Volume 91, Issue 3, March (2004), pp. 393-401 © The Author 2004
doi:10.1079/BJN20031074

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Isolated soya protein with standardised levels of isoflavones, cotyledon soya fibres and soya phospholipids improves plasma lipids in hypercholesterolaemia: a double-blind, placebo-controlled trial of a yoghurt formulation

Pekka Puska¹, Vesa Korpelainen², Lars H. Høie³, Eva Skovlund⁴, Knut T. Smerud^5
1National Public Health Institute, Mannerheimintie 166, FIN-00300 , Helsinki, Finland
²North Karelia Project, Joensuu, Finland
³Nutri Pharma A/S, Copenhagen, Denmark
⁴Section of Medical Statistics, University of Oslo, Oslo, Norway
⁵Smerud Medical Research International AS, Oslo, Norway

 (Received 17 April 2003–Revised 23 October 2003–Accepted 12 November 2003)

The objective was to study whether a yoghurt containing isolated soya protein with standardised levels of isoflavones, cotyledon soya fibres and soya phospholipids is more effective in lowering total and LDL-cholesterol than a placebo. One hundred and forty-three subjects were randomised to the soya group (n 69) or to the placebo (n 74). The mean baseline levels were 7·6 and 5·1 mmol/l for total and LDL-cholesterol, respectively. Fasting serum lipoproteins were assessed five times during the 8-week intervention period, and 4 weeks thereafter. The results were analysed by a mixed model for unbalanced repeated measurements. During the intervention, there were highly significant differences in lipid-lowering effect in favour of the active soya intervention group compared with the control group. The significant differences were for total cholesterol (estimated mean difference 0·40 mmol/l; P<0·001), LDL-cholesterol (0·39 mmol/l; P<0·001), non-HDL-cholesterol (0·40 mmol/l; P<0·001) and for the total:HDL-cholesterol ratio (0·23; P=0·005). There was no difference in the effects on HDL-cholesterol, triacylglycerols or homocysteine. The lipid-lowering effect occurred within 1–2 weeks of intervention, and was not due to weight loss. The safety profile for active soya was similar to the placebo group, except for gastrointestinal symptoms, which caused a significantly higher dropout rate (fourteen v. three subjects) among the subjects taking active soya.

Keywords:
Soya protein Fibre Isoflavones Phospholipids Hypercholesterolaemia