Efficacy proven by more than 70 clinical studies

  1. The first major study on plant stanol ester was published in the New England Journal of Medicine in 1995. Since then, over 70 clinical trials have been published in peer-reviewed journals showing that Plant stanol ester is effective and safe. It is apparent from all these studies that plant stanols lower total and low-density lipoprotein (LDL) cholesterol, but beneficially do not lower good HDL cholesterol.
  2. Esterified plant stanols have been proven to reduce cholesterol in a number of randomised, placebo-controlled double-blind clinical trials. Cholesterol-lowering effects have been noted »
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The latest finding:

Plant stanol ester gives significantly better maximal cholesterol lowering efficacy compared with plant sterol ester

A new meta-analysis [1], [2] revealed that the maximal LDL cholesterol reduction was 18.3% for plant stanol ester versus only 10.7% for plant sterol ester. In addition, plant stanol ester produces additional and dose-dependent reductions in LDL cholesterol with intakes above current recommendations (2 g plant stanols/sterols per day). For plant sterol ester, no such effect was evident.

"It is known that plant stanols and plant sterols have different structures and that they behave differently in the body, and so it was important to study the LDL cholesterol lowering effects of the two substances separately", says Kathy Musa-Veloso, PhD, the principle author of the article. "The results of the meta-analysis indicate that intakes of plant stanols in excess of 2 g/day - in fact, up to 9 g/day - are associated with further and dose-dependent reductions in LDL cholesterol. For plant sterols, however, we did not find a dose-response."

The meta-analysis was based on a large number of scientific studies and included a total of 183 data sets. The analysis based on end of treatment data for weighted strata.

 
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The findings of the new meta-analysis are also supported by two recently published independent clinical studies showing LDL cholesterol reductions of approximately 17% with daily consumption of 9g plant stanols [3], [4]. The new data may have significant implications for current practices: "The relationship between reductions in LDL cholesterol and a reduced risk of coronary heart disease is near to linear. In other words, the lower the LDL cholesterol, the lower the risk. These new results are clinically very important as the boosted effect of plant stanol ester with elevated daily intakes may further intensify the coronary heart disease risk reduction at a population level", concludes MD, professor Helena Gylling from the University of Helsinki in Finland. "No other single dietary means has proven to be as effective and easy in reducing cholesterol as the daily intake of sufficient amounts of plant stanol ester-containing Benecol foods."

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Key Clinical Studies

The key studies conducted on plant stanols are listed here. The complete list of plant stanol ester publications.

Cholesterol lowering efficacy in hypercholesterolaemic patients

Reduction of serum cholesterol with sitostanol-ester margarine in a mildly hypercholesterolemic population
Miettinen T et al. N Engl J Med. 1995;333:1308-12.

Double maximal efficacy

Meta-analysis showing that the maximal cholesterol LDL lowering efficacy of Plant stanol ester is double compared with plant sterol ester
Musa-Veloso K et al (2011a). A comparison of the LDL-cholesterol lowering efficacy of plant stanols and plant sterols: Results of a meta-analysis of randomized controlled trials. Prostaglandins, Leukotrienes and Essential Fatty Acids; 2011; 85: 9-28.
Musa-Veloso K et Poon TH (2011b). Rebuttal to comment from Demonty et al. (2011). Prostaglandins, Leukotrienes and Essential Fatty Acids; 2011; 85: 189-193.

Dose dependent efficacy of Plant stanol ester

The cholesterol lowering effect of plant stanols is further enhanced with daily doses higher than the current recommendation: studies have shown that a daily intake of 9 g plant stanols lowered LDL cholesterol by over 17 % without any adverse effects. Currently there are no corresponding data available for plant sterols.
Mensink RP et al. Am J Clin Nutr 2010; 92:24-33,
Gylling et al. Clin.Nutr. 29, 112-118 (2010)

Subjects with metabolic syndrome

A stanol yogurt drink alone or combined with a low-dose OTC statin lowers non-HDL cholesterol, but also lowers triglycerides & elevates HDL cholesterol in metabolic syndrome patients
Plat J et al. ISA Rome 2006. We-P14:477.

Consumption frequency

Effects on serum lipids, lipoproteins and fat-soluble antioxidant concentrations of consumption frequency of margarines and shortenings enriched with plant stanol ester
Plat J et al. Eur J Clin Nutr. 2000;54:671-7.

Postmenopausal women with and without coronary artery disease

Changes in serum level and metabolism of cholesterol with plant stanol ester in postmenopausal women with and without coronary artery disease.
Gylling H et al. Menopause. 2006;13(2):286-93.

Patients after cardiac transplantation

Regular Use of Margarine-Containing Stanol/Sterol Esters Reduces Total and Low-Density Lipoprotein (LDL) Cholesterol and Allows Reduction of Statin Therapy After Cardiac Transplantation: Preliminary Observations
Vorlat A et al. J Heart Lung Transplant. 2003;22:1059-62.

Normocholesterolaemic and mildly hypercholesterolaemic subjects

Plant stanol ester in low-fat yogurt reduces total and low-density lipoprotein cholesterol and low-density lipoprotein oxidation in normocholesterolemic and mildly hypercholesterolemic subjects
Hyun YJ et al. Nutrition Research. 2005;25:743-53.

Plant stanol ester supplied in low-fat yogurt

Effects of plant stanol ester supplied in low-fat yogurt on serum lipids and lipoproteins, non-cholesterol sterols and fat soluble antioxidant concentrations
Mensink RP et al. Atherosclerosis. 2002;160:205-13.

Statin therapy

Incremental reduction of serum total cholesterol and low-density lipoprotein cholesterol with the addition of plant stanol ester-containing spread to statin therapy
Blair SN et al. Am J Cardiol. 2000 Jul 1;86(1):46-52.

Healthy diet

Cholesterol-lowering effects of a stanol-ester containing low-fat margarine used in conjunction with a strict lipid-lowering diet
Andersson A et al. Eur Heart J Suppl. 1999;1 Suppl S:S80-90.

Diabetic patients

Serum cholesterol and cholesterol and lipoprotein metabolism in hypercholesterolaemic NIDDM patients before and during sitostanol ester-margarine treatment
Gylling H and Miettinen T. Diabetologia. 1994;37:773-80

Plant stanol ester lower LDL cholesterol level in statin-treated subjects with type 1 diabetes by interfering the absorption and synthesis of cholesterol.
Hallikainen M, Kurl S, Laakso M, Miettinen TA, Gylling H. Plant stanol esters lower LDL cholesterol level in statin-treated subjects with type 1 diabetes by interfering the absorption and synthesis of cholesterol. Atherosclerosis 2011; 217: 473‐478.

Children

Plant stanol ester margarine lowers serum total and low-density lipoprotein cholesterol concentrations of healthy children: the STRIP project
Tammi A et al. J Pediatr. 2000;136:503-10

Dual effect

Red cell and plasma plant sterols are related during consumption of plant stanol and sterol ester spreads in children with hypercholesterolemia
Ketomäki AM et al. J Pediatr. 2003;142:524-31.

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