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Soy in hypercholesterolaemia: a double-blind, placebo-controlled trial

European Journal of Clinical Nutrition volume 56, pages 352–357 (2002)Cite this article

Abstract

Objective: To study whether Abacor®, a product based on isolated soy protein with high and standardised levels of isoflavones and cotyledon soy fibres, was more effective in lowering total and LDL cholesterol than placebo.

Design: Randomised, placebo-controlled, double-blind, parallel group, single centre study.

Setting: Primary care in Joensuu, North Karelia, Finland.

Subjects: Subjects were screened from the patient database of the health centre; 30 were randomised to the Abacor® group and 30 subjects to placebo. Eight subjects were withdrawn, six from the active group, two from the placebo group.

Intervention: The preparations were given as two daily liquid supplements in addition to the subjects' regular diets for 6 weeks.

Results: Abacor® showed a statistically significant lipid-lowering effect as compared to placebo, although an unexpected reduction was seen in the placebo group. The estimated difference between active treatment and placebo was 0.25 mmol/l (95% CI 0.01, 0.50; P=0.049) for total cholesterol, corresponding to reductions of 8.3 and 5.1%, respectively. The difference in reduction of LDL-cholesterol was 0.27 mmol/l (95% CI 0.06, 0.49; P=0.014) and corresponded to a reduction of 13.2% in the active treatment group, and 8.0% in the placebo group. Abacor® showed a rapid onset of effect, as compared with placebo. During a wash-out period of 4 weeks after treatment, the subjects returned to pre-treatment cholesterol levels.

Conclusion: Added to a regular diet, Abacor® significantly reduced LDL-cholesterol and total cholesterol. These beneficial effects occurred within 6 weeks of treatment.

Sponsorship: Commercial organisation.

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Acknowledgements

We would like to acknowledge the dedicated assistance by Liisa Purmonen (study nurse), Arne Husebø (data management), Bo Dinesen, Nils Ove Hoem and Ron Budhram (comments on the manuscript). The study nutrients were provided by Contract Foods Ltd, Birmingham, UK. Nutri Pharma A/S supported the study financially.

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Author notes

  1. KT Smerud: Guarantor: K Smerud.

  2. P Puska, V Korpelainen, LH Høie, E Skovlund, T Lahti and KT Smerud: Contributors: PP provided clinical input to study protocol and analysis; VK contributed practical organization of the trial at the North Karelia Project field office in Joensuu, Finland; LHH provided product composition and background product information; ES was responsible for design and statistical analysis; TL monitored the study according to ICH guidelines for GCP; KS held overall responsibility for project management and quality control.

Authors and Affiliations

  1. North Karelia Project, National Public Health Institute, Helsinki, Finland

    P Puska & V Korpelainen

  2. Nutri Pharma A/S, Copenhagen, Denmark

    LH Høie

  3. Section of Medical Statistics, University of Oslo, Oslo, Norway

    E Skovlund

  4. Smerud Medical Research International AS, Oslo, Norway

    T Lahti & KT Smerud

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  1. P Puska
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Correspondence to P Puska.

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Puska, P., Korpelainen, V., Høie, L. et al. Soy in hypercholesterolaemia: a double-blind, placebo-controlled trial. Eur J Clin Nutr 56, 352–357 (2002). https://doi.org/10.1038/sj.ejcn.1601340

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