Rivellese 1994.
| Methods | RCT | |
| Participants | Adults with primary hyperlipoproteinaemia (Italy) CVD risk: moderate Intervention reduced fat: 33 randomised, 27 analysed Intervention modified fat: 30 randomised, 17 analysed Mean years in trial: reduced fat 0.4, modified fat 0.4 % male: reduced fat 82%, modified fat 63% Age, years: reduced fat 47.4 mean (sd 10.3), modified fat 48.6 (sd 8.1) | |
| Interventions | Reduced fat vs Modified fat diet Reduced fat aims: total fat 25%E, SFA 8%E, MUFA 15%, PUFA 2%, dietary chol <300mg/d, CHO 58%, protein 17%E, soluble fibre 41g/d Modified fat aims: total fat 38%E, SFA <10%E, MUFA 20%E, PUFA 10%E, dietary chol<300mg/d, CHO 47%E, protein 15%E, soluble fibre 19g/d Reduced fat methods:seen monthly by dietitian and doctor, feedback based on 7 day food diary each time Modified fat methods: seen monthly by dietitian and doctor, feedback based on 7 day food diary each time Total fat intake (at 5‐6 months): low fat 27 (sd unclear)%E, mod fat 36 (sd unclear)%E Saturated fat intake (at 5‐6 months): low fat 6 (sd unclear)%E, mod fat 7 (sd unclear)%E Style: diet advice Setting: community |
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| Outcomes | Stated trial outcomes: metabolic effects
Data available on total mortality? yes (no events)
Cardiovascular mortality? yes (no events)
Events available for combined cardiovascular events: total MI, cardiovascular deaths, stroke (no events) Secondary outcomes: stroke, total and non‐fatal MI (no events for any outcomes) Tertiary outcomes: total, LDL and HDL cholesterol, TGs |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Following 3 or 6 weeks compliance with control diet run‐in, stratified block randomisation with tables of random numbers |
| Allocation concealment (selection bias) | Unclear risk | Randomisation method not clearly described |
| Blinding (performance bias and detection bias) All outcomes | High risk | None |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear, deaths, cancer and CV events are drop‐outs ‐ 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 | Identical follow up. See Control and Intervention Methods in Interventions section of the Table of Characteristics of Included Studies |
| Free of dietary differences other than fat? | High risk | Some differences in soluble fibre intake |