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Phytosterol capsules and serum cholesterol in hypercholesterolemia: A randomized controlled trial

  • Author Footnotes
    1 During the practical implementation of this study Inger Ottestad and Marianne H. Wennersberg were employed at Lipid Clinic, Rikshospitalet, Oslo-University Hospital, Norway.
    Inger Ottestad
    Footnotes
    1 During the practical implementation of this study Inger Ottestad and Marianne H. Wennersberg were employed at Lipid Clinic, Rikshospitalet, Oslo-University Hospital, Norway.
    Affiliations
    Faculty of Health, Nutrition and Management, Akershus University College, P.O. Box 423, 2001 Lillestrøm, Norway

    Department of Nutrition, Institute for Basic Medical Sciences, University of Oslo, P.O. Box 1110, Blindern, 0317 Oslo, Norway
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  • Leiv Ose
    Correspondence
    Corresponding author. Tel.: +47 23075614.
    Affiliations
    Lipid Clinic, Oslo University Hospital, Rikshospitalet, 0027 Oslo, Norway
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  • Author Footnotes
    1 During the practical implementation of this study Inger Ottestad and Marianne H. Wennersberg were employed at Lipid Clinic, Rikshospitalet, Oslo-University Hospital, Norway.
    Marianne H. Wennersberg
    Footnotes
    1 During the practical implementation of this study Inger Ottestad and Marianne H. Wennersberg were employed at Lipid Clinic, Rikshospitalet, Oslo-University Hospital, Norway.
    Affiliations
    Haugesund Hospital of Helse Fonna, Postboks 2170, 5504 Haugesund, Norway
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  • Author Footnotes
    3 Research Manager at Mills DA, Norway whose product was used in this study.
    Linda Granlund
    Footnotes
    3 Research Manager at Mills DA, Norway whose product was used in this study.
    Affiliations
    Mills DA, Sofienberggt 19, P.O. Box 4644, 0506 Oslo, Norway
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  • Author Footnotes
    2 Bente Kirkhus was employed at Mills DA, Norway.
    ,
    Author Footnotes
    4 Worked as Research Manager at Mills DA at the time the project was conducted.
    Bente Kirkhus
    Footnotes
    2 Bente Kirkhus was employed at Mills DA, Norway.
    4 Worked as Research Manager at Mills DA at the time the project was conducted.
    Affiliations
    Nofima Mat, Norwegian Institute of Food, Fisheries and Aquaculture Research, Osloveien 1, 1430 Ås, Norway
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  • Kjetil Retterstøl
    Affiliations
    Lipid Clinic, Oslo University Hospital, Rikshospitalet, 0027 Oslo, Norway

    Department of Nutrition, Institute for Basic Medical Sciences, University of Oslo, P.O. Box 1110, Blindern, 0317 Oslo, Norway
    Search for articles by this author
  • Author Footnotes
    1 During the practical implementation of this study Inger Ottestad and Marianne H. Wennersberg were employed at Lipid Clinic, Rikshospitalet, Oslo-University Hospital, Norway.
    2 Bente Kirkhus was employed at Mills DA, Norway.
    3 Research Manager at Mills DA, Norway whose product was used in this study.
    4 Worked as Research Manager at Mills DA at the time the project was conducted.

      Highlights

      • We investigated the effect from intake of phytosterol capsules on LDL-cholesterol.
      • We conducted a double-blinded randomized controlled trial with 2.0 g phytosterols/d.
      • Subjects with mild to moderate hypercholesterolemia were included.
      • Phytosterol capsules had no significant effect on LDL-cholesterol after four weeks.

      Abstract

      Objective

      Phytosterols are recommended in combination with diet therapy to reduce elevated LDL-cholesterol level. Meta-analyses indicate a 10% reduction in LDL-cholesterol from intake of approximately 2 g phytosterols/d incorporated into fat-based foods. However, the cholesterol lowering effect from capsules containing phytosterols is less documented. The pre-specified primary endpoint of the present study was to investigate the effect of capsules with phytosterols on circulating LDL-cholesterol in patients with mild to moderate hypercholesterolemia.

      Methods

      In a double-blinded, randomized, placebo-controlled crossover study, 41 men and women were randomized into two four-weeks intervention periods with softgel capsules containing either phytosterols (2.0 g/d) or sunflower oil. There was a three-weeks washout period between the intervention periods.

      Results

      No significant difference in total- or LDL-cholesterol between the phytosterol and the placebo period were observed after four weeks intervention (0.0 mmol/L (95%CI: −0.3 to 0.2), P = 0.74 and −0.1 mmol/L (95%CI: −0.3 to 0.1), P = 0.32, respectively).

      Conclusion

      Daily intake of capsules containing 2 g phytosterols did not reduce total- or LDL-cholesterol significantly in a highly relevant target group for the use of phytosterol products. The present results may emphasize the importance of choosing a suitable dosage-delivery system in order to achieve optimal cholesterol lowering effect.
      The study was registered at www.clinicaltrials.gov, IDno:NCT00485095.

      Keywords

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