Sofi 2010.
| Methods | 2‐arm, parallel RCT (enriched olive oil vs olive oil), 12 months Summary risk of bias: moderate or high |
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| Participants | Non‐alcoholic fatty liver disease patients N: 6 intervention, 5 control Level of risk for CVD: low Men: 66.7% intervention, 100% control Median age: 55 intervention, 54 control Age range: 30‐41 intervention, 42‐70 control Smokers: not reported Hypertension: not reported Medications taken by at least 50% of those in the control group: not reported Medications taken by 20%‐49% of those in the control group: not reported Medications taken by some, but less than 20% of the control group: not reported Location: Italy Ethnicity: not reported |
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| Interventions | Type: supplement (oil) Comparison: EPA + DHA vs MUFA Intervention: 6.5 mL/d olive oil enriched with n‐3 (t‐Omega 3, tFarma srl, Italy) containing 0.47 g EPA, 0.24 g DHA plus dietary recommendations. Dose: 0.83 g/d EPA + DHA Control: 6.5 mL/d olive oil plus dietary recommendations Compliance: was verified by counting the empty boxes on return but no data reported Length of intervention: 12 months |
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| Outcomes | Main study outcome: fatty liver status Dropouts: unclear Available outcomes: lipids, glucose, insulin, HOMA, (BMI not in usable format, also LFTs, oxidative markers, adiponectin, fatty liver and steatosis outcomes) Response to contact: not yet attempted |
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| Notes | Study funding: oil supplied by tFarma and funding not stated | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "The patients were randomized into two groups" |
| Allocation concealment (selection bias) | Unclear risk | No details |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No details |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Numbers analysed for liver health are for those randomised. Numbers analysed for other outcomes not stated. No mention of dropouts |
| Selective reporting (reporting bias) | Unclear risk | No protocol or trial registration |
| Attention | Low risk | Both groups received same contact |
| Compliance | Unclear risk | Measured but no results reported |
| Other bias | Low risk | None noted |