SMART 2013.

Methods	SMART trial (from the Smart Foods Centre) RCT, 3‐arm parallel, (Fish + S: hypocaloric diet plus fish plus fish oil capsules vs Fish: hypocaloric diet plus fish plus olive oil capsules vs control: hypocaloric diet plus olive oil capsules), 12 months Summary risk of bias: moderate or high
Participants	Overweight adults N: fish + S intervention 41, fish 43, control 42. (analysed, fish + S intervention 21, fish 25, control 18) Level of risk for CVD: low Men: 27% fish + S intervention, 23% fish intervention, 28% control Mean age (SD) years: unclear by arm, overall 45.1 (8.4) Age range: not reported but 18‐60 years eligible Smokers: not reported but 5.9% overall 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 and food Comparison: EPA + DHA vs MUFA (Fish plus fish oil supplements vs Fish plus olive oil supplements vs olive oil supplements) Intervention, Fish + S: hypocaloric diet aiming at 30% E from fat, 25% E from protein, 45% E from CHO, plus 180 g fish/week plus capsules including 420 mg/d EPA + 210 mg/d DHA (Blackmores Promega Heart). Dose: 0.63 g/d EPA + DHA Intervention, fish: hypocaloric diet aiming at 30% E from fat, 25% E from protein, 45% E from CHO, plus 180 g fish/week plus capsules including 1 g olive oil/d Control: hypocaloric diet aiming at 30% E from fat, 25% E from protein, 45% E from CHO, plus capsules including 1 g olive oil/d Compliance: assessed through diet histories (fish) and erythrocyte fatty acid supplements (capsules), but results not reported Duration of intervention: 12 months
Outcomes	Main study outcome: total % body fat Dropouts: fish + supplement intervention 20, fish intervention 18, control 24 Available outcomes: weight, BMI, lipids, BP, fasting glucose, fasting insulin, % body fat (leptin also reported), no deaths or cardiovascular events occurred (authors report) Response to contact: authors provided data on CVD events (none) and mean/SD data for TGs and fasting insulin
Notes	To assess effects of omega 3 fats the best comparison in this study is fish + S vs fish, so numerical data reflect this comparison. Study funding: Australian National Health and Medical Research Council, fish and olive oil capsules were provided free by Blackmores Australia
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "A researcher independent of the subject interface undertook the randomisation of participants into diet groups (stratified by sex and block randomised...)"
Allocation concealment (selection bias)	Low risk	Quote: "Randomisation was performed centrally, off‐site and the holder of the allocation schedule provided the codes to a single researcher who was independent to the subject interface. The placebo and active ingredient capsules were coded off‐site . The codes were kept from the researchers collecting dietary data and delivering treatment. Allocation concealment was maintained as the persons responsible for screening eligible participants for inclusion in the trial was unaware to which supplement group the subject would be allocated. Different dietitians collected the dietary data and provided dietary advice"
Blinding of participants and personnel (performance bias) All outcomes	High risk	As above, but impossible to blind participants to the fish advice
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	As above
Incomplete outcome data (attrition bias) All outcomes	Low risk	Very high levels of attrition, though intention‐to‐treat analyses carried out
Selective reporting (reporting bias)	High risk	We were unable to find data on 24 hour energy expenditure, oxidation or heart rate which were stated as primary and secondary outcomes in the trials registry.
Attention	Unclear risk	While dietary education was for 1 hour then 6 further half hour follow‐ups plus written materials and monthly newsletters plus dietary interviews it is not clear whether this was in all arms or only some of them.
Compliance	High risk	Quote: "Of the 12 months completers, 57% were judged to be compliant, 39% (n = 7) for the control group who reported < 180 g fish/week, 48% (n = 12) for the Fish group who reported ≥180 g fish/week, and 85% (n = 17) for the Fish + S group who reported ≥180 g fish/week or ≥90% supplements". However, erythrocyte (EPA + DHA)/total fatty acids × 100 was significantly different for the fish oil supplemented group compared to the two others – but it was only measured in around half of the participants as the others dropped out, so presumably were non‐compliant.
Other bias	Low risk	None noted