Methods	RCT
Participants	Young overweight adults who had lost at least 8% of body weight (Denmark) CVD risk: low Intervention modified fat: 52 randomised, 52 analysed (39 completed) Intervention low fat: 48 randomised, 48 analysed (43 completed) Mean years in trial: moderate fat 0.44, low fat 0.47 % male: modified fat 41%, low fat 43% Age: modified fat 29.2 (sd 4.5), low fat 27.3 (sd 4.9) Baseline total fat intake: int cont Baseline saturated fat intake: int cont
Interventions	Reduced fat intake vs modified fat Modified fat aims: 35-45%E from fat, SFA <10%E, MUFA >20%E, PUFA 5-10%E, protein 10-20%E, CHO 40-50%E, added sugars <10%E, alcohol <5%E, glycaemic index low, energy density high, energy intake ad libitum Low fat aims: 20-30%E from fat, SFA <10%E, MUFA 5-15%E, PUFA 5-10%E, protein 10-20%E, CHO 55-65%E, added sugars <10%E, alcohol <5%E, glycaemic index medium, energy density low, energy intake ad libitum Control and intervention methods: supermarket model, all foods provided free, personal shoppers helped participants collect appropriate foods, not allowed to leave shop until dietary composition was correct, waste and leftovers returned to shop, minimum of 2 dietetic counselling sessions over 2 months Total fat intake (at 6 months): low fat 23.6 (sd 1.67)%E, mod fat 38.4 (sd 1.75)%E Saturated fat intake (at 6 months): low fat 7.9 (sd 1.17)%E, mod fat 7.1 (sd 0.80)%E Style: food provided Setting: community
Outcomes	Stated trial outcomes: CVD risk, diabetes risk, weight Data available on total mortality? yes (no events) Cardiovascular mortality? yes (no events) Events available for combined cardiovascular events: total MI, stroke (no events) Secondary outcomes: cancer deaths and diagnoses, total and non-fatal MI, stroke (no events in any group) Tertiary outcomes: weight, BMI, total, HDL, LDL cholesterol, TG
Notes
Risk of bias
Bias	Authors’ judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Independently randomised by 2 study personnel, stratified by sex and initial BMI
Allocation concealment (selection bias)	Unclear risk	Randomisation method not clearly described
Blinding (performance bias and detection bias) All outcomes	High risk	Participants were aware of their own allocated diet, those assessing outcomes unclear
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Reasons for dropouts provided, ITT analysis used for continuous outcomes
Selective reporting (reporting bias)	Low risk	Not relevant for primary and secondary outcomes as all trialists asked for data
Other bias	Low risk
Free of systematic difference in care?	Low risk	Yes, advice and shop system was the same across all groups
Free of dietary differences other than fat?	High risk	No, there were also differences in sugary foods, legumes, dietary glycaemic index etc