Gagliardi Parallel To compare the 75 subjects with Subjects continued Compliance by Margarine well Changes reported The butter 2010 effects of butter, metabolic syndrome regular diet and telephone matched on as median not group was not trans fat free were randomised, 53 exercise and monitoring. baseline clinical mean. No considered as margarine and completed the trial consumed either subjects characteristics. significant the trans fat plant sterol (37% male, mean age 18g butter, 36g excluded. Dietary Median difference in total, free margarine enriched 47y). trans fat free intake by 3x 1d food saturated fat LDL or HDL was margarine on margarine or 30g diaries. intake was cholesterol, but considered the blood lipids, plant sterol Blood lipids higher in plant there was a median appropriate lipoproteins, margarine per day. measured sterol group at decrease of 11.3% control for this inflammation 5wk trial. enzymatically, baseline, but in LDL-C in the review. and endothelial including LDL-C. difference was plant sterol group. Government function. RMANOVA not significant. funded study. Goncalves Parallel To test the 22 healthy (not Compliance Not well A significant No adverse 2007 efficacy and considered in review) subjects received unclear. Dietary controlled. reduction in total effects were safety of and 34 placebo or intake not Baseline and LDL cholesterol reported from phytosterols in phytosterol enriched assessed. characteristics is reported, but analysis of milk in healthy subjects (32% male, milk (2g per day) for Method of blood not reported, similar albeit various blood and 40-72y) randomised. 30d. lipid analysis not except parameters. detailed. difference in reductions were The subjects Statistical analysis gender observed in placebo intervention in by t-test distribution (20% group. Had the healthy Student’s only. male in control, change between subjects was 42% male in groups been not considered phytosterol compared it would for the review group). be unlikely to be as no placebo significant. groups was used. Industry funded
Gagliardi 2010 Parallel To compare the effects of butter, trans fat free margarine and plant sterol enriched margarine on blood lipids, lipoproteins, inflammation and endothelial function. 75 subjects with metabolic syndrome were randomised, 53 completed the trial (37% male, mean age 47y). Subjects continued regular diet and exercise and consumed either 18g butter, 36g trans fat free margarine or 30g plant sterol margarine per day. 5wk trial. Compliance by telephone monitoring. subjects excluded. Dietary intake by 3x 1d food diaries. Blood lipids measured enzymatically, including LDL-C. RMANOVA Margarine well matched on baseline clinical characteristics. Median saturated fat intake was higher in plant sterol group at baseline, but difference was not significant. Changes reported as median not mean. No significant difference in total, LDL or HDL cholesterol, but there was a median decrease of 11.3% in LDL-C in the plant sterol group. The butter group was not considered as the trans fat free margarine was considered the appropriate control for this review. Government funded study. Goncalves 2007 Parallel To test the efficacy and safety of phytosterols in milk in healthy and subjects 22 healthy (not considered in review) and 34 subjects (32% male, 40-72y) randomised. subjects received placebo or phytosterol enriched milk (2g per day) for 30d. Compliance unclear. Dietary intake not assessed. Method of blood lipid analysis not detailed. Statistical analysis by Student’s t-test only. Not well controlled. Baseline characteristics not reported, except difference in gender distribution (20% male in control, 42% male in phytosterol group). A significant reduction in total and LDL cholesterol is reported, but similar albeit reductions were observed in placebo group. Had the change between groups been compared it would be unlikely to be significant. No adverse effects were reported from analysis of various blood parameters. The intervention in healthy subjects was not considered for the review as no placebo groups was used. Industry funded
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