Ole Study 2002.
| Methods | RCT | |
| Participants | Moderately obese healthy men (USA) CVD risk: low Control: randomised 15, analysed 12 Intervention: randomised 15, analysed 13 Mean years in trial: control 0.68, intervention 0.70 % male: control 100%, intervention 100% Age: mean control 37.0 (SE 2.54), intervention 36.1 (SE 2.49) | |
| Interventions | Reduced fat vs usual diet Control aims: total fat 33%E, CHO 52%E, protein 15%E Intervention aims: total fat 25%E, CHO 58%E, protein 17%E, provided with 11% less energy than controls, but were allowed to ask for more Also second intervention arm with Olestra added to Control methods: 5 meals/week eaten in centre, other meals in takeout containers, asked to return uneaten food, allowed to ask for more Intervention methods: 5 meals/week eaten in centre, other meals in takeout containers, asked to return uneaten food, allowed to ask for more Total fat intake (at 6 months): low fat 26.2 (sd 2.8)%E, cont 34.1 (sd 2.7)%E Saturated fat intake (at 6 months): low fat 6.2 (sd 0.7)%E, cont 7.6 (sd 0.9)%E Style: diet provided Setting: community |
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| Outcomes | Stated trial outcomes: body weight, body fat, lipids, glucose, insulin
Data available on total mortality? yes (no events)
Cardiovascular mortality? yes (no events)
Events available for combined cardiovascular events: total MI, stroke, angina, CABG, angioplasty, peripheral vascular events (no events) Secondary outcomes: non‐fatal and total MI, stroke, cancer diagnoses and deaths (no events for any outcome), Quality of Life Tertiary outcomes: weight, 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 | Computer stratified and randomised by personnel not involved with participants |
| Allocation concealment (selection bias) | Low risk | |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Workers in the dietary kitchen, who provided the meals, were the only ones who knew the allocations |
| 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 | Most food provided 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? | High risk | Potential difference in energy intake, but unclear what effect this had |