Efficacy and Safety of Plant Stanols and Sterols in the Management of Blood Cholesterol Levels
- Martijn B. Katan, PhD,
- Scott M. Grundy, MD, PhD,
- Peter Jones, PhD,
- Malcolm Law, FRCP,
- Tatu Miettinen, MD, PhD,
- Rodolfo Paoletti, MD, PhD and
- Stresa Workshop Participants
- From the Division of Human Nutrition and Epidemiology, Wageningen University, Wageningen, the Netherlands (M.B.K.); University of Texas, Southwestern Medical Center, Center for Human Nutrition, Dallas (S.M.G.); School of Dietetics and Human Nutrition, McGill University, Montreal, Quebec (P.J.); Wolfson Institute of Preventive Medicine, St Bartholomew's and the Royal London School of Medicine and Dentistry, London, England (M.L.); Department of Internal Medicine, Helsinki University Central Hospital, Helsinki, Finland (T.M.); and Department of Pharmacological Sciences and Nutrition Foundation of Italy, Milano (R.P.). A complete list of participants in the Stresa Workshop on Sterols and Stanols appears at the end of this article
- Address reprint requests and correspondence to Martijn B. Katan, PhD, Division of Human Nutrition and Epidemiology, Wageningen University, Bomenweg 2, 6703 HD Wageningen, the Netherlands (e-mail: wcfs1{at}wur.nl).
Abstract
Foods with plant stanol or sterol esters lower serum cholesterol levels. We summarize the deliberations of 32 experts on the efficacy and safety of sterols and stanols. A meta-analysis of 41 trials showed that intake of 2 g/d of stanols or sterols reduced low-density lipoprotein (LDL) by 10%; higher intakes added little. Efficacy is similar for sterols and stanols, but the food form may substantially affect LDL reduction. Effects are additive with diet or drug interventions: eating foods low in saturated fat and cholesterol and high in stanols or sterols can reduce LDL by 20%; adding sterols or stanols to statin medication is more effective than doubling the statin dose. A meta-analysis of 10 to 15 trials per vitamin showed that plasma levels of vitamins A and D are not affected by stanols or sterols. Alpha carotene, lycopene, and vitamin E levels remained stable relative to their carrier molecule, LDL. Beta carotene levels declined, but adverse health outcomes were not expected. Sterol-enriched foods increased plasma sterol levels, and workshop participants discussed whether this would increase risk, in view of the marked increase of atherosclerosis in patients with homozygous phytosterolemia. This risk is believed to be largely hypothetical, and any increase due to the small increase in plasma plant sterols may be more than offset by the decrease in plasma LDL. There are insufficient data to suggest that plant stanols or sterols either prevent or promote colon carcinogenesis. Safety of sterols and stanols is being monitored by follow-up of samples from the general population; however, the power of such studies to pick up infrequent increases in common diseases, if any exist, is limited. A trial with clinical outcomes probably would not answer remaining questions about infrequent adverse effects. Trials with surrogate end points such as intima-media thickness might corroborate the expected efficacy in reducing atherosclerosis. However, present evidence is sufficient to promote use of sterols and stanols for lowering LDL cholesterol levels in persons at increased risk for coronary heart disease.
Footnotes
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Organization of the Stresa Workshop was made possible through unrestricted grants from McNeil Consumer Healthcare, Fort Washington, Pa; Unilever N.V., Rotterdam, the Netherlands; and Forbes Medi-Tech Inc, Functional Foods and Nutraceuticals, Vancouver, British Columbia. Dr Katan has received a grant from Unilever Research Laboratory to study the effects of sterols on lipoproteins. Dr Grundy has received grants from the McNeil Corporation for research in stanols. Dr Miettinen has contributed to a patent on preparation of plant stanol ester margarine (US patent 1996) and holds shares in the Raisio Group. Dr Jones holds one patent: US 5770, 75 (June 23, 1998).
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Stresa Workshop on Sterols and Stanols.—Workshop participants: Atif B. Awad, University at Buffalo, Buffalo, NY; Klaus von Bergmann, University of Bonn, Bonn, Germany; Nilo Cater, Southwestern Medical Center, University of Texas, Dallas; Jiri Frohlich, St Paul's Hospital and University of British Columbia, Vancouver, British Columbia; Helena Gylling, University of Kuopio, Kuopio, Finland; Paul A. Hepburn, Safety & Environmental Assurance Centre Unilever, Sharnbrook, United Kingdom; Thomas E. Kottke, Mayo Clinic, Rochester, Minn; Stephen B. Kritchevsky, University of Tennessee, Memphis; Gilbert A. Leveille, McNeil Consumer Healthcare, Fort Washington, Pa; Gert W. Meijer, Unilever Bestfoods NA, Englewood Cliffs, NJ; Ronald P. Mensink, Maastricht University, Maastricht, the Netherlands; Mohammed H. Moghadasian, University of British Columbia, Vancouver, British Columbia; Paul Nestel, Baker Medical Research Institute, Melbourne, Australia; Fady Y. Ntanios, Unilever Health Institute, Vlaardingen, the Netherlands; Richard E. Ostlund, Washington University Medical School, St Louis, Mo; Vieno I. Piironen, University of Helsinki, Helsinki, Finland; Andrea Poli, Nutrition Foundation of Italy, Milan; Pekka Puska, World Health Organization, Geneva, Switzerland; Jacques E. Rossouw, National Heart, Lung, and Blood Institute, Bethesda, Md; Gerald Salen, New Jersey Medical School, Newark; Olli Simell, University of Turku, Turku, Finland; Michihiro Sugano, Prefectural University of Kumamoto, Kumamoto, Japan; Matti Uusitupa, University of Kuopio and Kuopio University Hospital, Kuopio, Finland; Bengt Vessby, University of Uppsala, Uppsala, Sweden; Ingmar Wester, Raisio Group, Raisio, Finland; and Jan A. Weststrate, Unilever Health Institute, Vlaardingen, the Netherlands.
- © 2003 Mayo Foundation for Medical Education and Research
