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Sitostanol: Health Benefits, Side Effects, Uses, Dose & Precautions

Sitostanol

Other Name(s):

24-alpha-ethylcholestanol, Beta-sitostanol, Bêta-sitostanol, Dihydro-beta-sitosterol, Ester de Stanol Végétal, Fucostanol, Phytostanol, Plant Stanol, Plant Stanol Esters, Stanol Végétal, Stigmastanol.

Overview

Sitostanol is a plant product. It is made from vegetable oils or the oil from pine tree wood pulp, and is then combined with canola oil. Sitostanol is used for prevention of heart disease and treatment of high cholesterol.

Sitostanol is an ingredient in Benecol margarine and some salad dressings. The U.S. Food and Drug Administration (FDA) allows manufacturers of products that contain sitostanol or related plant chemicals (stanol esters) to claim that the product lowers the risk of getting coronary heart disease (CHD). The FDA reasons that sitostanol and other plant stanol esters along with a diet low in saturated fat and cholesterol might reduce the risk of CHD by lowering blood cholesterol levels. Although there is plenty of evidence that sitostanol does lower cholesterol levels, so far there is no proof that long-term use actually lowers the risk of developing CHD.

Do not confuse sitostanol with beta-sitosterol, an unsaturated plant sterol in the cholesterol-lowering margarine Take Control. Both sitostanol and beta-sitosterol are used to lower cholesterol levels in people with high cholesterol and appear to be equally effective.

How does work?

Sitostanol blocks both the cholesterol from food and the cholesterol made by the liver from entering the body.

Uses

Likely Effective for...

  • Reducing cholesterol levels. Sitostanol is effective for reducing cholesterol levels in adults with high cholesterol. It doesn't have to be taken with meals to work. Cholesterol levels decrease within 2 to 3 weeks of starting sitostanol, and return to pretreament levels within 2 to 3 weeks of discontinuation. Sitostanol may not have the same effect in all people. About 12% of patients do not respond to sitostanol.

    People usually take sitostanol as part of a sitostanol-enriched food such as margarine. Sitostanol alone can reduce total and "bad" low-density lipoprotein (LDL) cholesterol levels by 6% to 20%. Most research shows that a dose of about 2-3 grams per day lowers cholesterol the most. Higher doses do not seem to work any better. When added to a cholesterol-lowering prescription medication, sitostanol reduces total cholesterol by an additional 3% to 11% and LDL cholesterol by another 7% to 16%.

    Sitostanol also seems to be effective for reducing cholesterol levels in healthy children. However, treating children is not recommended unless "bad" low-density lipoprotein (LDL) cholesterol levels are greater than 190 mg/dL or greater than 160 mg/dL if the child also has other risk factors for heart disease.

Possibly Effective for...

  • Reducing cholesterol levels in people with an inherited tendency toward high cholesterol (familial hypercholesterolemia). Sitostanol is possibly effective for reducing cholesterol levels in children and adults with high cholesterol levels due to familial hypercholesterolemia. Taking sitostanol seems to reduce total cholesterol by 11% to 14% and "bad" low-density lipoprotein (LDL) cholesterol levels by 15% to 33% in children and adults already being treated with cholesterol-lowering drugs called statins. Sitostanol doesn't increase levels of "good" high-density lipoprotein (HDL) cholesterol or reduce levels of blood fats called triglycerides.

Insufficient Evidence to Rate Effectiveness for...

  • Heart disease.

QUESTION

What is cholesterol? See Answer

Side Effects

Sitostanol is LIKELY SAFE for most people when taken by mouth. Adults can safely use sitostanol for up to 1 year, and children can safely use it for up to 3 months. Sitostanol might cause stomach upset or too much fat in the stool (steatorrhea).

There is some concern that sitostanol might decrease absorption of some nutrients since it decreases fat absorption. Sitostanol does seem to reduce the absorption of dietary beta-carotene, but this reduction may not be important to health.

Precautions

Pregnancy and breast-feeding: Not enough is known about the use of sitostanol during pregnancy and breast-feeding. Stay on the safe side and avoid use.

Dosing

The following doses have been studied in scientific research:

ADULTS

BY MOUTH:

  • For high cholesterol: 200 mg to 9 grams of sitostanol-rich plant stanols have been used daily. Doses above 2-3 grams per day may be only slightly more effective. Single daily doses seem to be as effective as divided doses administered twice or three times daily.
  • For reducing cholesterol levels in adults with an inherited tendency toward high cholesterol (familial hypercholesterolemia): About 2 grams of sitostanol has been taken daily for up to 3 months.
CHILDREN

BY MOUTH:

  • For high cholesterol: 1.5 grams of sitostanol has been used daily in children up to age 6 years of age.
  • For reducing cholesterol levels in children with an inherited tendency toward high cholesterol (familial hypercholesterolemia): 1.5-6.0 grams of sitostanol per day have been used in children aged 2-15 years.

Natural Medicines Comprehensive Database rates effectiveness based on scientific evidence according to the following scale: Effective, Likely Effective, Possibly Effective, Possibly Ineffective, Likely Ineffective, and Insufficient Evidence to Rate (detailed description of each of the ratings).

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Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

References

Anon. FDA authorizes new coronary heart disease health claim for plant sterol and plant stanol esters. FDA. 2000. Available at: http://www3.scienceblog.com/community/older/archives/M/1/fda0642.htm. (Accessed 26 May 2016).

Becker M, Staab D, Von Bergmann K. Treatment of severe familial hypercholesterolemia in childhood with sitosterol and sitostanol. J Pediatr 1993;122:292-6. View abstract.

Berendschot TT, Plat J, de Jong A, Mensink RP. Long-term plant stanol and sterol ester-enriched functional food consumption, serum lutein/zeaxanthin concentration and macular pigment optical density. Br J Nutr. 2009 Jun;101(11):1607-10. View abstract.

Chen JT, Wesley R, Shamburek RD, et al. Meta-Analysis of natural therapies for hyperlipidemia: plant sterols and stanols versus policosanol. Pharmacotherapy 2005;25:171-83. View abstract.

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Gylling H, Miettinen TA. Effects of inhibiting cholesterol absorption and synthesis on cholesterol and lipoprotein metabolism in hypercholesterolemic non-insulin-dependent diabetic men. J Lipid Res 1996;37:1776-85. View abstract.

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

Gylling H, Puska P, Vartiainen E, et al. Serum sterols during stanol ester feeding in a mildly hypercholesterolemic population. J Lipid Res 1999;40:593-600. View abstract.

Gylling H, Puska P, Vartiainen E, et al. Retinol, vitamin D, carotenes and alpha-tocopherol in serum of a moderately hypercholesterolemic population consuming sitostanol ester margarine. Am J Cardiol 1999;145:279-85.

Gylling H, Radhakrishnan R, Miettinen TA. Reduction of serum cholesterol in postmenopausal women with previous myocardial infarction and cholesterol malabsorption induced by dietary sitostanol ester margarine: women and dietary sitostanol. Circulation 1997;96:4226-31. View abstract.

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Hallikainen MA, Sarkkinen ES, Gylling H, et al. Comparison of the effects of plant sterol ester and plant stanol ester-enriched margarines in lowering serum cholesterol concentrations in hypercholesterolaemic subjects on a low-fat diet. Eur J Clin Nutr 2000;54:715-25. View abstract.

Hallikainen MA, Sarkkinen ES, Uusitupa MI. Effects of low-fat stanol ester enriched margarines on concentrations of serum carotenoids in subjects with elevated serum cholesterol concentrations. Eur J Clin Nutr 1999;53:966-9. View abstract.

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Jones PJ, Ntanios FY, Raeini-Sarjaz M, et al. Cholesterol-lowering efficacy of a sitostanol-containing phytosterol mixture with a prudent diet in hyperlipidemic men. Am J Clin Nutr 1999;69:1144-50. View abstract.

Jones PJ, Raeini-Sarjaz M, Ntanios FY, et al. Modulation of plasma lipid levels and cholesterol kinetics by phytosterol versus phytostanol esters. J Lipid Res 2000;41:697-705. View abstract.

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Malhotra A, Shafiq N, Arora A, Singh M, Kumar R, Malhotra S. Dietary interventions (plant sterols, stanols, omega-3 fatty acids, soy protein and dietary fibers) for familial hypercholesterolaemia. Cochrane Database Syst Rev. 2014 Jun 10;6:CD001918. View abstract.

Mensink RP, de Jong A, Lütjohann D, Haenen GR, Plat J. Plant stanols dose-dependently decrease LDL-cholesterol concentrations, but not cholesterol-standardized fat-soluble antioxidant concentrations, at intakes up to 9 g/d. Am J Clin Nutr. 2010 Jul;92(1):24-33. View abstract.

Miettinen TA, Puska P, Gylling H, et al. Reduction of serum cholesterol with sitostanol-ester margarine in a mildly hypercholesterolemic population. N Engl J Med 1995;333(20):1308-12. View abstract.

Musa-Veloso K, Poon TH, Elliot JA, Chung C. A comparison of the LDL-cholesterol lowering efficacy of plant stanols and plant sterols over a continuous dose range: results of a meta-analysis of randomized, placebo-controlled trials. Prostaglandins Leukot Essent Fatty Acids. 2011 Jul;85(1):9-28. View abstract.

Nguyen TT, Dale LC, von Bergmann K, Croghan IT. Cholesterol-lowering effect of stanol ester in a US population of mildly hypercholesterolemic men and women: a randomized controlled trial. Mayo Clin Proc 1999;74:1198-206. View abstract.

O'Neill FH, Sanders TA, Thompson GR. Comparison of efficacy of plant stanol ester and sterol ester: short-term and longer-term studies. Am J Cardiol. 2005 Jul 4;96(1A):29D-36D. View abstract.

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Raeini-Sarjaz M, Ntanios FY, Vanstone CA, Jones PJ. No changes in serum fat-soluble vitamin and carotenoid concentrations with the intake of plant sterol/stanol esters in the context of a controlled diet. Metabolism. 2002 May;51(5):652-6. View abstract.

Ras RT, Geleijnse JM, Trautwein EA. LDL-cholesterol-lowering effect of plant sterols and stanols across different dose ranges: a meta-analysis of randomised controlled studies. Br J Nutr. 2014 Jul 28;112(2):214-9. View abstract.

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Spilburg CA, Goldberg AC, McGill JB, et al. Fat-free foods supplemented with soy stanol-lecithin powder reduce cholesterol absorption and LDL cholesterol. J Am Diet Assoc 2003;103:577-81. View abstract.

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Tammi A, Ronnemaa T, Gylling H, et al. Plant stanol ester margarine lowers serum total and low-density lipoprotein cholesterol concentrations of healthy children: the STRIP project. Spec Turku Coronary Risk Factors Intervention Project. J Pediatr 2000;136:503-10. View abstract.

Vanhanen HT, Kajander J, Lehtovirta H. Serum levels, absorption efficiency, faecal elimination and synthesis of cholesterol during increasing doses of dietary sitostanol esters in hypercholesterolaemic subjects. Clin Sci (Colch) 1994;87:61-7. View abstract.

Vásquez-Trespalacios EM, Romero-Palacio J. Efficacy of yogurt drink with added plant stanol esters (Benecol®, Colanta) in reducing total and LDL cholesterol in subjects with moderate hypercholesterolemia: a randomized placebo-controlled crossover trial NCT01461798. Lipids Health Dis. 2014 Aug 6;13:125. View abstract.

Vuorio AF, Gylling H, Turtola H, et al. Stanol ester margarine alone and with simvastatin lowers serum cholesterol in families with familial hypercholesterolemia caused by the FH-north karelia mutation. Arterioscler Thromb Vasc Biol 2000;20:500-6. View abstract.

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Williams CL, Bollella MC, Strobino BA, et al. Plant stanol ester and bran fiber in childhood: effects on lipids, stool weight and stool frequency in preschool children. J Am Coll Nutr 1999;18:572-81. View abstract.