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Effect of free plant sterols in low-fat milk on serum lipid profile in hypercholesterolemic subjects

European Journal of Clinical Nutrition volume 58, pages 860–870 (2004)Cite this article

Abstract

Objective: To determine the effect of nonesterified, nonhydrogenated plant sterols solubilized in a partly vegetable oil-filled low-fat milk on serum low-density lipoprotein cholesterol (LDL) in mildly hypercholesterolemic patients.

Design: Double-blind, randomized, placebo-controlled three-arm crossover study.

Setting: Outpatient clinical trial.

Subjects: A total of 138 patients were screened, providing 81 patients for randomization; 71 patients completed the study.

Interventions: The study product was a 500 ml milk blend with or without nonesterified, nonhydrogenated sterols. The daily consumption of sterols in the three groups was 0 g/day, control group (C); 1.2 g/day, (Lo); or 1.6 g/day, (Hi), respectively. The patients were randomly assigned to one of three different treatment sequences. Each intervention period was 4 weeks. The total study duration was 12 weeks.

Results: The milk product was well tolerated. The placebo-adjusted mean reduction in LDL was 7.13±12.31 and 9.59±12.44% (mean±s.d.) for Lo and Hi groups, respectively (P<0.0001); there was no statistically significant difference in LDL lowering for the Lo and Hi groups. There were no significant changes in serum vitamin E or carotenoid concentrations after standardization with LDL cholesterol during the study period.

Conclusion: The present study shows for the first time a substantial reduction in LDL cholesterol with a new, partly vegetable oil-filled 1.2% low-fat milk product, containing nonesterified plant sterols from soybean oil, in a randomized, placebo-controlled trial. This result encourages further development of novel low-fat dairy products containing free plant sterols for future use in cholesterol-lowering initiatives.

Sponsorship: The study was financed by Nestec Ltd, Switzerland.

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Acknowledgements

We thank the following Nestlé employees: Michel Groux and his team at PTC Konolfingen for preparing the milk samples; I Monnard and E Kratky for technical support; L Sagalowicz for microscopic evaluation of milk samples; C Hager for statistical support; L Fay and A Pellagrino for analysis of sterols in milks; JC Maire for serving as Study Monitor; B Decarli for assistance with food restrictions; J Hau and A Constable for assistance with safety evaluations, A Malnöe for scientific advice on fatty acid profile of OMEGA PLUS; and O Ballèvre, P Van Bladderen, A Pfeifer, Z Kratky, E Fern, and the Nestlé Dairy Strategic Business Unit, for their support of the project. Fat-soluble vitamins were measured by AS Vitas, University of Oslo.

From the CCBR, we thank J Dollerup for assistance in preparing the study protocol, and everyone working in the clinic and the laboratory for their cooperation in conducting the study. We also thank H Haagensen for helping with deliverance of the milk to the participants, and all the volunteers who helped us by completing the study.

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  1. A Berger

    Present address: Group Leader Analytical Biochemistry, Paradigm Genetics, 108 Alexander Drive, P.O. Box 14528, Research Triangle Park, North Carolina, 27709-4528, USA

Authors and Affiliations

  1. Centre of Clinical and Basic Research, Ballerup Byvej, Ballerup, Denmark

    A B Thomsen, H B Hansen & C Christiansen

  2. Nestlé Research Centre, Vers-chez-les-Blanc, Lausanne, Switzerland

    H Green & A Berger

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  1. A B Thomsen
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  2. H B Hansen
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Contributions

Guarantor: C Christiansen.

Contributors: ABT was responsible for planning of the study logistics, conducting the study, data collection and interpretation, data analysis and writing of the manuscript. HBH was responsible for data management and the statistical analysis of the data. CC was responsible for all formalities, and contributed to statistical analysis and writing of the manuscript. HG assisted in coordinating the activities of the different groups involved and contributed to writing of the manuscript. AB was responsible for the study protocol and design, development of the study product and contributed to writing of the manuscript.

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Correspondence to A B Thomsen.

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Thomsen, A., Hansen, H., Christiansen, C. et al. Effect of free plant sterols in low-fat milk on serum lipid profile in hypercholesterolemic subjects. Eur J Clin Nutr 58, 860–870 (2004). https://doi.org/10.1038/sj.ejcn.1601887

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