Sarkkinen Fat Mod 1995.

Methods	RCT (the 3 Kuopio trials share a common control group)
Participants	Free‐living people aged 30‐60 with serum total cholesterol levels 6.5‐8.0mmol/L (Finland) CVD risk: moderate Control: randomised 37, analysed 37 Intervention Mono: randomised 41, analysed 41 Mean years in trial: for both groups 0.5 % male: control 46, Mono 46 Age: mean control 43.2, Mono 46.4 (all 30‐60)
Interventions	Modified fat vs usual diet Control aims: advised total fat 38%E, SFA <18%E, MUFA 15%E, PUFA <5%E, rapeseed oil, butter and semi‐skimmed milk provided Intervention aims Mono: total fat 38%E, SFA <14%E, MUFA 18%E, PUFA <6%E, rapeseed oil, rapeseed spread and skimmed milk provided Control and intervention methods: given written dietary instructions and a diet plan with checking and reinforcement for 3 visits, then at 2, 6, 12, 18 and 26 weeks Total fat intake (weeks 14‐28): mod fat 35 (sd 5), cont 36 (sd 5)%E Saturated fat intake (weeks 14‐28): mod fat 11 (sd 2), cont 15 (sd 2)%E Style: dietary advice & supplement (food) Setting: community
Outcomes	Stated trial outcomes: lipids and blood pressure Data available on total mortality? yes (no events) Cardiovascular mortality? no Events available for combined cardiovascular events: none Secondary outcomes: none Tertiary outcomes: BMI, total, LDL and HDL cholesterol, TG, BP
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"randomisation stratified for men and women, singles and couples, random number tables"
Allocation concealment (selection bias)	Unclear risk	Randomisation method not clearly described
Blinding (performance bias and detection bias) All outcomes	High risk	Participants and researchers knew allocation
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?	Low risk	Similar intensity and duration for both groups. 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