numbers corresponding with boxes of capsules. For each enrolled subject, random envelope was opened."
Allocation concealment (selection bias)	Low risk	Allocation concealed from all this way
Blinding of participants and personnel (performance bias) All outcomes	High risk	Although double blind, the fishy taste of the active treatment was not matched (author states that the fishy taste was clear in the intervention capsules)
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Authors confirmed outcome assessors were unaware until afterwards.
Incomplete outcome data (attrition bias) All outcomes	Low risk	No dropouts
Selective reporting (reporting bias)	Unclear risk	No protocol or trial registry record
Attention	Low risk	No difference between groups
Compliance	Low risk	Significant difference in EPA concentration
Other bias	Low risk	None noted