Parallel To compare the 48 subjects with Same intervention Same methods as Dietary intake Significant reduction Government 2011 effects of moderate as Bañuls 2010 Bañuls 2010 for study not in total and LDL funded. consuming PS reported, but cholesterol in in low fat milk in (18-76y, 44% male, reference to an subjects without subjects with 24 with metabolic earlier trial was metabolic and without syndrome). included. syndrome. metabolic No significant syndrome change in cholesterol concentrations in subjects with metabolic syndrome. Khandelwal Parallel To assess the 200 subjects with Subjects consumed Compliance by daily Despite ANCOVA showed a Power 2009 independent and mildly elevated lipid normal diet with recording of intake, randomisation significant decrease calculation interactive levels (total placebo or plant return of unused the plant sterol in total and LDL performed for effects of plant cholesterol between sterol yoghurt drink, and empty test group had cholesterol. LDL-C and sterols and fish 5.0-8.0mmol/L) were and placebo products and phone significantly However, triglycerides. oil on blood randomised, 178 (safflower oil) or fish call follow ups. lower baseline unadjusted data Funding lipids completed trial (89% oil capsules. Control Dietary intake by LDL-C showed no effect of source male, 35-55y). group (placebo 2d, validated recall concentrations. plant sterols on unclear. Note: 4-arm trial, 2 yoghurt drink and questionnaire. LDL-C in the test arms considered for safflower oil Blood lipids group, with an review: control and capsules) and plant measured in increase observed plant sterol only arms. sterol only group certified laboratory. in the control group. (2g per day plant ANCOVA analysis sterol yogurt drink of “quasi” and safflower oil capsules) were considered. 2wk run-in prior to randomisation, then 4wk trial.
2011 Parallel To compare the effects of consuming PS in low fat milk in subjects with and without metabolic syndrome 48 subjects with moderate (18-76y, 44% male, 24 with metabolic syndrome). Same intervention as Bañuls 2010 Same methods as Bañuls 2010 Dietary intake for study not reported, but reference to an earlier trial was included. Significant reduction in total and LDL cholesterol in subjects without metabolic syndrome. No significant change in cholesterol concentrations in subjects with metabolic syndrome. Government funded. Khandelwal 2009 Parallel To assess the independent and interactive effects of plant sterols and fish oil on blood lipids 200 subjects with mildly elevated lipid levels (total cholesterol between 5.0-8.0mmol/L) were randomised, 178 completed trial (89% male, 35-55y). Note: 4-arm trial, 2 arms considered for review: control and plant sterol only arms. Subjects consumed normal diet with placebo or plant sterol yoghurt drink, and placebo (safflower oil) or fish oil capsules. Control group (placebo yoghurt drink and safflower oil capsules) and plant sterol only group (2g per day plant sterol yogurt drink and safflower oil capsules) were considered. 2wk run-in prior to randomisation, then 4wk trial. Compliance by daily recording of intake, return of unused and empty test products and phone call follow ups. Dietary intake by 2d, validated recall questionnaire. Blood lipids measured in certified laboratory. ANCOVA analysis of “quasi” Despite randomisation the plant sterol group had significantly lower baseline LDL-C concentrations. ANCOVA showed a significant decrease in total and LDL cholesterol. However, unadjusted data showed no effect of plant sterols on LDL-C in the test group, with an increase observed in the control group. Power calculation performed for LDL-C and triglycerides. Funding source unclear.
Systematic%20review%20phytosterols%20and%20cholesterol.docx