Sondergaard 2003.

Methods	RCT
Participants	People with IHD plus total cholesterol at least 5 mmol/L (Denmark) CVD risk: high Control: 63 randomised, 52 analysed Intervention: 68 randomised, 63 analysed Mean years in trial: 1.0 % male: control 79%, intervention 62% Age: control mean 62.8 (SD 10.5), intervention mean 62.1 (SD 9.3) Baseline BMI: intervention 26.6 (SD 3.9), control 26.7 (SD 4.2)
Interventions	Reduced and modified fat intake vs usual diet Control: aims unclear Intervention: aims reductions in total and saturated fat, replace fats with oils, 600 g fruit and vegetables/d, fatty fish at least once a week, eat plenty of bread and cereals Control methods: booklets plus one dietetic interview, and 3 monthly clinical review Intervention methods: 1‐hour nutrition interview every 3 months, plus 3 monthly clinical review Weight goals: weight not mentioned Total fat intake (at 12 months): low and mod fat 26.2 (SD 5.1), control 28.9 (SD 7.9) %E Saturated fat intake (at 12 months): unclear Style: diet advice Setting: community
Outcomes	Stated trial outcomes: endothelial function Available outcomes: weight, total, LDL and HDL cholesterol, TG
Notes	No outcome data provided on weight, except the statement "in both groups, body weight remained unchanged after 12 months".
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"randomised in unblinded 1:1 fashion"
Allocation concealment (selection bias)	High risk	"randomised in unblinded 1:1 fashion"
Blinding (performance bias and detection bias) All outcomes	High risk	Participants aware of allocation, unclear about others
Incomplete outcome data (attrition bias) All outcomes	High risk	16 of 131 (12%) lost over 1 year (> 5% per year)
Selective reporting (reporting bias)	Unclear risk	Protocol not seen
Other bias	Low risk
Free of systematic difference in care?	High risk	Additional dietetic time for intervention group. See 'Control methods' and 'Intervention methods' in the 'Interventions' section above
Free of dietary differences other than fat?	High risk	Additional dietary advice for intervention group (fruit, vegetables, fish, cereals)