1. 23.08.2011 Copyright® Raisio The effect of a very high daily plant stanol ester intake on serum lipids, carotenoids, and fat-soluble vitamins Gylling et al. Clin Nutr 2010; 29: 112-118.

2. Gylling et al. 20102 Background Only few studies done on the effect of plant stanol ester on cholesterol levels with plant stanol intake exceeding 2 to 3 grams. The aim of the study was to find out how high daily intake of plant stanol (9 g) effects plasma LDL-cholesterol and β-carotene levels.

3. Gylling et al. 20103 Methods I Randomized, double-blind, placebo-controlled parallel study. 49 subjects (control group n=24, plant stanol ester group n=25); moderately hypercholesterolemic (mean LDL-C 3.34 mmol/L). Subjects consumed placebo or plant stanol ester containing products for 10 weeks. Study products: a spread (20 g/d; 3 g/d plant stanols or placebo) oat drink (2.5 dL/d; 6 g/d plant stanols or placebo)

4. Gylling et al. 20104 Methods II Subjects kept food diaries for 3 days in the beginning and in the end of the study Fasting blood samples were collected in the beginning and in the end of the study lipids, carotenoids and fat-soluble vitamins cholesterol and other sterols liver enzymes blood count markers of hemolysis plasma glucose

5. Gylling et al. 20105 Results I There were no difference in subjects’ diets between the study groups. Actual intake of plant stanols was 8.8 g/day in plant stanol ester group. No change in weight, blood pressure, blood count or in any other safety parameters. Serum carotenoids and fat-soluble vitamin levels stayed within the reference values in all of the subjects. However, serum β-carotene reduced significantly in plant stanol ester group compared to placebo. This reduction was similar to that recorded in studies with 2 – 3 g/d plant stanols.

6. Gylling et al. 201066 CHANGES IN CHOLESTEROL LEVELS DURING THE 10- WEEK STUDY Total cholesterol was reduced by 12 % and LDL-cholesterol by 17.1 % in plant stanol ester group from controls Change (%) Control (n=24) Plant Stanol Ester (8.8 g/d plant stanols) (n=25) CHANGES IN CHOLESTEROL LEVELS DURING THE 10- WEEK STUDY Total Cholesterol LDL Cholesterol * * * p<0.01

7. Gylling et al. 20107 Conclusions LDL-cholesterol reduction achieved with 9 g/d of plant stanols was substantially higher (17.1 %) than what can be expected when plant stanols are used on currently recommended level (2.0 g/d  LDL-C: ~-10 %). High intake of plant stanol ester (9 g/d as plant stanols) is both effective and safe.

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