Original Article

European Journal of Clinical Nutrition (2006) 60, 633–642. doi:10.1038/sj.ejcn.1602362; published online 11 January 2006

Safety aspects and cholesterol-lowering efficacy of low fat dairy products containing plant sterols

Guarantor: R Korpela.

Contributors: RK helped in the initiation of the study and writing of the manuscript, JT was responsible for the study design, supervision of the clinical study in all four areas and the writing of the manuscript, PH for coordinating the clinical study, the statistical analysis and the writing of the manuscript, LS assisted in the writing of the manuscript, VP and PS-V performed fat-soluble vitamin analysis, JT performed sterol analysis, CL-A, MK and TO performed 25(OH) vitamin D analysis, JS and SV performed cholesterol analysis, and MJT was responsible for the safety aspects, the LDL oxidation analysis and the writing of the manuscript.

R Korpela1,2, J Tuomilehto3,7, P Högström3, L Seppo1, V Piironen4, P Salo-Väänänen4, J Toivo5,8, C Lamberg-Allardt4, M Kärkkäinen4, T Outila4, J Sundvall3, S Vilkkilä3 and M J Tikkanen6

  1. 1Foundation for Nutrition Research, Helsinki, Finland
  2. 2Institute of Biomedicine, Pharmacology, University of Helsinki, Helsinki, Finland
  3. 3Departments of Epidemiology and Health Promotion, Health and Functional Capacity, National Public Health Institute, Helsinki, Finland
  4. 4Department of Applied Food Chemistry and Microbiology, University of Helsinki, Helsinki, Finland
  5. 5Department of Applied Food Chemistry and Microbiology, University of Helsinki, Helsinki, Finland
  6. 6Division of Cardiology, Department of Medicine, Helsinki University Central Hospital, Helsinki, Finland
  7. 7Department of Public Health, University of Helsinki, Helsinki, Finland

Correspondence: Assistant Professor R Korpela, Institute of Biomedicine, Pharmacology, PO Box 63, FIN-00014 University of Helsinki, Helsinki, Finland. E-mail: riitta.korpela@valio.fi

8Present address: National Technology Agency of Finland.

Received 30 December 2004; Revised 6 October 2005; Accepted 24 October 2005; Published online 11 January 2006.

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Abstract

Objective:

 

The aim of this study was to investigate whether a plant sterol mixture would reduce serum cholesterol when added to low fat dairy products in subjects with hypercholesterolaemia, and to examine the effects of the mixture on the serum plant sterol and fat-soluble vitamin levels.

Design:

 

A parallel, double-blind study.

Setting:

 

The study was performed in three different locations in Finland.

Subjects:

 

In total, 164 mildly or moderately hypercholesterolaemic subjects participated in the study.

Methods:

 

The subjects were randomly divided into two groups: a plant sterol group and a control group. The subjects consumed the products for 6 weeks after a 3-week run-in period. The targeted plant sterol intake was 2 g/day in the sterol group.

Results:

 

During the treatment period, there was a 6.5% reduction in serum total cholesterol in the sterol group while no change was observed in the control group (P<0.0005). Serum low-density lipoprotein (LDL) cholesterol was reduced by 10.4% in the sterol group and by 0.6% in the control group (P<0.00005). There was no change during the trial in serum high-density lipoprotein (HDL) cholesterol or triacylglycerol concentrations. The HDL/LDL cholesterol ratio increased by 16.1% in the sterol group and by 4.3% in the control group (P=0.0001). Serum plant sterol levels increased significantly (P=0.0001) in the sterol group. None of the fat-soluble vitamin levels decreased significantly when changes in serum total cholesterol were taken into account. The hypocholesterolaemic effect of sterol administration was not influenced by apolipoprotein E phenotype.

Conclusions:

 

Yoghurt, low-fat hard cheese and low-fat fresh cheese enriched with a plant sterol mixture reduced serum cholesterol in hypercholesterolaemic subjects and no adverse effects were noted in the dietary control of hypercholesterolaemia.

Keywords:

cholesterol, LDL cholesterol, hypercholesterolaemia, plant sterols, dairy products, controlled trial

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