Methods	RCT
Participants	Women and men with mild hypercholesterolemia (USA) CVD risk: moderate Control: unclear how many randomised, 192 analysed Intervention: unclear how many randomised, 217 analysed Mean years in trial: unclear (max duration 0.5 years) % male: 52 (not divided by intervention group) Age: mean 43.2 (not divided by intervention group) (all >30)
Interventions	Reduced and modified fat vs usual diet Control aims:asked to delay dietary changes (provided intervention after the randomised trial) Intervention aims: total fat <30%E, SFA <7%E, dietary chol<200mg/d Control methods: usual intake Intervention methods: 8 weekly classes with nutrition info and behaviour modification with spouses, plus individual appointments at 3 and 6 months Total fat intake (at 6 months): int 25.2 (sd unclear)%E, cont unclear - no significant difference from baseline 34 (sd unclear)%E Saturated fat intake (at 6 months): int 7.6% (sd unclear)%E, cont unclear - no significant difference from baseline 12 (sd unclear)%E Style: diet advice Setting: community
Outcomes	Stated trial outcomes: lipids Data available on total mortality? yes (no events) Cardiovascular mortality? no Events available for combined cardiovascular events: unclear but authors stated that there were no CVD events Secondary outcomes: none Tertiary outcomes: weight, total, LDL and HDL cholesterol, TGs (but variance data only provided for the randomised comparison for LDL cholesterol)
Notes	Weight: control ‘no change’, intervention −2.7kg at 6 months
Risk of bias
Bias	Authors’ judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Stratified random sampling scheme
Allocation concealment (selection bias)	Unclear risk	Randomisation method not clearly described
Blinding (performance bias and detection bias) All outcomes	High risk	Participants knew their allocation, unclear for outcome assessors
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Unclear, deaths, cancer and CV events are drop-outs, trialists asked for data - unclear if any data missing
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?	High risk	Intensive intervention for intervention group, but no intervention during the 6 months of the randomised part of the study for the control group. See Control and Intervention Methods in Interventions section of the Table of Characteristics of Included Studies
Free of dietary differences other than fat?	Low risk	See Control and Intervention Aims in Interventions section of the Table of Characteristics of Included Studies