Sarkkinen Red & 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 AHA: randomised 41, analysed 41 Mean years in trial: for all 4 groups 0.5 % male: control 46, AHA 46 Age: mean control 43.2, AHA 47.3 (all 30‐60) |
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| Interventions | Reduced and 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 AHA: total fat 30%E, SFA <10%E, MUFA 10%E, PUFA 10%E, sunflower oil, sunflower 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): low & mod fat 34 (sd 4), cont 36 (sd 5)%E Saturated fat intake (weeks 14‐28): low & mod fat 11 (sd 2), cont 15 (sd 2)%E Style: dietary advice & supplement (food) Setting: community |
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| 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 |
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| 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 in 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 |