Scientific Evidence

Consensus and guidelines on phytosterols in lipid management

More than 200 studies confirm the effectiveness of phytosterols in lowering cholesterol levels.

According to several international medical associations, a daily consumption of 2 grams of phytosterols is recommended to achieve this goal.

Canadian Cardiovascular Society<br />
(Canada)

Canadian Cardiovascular Society

In 2021
The CCS guidelines recommend as a dietary component to reduce LDL-C:
Dietary patterns with plant sterols/stanols (≥2 g/day). Strong recommendation, high quality evidence.

In 2022
According to scientific evidence, plant sterols contribute to an improvement in LDL-C; it is recommended to include them in the dietary approach. Phytosterols (sterols and stanols) are bioactive compounds found in plants. An intake of 2g/day has been shown to result in an 8% to 10% drop in LDL-C, even in people receiving statin treatment.

Pearson GJ, et al. 2021 Canadian Cardiovascular Society guidelines for the management of dyslipidemia for the prevention of cardiovascular disease in the adult: supplementary material. Can J Cardiol 2021; S0828-282X (21)00165-3.

American Heart Association

As of 2006
The American Heart Association’s diet and lifestyle recommendations:

Plant stanols/sterols lower LDL-C levels by up to 15% and therefore are seen as a therapeutic option, in addition to diet and lifestyle modification, for individuals with elevated LDL-C levels.
Maximum effects are observed at plant stanol/sterol intakes of ~2 g per day.
The choice of vehicle should be determined by availability and by other considerations, including caloric content.

Lichtenstein AH, et al. Diet and lifestyle recommendations revision 2006: a scientific statement from the American Heart Association Nutrition Committee. Circulation 2006;114:82-96.

European Society of Cardiology (ESC)
European Atherosclerosis Society (EAS)

In 2019
The revised ESC/EAS guidelines for the management of dyslipidemia included for the first time a recommendation for plant sterols as part of lifestyle changes, aimed at reducing serum triglycerides.

Joint guidelines recommend 2 g phytosterol supplementation in individuals with high cholesterol levels at:

Intermediate and low cardiovascular risk;
In those who do not qualify for pharmacotherapy;
In high- and very-high risk patients on top of pharmacotherapy who fail to achieve LDL-C goals;
Who cannot be treated with statins;
In individuals with familial hypercholesterolemia.

Mach F, et al. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. European Heart Journal 2020;41:111-188.

Lower triglycerides by

-13,90%

compared to 0.6% plant sterol esters (PS-esters); p<0.05 (comparison of Cardiosmile with PS-esters is significant, but n/s from placebo)

Increase HDL-C by

+2,66%

compared to -0.04 for plant sterol esters; n/s.

Lower LDL-C by

-11,70%

compared to 11.6% for plant sterol esters; p<0.001 compared to placebo.

Lower non-HDL-C by

-11,13%

compared to 8.72% for plant sterol esters; p<0.001 compared to placebo.

Supplementation of Cardiosmile and PS-ester did not adversely influence fat soluble vitamin or carotenoid levels before or after adjustment for LDL-C levels, compared to control.¹

Cardiosmile and PS-ester favorably modified blood lipid profiles without altering plasma liver enzymes or CRP concentrations.¹

Efficacy results from Palmeiro-Silva, et al.

Effects of daily consumption of an aqueous dispersion of free phytosterol nanoparticles on individuals with metabolic syndrome: a randomized, double-blind, placebo-controlled clinical trial.

Safety profile in clinical trials:

Supplementation of Cardiosmile and PS-ester did not adversely influence fat soluble vitamin or carotenoid levels before or after adjustment for LDL-C levels, compared to control.²
No negative effect on plasma vitamin D levels was observed.²
At week 24, Cardiosmile demonstrated a 68% improvement in bowel habits (relieving constipation) from visit 1 (p=0.001).²

Health Canada’s assessment of foods containing plant sterols and blood cholesterol lowering

According to guidelines established by Health Canada, plant sterols are considered safe cholesterol-lowering ingredients.³

A Health Canada safety assessment of the addition of plant sterols to foods raised no safety concerns with plant sterol intakes ≤3 g (as free phytosterols) per day in adults and ≤1 g in children.³

Published studies have demonstrated that consuming 3 g of phytosterols/day posed no nutritionalrisk for the general population with respect to beta-carotene.⁴

1. Shaghaghi MA, et al. Water dispersible plant sterol formulation shows improved effect on lipid profile compared to plant sterol esters. J Funct Foods 2014;(6):280-289.

2. Palmeiro-Silva YK, et al. Effects of daily consumption of an aqueous dispersion of free-phytosterols nanoparticles on individuals with metabolic syndrome: a randomised, double-blind, placebo-controlled clinical trial. Nutrients 2020;12:2392; doi:10.3390/nu12082392.

3. Government of Canada. General questions and answers about plant sterols. Accessed March 2023 at: www.canada.ca/en/health-canada/services/food-nutrition/food-labelling/nutritionlabelling/general-questions-answers-plant-sterols-nutrition-claims.html.

4. Government of Canada. Notice of safety assessment of certain classes of foods containing added phytosterols. Accessed March 2023 at: https://www.canada.ca/fr/sante-canada/services/aliments-nutrition/aliments-genetiquement-modifiesautres-aliments-nouveaux/produits-approuves/avis-evaluation-certaines-categories-aliments-contenant-phytosterols-ajoutes.html.