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The effects of soy protein (35% of protein energy) given as a beverage and those of cow-milk proteins were investigated on plasma lipoprotein concentrations in children with familial hypercholesterolemia (FH). Subjects were randomly assigned to either the soy-protein or cow-milk-protein experimental period, with subsequent crossover after a washout period, each period lasting 4 wk. Diets were planned to provide 20% energy as protein, 28% as fat (polyunsaturated:monounsaturated:saturated fatty acids, 1:3:3) and less than 200 mg cholesterol/d. No changes were observed in either plasma cholesterol, low-density-lipoprotein cholesterol, or apolipoprotein concentrations. However, the soy beverage significantly reduced the concentrations of triglyceride and very-low-density-lipoprotein cholesterol (P less than 0.05) and significantly increased the concentrations of high-density-lipoprotein cholesterol (HDL-C) and HDL3-C (P less than 0.04 and P less than 0.03, respectively). These results indicate that the administration of soy protein may induce clinically beneficial effects in children with FH.