Clinical trials have shown that soya protein reduces the concentrations of some atherogenic lipids in subjects with normal renal function. The present study examined the effects of soya protein on serum lipid concentrations and lipoprotein metabolism in patients on hypercholesterolaemic haemodialysis. Twenty-six hypercholesterolaemic (total cholesterol > or =6.21 mmol/l) patients on haemodialysis were studied in a randomized, double-blind, placebo-controlled clinical trial. After a 4-week run-in phase, the subjects were randomly assigned to two groups. Isolated soya protein or milk protein 30 g was consumed daily as a beverage at breakfast or post-dialysis for 12 weeks. Soya protein substitution resulted in significant reductions in total cholesterol (17.2 (sd 8.9 )%), LDL-cholesterol (15.3 (sd 12.5 )%), apo B (14.6 (sd 12.1 )%) and insulin (23.8 (sd 18.7) %) concentrations. There were no significant changes in HDL-cholesterol or apo A-I. These results indicate that replacing part of the daily protein intake with soya protein has a beneficial effect on atherogenic lipids and favourably affects lipoprotein metabolism in hypercholesterolaemic patients undergoing haemodialysis.