Copyright® Raisio Effect of a plant stanol ester-containing spread, placebo spread, or Mediterranean diet on estimated cardiovascular risk and lipid, inflammatory and haemostatic factors Athyros et al. Nutr Metab Cardiovasc Dis 2011; 21(3):

Athyros et al. Nutr Metab Cardiovasc Dis Methods I Parallel, randomized, placebo-controlled study N=150, mildly hypercholesterolaemic (5,2–6,4 mmol/l) subjects 4-week run-in with a NCEP Step I diet, intervention for 16 weeks Placebo spread; NCEP Step I diet Plant stanol ester containing spread (2 g plant stanols/d); NCEP Step I diet Mediterranean diet

Athyros et al. Nutr Metab Cardiovasc Dis Methods II Outcome measures: Individual risk factors: changes in lipids and lipoproteins (TC, LDL-C, HDL-C, TG, apo B, apo A1) blood pressure haemostatic factors (plasma fibrinogen & PAI-1 activity) inflammatory marker (hsCRP) Estimated CVD risk (Framingham, PROCAM & Raynolds risk engines) Percentage of patients at NCEP Total Cholesterol target (< 5.2 mmol/l)

Athyros et al. Nutr Metab Cardiovasc Dis Results I Effect of intervention on risk factors: Placebo: no significant effect on any of the risk factors Plant stanol ester: TC, LDL and hsCRP (statistically significant change in all) Mediterranean diet: TC, LDL, TG, blood pressure, hsCRP and thrombotic markers ; HDL (statistically significant change in all)

Athyros et al. Nutr Metab Cardiovasc Dis * * ** * Plant Stanol Ester effectively lowers LDL-cholesterol Control spread n=50 Mediterranean diet n=50 Plant stanol ester spread (plant stanol 2 g/d) n=50 % CHANGE IN LDL-CHOLESTEROL * * % months * * * * p <0.01 vs. control

Athyros et al. Nutr Metab Cardiovasc Dis Results II Estimated cardiovascular disease risk: Placebo: no effect on estimated disease risk Plant stanol ester: eCVD risk reduction of 26–30 % in 1 month with all risk engines used, sustained the 4 months intervention Mediterranean diet: eCVD risk reduction of 24–32% in 4 months with all risk engines used

Athyros et al. Nutr Metab Cardiovasc Dis Effective reduction in the estimated risk of cardiovascular diseases with use of Plant Stanol Ester EFFECTIVE REDUCTION IN THE ESTIMATED RISK OF CORONARY ARTERY DISEASE (CAD) Control spread n=50 A change in the estimated CAD risk during the following 10 years (Framingham risk engine) Mediterranean diet n=50 Plant stanol ester spread (2 g of plant stanols / day) n=50 Months * * * * * *=p<0.05 vs. control

Athyros et al. Nutr Metab Cardiovasc Dis Results III Percentage of subjects meeting target level for total cholesterol (<5.2 mmol/L) by the end of the study: Placebo: 14 % Plant stanol ester: 80 % Mediterranean diet: 46 %

Athyros et al. Nutr Metab Cardiovasc Dis Conclusions Mediterranean diet was efficient in reducing the estimated CVD risk by several mechanisms but the change was fully seen only after 4 months Plant stanol ester reduced the estimated risk of CVD as effectively already after 1 month The use of plant stanol ester products is especially beneficial for those individuals who are unable to adopt Mediterranean diet

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