Reduction of serum cholesterol with sitostanol-ester margarine in a mildly hypercholesterolemic population
Abstract
BACKGROUND: Dietary plant sterols, especially sitostanol, reduce serum cholesterol by inhibiting cholesterol absorption. Soluble sitostanol may be more effective than a less soluble preparation. We tested the tolerability and cholesterol-lowering effect of margarine containing sitostanol ester in a population with mild hypercholesterolemia. METHODS: We conducted a one-year, randomized, double-blind study in 153 randomly selected subjects with mild hypercholesterolemia. Fifty-one consumed margarine without sitostanol ester (the control group), and 102 consumed margarine containing sitostanol ester (1.8 or 2.6 g of sitostanol per day). RESULTS: The margarine containing sitostanol ester was well tolerated. The mean one-year reduction in serum cholesterol was 10.2 percent in the sitostanol group, as compared with an increase of 0.1 percent in the control group. The difference in the change in serum cholesterol concentration between the two groups was -24 mg per deciliter (95 percent confidence interval, -17 to -32; P < 0.001). The respective reductions in low-density lipoprotein (LDL) cholesterol were 14.1 percent in the sitostanol group and 1.1 percent in the control group. The difference in the change in LDL cholesterol concentration between the two groups was -21 mg per deciliter (95 percent confidence interval, -14 to -29; P < 0.001). Neither serum triglyceride nor high-density lipoprotein cholesterol concentrations were affected by sitostanol. Serum campesterol, a dietary plant sterol whose levels reflect cholesterol absorption, was decreased by 36 percent in the sitostanol group, and the reduction was directly correlated with the reduction in total cholesterol (r = 0.57, P < 0.001). CONCLUSIONS: Substituting sitostanol-ester margarine for part of the daily fat intake in subjects with mild hypercholesterolemia was effective in lowering serum total cholesterol and LDL cholesterol.
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Clinical trials and meta-analyses have not shown any major safety concerns for phytosterols, nor is there evidence of direct vascular effects after their persistent use.
“Clinical trials and meta-analyses have not shown any major safety concerns (131), nor is there any evidence of direct vascular effects after their persistent use (19).”
From The Role of Nutraceuticals in Statin Intolerant Patients (2018) · cites this paper as [131]
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Self-citation
- Authors
- Miettinen, T. A., Puska, P., Gylling, H., Vanhanen, H., & Vartiainen, E.
- Affiliations
- University of Helsinki (FI)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 1995-11-16
- Volume
- 333
- Issue
- 20
- Pages
- 1308-1312
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2321309958
- Cited by
- 739
- References
- 21
- Citations by year
- 2026: 2 · 2025: 8 · 2024: 12 · 2023: 6 · 2022: 6 · 2021: 6 · 2020: 9 · 2019: 14 · 2018: 13 · 2017: 11 · 2016: 17 · 2015: 16 · 2014: 17 · 2013: 21 · 2012: 28
- FWCI
- 13.04
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Surgery › Cholesterol and Lipid Metabolism
- Health Sciences › Medicine › Surgery › Natural Products and Biological Research
- Keywords
- phytosterols, dietary cholesterol absorption, serum cholesterol lowering, LDL cholesterol, margarine, campesterol, tolerability, fat replacement
- MeSH terms
- Adult, Anticholesteremic Agents, Cholesterol, Dietary Fats, Double-Blind Method, Female, Humans, Hypercholesterolemia, Cholesterol, HDL, Cholesterol, LDL, Male, Margarine, Middle Aged, Phytosterols, Sitosterols, Triglycerides
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